Oxyclozanide Vet BP 85: Certificate of Analysis

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Email: siflon_drugs@rediffmail.com
CERTIFICATE OF ANALYSIS
Name of the Product: OXYCLOZANIDE VET BP 85
Batch No: OX2780121 Analytical Report No: AR/FP/OXY/21278
Batch Size: 800Kgs Date of Release: 21/01/21
Date of Manufacture: JAN,2021

Dispatch Quantity: 800 Kgs
Date of Expiry: DEC,2025

No. of containers 16
B.No. Test Specification Result
1 Appearance A pale cream or cream colored powder. Cream colored powder
Very Slightly Soluble in water, freely soluble in

Very Slightly soluble in water, Freely soluble in acetone,
2 Solubility acetone, Soluble in ethanol (96%), Slightly soluble
soluble in ethanol (96%) Slightly soluble in Chloroform.
in Chloroform
Identification
The infrared absorption spectrum of sample should be

a)By IR Complies
concordant with the spectrum of Oxyclozanide Standard.
3 The light absorption of 0.003% solution of test sample in the

b)By UV range 250-350 nm exhibits absorption maxima at 300 nm about Complies
0.76
c)Melting point About 208°C 208.0°C
Ionisable Chlorine
4 Not More than 0.25 0.14 %
(% w/w)
Related substances by HPLC (%)
5 Before main peak Not more than 0.3 0.19 %
After main peak Not more than 1.0 0.23 %
Loss on drying (% w/w)

6 Not more than 1.0 0.27 %
(at 60°C under vacuum)
7 Sulphated ash (% w/w) Not more than 0.2 0.03%
Assay (% w/w)
8 Between 98.0 and 101.0 99.43 %
(On Dried basis)
Remarks: The material conforms to the specifications as per BP VET
Storage condition: Preserve in well closed container.
Tested by: Checked by: Approved by:
Date: Date: Date:
Plant: Sy. No. 25-4, Rachanapalli (Vill), Ananthapur (Rural), ANANTHAPUR. (A.P) INDIA. Ph. No. 08554270285
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Name of the Product:

OXYCLOZANIDE VET BP 85



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.63 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.75 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Batch Size: 800Kgs Date of Release:

22/01/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.55 %
(On Dried basis)
Date: Date: Date:
Dispatch Quantity: 800 Kgs Date of Manufacture: JAN,2021
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,


in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.40 %
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.47 %
(On Dried basis)
Date: Date: Date:


2 Solubility Very Slightly soluble in water, Freely soluble in acetone, Very Slightly Soluble in water, freely soluble in
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
acetone, Soluble in ethanol (96%), Slightly soluble

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.70 %
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

a)By IR Complies
The light absorption of 0.003% solution of test sample in the

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.27 %
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE IP VET
Date of Manufacture: FEB,2021

Date of Expiry: JAN,2026


in Chloroform
3 Identification
a)By IR The infrared absorption spectrum of sample should be Complies

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)
After main peak Not more than 1.0 0.33%

6 Not more than 1.0 0.29%
Assay (% w/w)
8 Between 98.0 and 101.0 99.32 %
(On Dried basis)
Remarks: The material conforms to the specifications as per IP VET
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies
3
0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.35 %
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.22 %
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDEIP VET



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.54 %
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.82%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
4 Not More than 0.25 0.14%
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.37%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.28%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.43%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,




in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.55%
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE BP VET
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

7 Moisture content Not more than 0.5 0.14 %
Assay (% w/w)
9 Between 98.0 and 101.0 99.54 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

03/03/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

7 Moisture content Not more than 0.5 0.17 %
Assay (% w/w)
9 Between 98.0 and 101.0 99.26 %
(On Dried basis)
Date: Date: Date:
Date of Manufacture: MAR,2021

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
No. of containers 16 Date of Expiry: FEB,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.33 %
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDEIPVET

Date of Expiry: FEB,2026

Very Slightly soluble in water, Freely soluble in acetone, Very Slightly Soluble in water, freely soluble in
2 Solubility
soluble in ethanol (96%) Slightly soluble in Chloroform. acetone, Soluble in ethanol (96%), Slightly soluble
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.54 %
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE BP VET (MICRONIZED)



in Chloroform
Identification
3
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.26 %
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE VET BP 85 (MICRONIZED)



in Chloroform
Identification

a)By IR Complies
3
0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)
5 Moisture content Not More than 0.5% 0.14%

Assay (% w/w)
9 Between 98.0 and 101.0 99.31 %
(On Dried basis)
10 Particle size 90% < 20µm 90% < 10.0µm
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
4 Ionisable Chlorine Not More than 0.25 0.15%
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.56%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.37%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

8 Assay (% w/w) Between 98.0 and 101.0 99.76%
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.40%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.28%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,




in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.61%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

23/03/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.47%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.24%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.68%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.37%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.68%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

