Chiral Method Development Training for Complex APIs – Corporate Training

Description

Corporate Chiral Method Development Training for Complex APIs

This training program provides in-depth knowledge of stereochemical analysis and Quality by Design (QbD)-driven approaches for the development and optimization of chiral analytical methods in pharmaceutical compounds.

Key Learning Areas:

• Fundamentals of Stereochemistry in APIs
  Understanding chirality in pharmaceutical compounds, including enantiomers and diastereomers, and their impact on pharmacodynamics, pharmacokinetics, safety, and therapeutic efficacy.
• Chiral Separation & Resolution Strategies
  Exploring advanced techniques for enantiomer separation, including selection of chiral stationary phases (CSPs), use of chiral selectors, enantiomeric enrichment approaches (synthetic and separation-based), and chromatographic techniques such as chiral HPLC.
• QbD Application in Chiral Method Development
  Defining critical quality attributes (CQAs) such as enantiomeric purity, resolution, and peak tailing, and identifying critical method parameters (CMPs) including temperature, mobile phase composition, and pH. Application of Design of Experiments (DoE) for systematic optimization of chiral separations.
• Regulatory Control Strategy for Chiral Impurities
  Establishing scientifically justified specification limits for chiral impurities, ensuring sensitive detection of minor enantiomers, and maintaining compliance through robust method validation and continuous monitoring.