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Certificate of Analysis, Quality and Conformity: ... Continued

The Certificate of Analysis for Bismuth Sulphite Agar confirms that the product, manufactured on June 17, 2024, complies with all specified quality tests and parameters. The analysis includes tests on both dehydrated and prepared mediums, showing consistent results in color, pH, gel strength, and clarity. Cultural response tests indicate satisfactory growth for specific organisms, with all observations meeting compliance standards.

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0% found this document useful (0 votes)
53 views2 pages

Certificate of Analysis, Quality and Conformity: ... Continued

The Certificate of Analysis for Bismuth Sulphite Agar confirms that the product, manufactured on June 17, 2024, complies with all specified quality tests and parameters. The analysis includes tests on both dehydrated and prepared mediums, showing consistent results in color, pH, gel strength, and clarity. Cultural response tests indicate satisfactory growth for specific organisms, with all observations meeting compliance standards.

Uploaded by

shaine premkumar
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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CERTIFICATE OF ANALYSIS, QUALITY AND CONFORMITY

Product Name : Bismuth Sulphite Agar Mfg. Date 17-6-2024

Product Code : DM039 Expiry Date 16-6-2029

Lot Number : 02580624 Release Date 26-6-2024

Analytical Report Number : QAD/AR-24/06-0423 Page No Page 1

DEHYDRATED MEDIUM
TESTS CONDUCTED SPECIFICATIONS OBSERVATIONS REMARKS
Color Light yellow to greenish yellow Colored greenish Colored powder Complies
powder
Consistency Homogenous, free flowing powder Homogenous, free flowing powder Complies
PREPARED MEDIUM
TESTS CONDUCTED SPECIFICATIONS OBSERVATIONS REMARKS
Color of Medium Greenish Yellow colored medium Greenish Yellow colored medium Complies
pH (After sterilization) 7.5 to 7.9 at 25oC 7.68 Complies
Gel strength Firm as compared to 2.0% Agar gel Firm as compared to 2.0% Agar gel Complies
Clarity of Medium(After Sterilization) Opalescent gel with flocculent Opalescent gel with flocculent Complies
precipitate forms precipitate forms
in Petri plates in Petri plates
CULTURAL PARAMETERS : Cultural response on Bismuth Sulphite Agar observed after incubation at 35-37°C for 40-48 hours.

Type Organisms No. of No. of Percent- Growth Color of Remarks


Organisms Organi- age colony
inoculated sms recovery
recovered
Standard Enterobacter Aerogenes ATCC 13048 50-100 0-10 <10% None to poor Brown-green
Test Enterobacter Aerogenes ATCC 93 8 8.602% None to poor Brown Complies
13048
Standard Enterococcus Faecalis ATCC 29212 >1000 0 0% Inhibited -
Test Enterococcus Faecalis ATCC 29212 63 0 0% Inhibited - Complies
Standard Escherichia Coli ATCC 25922 50-100 0-10 <10% None to poor Brown-green
Test Escherichia Coli ATCC 25922 67 0 0% None to poor - Complies
Standard Salmonella Typhimurium ATCC 23564 50-100 25-200 >=50% Good luxuriant Black with
metallic sheen
Test Salmonella Typhimurium ATCC 68 53 77.941% Good Black with Complies
23564 luxuriant Metallic Sheen
Standard Salmonella Typhi ATCC 6539 50-100 25-200 >=50% Good luxuriant Black with
Metallic sheen

Test Salmonella Typhi ATCC 6539 73 67 91.78% Good Black with Complies
luxuriant Metallic Sheen
...continued
CERTIFICATE OF ANALYSIS, QUALITY AND CONFORMITY

Product Name : Bismuth Sulphite Agar Mfg. Date 17-6-2024

Product Code : DM039 Expiry Date 16-6-2029

Lot Number : 02580624 Release Date 26-6-2024

Analytical Report Number : QAD/AR-24/06-0423 Page No Page 2

Standard Salmonella Typhimurium ATCC 50-100 25-200 >=50% Good luxuriant Black with
14028 Metallic sheen

Test Salmonella Typhimurium ATCC 65 51 78.461% Good Black with Complies


14028 luxuriant Metallic Sheen

Standard Shigella Flexneri ATCC 12022 50-100 0-10 <10% None to poor Brown
Test Shigella Flexneri ATCC 12022 80 7 8.75% None to poor Brown Complies
Standard Escherichia Coli ATCC 8739 50-100 0-10 <=10% None to poor Brown-green
Test Escherichia Coli ATCC 8739 76 0 0% None to poor - Complies
Standard Escherichia Coli NCTC 9002 50-100 0-10 <=10% None to poor Brown-green
Test Escherichia Coli NCTC 9002 61 0 0% None to poor - Complies
Standard Salmonella Abony NCTC 6017 50-100 25-200 >=50% Good luxuriant Black with
Metallic sheen

Test Salmonella Abony NCTC 6017 87 63 72.413% Good Black with Complies
luxuriant Metallic Sheen

Final Results : COMPLIES


This is to certify that this lot passes and it conforms to the above mentioned tests and specifications.

TESTED BY CHECKED BY APPROVED BY


Sharayu Kishore Rupali
MICROBIOLOGIST QC Head HEAD QUALITY ASSURANCE
End of the Report

43, Kalpataru Industrial Estate, Near Runwal Estate,, Behind R-Mall, Ghodbunder Road,, Thane (W) - 400607, CIN: U74999MH1999PTC122807, E
-Mail : sales@micromasterlab.com

This is a Computer Generated Document

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