5
Before main peak Not more than 0.3 0.27 %
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.28%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.40%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.40%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.40%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.55%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE IP VET



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.28%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Batch Size: 800 Kgs Date of Release:

30/03/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.58%
(On Dried basis)
Date: Date: Date:
Batch Size: 800 Kgs Date of Release: 30/03/21

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.42%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:



in Chloroform
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.22%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76

Ionisable Chlorine
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.30%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.69%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

8 Assay (% w/w) Between 98.0 and 101.0 99.63%
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.29%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.42%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.30%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE IP VET



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.30%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

07/04/21
Date of Manufacture: APR,2021

Date of Expiry: MAR,2026


in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.30%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
No. of containers 04 Date of Expiry: MAR,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.72%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.46%
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE VET BP 85(MICRONIZED)



in Chloroform
Identification
3 The infrared absorption spectrum of sample should be

a)By IR Complies
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.24%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.78%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

5
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.52%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.31%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.66%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.46%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.24%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE BP VET



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.56%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

14/04/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.61%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
5 Moisture content Not More than 0.50 0.19%

Assay (% w/w)
9 Between 98.0 and 101.0 99.26%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.86%
(On Dried basis)
Date: Date: Date:
Name of the Product: OXYCLOZANIDE BP VET (MICRONIZED)


2 Solubility
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.66%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification
3
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.37%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies
3
0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.44%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.27%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
6 Loss on drying (% w/w) Not more than 1.0 0.26%
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.52%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.26%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.38%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.24%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.53%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,




in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.78%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

30/04/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.36%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:
Date of Manufacture: MAY,2021

Date of Expiry: APR,2026


in Chloroform
3 Identification
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.54%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.68%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.46%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

5
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.52%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.36%
(On Dried basis)
Date: Date: Date:


No. of containers 1

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.54%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.36%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.76%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,




in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.76%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

14/05/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.68%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
No. of containers 16 Date of Expiry: APR,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.47%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.26%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.52%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.33%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.76%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

5
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.57%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.28%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.45%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.54%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.47%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE BP VET



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.34%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

27/05/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.82%
(On Dried basis)
Date: Date: Date:

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
No. of containers 16 Date of Expiry: APR,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.42%
(On Dried basis)
Date: Date: Date:


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.26%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.58%
(On Dried basis)
Date: Date: Date:



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.40%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.63%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

5
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.83%
(On Dried basis)
Date: Date: Date:



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.36%
(On Dried basis)
Date: Date: Date:
31/05/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.16%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:
03/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.22%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
04/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.76%
(On Dried basis)
10 Particle size 90% < 20 µm 90% < 6.92 µm
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE VET BP 85 (MICRONIZED)
04/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.37%
(On Dried basis)
10 Particle size 90% < 20 µm 90% < 7.85 µm
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

03/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.22%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date of Manufacture: JUN,2021

Date of Expiry: MAY,2026


in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.29%
(On Dried basis)
Date: Date: Date:
06/06/21
Dispatch Quantity: 500 Kgs Date of Manufacture: JUN,2021
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date of Expiry:
No. of containers 10 MAY,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.39%
(On Dried basis)
Date: Date: Date:
06/06/21


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.39%
(On Dried basis)
Date: Date: Date:
06/06/21


2 Solubility
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.39%
(On Dried basis)
Date: Date: Date:
23/06/21
Date of Manufacture: JUNE,2021



in Chloroform
3 Identification

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.78%
(On Dried basis)
Date: Date: Date:
23/06/21



in Chloroform
Identification

a)By IR Complies
3
0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.78%
(On Dried basis)
Date: Date: Date:
27/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.27%
(On Dried basis)
Date: Date: Date:
27/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.61%
(On Dried basis)
Date: Date: Date:
27/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
8 Between 98.0 and 101.0 99.83%
(On Dried basis)
Date: Date: Date:
27/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.42%
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:
27/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.52%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
30/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.68%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

OXYCLOZANIDE BP VET
30/06/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.42%
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.31%
(On Dried basis)
Date: Date: Date:
30/06/21
Dispatch Quantity: 800 Kgs Date of Manufacture: JUNE,2021
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date of Expiry:
No. of containers 16 MAY,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.78%
(On Dried basis)
Date: Date: Date:
04/06/21


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.37%
(On Dried basis)
Date: Date: Date:
Batch No: OX2011018 Analytical Report No: AR/FP/OX/18201
25/10/18
Date of Manufacture: OCT,2018

Date of Expiry: SPE,2023

2 Solubility Very Slightly soluble in water, Freely soluble in acetone, Very Slightly Soluble in water, freely soluble in
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
acetone, Soluble in ethanol (96%), Slightly soluble

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
9 Between 98.0 and 101.0 99.37%
(On Dried basis)
Date: Date: Date:
25/10/18

Date of Expiry: SEP,2023


in Chloroform
Identification
3
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

