Pharmaceutical Analysis

We develop customized solutions for our customers in the pharmaceutical industry in the areas of cleaning validation, content determination and impurity testing.

 

 

 

 

To meet your requirements we combine highly specialized analytics and certified quality standards with know-how from research and development.

Our Services

 

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

Our Expertise

 

  • 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

More information

To learn more about our services for the pharmaceutical industry, please download our detailed folder

Contact Us

 

Learn more about our services

Schedule a conversation with
our Pharmaceutical Analysis Experts.

 

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