Alternative Thioglycollate Medium

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SKU:
MM010
For sterility testing of turbid or viscous biological products in accordance with Indian Pharmacopoeia.


Composition**

Ingredients Gms/Litre
Pancreatic digest of C 15.000
Yeast extract 5.000
Dextrose 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

Suspend 28.50 grams of dehydrated medium in 1000 ml purified/distilled water. Distribute into tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 20 minutes.

Principle And Interpretation

Alternative Thioglycollate Medium is formulated as described in N.I.H. Memorandum (1), Indian 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 at 25°C (after sterilization). pH : 7.1±0.2

pH
6.90-7.30

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

Cultural Response
MM010: Cultural characteristics observed after an incubation at 30-35°C for <=3 days.

Organism Inoculum (CFU) Growth
Clostridium sporogenes ATCC 19404 50-100 luxuriant
Clostridium sporogenes ATCC 11437 50-100 luxuriant
Bacteroides vulgatus ATCC 8482 50-100 luxuriant

Additional Microbiological testing

Organism Inoculum Growth
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 prepared medium at 2-8 °C. Use before expiry date on label.

More Information
Product Name Alternative Thioglycollate Medium
SKU MM010
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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