Elemental Impurities

Since 2018 Brightlabs possesses an opium exemption from the BMC (Bureau for Medicinal Cannabis), for the analysis of cannabis and related products. The combination of this opium exemption, combined with our GMP accreditation, makes Brightlabs an important partner for the analysis of cannabis and related ma...

We are specialist in the method development of analytical methods for analysis of API, Final Drug Products or low level impurities. Usually followed by full validation in accordance to ICH guidelines.

In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...

Brightlabs has developed and validated multiple methods (GC-MS/MS & LC-MS/MS) to determine low level concentrations of Nitrosamines and NDSRIs in Drug Products