Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
Recommended for microbiological assay of Vancomycin in accordance with USP and Oxytetracycline and tetracycline in accordance with IP.
Composition
| Ingredients | g/L |
|---|---|
| Peptone | 6.000 |
| Yeast extract | 3.000 |
| HM peptone B # | 1.500 |
| Agar | 15.000 |
| Final pH (at 25°C) | 5.9±0.1 |
**Formula adjusted, standardized to suit performance parameters
# Equivalent to Beef extract
Directions
Suspend 25.5 grams in 1000 ml purified / distilled water. Heat to boiling to dissolve the medium completely. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes. Cool to 45-50°C. Mix well and pour into sterile Petri plates.
Principle And Interpretation
Antibiotic Assay Media are used in the performance of antibiotic assays. Grove and Randall have elucidated those antibiotic assays and media in their comprehensive treatise on antibiotic assays (1). Schmidt and Moyer have reported the use of antibiotic assay medium for the liquid formulation used in the performance of antibiotic assay (2). These media are prepared according to the specifications detailed in the USP (3), IP (4) and FDA (5). HM peptone B, yeast extract and Peptone serves as a source of nutrients and growth factors.
Type of specimen
Pharmaceutical preparations
Specimen Collection and Handling
For pharmaceutical samples follow appropriate techniques for handling specimens as per established guidelines (3,4). 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 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
Gelling
Firm,comparable with 1.5% Agar gel
Colour and Clarity of prepared medium
Light amber coloured opalescent gel forms in Petri plates
pH
5.80-6.00
Cultural Response
Cultural characteristics observed after an incubation at 32-35°C for 18-24 hours.
| Organism | Inoculum (CFU) | Growth | Recovery | Antibiotics assayed |
|---|---|---|---|---|
| In accordance with USP | ||||
| ** Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | luxuriant | >=70% | Vancomycin |
| In accordance with IP | ||||
| Bacillus cereus var mycoides ATCC 11778 (00001*) | 50-100 | luxuriant | >=70% | Oxytetracycline, Tetracycline |
Key: *Corresponding WDCM numbers.
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 (6,7).
| Product Name | Antibiotic Assay Medium No.8 |
|---|---|
| SKU | MAP041 |
| Customized Product Available | No |
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