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 Amphotericin B, Nystatin using Saccharomyces cerevisiae as the test organisms in accordance with USP.
Composition
| Ingredients | Gms / Litre |
|---|---|
| Peptone | 9.400 |
| Yeast extract | 4.700 |
| HM peptone B # | 2.400 |
| Dextrose | 10.000 |
| Sodium chloride | 10.000 |
| Agar | 23.500 |
| pH after sterilization | 6.1±0.1 |
**Formula adjusted, standardized to suit performance parameters
# Equivalent to Beef extract
Directions
Antibiotic Assay Medium No.19 is a ready to use solid media in glass bottle. The medium is pre-sterilized, hence it does not need sterilization. Medium in the bottle can be melted either by using a pre-heated water bath or any other method. Slightly loosen the cap before melting. When complete melting of medium is observed dispense the medium in tubes as butts/slants or in plates as desired and allow to solidify. If on plate, either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically.
Principle And Interpretation
The medium composition is in accordance to USP and CFR (1,2). This medium is used as seed agar for assay of anti fungal agents like Amphotericin B and Nystatin. This medium is used for maintenance and inoculum development of Saccharomyces cerevisiae. This medium is also used for assaying mycostatic activity in pharmaceutical formulations. This medium is formulated as reported by Kirshbam and Arret (3).
Ingredients like peptone, yeast and HM peptone B supplement essential nutrients, minerals and growth factors for the growth of test organism. Dextrose in the medium provides enhanced source of carbon and energy. Osmotic equilibrium in the medium is maintained by sodium chloride which retains the cell integrity and viability. Antibiotic assay medium No.19, is used as both base and seed medium for agar diffusion assay for antibiotics like Amphotericin B and Nystatin.
Type of specimen
Antibiotics as per USP
Specimen Collection and Handling
Spread evenly over the surface of solidified base agar. Pre-diffusion of antibiotics for 20 minutes in the agar by incubating at temperature below the optimal growth temperature for microorganism would facilitate better diffusion of antibiotic, followed by incubation of the plates for microbial growth. 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: Sterile Antibiotic Assay Medium No.19 in glass bottle.
Colour of the medium: Yellow coloured medium
pH: 6.00-6.20
Quantity of medium: 500 ml of medium in glass bottle.
Sterility Check: Passes release criteria
Growth Promotion Test: As per United States Pharmacopoeia.
Cultural Response
Cultural characteristics observed after an incubation at 29-31°C for 48 hours.
| Organism | Inoculum (CFU) | Growth | Recovery | Antibiotics assayed |
|---|---|---|---|---|
| #Saccharomyces kudriavzevii ATCC 2601 | 50-100 | luxuriant | >=70% | Nystatin |
| Saccharomyces cerevisiae ATCC 9763 (00058*) | 50-100 | luxuriant | >=70% | Amphotericin B |
Key: *- Corresponding WDCM numbers
Storage and Shelf Life
On receipt store between 15-30°C. Use before expiry date on the label. 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 (4,5).
| Product Name | Antibiotic Assay Medium No. 19 |
|---|---|
| SKU | SMU101D |
| Customized Product Available | No |
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