FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

Titel:
FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
Herkunft/Verlag:

FDA

Inhalt:
This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine2 impurities in pharmaceutical products

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