7 Sulphated ash (% w/w) Not more than 0.2 0.06 %
Assay (% w/w)
8 Between 98.0 and 101.0 99.72 %
(On Dried basis)
Date: Date: Date:
05/09/21
Date of Manufacture: SEP,2021

Date of Expiry: AUG,2026


in Chloroform
Identification

a)By IR Complies
3
0.76
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.66 %
(On Dried basis)
Date: Date: Date:
26/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.78 %
(On Dried basis)
Date: Date: Date:
25/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

Assay (% w/w)
8 Between 98.0 and 101.0 99.28 %
(On Dried basis)
Date: Date: Date:
03/10/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
5 Moisture content Not more than 0.50 % 0.12%

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Assay (% w/w)
9 Between 98.0 and 101.0 99.54 %
(On Dried basis)
10 Particle size 90%<20µm 90%<12.298 µm
Date: Date: Date:
04/10/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)
5 Moisture content Not More than 0.50 % 0.14%

8 Assay (% w/w) Between 98.0 and 101.0 99.38 %
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
(On Dried basis)
9 Particle size 90%<20µm 90%<12.298 µm
Date: Date: Date:
17/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.57 %
(On Dried basis)
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: Date: Date:
30/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.56 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
05/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.37 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

30/09/21



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.56 %
(On Dried basis)
Date: Date: Date:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,



in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.71 %
(On Dried basis)
Date: Date: Date:
02/11/21
Dispatch Quantity: 800 Kgs Date of Manufacture: OCT,2021
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date of Expiry:
No. of containers 16 SEP,2026

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.46 %
(On Dried basis)
Date: Date: Date:
02/11/21


Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.81 %
(On Dried basis)
Date: Date: Date:
02/11/21


2 Solubility
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
in Chloroform
Identification

a)By IR Complies

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.27 %
(On Dried basis)
Date: Date: Date:
02/11/21



in Chloroform
Identification
3 The infrared absorption spectrum of sample should be

a)By IR Complies
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,

0.76
Ionisable Chlorine
(% w/w)

Assay (% w/w)
8 Between 98.0 and 101.0 99.51 %
(On Dried basis)
Date: Date: Date:
PRODUCTION QUALITY STATEMENT
This is to ensure that M/s. Siflon Drugs, Sy. No. 25-4, Rachanapalli (V), Anantapuram -515004, Anantapuram District, Andhra Pradesh, India is a WHO
audited & approved manufacturing site strictly following the good manufacturing practices.
We hold the license to manufacture the following list of products:
1. Oxyclozanide – IP/USP/BP
2. Rafoxanide – IP/BP
3. Niclosamide – IP/USP/BP
4. Closantel sodium dihydrate – IP/USP/BP
5. Closantel base – In-house
6. Triclabendazole – IP/USP/BP
7. Clorsulon - USP
8. Albendazole – IP/USP/BP
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
9. Fenbendazole – IP/USP/BP
10. Praziquantel – IP/USP/BP
11. Butaphosphan
For Siflon Drugs
Authorized signatory
PRODUCTION QUALITY STATEMENT
As per the reports sent by Vetpharma, the results are slightly out of specification i.e., 102.5 %
(Assay by potentiometry should be in the range of 98.5 – 101.5 %) for Closantel sodium
dihydrate (Batch No.: CLS0470921). In general, the acceptance limit of relative standard
deviation is NMT 2%. Based on this, the RSD for the obtained results has been calculated
(calculation is presented below) and found to be RSD 1.4 % which is well below the 2 %
limit. From the RSD value, although the material is slightly out of specification but well
within the standard acceptance RSD. we request the end user to consume the material for
their production as the assay values depend on several parameters like man, machine,
material which could lead to marginally higher or lower values.
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
For Siflon Drugs
Letter of Commitment
Concerning the product quality of Oxyclozanide BP Vet
Manufactured by: Siflon Drugs (Sy. No.; 25-4, Rachanapalli (V), Anantapuram – 515004, Andhra Pradesh, INDIA)
For the Company: CEVA HAYVAN SAĞLIĞI A.Ş.
Eski Büyükdere Cad. No.9, Iz Plaza Giz Kat. 21-20 - Maslak, 34398 Sarıyer/İstanbul, Turkey
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
We hereby confirm, that we will inform CEVA HAYVAN SAĞLIĞI A.S., about all major changes in the manufacturing process of the
active ingredient that may have influence on its quality and stability, and will also inform about any major changes made in the
specification.
For Siflon Drugs
Authorized Signatory
Manufacturer Name: SIFLON DRUGS

Sy. No. 25-4, Rachanapalli (V),
Anantapuram – 515004, Andhra Pradesh (INDIA)

Tel.: +91-8554-270285
Fax: +91-8554-270286
E-mail: siflon_drugs@rediffmail.com
Addressed to:
REPUBLIC OF TURKEY
MINISTRY OF AGRICULTURE & FORESTRY

