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Scharlab S.L. Certificate of Analysis: TRYPTIC SOY AGAR (TSA) (Eur. Pharm.)

This document provides analysis and certification for a batch of tryptic soy agar. It identifies the product and batch details, describes the dehydrated and prepared medium, lists growth control tests and results using standard microorganisms, and includes representative photos.

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Andres Benavides
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100% found this document useful (1 vote)
147 views1 page

Scharlab S.L. Certificate of Analysis: TRYPTIC SOY AGAR (TSA) (Eur. Pharm.)

This document provides analysis and certification for a batch of tryptic soy agar. It identifies the product and batch details, describes the dehydrated and prepared medium, lists growth control tests and results using standard microorganisms, and includes representative photos.

Uploaded by

Andres Benavides
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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Scharlab S.L.

Tel. int.: +34 93 745 64 00


Email: scharlab@scharlab.com

CERTIFICATE OF ANALYSIS
IDENTIFICATION
Product: TRYPTIC SOY AGAR (TSA) (Eur. Pharm.)
Code: 01-200 Manufacturing date: 9/2016
Batch: 106014 Expiry date: 9/2021
DEHYDRATED MEDIUM
Colour: Yellow Remarks:
Appearance: Homogeneous hygroscopic powder All raw materials of animal origin, which have been used to
manufacture the culture media, come from animals free of
Granulometry: 0,6 - 0,45 mm
BSE.
Additives: -

PREPARED MEDIUM
Directions: 40 g /L Remarks:
Clarity/Colour: Transparent / Yellowish -

Deposit: -
Gel strength: Conform

pH after sterilization: 7,15 at 25 °C


Sterilization: by autoclaving at 121°C for 15 minutes

GROWTH CONTROL
Incubation temperature: 30-35 ºC Incubation time: 24-48 h - 5 days
Remarks: Practical range 50-100 CFU (Productivity) according to Eur. Pharm. harm. & ISO 11133:2014. Spiral Plate Method.

Microorganism Specification Pr. Remarks


®
Bacillus subtilis ATCC 6633 Productivity > 0.70 1 -

Staphylococcus aureus ATCC® 6538 Productivity > 0.70 1 -

Escherichia coli ATCC® 8739 Productivity > 0.70 0,95 -

Candida albicans ATCC® 10231 Productivity > 0.70 0,9 48 h / 5 d

Pseudomonas aeruginosa ATCC® 9027 Productivity > 0.70 1 -

Aspergillus brasiliensis ATCC® 16404 Productivity > 0.70 0,76 5 d (Black sporulation)

Listeria monocytogenes ATCC® 13932 Productivity > 0.70 1 -

Bacillus subtilis ATCC 6633 Escherichia coli ATCC 8739 Staphylococcus aureus ATCC 6538

Photos are not batch-specific.


This certificate does not release the user from the reception control upon This certificate is an electronic copy of the certificate available
receipt of the good. in our laboratory and does not require signature
You can get a copy of any of our COA from our website: www.scharlab.com
Quality release date: 13/09/2016

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