Development, validation and tests in alignment with ICH-guidelines
We experience an increasing demand for analyses, and our highly skilled QC team consists of analytical chemists and laboratory technicians.
NCK runs a state of the art analytical laboratory, which includes HPLC (DAD and CAD), IC, GC-MS and LC-MS/MS (QTOF). In connection with process development and API manufacture, NCK offers development and validation of analytical test methods as well as stability studies according to ICH guidelines. Our analytical laboratory is constantly being updated to meet industry standards and client expectations.
The analytical services include: method transfer, method development (HPLC, LC/MS, IC and GC), drug substance release testing, impurity profiling, method validation according to ICH guidelines as well as genotoxic impurity investigations e.g. test methods for low quantity determination.
600 East Cresent Avenue
Upper Staddle River
New Jersey 07458
Chukan Butsu Ltd
7th Floor, Shiono Nissei Building
6-6, 2-Chome, Doshomachi
Chuo-Ku, Osaka, 541-0045
+81 06 6231 5127