S. No. | Drug product | Analytical method | Assay | RS |
1. | Quality target Product Profile (QTPP) | Analytical target profile (ATP) | ・ Accurate quantitation of Active substance ・ Shorter runtime ・ Stability indicating method. ・ Common method. | ・ Accurate quantitation of Impurities ・ Stability indicating method, ・ Resolution should be not less than 2.0 |
2. | Critical Quality Attributes (CQA) | Critical Method Attributes (CMA) | ・ Peak Tailing, ・ Recovery. | ・ Spectral peak purity, ・ Resolution between critical pair of peaks. |
3. | Critical Process parameters (CMP) | Critical Method parameters (CMP) | ・ Flow, ・ Mobile phase pH ・ Column temperature ・ Diluent composition ・ Sonication time. | ・ Flow, ・ Mobile phase pH ・ Column temperature. |
4. | Proven acceptable range (PAR) | Method operational design range (MODR) | Mobile phase pH ±0.2, Flow rate ±10%. Diluent composition range. Sonication time range. | Mobile phase pH ±0.2, Flow rate ±10%. |