Impurities 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
Control of Impurities in Ph.Eur.
- Which impurities are controlled?
- General texts/monographs/ICH Guidelines
- Organic impurities in Ph. Eur.
- Specification Setting
- Elemental impurities
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: Analytical Techniques for Determination and Qualification of Impurities in Starting Materials and Intermediates
Applying an example of an API synthesis the participants will learn in the Workshop 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
Extractables and Leachables – What is Expected from Packaging Materials for Drug Products?
- Why should Extractables & Leachables be assessed?
- Regulatory requirements and guidelines in the EU and US and pitfalls
- General flow and critical aspects of Extractables & Leachables studies
- Safety qualification of Extractables and Leachables
How to Avoid Unexpected Impurities: Approaches to Establish a Holistic Understanding of Impurity Risks
- 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?