Pharmaceutical Analysis

Analytical method development and validation

• development, optimization of highly sensitive and highly selective analytical methods depending on the required detection limits: e.g. (U)HPLC-UV, (U)HPLC-MS, GC-MS
• customised to specific inquries
• according to international guidelines and GLP, GMP
• method transfer to and from our lab

API assay testing 

• assay method development and validation
• detect and analyse API content in drug formulations and all dosage forms
• HPLC-UV, HPLC-MS

Nitrosamine testing

• ...

Impurity testing

• Testing for specific impurities in raw materials, intermediate and end products
• Identification of unknown process-related by-products and stability-related degradation products using high-resolution mass spectrometry (LTQ Orbitrap XL, Exactive, Q-Exactive)
• Analysis of the molecular profile of a sample

Cleaning Validation

• Conceptual design of sampling: surface sampling using swab technique or rinse technique
• Optimization of sampling procedures
• Development of customized sample preparation
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• Flexible sample analysis tailored to your cleaning validation projects
• Analytics to support qualification of sampling by factory employees (incl. employee training)

• Long-term experience in analysis for the pharmaceutical industry
• Long-term experience with pharmaceutical formulations
• Flexible implementation of your project from method development to sample analysis
• Sampling and sample preparation
• Sample logistics
• Analytics for batch release
• Analytics for stability tests of drug formulations
• Analytics for cleaning validation projects
• Support in the creation of documents relevant to authorities
• Data management and data transfer