General Directorate of Food and Control
Eskisehir Yolu 9.Km. 06060

Lodumlu I ANKARA TURKEY
01-04-2022
LETTER OF ACCESS
Active Substance Name: OXYCLOZANIDE BP Vet
Active Substance Master File No.:
Manufacturing Site: Siflon Drugs, Anantapuram Unit
Active Substance Master File Holder: Mr. R. Ananthaiah, Managing Director, Siflon Drugs.
The aforementioned Active Substance Master File holder hereby authorizes REPUBLIC OF TURKEY MINISTRY OF FOOD AGRICULTURE
AND FORESTRY General Directorate of Food and Control Eskischir Yolu 9.Km., Lodumlu / ANKARA TURKEY to refer to and review the above-
mentioned Active Substance Master File Marketing Authorization Application(s) submitted by CEVA HAYVAN SAĞLIĞIA.Ş. on
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Name of the product:
Applicant Name & Address:
The aforementioned Active Substance Master File holder commits to ensure batch to batch
consistency and inform CEVA HAYVAN SAĞLIĞIA.Ş. and REPUBLIC OF TURKEY MINISTRY OF FOOD AGRICULTURE AND
FORESTRY General Directorate of Food and Control Eskisehir Yolu 9.Km., Loclumlu / ANKARA TURKEY of any change in the Active Substance
Master File.
Signature for the Active Substance master file holder
CESP REGISTRATION
Company Director Name: Mr. R. Ananthaiah
Contact Email: rswethasr26@gmail.com
Contact Telephone Number: +91 9346856491
Company Registration number or VAT No: 067606
Company Administrator First Name: Dr BHARATH
Company Administrator Last Name: KUMAR
Company Administrator Email: kurubabharath@gmail.com
Organization Name: SIFLON DRUGS
Registration Date: 20/06/2022
Registration ID: 9253
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
For Siflon Drugs
(R. Ananthaiah, Managing Director)
To
Republic Of Türkiye
Ministry Of Agriculture And Forestry
Eskisehir Road 9th Km Lodumlu /ANKARA
LETTER OF ACCESS
Date: 31 March 2023
Version of Active Substance Master File: Siflon/DMF/Oxyclozanide/AP/00/October, 2018
Name of Active Substance: Oxyclozanide
Internal API Code (if applicable): OXY
Active Substance Master File holder: Siflon Drugs
Sy. No. 25/4, Rachanapalli Village, Anantapur, Anantapur District-515 004, Andhra Pradesh State, India
The aforementioned Active Substance Master File holder hereby authorises the Ministry of Agriculture And Forestry, Turkey to refer to and
review the above mentioned Active Substance Master File (Applicant’s part & Restricted part) in support of the registration process of LEVOVAP
(bolus) in Turkiye submitted by VETERINARY AND AGRICULTURAL PRODUCTS MAN. CO. LTD SHEMISANI.
Marketing Authorisation holder: VETERINARY AND AGRICULTURAL PRODUCTS MAN. CO. LTD, SHEMISANI, PRINCE SHAKER BIN
ZAID STREET /BUILDING NO (12) P.O.BOX : 17058, AMMAN - 11195 - JORDAN
The aforementioned Active Substance Master File holder commits to ensure batch to batch consistency and to inform VAPCO Ltd and Competent
Authority of any change in the Active Substance Master File.
For Siflon Drugs
Dr K. BHARATH KUMAR
Signature:
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Siflon Drugs, Sy. No. 25-4, Rachanapalli (V),
Anantapur (District), Andhra Pradesh, India.
To
RWANDA FOOD AND DRUG AUTHORITY (FDA)
P.O BOX 1948 KIGALI.
LETTER OF ACCESS
Date: 31 March 2023
Version of Active Substance Master File: Siflon/DMF/Oxyclozanide/AP/00/October, 2018

Sy. No. 25/4, Rachanapalli Village, Anantapur, Anantapur District-515 004, Andhra Pradesh State, India
The aforementioned Active Substance Master File holder hereby authorises the Health authority of Rwanda to refer to and review the above
mentioned Active Substance Master File (Applicant’s part & Restricted part) in support of the registration process of Levozan (suspension) in
Rwanda submitted by VETERINARY AND AGRICULTURAL PRODUCTS MAN. CO. LTD SHEMISANI.
Marketing Authorisation holder: VETERINARY AND AGRICULTURAL PRODUCTS MAN. CO. LTD, SHEMISANI, PRINCE SHAKER BIN
ZAID STREET /BUILDING NO (12) P.O. BOX: 17058, AMMAN - 11195 - JORDAN
The aforementioned Active Substance Master File holder commits to ensure batch to batch consistency and to inform VAPCO Ltd and Competent
Authority of any change in the Active Substance Master File.
For Siflon Drugs
Dr K. BHARATH KUMAR
Signature:
Siflon Drugs
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
CAPA report
Complaint: Appearance of black particles in the Oxyclozanide API (B. No.:

