- 1) We offer unrivaled expertise in residual impurity testing and analysis for biopharmaceuticals, backed by our global network and regulatory knowledge.
- 2) At Intervein, all residual solvent studies are performed in accordance with defined USP Residual Solvents <467> method.
- 3) We provide a comprehensive range of advanced chromatography and mass spectrometry instrumentation, coupled with extensive method development expertise, to optimize analytical methods for impurity analysis. The optimized method can be validated as a limit test or through full ICH Q2(R1) validation in compliance with GMP standards.
- 4) To find out more about our process related impurities analysis services, contact us today.