Alternative Thioglycollate Medium

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SKU:
MU010
For sterility testing of turbid or viscous biological products in accordance with US Pharmacopoeia.


Intended Use

Alternative Thioglycollate Medium is recommended for sterility testing of turbid or viscous biological products in accordance with United States Pharmacopoeia

Composition

Ingredients g / L
Pancreatic digest of Casein 15.000
Yeast extract 5.000
Dextrose monohydrate 5.500
Sodium chloride 2.500
L-Cystine 0.500
Sodium thioglycollate 0.500
pH after sterilization 7.1±0.2

Formula adjusted, standardized to suit performance parameters

Directions

Suspend 28.5 grams (the equivalent weight of of dehydrated medium per litre) in 1000 ml purified/ distilled water. Heat if necessary to dissolve the medium completely. Distribute into flasks or tubes as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.

Note: It is preferable to use freshly prepared medium, alternatively it should be boiled and cooled just once prior to use or with reheating, toxic oxygen radicals are formed.

Principle and Interpretation

Alternative Thioglycollate Medium is formulated as described in N.I.H. Memorandum (1), U.S. Pharmacopoeia (2). This medium is recommended for sterility testing for detecting the presence of viable forms of microorganisms in or on pharmaceutical preparations. This medium is also used for sterility checking for devices having tubes with small lumina. Alternative thioglycollate Medium is generally used for products containing mercurial preservatives when the oxidation-reduction indicator is not present or required. Lack of an indicator in the medium avoids possible toxicity to organisms.

Alternative Thioglycollate Medium contains sodium thioglycollate that can neutralize the bacteriostatic effect of mercurial preservatives. Absence of agar makes it suitable for testing viscous materials and devices having tubes with small lumina.

Pancreatic digest of casein, yeast extract, dextrose monohydrate, L-cystine provides nitrogenous and carbonaceous compounds, vitamin B complex, trace elements and other essential growth nutrients. Sodium Thioglycollate and L-cystine lower the oxidation-reduction potential of the medium by removing oxygen radicals and thus preventing the accumulation of peroxides that can be toxic to some organisms. The sulfhydryl groups of these compounds also neutralize the antibacterial effect of mercurial preservatives with heavy metals. Dextrose is the fermentable carbohydrate energy source, and Sodium Chloride maintains the osmotic balance of the medium.

Quality Control

Appearance: Cream to yellow homogeneous free flowing powder

Colour and Clarity of prepared medium: Light yellow coloured clear solution without any precipitate.

Reaction: Reaction of 2.85% w/v aqueous solution. pH: 7.1±0.2

Cultural Response

MU010: Growth Promotion observed in accordance with USP, under anaerobic condition after an incubation at 30-35°C for <=3 days.

Organism Inoculum (CFU) Growth
Growth Promotion Test
Clostridium sporogenes ATCC 19404 50-100 luxuriant
Clostridium sporogenes ATCC 11437 50-100 luxuriant
Bacteroides vulgatus ATCC 8482 50-100 luxuriant
Additional Microbiological testing
Staphylococcus aureus ATCC 25923 50-100 luxuriant
Staphylococcus aureus ATCC 6538 50-100 luxuriant
Pseudomonas aeruginosa ATCC 27853 50-100 luxuriant
Pseudomonas aeruginosa ATCC 9027 50-100 luxuriant
Escherichia coli ATCC 25922 50-100 luxuriant
Escherichia coli ATCC 8739 50-100 luxuriant
Escherichia coli NCTC 9002 50-100 luxuriant
Salmonella Abony NCTC 6017 50-100 luxuriant
Clostridium perfringens ATCC 13124 50-100 luxuriant
Bacteroides fragilis ATCC 23745 50-100 luxuriant

Storage and Shelf Life

Store below 30°C in tightly closed container and the prepared medium at 2-8°C. Use before expiry date on the label.

More Information
Product Name Alternative Thioglycollate Medium
SKU MU010
Product Type Regular
Physical Form Powder
Origin Animal
Packaging type HDPE
References 1. N.I.H. Memorandum, 1955: Culture Media for Sterility Tests, 4th
Customized Product Available No
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