USP launches new standards

July 9, 2020 by Chain Drug Review Jaap Venema, nitrosamine impurities in the drug supply chain, United States Pharmacopeia—National Formulary general chapte, USP Pharmacy

ROCKVILLE, Md. – USP has announced the release of six new Reference Standards to support manufacturers and regulators in analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain. N-Nitrosodimethylamine (NDMA) (1 mg/mL in methanol) N-Nitrosodiethylamine (NDEA) (1 mg/mL in methanol) N-Nitrosodiisopropylamine (NDIPA) (1 mg/mL in methanol) N-Nitrosodibutylamine (NDBA) (1 mg/mL in methanol) N-Nitrosoethylisopropylamine (NEIPA)