- *-* S £

ACG ASSOCIATED CAPSULES PVT. LTD.

CERTIFICATE OF ANALYSIS

Format No : FT-QAL-05

Material Code : rmgrgbro2
Qty Received : 5,000.000 kg
Qty. Sampled : 1.001 kg
Sampled By : vvj
Manufacturer: RAMA INDUSTRIES LIMITED
Supplied By : RAMA INDUSTRIES LIMITED
Material Name : GELATIN I.P. (RAMA), 210 BLOOM
Date of Sampling : 18.05.2020
Date of Analysis : 23.05.2020
Date Of Report : 23.05.2020
Reassesment Date : 16.05.2021
GR No: 5012828321 GR Date: 16.05.2020

SLNO TEST
1 DESCRIPTION
2 SOLUBILITY IN COLD WATER
3 WATER ABSORPTION & SWELLING
4 SOLUBILITY-HOT WATER
5 SOLUBILITY -6N ACETIC ACID*
6 SOLUBILITY-HOT GLYCERIN&WATER*
7 SOLUBILITY-ALCOHOL
8 SOLUBILITY-ETHER
9 SOLUBILITY-CHLOROFORM
10 SOLUBILITY-VOLATILE OILS*
11 IDENTIFICATION CUS04
12 IDENTIFICATION GELLING PROPERTY
13 APPEARANCE OF SOLUTION
14 PH OF 1% W/V SOL.
15 ARSENIC*
16 HEAVY METALS(NMT 20 PPM)*
17 SULPHUR DIOXIDE
18 ASH
19 LOSS ON DRYING
20 ODOR & WATER INSOLUBLE SUBSTANCES*
21 BLOOM STH OF 6.67% GL.SOL.
22 BLACK PARTICLES*
23 VISCOSITY (6.67 % SOLN)

CERTIFICATE OF ANALYSIS

Lot No : 010000838636

24 % LOSS IN VISCOSITY
25 TRANSMITTANCE (6.67%SOL AT 510NM)
26 PARTICLE SIZE (ABOVE 4 MESH)*
27 PARTICLE SIZE (BETWEEN 4 & 22 MESH)*
28 PARTICLE SIZE (BETWEEN 22&30 MESH)*
29 PARTICLE SIZE (BELOW 30 MESH)*
30 HYDROGEN PEROXIDE
31 KEEPING QUALITY
32 ISOELECTRIC PH
33 CONDUCTIVITY
34 PHENOLIC PRESERVATIVE*
35 GREASE CONTENT*
36 IRON*
37 CHROMIUM*
38 ZINC*
39 MERCURY*
40 NITRATE*
41 TOTAL MICROBIAL COUNT
42 E.COLI
43 SALMONELLA
44 S.AUREUS
45 PSEUDOMONAS
46 SHIGELLA
47 GELLIQUIFYING ORGANISMS
48 THERMOPHILIC SPORES*
49 ANAEROBIC BACTERIA
50 TOTAL YEAST & MOLD COUNT
51 ENTEROBACTERIACEAE
52 COLIFORMS
53 CLOSTRIDIUM
54 BILE TOLERANT GRAM NEGATIVE BACTERIA
55 LEAD*
56 CADMIUM*
* Values taken based on reduced test monitorinq programme.
Disposition : The batch tested conforms to the prescribed release specification. STATUS OF THE MATERIAL

0lcvma S’ndtrtfoiet
---x

WORKS : VILL. CHAUNDHERI,

P.O. DAPPAR, TEH. DERABASSI,

AMBALA-CHANDIGARH HIGHWAY, NEAR LALRU

DISTT. MOHALI-140 506, PUNJAB, INDIA

CIN : U24110MH1987PLC043127
PHONE : 01762-248810-12

Fax : 01762-248761

E-mail : rama.gelatine@ramagroup.co.in

Website : www.ramagelatine.com

Quality Assurance (Department

Certificate of Analysis ( Gelatin I(P)
Customer

M/s ACG Associated Capsules Pvt. Ltd., Shirwal.

Date

11.05.2020

Customer D.O. No.

RIM/HO/90 dt 09.05.2020

Batch No.

B-2545

Quantity

100x 50 kg = 5.000 M.T.

