Method development for APIs, proprietary chemicals, and intermediates
Bureau Veritas provides method development and validation services for a wide variety of compounds for which sampling and analysis protocols are not available. The service is applicable for active pharmaceutical ingredients (APIs), proprietary chemicals and intermediates, as well as final products in the client pipeline. We use the latest technology in high pressure chromatography, mass spectrometry, elemental analysis, optical analysis, and Ion Chromatography to provide Industrial Hygiene solutions to challenging compounds.
Bureau Veritas has developed methods validation acceptance parameters in accordance with guidelines from OSHA and NIOSH. Within that framework, protocols can be customized to meet the validation requirements for your project. For pharmaceutical applications, assuming you do not have a defined method validation protocol for new methods, we suggest the following protocols to define scope and validation criteria: LC and LC/MS methods, Adaptation of HPLC to LC/MS to Enhance Sensitivity, Adaptation of Air Sampling Methods to Surface Applications.