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| Pharmaceutical Expertise > Chemical Analysis of Pharmaceutical and Bio-pharmaceutical Products and Materials |
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Chemical Analysis of Pharmaceutical and Bio-pharmaceutical Products and Materials |
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Intertek ASG provides comprehensive laboratory services in chemical analysis for Pharmaceuticals and Biopharmaceuticals. These including a range of advanced analytical services for complex characterization, problem solving, regulatory analysis and combined regulatory packages. A dedicated routine testing department offers compliant, cost-effective services in more standardized areas of analysis.
Pharmaceutical and Biopharmaceutical Chemical Analysis Services Include:
Standard and Routine Testing Services:
- QC services including pharmacopoeial testing of raw materials, intermediates, APIs and finished products
- Long term stability studies
- Pharmaceutical trace element analysis
- Pharmaceutical trace metal analysis
- Physical property prediction and measurement
Advanced Analytical Services for Chemical Analysis of Pharmaceuticals:
- Method development and validation
- Characterization of products, impurities and product related impurities (e.g. for CMC sections) by:
- NMR, MS, MS/MS, LC-MS/M, vibrational spectroscopy
- Organic volatile impurity (OVI) and residual solvent analysis
- Characterization of macromolecules including:
- Peptides, proteins and oligonucleotides
- Synthetic oligomers and polymers
- Surfactant analysis in pharmaceuticals, detergents and toiletries
- Chiral analysis:
- Chiral chromatography and chiral NMR
- Physical Sciences Analysis:
- Polymorphism studies, crystal habit
- Aggregation studies for proteins and viral vectors
- Early phase stability studies with characterization of degradation products
- Extractables and leachables studies:
- The interaction and compatibility of pharmaceutical products with packaging
- Ink and colorant analysis for pharmaceuticals
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