Mfg. Date

May • 2020

Grade

210 + Bloom

Exp. Date

Apr■2025

Report No,

3610

Page
1 of 2

Physical & Chemical Parameters

S. No.

Parameters

Units

Standard

Methods

Specification

Actual Findings

Description

IP

Passes

Passes

Solubility

IP

Passes

Passes

Identification

IP

Passes

Passes

Appearance of Solution

IP

Passes

Passes
pH of 1% solution at 25°C

IP

5.0 to 6.0

5.41

Arsenic

ML

IP

0.1(Max.)

Passes

Lead

ML

IP

0.5(Max.)

Passes

Sulphur Di-Oxide(Titration)

ML

IHS

40(Max.)

64

Residue on ignition

IP

1.0 (Max.)

0.42

10
Loss on drying at105°C

IP

9.0 to 12.5

10.21

11

Odor & water insoluble

substances

IHS

No foreign particle &

disagrreable odor

Passes

12

Bloom strength (6.67%) w/v

solution.

gms

IP

205-230

(Corrected to 11.50%
moisture)_

215

13

Black Particles

IHS

20(Max.)/100g

Passes

Viscosity of 6.37% w/v

solution( at 60°C)
mps

ihb

43 io 47
(Corrected to
11.50%moisture)

46.49

15

Viscosity Drop

IHS

18(Max.)

16.10

16

Transmittance at 510 nm

IHS

82 (Min.)

93.1

17

Particle Size BSS (-4+22)

IHS

90%

Passes
jn Peroxide

peeping quality at 37°C

ML

IHS

10 (Max.)

Absent

IHS

No. foul odor after 72

hrs.

Passes

c pH at 25°C

IHS

4.7 to 5.2

4.96

:ivity 1% Solution at

mS/cm

IHS

1(Max.)

0.336

Corporate Office : 51/52, Free Press House, 215, Nariman Point, Mumbai - 400 021, Maharashtra, India
Ph.: 022-2283-3355/2283-4126 Fax:022-2204-9946 E-mail: rama@ramagroup.co.in
Regd. Office : 812, Raheja Chambers, Nariman Point, Mumbai - 400 021, Maharashtra, India

0lamU' J?nda&tree& ^£cnuied

---- \

WORKS : VILL. CHAUNDHERI,

P.O. DAPPAR, TEH. DERABASSI,

AMBALA-CHANDIGARH HIGHWAY, NEAR LALRU

DISTT. MOHALI-140 506, PUNJAB, INDIA

CIN : U24110MH1987PLC043127

PHONE : 01762-248810-12

Fax : 01762-248761

E-mail : rama.gelatine@ramagroup.co.in

Website : www.ramagelatine.com

QuaCity Assurance (Department

Certificate ofjinaCysis (QeCatin IP)
Customer
Customer D.O. No.
Quantity
Grade
Report No.
Physical & Chemical Parameters
S.No. Parameters
22 Phenolic Preservatives
23 Grease Content
24 Iron
25 Chromium
26 Zinc
27 Mercury
28 Nitrate
29 Cadmium
Microfc iological Parameters
1 Total bacterial counts
2 Presence of E.coli
3 Salmonella
4 Pseudomonas
5 Staphylococcus aurous
6 Gelatin Liquefying Organisms
7 Thermophilic bacteria
8 Coliform organisms
9 Total yeast & Mould
-Enterobacteriaceae
Anaerobic
12 Clostridiun
JL* Shigella

C LRTIF<]

st(Q.C)

Checked By
Manager(Q.C)

*OV(

ed By
Chief Manager(Q.A)

Corporate Office : 51/52, Free Press House, 215, Nariman Point, Mumbai - 400 021, Maharashtra, India
Ph.: 022-2283-3355/2283-4126 Fax : 022-2204-9946 E-mail : rama@ramagroup.co.in
Regd. Office : 812, Raheja Chambers, Nariman Point, Mumbai -400 021, Maharashtra, India
Batch No : 1120114349 Vendor Batch : B-2545
Mfg. Date : 01.05.2020
Exp. Date : 30.04.2025
AR No.: 010000838636
Specific No.: SP-QAL-129(IP+USP+PH.EUR+BS+ACG)
COA of Supplier: Ye>/No

METHOD SPECIFICATIONS
SOPQAL03 Lt amber/ ft yellow granules,charac odor
Insoluble in cold H20 but swells &soften
Should absorb 5-10 times its weight
* Soluble in hot water
Soluble in 6N acetic acid
Soluble in hot mixture of glycerin & H20
Insoluble in alcohol
Insoluble in ether
Insoluble in chloroform
Insoluble in volatile oils
Violet colour is produced
Contents will not immediately flow out
Soln compares with std OS4 & YS4
5.00 - 6.00
NMT O.IOppm
NMT 0.5 ppm
NMT 40.00ppm
NMT 2.00% w/w
9.00% w/w -12.50% w/w
Free from foul/disagreeable odor
197.OOg - 230.OOg
NMT 20.00NO.
40.00MilliPoise -50.00MilliPoise

NMT 18.00%
NLT 82.00%
NMT 0.50% w/w
NLT 95.00% w/w
NMT 5.00% w/w
NMT 1.00% w/w
 NMT 10.00ppm
No turbidity, foul, fishy odor & liquefy
4.70-5.20
NMT 1.00mSiemen/cm
Not detected/q
NMT 0.15% w/w
NMT 30.00ppm
NMT 2.00ppm
NMT 30.00ppm
NMT 0.10ppm
NMT 100.00ppm
NMT 50.00cfu
Absent in 1g
Absent in 10q
Absent in 1g
Absent in 1g
Absent in 10g
NMT 50.00cfu
NMT O.OOcfu
NMT O.OOcfu
NMT 50.00cfu
Absent in 10q
Absent in 10q
Absent in 1g
Absent in 1g
NMT 0.5 ppm
Maximum 0.5 ppm

S OF THE MATERIAL : APPROVED a* _......< ANALYSED BY CHECKED BY APPROVED BY_Y--- Name: s'/O
fvl/s ACG Associated Capsuies Pvt. Lid., Shirwai.
RIM/HO/90 dt 09.05.2020
100x 50 kg = 5.000 M.T.
210 + Bloom
3610
Bacteria
n
RESULTS
GRANULE, LT AMBER TO FT.YELLOW,CHAR ODOR
INSOLUBLE IN COLD H20 BUT SWELLS &SOFTEN
ABSORBS 5-10TIMES ITS WEIGHT
SOLUBLE
SOLUBLE
SOLUBLE
INSOLUBLE
INSOLUBLE
INSOLUBLE
INSOLUBLE
VIOLET COLOUR
CONTENT DO NOT IMMEDIATELY FLOW OUT
COMPLIES
5.40
NMT 0.10 ppm
COMPLIES
9.10 ppm
0.42 % w/w
10.87 % w/w
FREE FROM FOUL/DISAGREEABLE ODOR
210.90 g
NMT 20.00 No.
43.79 MilliPoise

15.58 %
91.96 %
NMT 0.50% w/w
NLT 95.00 % w/w
NMT 5.00 % w/w
NMT 1.00% w/w
 NMT 10.00 ppm
NOTURBIDITY,FOUL/FISHYO DOR.LIQUEFACTN
5.00
0.15 mSiemen/cm
ABSENT
NMT 0.15% w/w
NMT 30.00 ppm
NMT 2.00 ppm
NMT 30.00 ppm
NMT 0.10 ppm
NMT 100.00 ppm
20.00 cfu
ABSENT IN 1 GM
ABSENT IN 10 GMS
ABSENT IN 1 GM
ABSENT IN 1 GM
ABSENT IN 10 GMS
NMT 10.00 cfu
NMT 0.00 cfu
NMT 0.00 cfu
NMT 10.00 cfu
ABSENT IN 10 GMS
ABSENT IN 10 GMS
ABSENT IN 1 GM
ABSENT IN 1 GM
COMPLIES
Complies

Y--- Name: s'/Oc^ Designation: ' Date: -V3 p '

0
ies Pvt. Lid., Shirwai. Date 11.05.2020
Batch No. B-2545
Mfg. Date May - 2020
Exp. Date Apr- 2025
Page 2 of 2

Units Standard MethodsSpecification Actual Findings

- IHS Absent Passes
% BS 757-1975 0.1500 %W/W 0.0614
ppm IHS 30 (Max.) 03
ppm IHS 2 (Max.) Passes
ppm IHS 30 (Max.) Passes
ppm IHS 0.1(Max.) Passes
ppm IHS 100( Max.) Passes
ppm IHS 0.5 (Max.) Passes

1gm IP 50 CFU/gm(Max.) 10
1gm IP Absent Passes
10gms IP Absent Passes
1gm IP Absent Passes
Igm IP Absent Passes
1gm IHS 50 CFU/gm(Max.) Passes
1gm IHS Passes Passes
10gms IHS Absent Passes
1gm Ph.Eur 50 CFU/gm(Max.) Passes
1 gm IHS Absent Passes
10gms IHS Absent Passes
1gm IP Absent Passes
10gms IP Absent . Passes^