Pharmaceutical Analysis

Cleaning Validation

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

Content determination

• Validation of analytical methods according to international standards
   

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)
• Fingerprinting of complex products using metabolomics technologies
• Analysis of the micro molecular profile of a sample

• 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