Critical process parameter identification of manufacturing processes of Astragali Radix extract with a weighted determination coefficient method.

ABSTRACT:

Objective

Critical process parameters (CPPs) identification is an important step of the implementation of quality by design (QbD) concept. There are many CPP identification methods, such as risk analysis method, sensitivity analysis method, multiple linear regression method, standard partial regression coefficient (SPRC) method, and so on. The SPRC method can consider multiple process critical quality attributes (CQAs) simultaneously, but the determination of CPP number is subjective. Therefore, new CPP identification method is still required.

Methods

The manufacturing process of Astragali Radix extract, which contained water reflux extraction, concentration, and ethanol precipitation, was used as an example. First, the multiple process CQAs were determined to be the

SUBMITTER: Sun MF 

PROVIDER: S-EPMC9476637 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature