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IntroductionThe batch‐to‐batch quality consistency of herbal drugs has always been an important issue.
ObjectivesTo propose a methodology for batch‐to‐batch quality control based on HPLC–MS fingerprints and process knowledgebase.
MethodsThe extraction process of Compound E‐jiao Oral Liquid was taken as a case study. After establishing the HPLC–MS fingerprint analysis method, the fingerprints of the...
IntroductionThe concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs)...
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