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Veterinary Drug Stability Report

This document summarizes stability testing results for Sulphaquinoxaline sodium powder stored at different conditions over multiple time periods. The powder was tested for organoleptic properties, pH, microbial counts, pathogenic organisms, and assay percentage. The results showed the product remained stable physically and chemically when stored at 30°C ± 2 and 65% RH ± 5 for four years, and at 40°C ± 2 and 75% RH ± 5 for six months.

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عبدالعزيز بدر
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57 views2 pages

Veterinary Drug Stability Report

This document summarizes stability testing results for Sulphaquinoxaline sodium powder stored at different conditions over multiple time periods. The powder was tested for organoleptic properties, pH, microbial counts, pathogenic organisms, and assay percentage. The results showed the product remained stable physically and chemically when stored at 30°C ± 2 and 65% RH ± 5 for four years, and at 40°C ± 2 and 75% RH ± 5 for six months.

Uploaded by

عبدالعزيز بدر
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

----------- Company

Research & Control Sector


Stability Department
Stability Report
Product : Sulphaquinoxaline sodium powder 100 % for vet. Package : Bottles of 250 gm, 500 gm, 1 kgm
Date : 18-11-2008
B. No. : 211069777777 Man. Date : 11 - 02 Validity : Four years
Storage condition : At 30 ºC ± 2 and 65 % R.H ± 5 for four years . Exp. Date : 11 - 06
Items Specifications Initial 2/03 5/03 8/03 11/03 11/04 11/05 11/06
11/02
Organoleptic properties

Description Yellowish white powder …...… …..…… yellowish white powder ……..… ……..… ….…….

PH of 10 % w/v solution 10 – 11 11 11 10.9 10.9 10.8 10.7 10.7 10.7

Identification test of
Sulphadimidine sodium Positive Positive ………. ………. Positive ……….. ……… Positive ……….

Assay :

% of Sulphaquinoxaline 90 % - 110 % 105 % 104.2 % 104 % 103 % 102 % 100.9 % 100 % 99.3 %
sodium
≯1000 cfu/gm for bacteria,
110cfu/g ……… …..…… ………… ……. ….. …. Conform
Microbial count ≯100 cfu/gm for fungi 31 cfu/g ………. …..…… ……..… ……….. ……… ……….. Conform
.. …..… …..
Free from pathogenic Free ………. ……….. ……..… Free
Pathogenic organisms organisms ………. ……….. ……….

Comments : The product remains stable physically and chemically when stored at 30 ºC ± 2 and 65 % R.H ± 5 for Four years .
Chief Department : Chief Sector :
-------- Drug Company
Research & Control Sector
Stability Department
Stability Report
Product : Sulphaquinoxaline sodium powder 100 % for vet. Package : Bottles of 250 gm, 500 gm, 1 kgm
Date : 18-11-2008
B. No. : 211069777777 Man. Date : 11 - 02 Validity : Four years
Storage condition : At 40 ºC ± 2 and 75 % R.H ± 5 for six months . Exp. Date : 11 - 06
Items Specifications Initial 12/02 1/03 2/03 3/03 4/03 5/03
11/02
Organoleptic properties

Description Yellowish white powder ……...… …..…… yellowish white powder ……..… ….…….

PH of 10 % w/v solution 10 – 11 11 11 10.7 10.7 10.6 10.6 10.5

Identification test of
Sulphaquinoxaline sodium Positive Positive ………. ………. Positive ……….. …….… ……….

Assay :

% of Sulphaquinoxaline 90 % - 110 % 105 % 105 % 103.9 % 103.1 % 101.8 % 99.9 % 99 %


sodium
≯1000 cfu/gm for bacteria,
110cfu/g ……… ……… ………… …. …. Conform
≯100 cfu/gm for fungi 31 cfu/g ……. ……… ……… ……….. ……….. Conform
Microbial count
….... ……
Free from pathogenic organisms Free ………. ……….. ……… Free
Pathogenic organisms ………. ………..

Comments : The product remains stable physically and chemically when stored at 40 ºC ± 2 and 75 % R.H ± 5 for six months.
Chief Department : Chief Sector :

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