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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