OX3451221)
Explanation: we understand that the black particle is a carbon particle used during the
filtration, their seepage has not been detected since the last incident. We conclude that
the usage of candi-filters for more than one time might have created pressure and
thereby allowing it to seep.
Corrective & Preventive action: Replacement of candi-filters with a new one after
every batch.
Risk assessment: Zero impact on the API or further processed final product.
For Siflon Drugs
TO WHOMSOEVER IT MAY CONCERN
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Analysis report for the water sample analysed at Siflon Drugs, Sy. No. 25-4,
Rachanapalli (V), Anantapuram unit; for various parameters is as below:
Type of water. Parameter Result

pH 7.51
Bore water TDS 650 ppm
Hardness 500 ppm
pH 7.54
Hand Pump TDS 1150 ppm
Conductivity 725 ppm
Sampled on: 15/09/2022
Sampled by:
For Siflon Drugs
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
TO WHOMSOEVER IT MAY CONCERN
Name of Active Substance: Closantel base
Manufacturing Site: Sy. No. 25/4, Rachanapalli Village, Anantapur, Anantapur District-515
004, Andhra Pradesh State, India
 The aforementioned active pharmaceutical ingredient is manufactured at Siflon Drugs
of Anantapur Unit, which is conscientiously adhering to the good manufacturing

practices.
 The aforementioned active pharmaceutical ingredient is micronized at Siflon Drugs,
Anantapur Unit and the particle size is analyzed through an accredited contract
laboratory.
For Siflon Drugs
END USER CERTIFICATE
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
To
Sy No: 488 Bonthapally Temple Road ,Bonthapally

Village ,Gummadidala Mandal Sangareddy
District,Telangana-502313
Dear Sir,
Sub: END-USE CERTIFICATE
With reference to clause 3 (4) of Solvent, Raffinate & Slop (Acquisition, Sale, Storage
and prevention of use in automobiles) order 2000 we certify that the following Materials
purchased from you during the period 01-Jul-2022 to 30-Sep-2022 have been
consumed as raw-materials in our process/production only and not used by us for
adulteration in motor spirit / HSD / SD or any other fuel permitted by the central
Government for use in any automobiles.
Product Name License Nature of Invoice Invoice Quantity

ref. No. End use No. Date. Purchase Consumed Balance
EXXSOL HEXANE FLUID HYBD2333 16.08.2022 2,603.000
d 2603.00 00
We understand the contravention of the Solvent, Raffinate & Slop (Acquisition, Sale, Storage
and Prevention of use in Automobiles) Order 2000 will result in criminal proceedings against
us
Thanking You,
Yours Faithfully
For SIFLON DRUGS
11/11/2022
To
KEPRO BV
Maagdenburgstraat 17
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
7421 ZA Deventer
The Netherlands
Dear Sir/Madam
AUTHORISATION TO ACCESS ACTIVE PHARMACEUTICAL INGREDIENT MASTER

(APIMF)
Reference is made to the above subject matter.
Consent is hereby granted to KEPRO BV to make reference to this company’s Active Pharmaceutical
Ingredient Master File(s) APIMF for [API] (s) OXYCLOZANIDE in the evaluation of the
application relating to the registration of KEPXAN ORAL submitted to KEPRO BV by OFICHEM
The substance is manufactured by: SIFLON DRUGS, Sy. No. 25-4, Rachanapalli (V), Anantapur –
515004, Andhra Pradesh, INDIA.
A copy of the applicant’s part of the APIMF as specified in the APIMF procedure has been supplied
to the applicant of the FPP.
A formal agreement exists between the applicant of the medicine and the manufacturer of the API,
which ensures that information will be communicated between them and KEPRO BV before any
significant change is made to the site of manufacture, manufacturing procedure or quality control
specifications of the API. Except as permitted by KEPRO BV guidelines relating to changes to
medicines, such changes will not be made to the API to be used in the manufacture of the medicine
destined to be distributed in the Netherlands before written approval is granted by KEPRO BV.
I understand that the consequences of failure to obtain approval for changes where approval is
necessary may include de-registration and recall of batches of medicines.
Any questions arising from KEPRO BV’S evaluation of this APIMF should be forwarded to:
Dr K BHARATH KUMAR
Manager – quality, Siflon drugs
Sy. No, 25-4, Rachanapalli (v), Anantapur - 515004
Andhra Pradesh, INDIA
mail: qa@siflondrugs.com
Your Sincerely
[Dr K. BHARATH KUMAR]
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: 05/12/2022
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
GMO Declaration
We, Siflon Drugs, a WHO-GMP certified veterinary API manufacturer,

herewith declare that the manufacturing process of Oxyclozanide API is through
chemical synthesis and no genetically modified organisms or extractions from
such organisms are used at any stage of the synthesis.
For SIFLON DRUGS
CAPA REPORT
Material: CLOSANTEL BASE
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Batch No.: CL0190622

