Journal of Chemistry / 2015 / Article / Tab 2

Review Article

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 numberMethod requirements for impurity profile

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