Certified : ISO 9001:2015, ISO 13485:2016 , WHO GMP
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HiMedia Laboratories Private Limited
C-40, Road No.21Y, MIDC, Wagle Ind. Area,Thane(W) - 400604
Website : [Link], Email : info@[Link]
Certificate of Analysis , Quality and Conformity
Material Code : RM027 Material Name : Lot No : 0000593555
Yeast Extract Powder
AR No.: 40001364701 Date of Report : 2023-06-10 Exp. Date : 2028-05
TEST SPECIFICATIONS RESULTS
Appearance
1 Colour of powder Light yellow to brownish yellow Yellow
2 Nature Homogenous Complies
3 Consistency Free flowing powder Complies
4 Odour Characteristic odour but not putrescent. Complies
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Solubility
1 Solubility Freely soluble in distilled/ purified water, Complies
insoluble in alcohol.
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Clarity
1 Clarity 2% w/v aqueous solution remains clear Complies
and neutral without any haziness a fter
autoclaving at 15 lbs pressure (121ºC) for
15 minutes.
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pH
1 pH of 2% w/v aqueous solution at 6.50 - 7.50 6.96
25°C
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Microbial Load
1 Total aerobic microbial count By plate method, when incubated at -
(cfu/gm) 30-35ºC for not less than 3 days.
2 total aerobic microbial count ≤ 2000 30
(cfu/gm)
3 Total yeast and mold count By plate method, when incubated at -
(cfu/gm) 20-25ºC for not less than 5 days.
4 total yeast and mold count ≤ 100 7
(cfu/gm)
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Test for pathogens
1 Test for pathogens 1. Escherichia coli- Absent/gram of sample Absent
2. Salmonella species- Absent/10 gram of
sample 3. Pseudomonas aeruginosa-
Absent/gram of sample 4. Staphylococcus
aureus- Absent/gram of sample 5. Candida
albicans- Absent/gram of sample 6.
Clostridia- Absent/gram of sample
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Indole test
1 Indole Tryptophan content: Passes Complies
PAGE : 1/3
Certified : ISO 9001:2015, ISO 13485:2016 , WHO GMP
----------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited
C-40, Road No.21Y, MIDC, Wagle Ind. Area,Thane(W) - 400604
Website : [Link], Email : info@[Link]
Material Code : RM027 Material Name : Lot No : 0000593555
Yeast Extract Powder
AR No.: 40001364701 Date of Report : 2023-06-10 Exp. Date : 2028-05
TEST SPECIFICATIONS RESULTS
Cultural response
1 Test for coagulable protein As per method specified in USP 37,NF32. Complies
No formation of precipitate
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Cultural response
1 Cultural response Cultural response observed after .
incubation at 35-37°C for 18-24 hours by
preparing Plate Count Agar (M091) and
Plate Count Hiveg™ Agar (MV091) using
Yeast extract powder as an ingredient.
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Bacillus subtilis subsp.
Spizizenii ATCC 6633 (WDCM
00003)
1 Growth Luxuriant Complies
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Enterococcus faecalis ATCC
29212(WDCM 00087)
1 Growth Luxuriant Complies
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Escherichia coli ATCC 25922
(WDCM 00013)
1 Growth Luxuriant Complies
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Lactobacillus rhamnosus
ATCC 9595
1 Growth Luxuriant Complies
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Staphylococcus aureus subsp.
aureus ATCC 25923 (WDCM
00034)
1 Growth Luxuriant Complies
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Streptococcus pyogenes ATCC
19615
1 Growth Luxuriant Complies
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Chemical Analysis
1 Total Nitrogen ≥ 10.50% 11.39%
2 Amino Nitrogen ≥ 4.50% 6.01%
PAGE : 2/3
Certified : ISO 9001:2015, ISO 13485:2016 , WHO GMP
----------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited
C-40, Road No.21Y, MIDC, Wagle Ind. Area,Thane(W) - 400604
Website : [Link], Email : info@[Link]
Material Code : RM027 Material Name : Lot No : 0000593555
Yeast Extract Powder
AR No.: 40001364701 Date of Report : 2023-06-10 Exp. Date : 2028-05
TEST SPECIFICATIONS RESULTS
3 Sodium chloride ≤ 5% 0.03%
4 Loss on drying ≤ 6% 5.12%
5 Residue on ignition ≤ 15% 12.71%
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STATUS OF THE MATERIAL : APPROVED
This is to certify that this lot passes and it confirms to the above mentioned tests and specifications . The information given
here is believed to be correct and accurate, however, both the information and products are offered without warranty for any
particulars use, other than that specified in the current HiMedia manual or product sheets.
This document has been produced electronically and is valid
Microbiologist/[Link] Microbiologist Asst./Dy/QC Manager Dy/QA Manager
PAGE : 3/3
