Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Table 2

Common ATPs for impurity profile by HPLC method.

Serial number	Method requirements for impurity profile
1	Number of analytes (API and impurities)
2	Separation of all analytes
3	Mobile Phase (buffer and organic modifier)
4	Elution method (gradient or isocratic)
5	Sample concentration
6	Sample diluent
7	Sample solution stability
8	Sample preparation process (dilution process and sonication time, etc.)
9	Filter or centrifuge
10	Impurity specification limits
11	Column type (stationary phase and dimensions)
12	Detection (UV/RID/ELSD)
13	RRT, RRF establishment
14	Flow rate
15	Injection volume
16	Column oven temperature
17	Runtime
18	System suitability parameters selection with limits
19	LOD and LOQ concentrations establishment
20	Impurities calculation method
21	Recovery establishment