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Referenzsubstanzen

Reference Substances

The test methods used for the testing of active ingredients and finished products are usually calibrated and validated by using primary and secondary standards. Thus, the quality of the reference substance is significantly relevant for the accuracy of the analytical methods. 

We offer an extensive service for reference substances. Participate from our service and our custom-made solutions for your specific needs:

  • Preparation of reference substance monographs (documentation and validation) which fulfills the legal requirements for application
  • Implementation of working standards including derivation of primary standards or official standards such as USP or Ph.Eur.
  • Shelf-life accompanying requalification of standards used in stability testings according to the necessary tests and quality assessments
  • Production and characterization of reference substances including complete documentation and certification

Contact us. We will be happy to advise you.

GBA PHARMA GMBH

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