Analytical Development Services

Chempartner Europe APS offers a wide range of process r&d & cmc manufacturing services which includes analytical development services. Features: it provides strong support for drug substance and drug product development. The quality of our analytical development is backed by the experience of our highly skilled scientists and scientific management, state- of-the-art instrumentation, close cross-functional interaction, adherence to standard operating procedures, extensive regulatory training, and quality assurance oversight. All standard test and protocols are carried out per ich and usp guidelines, where applicable. Chemical and formulation development support includes analytical methods development and validation;in-process control method development; starting material and raw material testing; impurity profiling; etc. Release testing for drug substances and drug products includes methods development and validation; purity assay; total related substances; dissolution and content uniformity; residual solvent quantification; etc. Reference standard qualification as per ich guidelines includes appearance (usp); id (by hplc and ir); ph (usp); assay (stability indicating method); related substances. Contact us for more information.