Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF

Guidance, Documents, Resources
#1

A little off our core Nitrosamine Impurity discussions. I want to make all you aware of the recent publication of USP’s Stimuli Article ’ Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF ’
Recent concerns about the presence of mutagenic impurities in the commercial drug supply have focused attention on the need to address this important category of impurities in both general chapters and in monographs for official articles within the USP–NF . The purpose of this Stimuli article is to briefly describe some of the unique challenges posed by both mutagenic impurities and potentially mutagenic impurities and to solicit early input on how USP could best support manufacturers to ensure product quality.

Link to access the document and submit comments: USPPF Stimuli Article access

@trust_user_a @trust_user_b

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#2

Hi Nafier;
Can you please let me know of a specific chemical testing company that will test my medications and assay them for NDMA or any nitroso-amines in them? I have reached a website from the FDA but to no avail. I thought I would come to the source to get a more direct response.
Thank you in advance for your time and consideration.

Best Regards;

John Caponetto

#3

Sorry Naffier, I misspelled your first name. Hope you are well.

#4

Unfortunately just FDA can provide the guidance and answer you might be looking for. There is a website with common Q&A: Information about Nitrosamine Impurities in Medications | FDA

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#5