The Microbial Assays for Antibiotics Package is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
The Microbial Assays for Antibiotics Package provides the following document types:
Assay document types
- Cylinder-plate assay (USP <81>): Provides the features you need to determine the potency of antibiotics according to the cylinder-plate method described in USP <81>. The application uses a linear regression model to fit the standard curve. You select the method to correct for plate-to-plate variation. To determine absolute potencies, the application interpolates the response values of the test samples on the standard curve. It calculates relative potencies based on the reference step of the standard.
- Cylinder-plate assay (JP 4.02): Provides the features you need to determine the potency of antibiotics according to the cylinder-plate method described in JP 4.02. The application compares the response values of the test sample at high and low concentration to the response of the standard at high and low concentration.
- Turbidimetric assay (USP <81>, JP 4.02): Provides the features you need to determine the potency of antibiotics according to the turbidimetric methods described in USP <81> and JP 4.02. The application uses a linear regression model to fit the standard curve. To determine absolute potencies, the application interpolates the response values of the test samples on the standard curve. It calculates relative potencies based on the reference step of the standard.
Advanced analysis document types
- Combination of microbial assays: Provides the features you need to aggregate data of assay documents, apply confidence limits, check for outliers, perform combination of assays calculations, and define statistical tests. Calculations are performed according to the guidelines laid out in USP <81>.