Microbiological Assay of Antibiotics
According to USP and Ph. Eur.
The Microbial Assay is the method of choice to assess activity (potency) of antibiotics.
The antimicrobial activity is assessed by measuring the inhibitory
effect of an antibiotic on micro-organisms. As stated in USP
<81>: “A reduction in antimicrobial activity also will reveal subtle
changes not demonstrable by chemical methods.”
USP <81> ANTIBIOTICS – MICROBIAL ASSAYS
The activity of antibiotics is estimated by comparing the
inhibition of growth of sensitive micro-organisms produced by
5 doses of reference substance and 1 dose of antibiotic to be
examined.
PH. EUR. 2.7.2 MICROBIOLOGICAL ASSAY OF ANTIBIOTICS
The activity of antibiotics is estimated by comparing the
inhibition of growth of sensitive micro-organisms produced by
3 doses of reference substance and 3 doses of the antibiotic to
be examined.
LITERATURE
USP <81> Antibiotics – Microbial Assays
Ph. Eur. 2.7.2 Microbiological assay of antibiotics
FAB-0720
SERVICES
• Method verification for raw materials
• Method validation for finished products
• Assay of raw materials and finished products
• Single or multiple measurements
• Automated system for diffusion assay reading
• Analysis of high potent substances
STANDARDS
• USP <81> and Ph. Eur. 2.7.2.
• The diffusion method under GMP and CGMP
WHY CONFARMA?
• Over 15 years of experience in Microbial Assays
• Dedicated project teams and flexible capacity planning
Confarma France SAS
ZI, rue du Canal d’Alsace, F-68490 Hombourg
info@confarma.fr | www.confarma.fr
ANTIBIOTIC USP <81> Ph. Eur. 2.7.2.
AMOXICILLIN √
AMPHOTERICIN B √ √
BACITRACIN √
BACITRACIN ZINC √
BLEOMYCIN √
BLEOMYCIN SULFATE √
CLOXACILLIN √
COLISTEMETHATE √
COLISTEMETHATE SODIUM √
COLISTIN √
COLISTIN SULFATE √
DIHYDROSTREPTOMYCIN √
ERYTHROMYCIN √
FRAMYCETIN SULFATE √
GENTAMICIN √
GENTAMICIN SULFATE √
JOSAMYCIN √
JOSAMYCIN PROPIONATE √
KANAMYCIN MONOSULFATE √
KANAMYCIN ACID SULFATE √
NAFCILLIN √
NEOMYCIN √
NEOMYCIN SULFATE √
NETILMYCIN SULFATE √
NOVOBIOCIN √
NYSTATIN √ √
PAROMOMYCIN √
PENICILLIN G √
POLYMYXIN B √
POLYMYXIN B SULFATE √
RIFAMYCIN SODIUM √
SPIRAMYCIN √
STREPTOMYCIN SULFATE √
TEICOPLANIN √
TYLOSIN FOR VETERINARY USE √
TYLOSIN FOR VETERINARY USE PHOSPHATE √
TYLOSIN FOR VETERINARY USE TARTRATE √
VANCOMYCIN (HYDROCHLORIDE) √ √