CERTIFICATE OF ANALYSIS

Product Name: Dey Engley Neutralizing Agar Plate (55 mm) (Triple Layer Pack, Gamma Irradiated)

Lot No.: K02-2006

K02-2005 Catalogue No.: 205040240200

Mfg.: 14-05-2020
21-02-2020 Exp.: 20-06-2020
14-09-2020

Pack Size: 200 Plates Storage Temperature: 15°C-25°C

Test Certificate No.: MX/FPPP/2020/0137 Date Of Release: 02-03-2020

28/05/2020

Composition/Litre:

Description Quantity UOM

Pancreatic Digest of Casein 5.0 g

Yeast Extract 2.5 g

Glucose 10.0 g

Sodium Thiosulfate 6.0 g

Sodium Thioglycollate 1.0 g

Sodium Bisulfite 2.5 g

Lecithin 7.0 g

Polysorbate 80 5.0 g

Bromocresol Purple 0.02 g

Agar 15.0 g

* Formula adjusted to suit performance parameters.

Testing Parameters :

Test Specification Results

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

Colour of medium Purple coloured, slightly opalescent gel in 55 mm plates. Complies

Quantity of medium 15.5 ± 1 g in 55 mm plate. 14.993 g

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

Final pH at 25°C ± 2°C 7.40 - 7.80 7.72

Neutralization of Quaternary ammonium The average number of cfu recovered from the test plates is not less than 70% of that
Complies
compound and aldehyde recovered from inoculum control.

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 CERTIFICATE OF ANALYSIS

Gamma Irradiation : The above said product was Gamma Irradiated between 12 KGy - 21KGy

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 bacteria and at 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.

Growth Promoting

Organism Type Culture Growth Incubation Temperature Incubation 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

Candida albicans ATCC (10231) Good 20-25°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 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.

Neutralizing Activity for Quaternary Ammonium

Organism Type Culture Incubation Temperature Incubation Period
Compound and Aldehyde

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

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

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

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.

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 CERTIFICATE OF ANALYSIS

Suchita Naik Chetalee Naik

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

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