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Certified : ISO 9001:2008, ISO 13485-2003 and WHO GMP-------------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited23, Vadhani Industrial Estate, L.B.S. Marg, Mumbai - 400086Website : www.himedialabs.com, Email : [email protected]
Certificate of Analysis, Quality and Conformity
AppearanceCream to yellow homogeneous free flowing powder . Observed : Light yellow
GellingFirm, comparable with 1.5% Agar gel
Colour and Clarity of prepared mediumLight yellow coloured clear to slightly opalescent gel forms in Petri plates
ReactionReaction of 2.35% w/v aqueous solution at 25C.
pHpH Range :6.80-7.20 Observed : 7.15
Cultural ResponseCultural characteristics observed after an incubation at 35 - 37C for 18 - 48 hours.
Organism Inoculum (CFU) Growth RecoveryCultural ResponseBacillus subtilis ATCC 6633 50-100 luxuriant >=70%Enterococcus faecalis ATCC29212
50-100 luxuriant >=70%
Escherichia coli ATCC 25922 50-100 luxuriant >=70%Lactobacillus casei ATCC 9595 50-100 luxuriant >=70%Staphylococcus aureus ATCC25923
50-100 luxuriant >=70%
Streptococcus pyogenes ATCC19615
50-100 luxuriant >=70%
. ATCC is a registered trade mark of the American Type Culture Collection
. NCTC and National Collection of Type Culture are registered trade mark of the Health Protection Agency
Control Media :. For Bacteria : Soyabean Casein Digest Agar / Columbia Blood Agar base enriched with 5% v/v Sheep/Horse blood.. For Yeast & Mold : Sabouraud Dextrose Agar.
. All ISO/CEN 11133-2 control strains are included in the Quality parameter
. HiMedia Laboratories Pvt Ltd is certified for ISO 9001-2008, ISO 13485-2003 and WHO GMP.
. Information for BSE/TSE Risk: The material was subjected to pH
Certified : ISO 9001:2008, ISO 13485-2003 and WHO GMP-------------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited23, Vadhani Industrial Estate, L.B.S. Marg, Mumbai - 400086Website : www.himedialabs.com, Email : [email protected]
Certificate of Analysis, Quality and Conformity
Preservation Act Govt. of Maharashtra, India.
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 givenhere is believed to be correct and accurate, however, both the information and products are offered without warranty for anyparticulars use, other than that specified in the current HiMedia manual or product sheets. The results reported were obtainedat the time of release.
This document has been produced electronically and is valid
Microbiologist/Analyst Dy QC/Dy QA Manager Quality Assurance Manager30.05.2014
PAGE : 2/2
Material Code : M091
Report No.: 040000498629 Date of Report : 30.05.2014
Lot No : 0000200114
Expiry Date : May-2018
Material Name :Standard Methods Agar(Plate Count Agar)