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Alternative Thioglycollate Medium
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.
| 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 |