Mfg. date: June 2022
Complaint: pH is not in compliance with the specification (As per spec: pH: 4.5 – 7.0)
Root cause analysis: As per our investigation, the primary reason for the out of specification
of pH (result: 3.4) for the above batch is inadequate water wash. This has happened during
the process of effluent optimization.
Impact & risk assessment: pH has a negligible effect on product quality except for
absorptivity.
CAPA
Corrective action: The material’s pH depends on sufficient water wash. Adequate water
wash will be provided to increase the pH.
Preventive action: Optimization in terms of effluent generation will be carried out on the
R&D scale before bringing it to the plant batches to avoid pH issues.
Conclusion: The material’s purity is more than 99% but failed to reach the spec with respect
to pH. The issue will be resolved to produce a material which complies with the spec for all
parameters.
For SIFLON DRUGS

Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
STATEMENT ON ORIGIN
We, Siflon Drugs, manufacturer of veterinary APIs, located at Sy. No. 25-4,
Rachanapalli (V), Anantapur – 515004, Andhra Pradesh, INDIA; hereby declare
that the Closantel base manufactured at our facility is only through chemical
synthesis and does not involve any kind of biosynthesis at any stage of reaction
process.
For Siflon Drugs

(Dr K. Bharath Kumar, Manager - Quality)
Rwanda Food and Drugs Authority
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
P.O. Box 84 Kigali, Rwanda

28-12-2022
Number of Active Substance Master File:
SIFLON/OX/AP/2011-10-10 (VERSION: 02)

Sy. No. 25-4, Rachanapalli (Vill), Ananthapur (Rural), Ananthapur (A.P.) India
The aforementioned Active Substance Master File holder hereby authorises the Rwanda FDA to
refer to and review the above-mentioned Active Substance Master File in support of the following
Marketing Authorisation Application(s) or Marketing Authorisation Variation(s) submitted by
Interchemie werken “De Adelaar” B.V. on 24 -02-2023.
Interzan Oral
Interzan Gold Oral
Interchemie werken “De Adelaar” B.V.
The aforementioned Active Substance Master File holder commits to ensure batch to batch
consistency and to inform Interchemie werken “De Adelaar” B.V. and Rwanda FDA of any change
in the Active Substance Master File.
The aforementioned Active Substance Master File holder hereby is informed of and accepts that
the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their
experts, and the Certification of Substances Division of the European Directorate for the Quality of
Medicines & Healthcare may share the assessment reports of the above-mentioned Active
Substance Master File amongst themselves.
FOR SIFLON DRUGS
Dr K. BHARATH KUMAR
MANAGER – QC & QA
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Quality statement
Name of the API: Oxyclozanide
The aforementioned active pharmaceutical ingredient is manufactured at Siflon Drugs, Sy.

No. 25-4, Rachanapalli (V), Anantapur, Andhra Pradesh (INDIA), conscientiously adhering
to good manufacturing practices.
As per BP monograph, the aforementioned API’s physical appearance is described as pale
cream or cream coloured powder.
1. The Oxyclozanide API manufactured by Siflon strictly adheres to the BP specification.

Although, the preparation process and the key raw materials will remain constant, slight
colour variation is often inevitable. Albeit the slight variation, each of these batches are in
coherence with the BP. (Even the Siamese twins are not same)
2. We have not received such a complaint from Vapco before. Below are the batch numbers
of the earlier dispatch (12T).
Batch No’s: OX4450322, OX4480322, OX4490322, OX4500322, OX0010422,
OX0020422, OX0030422, OX0040422, OX0050422, OX0060422, OX0070422,
OX0080422, OX0090422, OX0100422, OX0110422.
3. The control samples of the batches sent to Vapco are inspected at our end. As mentioned
in the first point; individually, these samples are in accordance with BP, but slight colour
variation was observed.
4. This colour change is not because of any change in the process or key materials. Since,
the colour is not under the control, even in the pharmacopoeia they have mentioned a
colour range (pale cream or cream) instead of a particular colour.
5. At this stage, nothing can be done with the physical appearance of the final product. Any
change shall be validated, stability has to be initiated and shall be communicated to
regulatory.
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Since the physical appearance does not affect the quality of the final product and in
general the packing material for veterinary suspensions is white coloured HDPE bottles,
slight change in the physical appearance will not have much impact. If they have different
percentages of suspension like 5% & 10%, uniformity in terms of colour could be
achieved based on the colour of the API.
We deeply regret the inconvenience caused to VAPCO and we assure that this won’t
happen again. VAPCO will remain our valuable customer and we are looking forward to
establish strong relationship in terms of business.
For Siflon Drugs

