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ANTIBIOTIC ASSAY

1The Antibiotic Potency Test measures the Bioactivity or Potency of various Antibiotics. All Antibiotics must go through Potency Testing prior to Market Release.

[Premarket Potency Testing of Antibiotics reveals its Bioactivity or Potency  and is mandated by National & Internal Regulations.]

2In 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 is diluted in a similar manner with several Dilutions used to create a Standard Curve.

[Test samples from a seed layer of biotic culture grown and adjusted using Turbidimetric Measurement Techniques are diluted to match the Labeled Potency claimed. Comparison with a similarly diluted Reference Standard Antibiotic is used to generate a Standard Curve.]

3The 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.

[Log value of concentrations are obtained from the corrected value of the average of Reference Standard Zone (RSZ) and Sample Zone (SZ) diameters on 3 plates.   Multiplying the antilog value with the Dilution Factor reveals the concentration of the Active Antibiotic in mg/ml. All calculations are worked out on a Validated Spreadsheet for Antibiotic Potency.]

EFRAC has experience in Testing Various Antibiotics in compliance with the Cylinder Plate Method as per different Pharmacopoeias IP, BP, USP General Chapter on Antibiotics- Microbial Assays. At EFRAC, the microbiology department is capable of dealing with their exhaustive range of tests like bio-method validation, assay, sterility testing, preservation efficacy, microbiological limit determination catering to industries like Drug and Pharma, Ayurveda, Unani medicine and so on.

[EFRACs expertise in Testing Various Antibiotics by the Cylinder Plate Method as per different Pharmacopoeias IP, BP, and USP General Chapter on Antibiotics- Microbial Assays is well established.  The Microbiology Department adroitly carries out an exhaustive range of tests like bio-method validation, assay, sterility testing, preservation efficacy, and microbiological limit determination in catering to industries in Drug and Pharma, Ayurveda, and Unani medicine domains.]

Antibiotic Assay