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Antibiotic Assay Medium No. 11
Intended Use
Recommended for microbiological assay of antibiotics in accordance with USP.
Composition
| Ingredients | g/L |
|---|---|
| Peptone | 6.000 |
| Tryptone | 4.000 |
| Yeast extract | 3.000 |
| HM peptone B # | 1.500 |
| Dextrose (Glucose) | 1.000 |
| Agar | 15.000 |
| pH after sterilization | 8.3±0.1 |
Formula adjusted, standardized to suit performance parameters
Equivalent to Beef extract
Directions
Suspend 30.5 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 or dispense as desired.
Advice: Recommended for the Microbiological assay of Erythromycin, Netilmicin, Gentamicin, Sisomicin, Neomycin, Paromomycin.
Principle And Interpretation
This medium is formulated in accordance to USP and CFR; and is employed to analyze the neomycin content as per FDA and the USP (1,2). It is indentical numerically with the name assigned by Grove and Randall (3). This medium provides a pH range of 8.3 while Antibiotic assay medium no.1 provides pH range of 6.5-6.7.
Peptone, tryptone, yeast and HM peptone B supply essential nutrients, vitamins, mineral, trace elements and growth factors. Dextrose in the medium serves as the carbon source for stimulating the growth of the test microorganism. Agar provides excellent medium for antibiotic diffusion and gives well defined zones of inhibition. Higher pH provides the optimal conditions for activity of antibiotic and also supports the growth of test organisms.
Type of specimen
Antibiotics as per USP
Specimen Collection and Handling
Freshly prepared plates should be used for antibiotic assays. Test organisms are inoculated in sterile seed agar pre-cooled to 40-45°C and spread evenly over the surface of solidified base agar. All conditions in the microbiological assay must be controlled carefully. 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 yellow coloured clear to slightly opalescent gel forms in Petri plates.
Reaction: Reaction of 3.05% w/v aqueous solution after sterilization.
pH: 8.20-8.40
Growth Promotion Test: As per US Pharmacopoeia
Cultural Response: Cultural characteristics observed after an incubation at 32-35°C for 24 hours.
| Organism | Inoculum (CFU) | Growth | Recovery | Antibiotics assayed |
|---|---|---|---|---|
| $ Kokuria rhizophila ATCC 9341 | 50-100 | luxuriant | >=70% | Erythromycin |
| Staphylococcus epidermidis ATCC 12228 (00036*) | 50-100 | luxuriant | >=70% | Gentamicin, Netilmicin, Neomycin, Sisomicin, Paromomycin |
Key: *- Corresponding WDCM numbers
$ Formerly known as Micrococcus luteus
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 (4,5).
| Product Name | Antibiotic Assay Medium No. 11 |
|---|---|
| SKU | MU004 |
| Application/ Industry | Pharmaceutical |
| Product Type | Regular |
| Physical Form | Powder |
| Regulatory | FDA, CFR, USP |
| Origin | Animal |
| Packaging type | HDPE |
| References | 1. Grove and Randall, 1955, Assay Methods of Antibiotics Medical Encyclopedia, Inc, New York. 2.Schmidt and Moyer, 1944; J. Bact, 47:199. 3.United States Pharmacopoeia 2018, US Pharmacopoeial Convention Inc, Rockville, MD 4.Tests and Methods of Assay of Antibiotics and Antibiotic containing Drugs, FDA, CFR, 198 3.Title 21, part 436, SubpartD, Washington, D.C. U.S Government printing office, paragraphs 436, 100-436, 106 pg 242-259 (April 1). 4.Isenberg, H.D. Clinical Microbiology Procedures Handbook. 2nd Edition. 5.Jorgensen,J.H., Pfaller , M.A., Carroll, K.C., Funke, G., Landry, M.L., Richter, S.S and Warnock., D.W. (2015)Manual of Clinical Microbiology, 11th Edition. Vol. 1. |
| Customized Product Available | No |








