Quality control

In addition to synthesis development and GMP manufacturing, we offer a wide range of instrumental and wet-chemical analytics services (including stability tests) for identity, purity and content tests. Our portfolio includes the creation of specifications for active pharmaceutical ingredients according to ICH Q6A as well as routine analysis according to verified pharmacopoeial methods and the development of analytical methods, including their validation for active ingredients and other end products, their intermediates and regulatory starting materials.

Quality control tasks also include testing the stability of our active pharmaceutical ingredients (chemical-physical stress tests, formal stability studies), including photostability studies (stress tests, confirmatory tests).

Our extensive stability studies according to ICH Q1A/Q1E or Q1B give you the security you need for the stability of your product.

Our equipment of qualified analysis devices:

HPLC, UHPLC
gas chromatography with FID and MS detection, Headspace GC
IR and UV-Vis spectroscopy, polarimetry and refractometry (focus on identity tests)
thin layer chromatography (focus on turnover control)
titrations (incl. Karl Fischer)
PSD via laser diffraction
further methods for pharmacopoeial analytics (Ph. Eur., USP, JP)

You still have questions? Then contact us!

Contact Person: Dr Uwe Müller