Antibiotic Assay Medium No. 11

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SKU:
MU004
For microbiological assay of antibiotics in accordance with US Pharmacopoeia.


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).

More Information
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.
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