Quality Control Services
The company provides extensive quality control services, focusing on synthesis development and GMP manufacturing, alongside a wide array of both instrumental and wet-chemical analytics services. These services encompass identity, purity, and content testing, which include stability tests. Their comprehensive portfolio ranges from the creation of specifications for active pharmaceutical ingredients in alignment with ICH Q6A guidelines, to routine analyses adhering to validated pharmacopoeial methodologies. Furthermore, they specialize in the development and validation of analytical methods for active ingredients, intermediates, and regulatory starting materials. A noteworthy component of their quality control tasks is the evaluation of active pharmaceutical ingredient stability through chemical-physical stress tests and formal stability studies, which are conducted in accordance with ICH Q1A/Q1E or Q1B standards to ensure product stability. The company employs advanced, qualified analytical devices to execute these critical analyses effectively.
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)