[Dr K. BHARATH KUMAR
MANAGER – QC & QA]
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
TSE/BSE DECLARATION
All the products manufactured at Siflon drugs (Sy. No. 25/4, Rachanapalli (V),
Anantapur – 515004, Andhra Pradesh) are completely from synthetic or manufactured
materials and do not contain any raw materials produced from, or substances derived
from animal origin.
The manufacturing process does not use any ingredient of animal origin nor do our
products come in contact with animal products during storage and transportation. All
products produced by Siflon drugs are free from Transmissible Spongiform
Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE).
We further declare that all the products are also free from toxic substances, growth
promoters and hormones.
For Siflon Drugs
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
LETTER OF ACCESS TO THE APIMF
To
The Director General,
Rwanda FDA
P. O. Box. 84, Kigali
Rwanda
Dear Sir/Madam,
Authorization to access Active Pharmaceutical Ingredient Master File (APIMF)
Consent is hereby granted to Rwanda FDA to make reference to Siflon Drug’s APIMF for
Oxyclozanide submitted to Rwanda FDA by Nerix Pharma Ltd. This consent does/does not
include authorization to supply information or extracts from or the whole of the data to: Nerix
Pharma Ltd. The substance is manufactured by: Siflon Drugs, Sy. No. 25-4, Rachanapalli
(V), Anantapur – 515004 (Andhra Pradesh), INDIA.
A copy of the applicant’s part APIMF as specified in the Rwanda FDA APIMF procedure has
been supplied to the applicant of the VMP – Veterinary Medicinal product.
A formal agreement exists between the applicant of the veterinary medicinal products and the
manufacturer of the API, which ensures that the information will be communicated between
them and to Rwanda FDA before any significant change is made to the site of manufacture,
manufacturing procedure or quality control specifications of the API. Except as permitted by
the Rwanda FDA guidelines relating to changes to veterinary medicinal products, such
changes will not be made to the API to be used in manufacture of the veterinary medicinal
products destined to be distributed in Rwanda before written approval is granted by the
Rwanda FDA.
I understand that the consequences of failure to obtain approval for changes where approval
is necessary may include de-registration and recall of batches of veterinary medicinal
products.
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
This APIMF (or data identical to that contained therein) has also been submitted to and
approved by the regulatory authorities in Turkey & Netherlands; and Rwanda FDA is
authorized to request and refer to the evaluation reports of these agencies.
Rwanda FDA is also authorized to exchange its own evaluation reports with these and other
regulatory authorities.
Any questions arising from Rwanda FDA’s evaluation of this APIMF should be forwarded
to:
Nerix Pharma Ltd.
P.O. Box 27747-00506,
NAIROBI, KENYA.
Yours Sincerely
[Dr K. Bharath Kumar]

Manager – Quality
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: 22.02.2023
ELEMENTAL IMPURITIES DECLARATION
TO WHOM IT MAY CONCERN

(ICH guideline Q3D “Guideline for Elemental Impurities”)
We, Siflon Drugs hereby declare that the Rafoxanide API manufactured at Siflon Drugs, Sy.
No. 25-4, Rachanapalli (V), Anantapur (AP, INDIA) is free from Elemental impurities or
any metal residues.
The manufacturing process does not include any kind of metal catalysts and demineralized
water is used for during the process which is free from metal impurities.
The utensils used during the manufacturing process and packing are also free of Elemental
impurities or any metal residues.
For Siflon Drugs.,
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
To
Rwanda FDA
Rwanda
Dear Sir/Madam,
Rafoxanide submitted to Rwanda FDA by Nerix Pharma Ltd. This consent does/does not
Rwanda FDA.
products.
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
approved by the regulatory authorities in Turkey & Ireland; and Rwanda FDA is authorized
to request and refer to the evaluation reports of these agencies.
to:
Nerix Pharma Ltd.
P.O. Box 27747-00506,
NAIROBI, KENYA.
Yours Sincerely

Manager – Quality
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
To
Rwanda FDA
Rwanda
Dear Sir/Madam,
Fenbendazole submitted to Rwanda FDA by Nerix Pharma Ltd. This consent does/does not
Rwanda FDA.
products.
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
approved by the regulatory authorities in Turkey & Netherlands; and Rwanda FDA is
authorized to request and refer to the evaluation reports of these agencies.
to:
Nerix Pharma Ltd.
P.O. Box 27747-00506,
NAIROBI, KENYA.
Yours Sincerely

Manager – Quality
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
ALLERGEN DECLARATION
To whom it may concern
We, Siflon Drugs, a veterinary pharmaceutical company, located at Sy. No. 25-4,
Rachanapalli (V), Anantapur – 515004, Andhra Pradesh (state), INDIA, is a WHO-GMP
certified unit.
We declare that, we do not use any of the following allergen material or their derivatives
during the synthesis of any of our APIs, at any stage of the manufacturing process.
1. Crustaceans and their products (e.g. prawns, crab, crayfish etc.)

