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Alternative Thioglycollate Medium
Intended Use
Sterility test media prepared in accordance with USP.
Composition**
| Ingredients | Gms / Litre |
|---|---|
| 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 |
| Final pH (at 25°C) | 7.1±0.2 |
**Formula adjusted, standardized to suit performance parameters
Directions
Label the ready touse LQ028 bottle. Inoculate the sample and Incubate at specified temperature and time.
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: Sterile Alternative Thioglycollate Medium in a glass bottle.
Colour: Yellow coloured clear solution
Quantity of Medium: 100 ml of medium in glass bottle.
Reaction: 6.90-7.30
Sterility test: Passes release criteria
Cultural response
Cultural characteristics was observed after an incubation at 35-37°C for 24-72 hours.
| Organism | Inoculum (CFU) | Growth |
|---|---|---|
| Neisseria meningitidis ATCC 13090 | 50-100 | Luxuriant |
| Staphylococcus aureus ATCC 25923 | 50-100 | Luxuriant |
| Streptococcus pyogenes ATCC 19615 | 50-100 | Luxuriant |
| Bacteroides vulgatus ATCC 8482* | 500-100 | Luxuriant |
| Clostridium sporogenes ATCC 11437* | 50-100 | Luxuriant |
| Candida albicans ATCC 10231** | 50 - 100 | Luxuriant |
| Bacillus subtilis ATCC 6633 | 50-100 | Luxuriant |
| Bacteroides fragilis ATCC 25285* | 50-100 | Luxuriant |
| Micrococcus luteus ATCC 10240 | 50-100 | Luxuriant |
Storage and Shelf Life
Store between 15-25°C. Use before expiry date on the label.
| Product Name | Alternative Thioglycollate Medium |
|---|---|
| SKU | LQ028 |
| Customized Product Available | No |

