Intertek Pharmaceutical Services offer service "Pharmaceutical Impurity Analysis and Identification Testing"
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Service Name
Pharmaceutical Impurity Analysis and Identification Testing
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Specifications
- Test Method: ICH Q3A(R2) and Q3B(R2) impurity testing covering extractables and leachables, elemental impurities, residual solvent (OVI/VOC) analysis and process-related impurities.
- Accreditation Standard: GMP-compliant laboratories deliver impurity testing supporting new drug substances and drug products throughout the product life cycle.
- Sample Type: Applies across dosage forms, product classes and delivery technologies, including inhaled products, with expertise in difficult sample matrices.
- Detection Limit: Scientists routinely address low detection limits required for genotoxic and elemental impurity control in difficult sample matrices.
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