Nitrosamine Testing
Product
Information
Nitrosamines — potent genotoxic impurities classified as probable human carcinogens — have become one of the most closely scrutinized areas of pharmaceutical quality and regulatory compliance. ResolveMass Laboratories provides sensitive, validated, and fully compliant nitrosamine testing services in direct alignment with FDA, EMA, Health Canada, and ICH M7 guidances. Our nitrosamine capabilities span the full scope of risk assessment and quantification, beginning with Nitrosamine Risk Assessments (NRA) to identify potential nitrosamine formation pathways in your drug substance, drug product, and manufacturing process. Based on this assessment, we design and validate targeted analytical methods capable of detecting nitrosamines at or below the established ...
Distribution Areas
OceaniaNorth America (USA, Canada)Middle East Region (e.g. UAE)Central America (e.g. Mexico)East Asia (e.g. China, Japan, Korea)Europe - EU countriesEurope - non EU (e.g. UK, Russia, ex-CIS countries)South America (e.g. Brazil, Colombia)South Asia (e.g. India, Pakistan, Sri Lanka)
Supplied From
Canada
Main Categories
Contract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs) (Services)Innovative APIsBiopharmaceutical ServicesContract Research Organisations (CROs) (Services)
All Categories
PeptidesExclusive Synthesis of APIsAnalytical Chemistry (Biopharmaceutical Services)Medicinal Chemistry (Biopharmaceutical Services)Analytical DevelopmentDevelopment & Validation of Analytical MethodsBio Analytical ServicesChemical synthesis/analysis
