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%.