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Pharmaceutical Laboratory Testing#CC293D
Intended Use:
Recommended for preparation of suspension of Mycobacterium smegmatis used as the test organism for the assay of Bleomycin.
Composition**
| Ingredients | Gms / Litre |
|---|---|
| Peptone | 10.000 |
| HM peptone B # | 10.000 |
| Sodium chloride | 3.000 |
| Final pH (at 25°C) | 7.0±0.2 |
**Formula adjusted, standardized to suit performance parameters
# Equivalent to Beef extract
Directions
Suspend 23 grams in 1000 ml purified / distilled water containing 10 gms glycerol. Heat if necessary to dissolve the medium completely. Dispense into tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.
Advice: Recommended for the microbiological assay of Bleomycin
Principle And Interpretation
This medium is formulated in accordance with CFR (3). This medium is generally employed to prepare Mycobacterium smegmatis suspension required for assaying antineoplastic agents like Bleomycin.
This medium provides optimal conditions to maintain the viability of the test organism i.e Mycobacterium smegmatis. Peptone and HM peptone B in the medium provides nutrients essential for growth, while addition of glycerol provides slow and continuous supply of carbon and energy source. The osmotic equilibrium for integrity of cell and its viability is maintained in presence of sodium chloride present in this medium.
Type of specimen
Pharmaceutical sample
Specimen Collection and Handling
For pharmaceutical sample samples follow appropriate techniques for handling specimens as per established guidelines (3). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
Read the label before opening the container. Wear protective gloves/protective clothing/eye protection/face protection. Follow good microbiological lab practices while handling specimens and culture. Standard precautions as per established guidelines should be followed while handling specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- Freshly prepared medium plates must be used or it may result in erroneous results.
Performance and Evaluation
Performance of the medium is expected when used as per the direction on the label within the expiry period when stored at recommended temperature.
Quality Control
Appearance: Cream to yellow homogeneous free flowing powder
Colour and Clarity of prepared medium: Yellow coloured clear solution without any precipitate
Reaction: Reaction of 2.3% w/v aqueous solution containing 1% glycerol at 25°C. pH: 7.0±0.2
pH: 6.80-7.20
Cultural Response
Cultural characteristics observed after an incubation at 35-37°C for 18-48 hours
| Organism | Inoculum (CFU) | Growth | Serial dilution with |
|---|---|---|---|
| Mycobacterium smegmatis ATCC 607 | 50-100 | luxuriant | Bleomycin sulphate |
Storage and Shelf Life
Store between 10-30°C in a tightly closed container and use freshly prepared medium. Use before expiry date on the label. On opening, product should be properly stored dry, after tightly capping the bottle in order to prevent lump formation due to the hygroscopic nature of the product. Improper storage of the product may lead to lump formation. Store in dry ventilated area protected from extremes of temperature and sources of ignition. Seal the container tightly after use. Product performance is best if used within stated expiry period.
Disposal
User must ensure safe disposal by autoclaving and/or incineration of used or unusable preparations of this product. Follow established laboratory procedures in disposing of infectious materials and material that comes into contact with sample must be decontaminated and disposed of in accordance with current laboratory techniques (1,2).
| Product Name | Antibiotic Assay Medium No. 34 |
|---|---|
| SKU | M797 |
| Product Type | Regular |
| Physical Form | Powder |
| Origin | Animal |
| Packaging type | HDPE |
| References | 1. Tests and Methods of Assay of Antibiotics and Antibiotic containing Drugs, FDA, CFR, 1983 Title 21, Part 436, SubpartD, Washington, D.C.: U.S. Government Printing Office, paragraphs 436, 100-436, 106, p. 242-259, (April 1). |
| Customized Product Available | No |
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