MU004 - Antibiotic Assay Medium 11

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Technical Data
Antibiotic Assay Medium No.11 MU004
Intended Use:
Recommended for microbiological assay of antibiotics in accordance with USP.
Composition**
Ingredients Gms / Litre
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
1. 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.
Please refer disclaimer Overleaf.

HiMedia Laboratories Technical Data
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 Growth Recovery Antibiotics
(CFU) assayed
Micrococcus luteus ATCC 50-100 luxuriant >=70% Erythromycin
9341
Staphylococcus epidermidis 50-100 luxuriant >=70% Gentamicin,Netilmicin,
ATCC 12228 (00036*) Neomycin, Sisomicin,
Paromomycin
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 (4,5).
Reference
1. Tests and Methods of Assay of Antibiotics and Antibiotic containing Drugs, FDA, CFR, 1983 Title 21, Part 436,Subpart
D, Washington, D.C.: U.S. Government Printing Office, paragraphs 436, 100-436, 106, p. 242-259, (April1).
2. The United States Pharmacopoeia-National Formulatory (USP-NF), 2022.
3. Grove and Randall, 1955, Assay Methods of Antibiotics Medical Encyclopedia, Inc. New York.
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.
Revision : 04/2022
Disclaimer :
User must ensure suitability of the product(s) in their application prior to use. Products conform solely to the information contained in this and
other related HiMedia™ publications. The information contained in this publication is based on our research and development work and is to the best
of our knowledge true and accurate. HiMedia™ Laboratories Pvt Ltd reserves the right to make changes to specifications and information related
to the products at any time. Products are not intended for human or animal or therapeutic use but for laboratory,diagnostic, research or further
manufacturing use only, unless otherwise specified. Statements contained herein should not be considered as a warranty of any kind, expressed or
implied, and no liability is accepted for infringement of any patents.
HiMedia Laboratories Pvt. Ltd. Corporate Office : Plot No.C-40, Road No.21Y, MIDC, Wagle Industrial Area, Thane (W) - 400604, India.
Customer care No.: 022-6147 1919 Email: [email protected] Website: www.himedialabs.com

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