Part I: General Strategies for Identification and Control of Impurities on 01 December
Analysis and Qualification of Impurities in Drug Substances and Drug Products – General Overview
- Impurity profiling in synthetic drug substances
- Qualification of impurities
- Degradation studies
- Identification of chiral impurities, polymorphic phases and new impurities
- Residual solvents
- Impurities in starting materials and intermediates
- Pharmacopoeial tests and acceptance criteria
- Drug product specifications and parametric release
Analytical Method Validation for Impurities
- Determination at Various Development Stages
- Quantification of impurities
- How to define an impurity profile (stress tests)
- Reference substances
- Validation of methods at various development stages
- Statistical approaches to method validation (LOD & LOQ)
Presentation and Workshop: Selecting Analytical Procedures and Setting Acceptance Criteria of Impurities during Drug Substances Synthesis
- Purity analysis by HPLC, impurity profile
- Residual solvents by GC
- Inorganic impurities (heavy metals, sulphated ash)
- For chiral compounds in addition: enantiometric purity and proof of the absolute configuration
In the Workshop the participants will learn which activities are necessary to characterize drug substances taking into account the following aspects:
- Analytical procedures are necessary for the characterization
- Experiments necessary to check the downstream impurities in order to justify acceptance criteria for the respective impurities
- Other impurities have to be taken into account
- Experiments to be performed in order to get a stability-indicating analytical procedure
Leachables and Extractables
- Why should Extractables & Leachables be assessed?
- Regulatory requirements in the EU and US
- Compendial requirements and industry standards
- Safety qualification of Leachables and Extractables
Unexpected Impurities: Approaches for Investigation and Determination
- Is there such a thing as ‘unexpected impurities” or is there a lack of process understanding?
- Valsartan – overview of events
- Source of contamination
- Mechanistic understanding
- Examination of risk within other Sartans – overview of how to conduct a risk assessment and to identify key factors
- Are there other Mutagenic Impurities related risks?