FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
Titel:
FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products.