The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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



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

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GMP Conferences by Topics

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