2. Peanuts and peanut products
3. Soybeans and soybean products
4. Tree nuts and tree nut products (e.g. almond, hazelnut, walnut, cashew, pecan, Brazil,
pistachio, macadamia etc).
5. Sesame seeds and sesame seed products
6. Fish and fish products except for isinglass derived from swim bladders and used as a
clarifying agent in beer and wine)
7. Egg and egg products
8. Milk and milk products
9. Gluten and cereals containing gluten (e.g. wheat, rye, oats, barley and spelt)
For Siflon Drugs
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
Date: 27.02.2023
ELEMENTAL IMPURITIES DECLARATION
TO WHOM IT MAY CONCERN
(ICH guideline Q3D “Guideline for Elemental Impurities”)
We, Siflon Drugs, declare that the Rafoxanide API manufactured at our site located at Sy.
No. 25-4, Rachanapalli (V), Anantapur (AP, INDIA) is free from Elemental impurities or
any metal residues.
The manufacturing process does not include any kind of metal catalyst and demineralized
water is used for the work-up procedure.
The Utensils used for manufacturing and packing are also free of Elemental impurities or
metal residues.
For Siflon Drugs.,
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
2-(cyclohexanecarbonyl)-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]
isoquinolin-4-one
Route of Synthesis
For Siflon Drugs.,
Ph no: 0091-8554-270285,
Fax: 0091-8554-270286,
LETTER OF DECLARATION
We, Siflon Drugs, an API manufacturing company hereby declare that if there is any
change (including synthesis method, raw material, specification, test procedure, etc.,)
during the manufacturing process of the product Rafoxanide, we will inform our
clients as soon as possible.
For Siflon Drugs
Dr K. BHARATH KUMAR
Title: Manager – Quality
Signature:

Oxyclozanide Vet BP 85: Certificate of Analysis

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Oxyclozanide Vet BP 85: Certificate of Analysis

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Ph no: 0091-8554-270285,

Name of the Product: OXYCLOZANIDE VET BP 85

Batch No: OX2780121 Analytical Report No: AR/FP/OXY/21278

Batch Size: 800Kgs Date of Release: 21/01/21

Date of Manufacture: JAN,2021

Date of Expiry: DEC,2025

B.No. Test Specification Result

1 Appearance A pale cream or cream colored powder. Cream colored powder

Very Slightly Soluble in water, freely soluble in

The infrared absorption spectrum of sample should be

3 The light absorption of 0.003% solution of test sample in the

c)Melting point About 208°C 208.0°C

Related substances by HPLC (%)

5 Before main peak Not more than 0.3 0.19 %

After main peak Not more than 1.0 0.23 %

Loss on drying (% w/w)

7 Sulphated ash (% w/w) Not more than 0.2 0.03%

Remarks: The material conforms to the specifications as per BP VET

Storage condition: Preserve in well closed container.

Tested by: Checked by: Approved by:

Date: Date: Date:

Name of the Product:

Batch No: OX2790121 Analytical Report No: AR/FP/OXY/21279

Batch Size: 800Kgs Date of Release: 22/01/21

Date of Manufacture: JAN,2021

Date of Expiry: DEC,2025

B.No. Test Specification Result

1 Appearance A pale cream or cream colored powder. Cream colored powder

Very Slightly Soluble in water, freely soluble in

The infrared absorption spectrum of sample should be

3 The light absorption of 0.003% solution of test sample in the

c)Melting point About 208°C 208.0°C

Related substances by HPLC (%)

5 Before main peak Not more than 0.3 0.21 %

After main peak Not more than 1.0 0.22 %

Loss on drying (% w/w)

7 Sulphated ash (% w/w) Not more than 0.2 0.04%

Remarks: The material conforms to the specifications as per BP VET

Storage condition: Preserve in well closed container.

Tested by: Checked by: Approved by:

Date: Date: Date:

Name of the Product: OXYCLOZANIDE VET BP 85

Batch No: OX2800121 Analytical Report No: AR/FP/OXY/21280

Batch Size: 800Kgs Date of Release: 22/01/21

Date of Manufacture: JAN,2021

Date of Expiry: DEC,2025

B.No. Test Specification Result

1 Appearance A pale cream or cream colored powder. Cream colored powder

Very Slightly Soluble in water, freely soluble in

The infrared absorption spectrum of sample should be

3 The light absorption of 0.003% solution of test sample in the

c)Melting point About 208°C 208.0°C

Related substances by HPLC (%)

5 Before main peak Not more than 0.3 0.22 %

After main peak Not more than 1.0 0.29 %

Loss on drying (% w/w)

7 Sulphated ash (% w/w) Not more than 0.2 0.05%

Remarks: The material conforms to the specifications as per BP VET

Storage condition: Preserve in well closed container.

Tested by: Checked by: Approved by:

Date: Date: Date:

Name of the Product: OXYCLOZANIDE VET BP 85