ANTIBIOTIC ASSAY

The Antibiotic Potency Test measures the Bioactivity or Potency of various Antibiotics. All Antibiotics must go through Potency Testing prior to Market Release.

In the Antibiotic Potency Test Procedure, Cultures are grown and adjusted using Turbidimetric Measurement Techniques. An Aliquot of the adjusted Culture is added to a Thin Layer of Agar to create a Seed Layer. Test Samples are diluted to an appropriate Test Concentration according to Labeled Potency Claims. A Reference Standard Antibiotic diluted in a similar manner, is used to create a Standard Curve.

The Sample Potency is estimated by averaging the Reference Standard Zone Diameters and the Sample Zone diameters on the Three Plates used. Concentrations are calculated from the corresponding Corrected Values of Zone Diameters. The log value is converted to the antilog. The antilog value is multiplied by the Dilution Factor to obtain the Concentration in mg/ml of Active antibiotic. These calculations are done with a Validated Spreadsheet for Antibiotic Potency.

EFRAC is experienced in Testing Various Antibiotics in compliance with the Cylinder Plate Method as per different Pharmacopoeias IP, BP, and USP General Chapter on Antibiotics- Microbial Assays. EFRAC’s Microbiology Department is Equipped & Manned to deal with an Exhaustive Range of Tests like Bio-method Validation, Assay, Sterility Testing, Preservation Efficacy, and Microbiological Limit Determination and caters to Drug and Pharma, Ayurveda, Unani Manufacturers.