The metabolically competent human cell system reported here may be a useful model for risk assessment of nitrosamine impurities found in drugs.doi:10.1007/s00204-022-03347-6Li, XilinNational Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, USAHe, Xiaobo...
Karassali, H. N‐Nitrosamine Impurities in Ethalfluralin: Keywords: pesticide; impurity; N-nitrosamine; GC-MS; chemical ionization; SPE; dilute and shoot DetermiCniatattiioonn :oBfa laany iaOnvneisr,lGo.oP.k; Kedar asali, DeleteriHou. Ns -SNoituro...
数据保密与知识产品 保护,让您更安心法规指导 《中华人民共和国药品管理法》 《药品注册管理办法》 《药品生产质量管理规范》 《中国药典》2020版 欧盟标准:BS EN 12868. 美国联邦法规:21CFR 201.323 ICH USP FDA-Control of Nitrosamine ...
The recent detection of potent carcinogenic nitrosamine impurities in several human medicines has triggered product recalls and interrupted the supply of critical medications for hundreds of millions of patients, illuminating the need for increased testing of nitrosamines in pharmaceutical products. However, ...