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Certificate of Analysis: RVSEB-2023 21-06-2019 20-06-2020

This document is a certificate of analysis for Rappaport Vassiliadis Salmonella Enrichment Broth. It provides information on the product name, lot number, manufacturer, expiration date, composition, testing parameters and results, sterilization method, sterility assurance level, growth promotion test, inhibitory properties test, and certification that the lot passes specifications.

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197 views

Certificate of Analysis: RVSEB-2023 21-06-2019 20-06-2020

This document is a certificate of analysis for Rappaport Vassiliadis Salmonella Enrichment Broth. It provides information on the product name, lot number, manufacturer, expiration date, composition, testing parameters and results, sterilization method, sterility assurance level, growth promotion test, inhibitory properties test, and certification that the lot passes specifications.

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
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CERTIFICATE OF ANALYSIS

Product Name: Rappaport Vassiliadis Salmonella Enrichment Broth (Harmonized)

Lot No.: RVSEB-2023


RVSEB-2022 Catalogue No.: 203180240010

Mfg.: 20/05/2020
21-06-2019 Exp.: 20-06-2020
19/05/2021

Pack Size: 25 x 10 mL Storage Temperature: 15 °C – 25 °C

Test Certificate No.: MX/FPRTU/2020/0168 Date Of Release:01-07-2019


28/05/2020

Composition (Ingredients in grams per litre):

Description Quantity UOM

Soya Peptone 4.5 g

Magnesium Chloride hexahydrate 29.0 g

Sodium Chloride 8.0 g

Dipotassium Phosphate 0.4 g

Potassium Dihydrogen phosphate 0.6 g

Malachite green 0.036 g

Testing Parameters:

Test Specification Results

Appearance Blue coloured, clear solution Blue coloured, clear solution

Final pH at 25°C ± 2 °C 5.00 – 5.40 5.31

Preincubation Check No growth is observed after 7 days of incubation at 30°C - 35°C Complies

Sterilization Method:
Sterilized by autoclaving at 115 °C for 30 minutes.

Sterility Assurance Level:


Sterility assurance level of media was validated against Bacillus subtilis '5230' biological indicator. The spore ampoules were exposed at 115 °C and
incubated at 35 °C – 39 °C for 3 days along with unexposed spore ampoules.
Exposed Spore Ampoules - No turbidity and no colour change (Red).
Unexposed Spore Ampoules - Turbidity observed with change in colour to yellow.

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 °C –
35 °C for 18 - 24 hours. Subculturing is carried out using Xylose Lysine Deoxycholate Agar (Harmonized) after enrichment in Rappaport Vassiliadis
Salmonella Enrichment Broth (Harmonized) and incubated at 30 °C – 35 °C for 18 - 48 hours.

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CERTIFICATE OF ANALYSIS

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, inoculating 10 - 100 cfu (at 30 °C – 35 °C for 18 - 24 hours)

Inhibitory Properties:
No growth of the test microorganism occurs for the specified temperature and the longest period of time specified inoculating >100 cfu (at 30 °C –
35 °C for ≥ 24 hours).

Growth Promoting:

Incubation Incubation
Organism Type Culture Growth
Temperature Period

Salmonella enterica subsp. enterica serovar Typhimurium ATCC 14028 Good 30 °C – 35 °C 18 hours

Salmonella enterica subsp. enterica serovar Abony NCTC 6017 Good 30 °C – 35 °C 18 hours

Inhibitory

Staphylococcus aureus ATCC 6538 Inhibited 30 °C – 35 °C 24 Hours

Note:
Clearly visible growth of the microorganisms comparable to that previously obtained with a previously tested and approved batch of medium should
occur.
No growth of the organism should occur for the inhibitory test.
Inoculum for Good growth is 10 – 100 cfu and that for Inhibition is greater than 100 cfu.

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.

Sheetal Rane Chetalee Naik


Quality Control Quality Assurance
Date: 28/05/2020 Date: 28/05/2020

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