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Certificate of Analysis

This document provides a certificate of analysis for a lot of Soyabean Casein Digest Agar Plates. It details the product name, lot number, manufacturing and expiration dates, packaging details, and composition. Tests were performed to verify appearance, color, quantity, pH, irradiation levels, and growth promotion of bacteria, yeast, and mold. All tests showed compliance with specifications. The certificate concludes that this lot passes all required tests.

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

Certificate of Analysis

This document provides a certificate of analysis for a lot of Soyabean Casein Digest Agar Plates. It details the product name, lot number, manufacturing and expiration dates, packaging details, and composition. Tests were performed to verify appearance, color, quantity, pH, irradiation levels, and growth promotion of bacteria, yeast, and mold. All tests showed compliance with specifications. The certificate concludes that this lot passes all required tests.

Uploaded by

dhairyasheel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Composition: Lists the components and their quantities present in the agar plate composition.
  • Test Parameters: Specifies the tests conducted, including aspects like physical appearance and solubility, with expected results.
  • Product Details: Provides basic product information including name, lot number, manufacturing date, and storage conditions of the agar plate.
  • Growth Promoting Test: Details the organisms tested for growth promotion, with strain culture and incubation periods provided.

CERTIFICATE OF ANALYSIS

Product Name: Soyabean Casein Digest Agar Plate (90 mm) (Triple Layer Pack, Gamma Irradiated)

Lot No.: P02-1905


P01-2025 Catalogue No.: 205190900100

21-12-2019
Mfg.: 02-06-2020 Exp.: 02-12-2020
21-06-2020

Pack Size: 100 Plates Storage Temperature: 15°C-25°C

Test Certificate No.: MX/FPPP/2020/0158 Date Of Release: 31-12-2019


13/06/2020

Composition/Litre:

Description Quantity UOM

Pancreatic Digest of Casein 15.0 g

Papaic Digest of Soyabean Meal 5.0 g

Sodium Chloride 5.0 g

Glycerol 1.0 %

Agar 15.0 g

* Formula adjusted to suit performance parameters.

Testing Parameters :

Test Specification Results

Appearance Gel with smooth and even surface without any cracks, bubbles and drying or shrinking of media. Complies

Colour of medium Light yellow coloured, very slightly opalescent gel in petriplates. Complies

Quantity of medium 29 ± 2 g in 90 mm petriplate. 27.956 g

Plates do not have any microbial contamination after incubation at 30-35°C & 20-25°C for more
Preincubation Complies
than or equal to 5 days.

Final pH at 25°C ± 2°C 7.10 - 7.50 7.43

Gamma Irradiation : The above said product was Gamma Irradiated between 23KGy - 32KGy.
Growth Promotion Test :
Growth promotion was carried out in accordance with the harmonized method of USP/EP/JP and growth was observed after an incubation at 30-35°C
for ≤ 3 days for aerobic bacteria, 48 hours for anaerobic bacteria and at 30-35°C and 20-25°C for ≤ 5 days for fungi.

Growth Promoting Properties :


Growth promoting properties are comparable to the previously tested and approved lot. The test results observed are within the specified
temperature and shortest period of time specified in the test, inoculating ≤ 100 cfu of appropriate microorganism.

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CERTIFICATE OF ANALYSIS

Growth Promoting

Incubation Incubation
Organism Type Culture Growth
Temperature Period

Escherichia coli ATCC (8739) Good 30-35°C 18 Hours

Staphylococcus aureus ATCC (6538) Good 30-35°C 18 Hours

Pseudomonas aeruginosa ATCC (9027) Good 30-35°C 18 Hours

Bacillus subtilis ATCC (6633) Good 30-35°C 18 Hours

Salmonella enterica subsp.


NCTC (6017) Good 30-35°C 18 Hours
enterica serovar Abony

Salmonella enterica subsp.


ATCC (14028) Good 30-35°C 18 Hours
enterica serovar Typhimurium

30-35°C
Clostridium sporogenes ATCC (11437) Good 48 Hours
(Anaerobic)

Candida albicans ATCC (10231) Good 30-35°C 24 Hours

Candida albicans ATCC (10231) Good 20-25°C 48 Hours

Aspergillus brasiliensis ATCC (16404) Good 30-35°C 48 Hours

Aspergillus brasiliensis ATCC (16404) Good 20-25°C 72 Hours

Note:
For Good growth - growth obtained on test media should not differ by a factor greater than 2 from calculated value for a standardized inoculum.

Growth for Aspergillus brasiliensis was observed after 48 hours at 30-35°C & 72 hours at 20-25°C for quantitative test and the same is carried out
for qualitative test and confirmed characteristic growth (White mycelial growth with black spores) after 4-5 days.

ATCC is a registered trade mark of the American Type Culture Collection.

NCTC (National Collection of Type Culture) is a registered trade mark of the Public Health England.

Microxpress dehydrated culture media incorporates raw materials and additives originating from BSE/TSE risk-free countries.

This is to certify that this lot passes and complies with the above mentioned tests and specifications.

Suchita Naik Chetalee Naik


Quality Control Quality Assurance
Date: 13/06/2020 Date: 13/06/2020

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