📚 Nitrosamine Exchange - Analytical Hub

@trust_user_a @trust_user_b @trust_user_c Another milestone for our Nitrosamine Knowledge Community … We are beyond excited about the launch of the new Nitrosamine Exchange - Analytical Hub!

Our entire community across the world reacted swiftly to address the new and previously unrecognized risk associated with the safety and quality of medicines due to the presence of nitrosamine impurities. In response to the challenge posed by the presence of nitrosamines
in pharmaceuticals, Pharmacopeias around the world supported manufacturers and regulators with standards as well as other tools and solutions to test for and assess the risk of nitrosamine
impurities. The USP’s Nitrosamine team has been working to develop sensitive and selective analytical procedures for nitrosamines monitoring in pharmaceuticals.

The Analytical Hub is a public repository of non-compendial analytical methods developed to provide an analytical resource to monitor nitrosamine impurities in drug products, drug substances, or other matrices. It is intended as a resource for informational purposes only and not as a USP-NF compendial documentary standard. The analytical methods, aka “Application Notes” are developed by USP staff without a public comment period. They do not reflect USP or USP’s Expert Body opinions on future revisions to the official text of the USP-NF. The procedures described in the analytical notes should be validated by the user for the intended use

USP’s scientists have curated the analytical methods described in the analytical notes through internal development/validation or scientific review of non-compendial donations. If you are interested in donating an analytical method for the hub, collaborating with USP for the development of a novel method, or inquiring about specific analytical methods needs, please do by messaging @Naiffer_Host - community manager

Access the Analytical Hub inside the community here:


If you would like to invite a colleague or members of your team to join Nitrosamine Exchange and explore the new Analytical Hub, follow this two steps:

  1. Click “Share”

  2. In the pop window click “Invite”

  3. Add the email address of your colleague or team member, Click “Save and Send Email”



Is it possible to share nitrite methodology as well? I know that the group from Lhasa has some specific guidance around the method and validation that may be mutually beneficial to post.

That’s an excellent initiative @Naiffer_Host @romnaiffer .
Will be sharing it across my network​:+1:


Yes, that is the plan. We are currently validating the method and will post the app note after completion of validation exercise here.


That is great to hear!

1 Like