Indian Pharmacopoeia introduces a new General Chapter on Nitrosamine Impurities in its 2022 edition

DAB · September 9, 2022, 10:59am

A new General Chapter 5.11 on Nitrosamine Impurities has been introduced in Indian Pharmacopoeia, IP 2022, tentative effective date is 1st December;2022.

Naiffer_Host · September 9, 2022, 10:18pm

@DAB can we get a copy of it?

Yosukemino · September 13, 2022, 5:14pm

Hi, @Naiffer_Host and @DAB.
I found the draft version of 5.11 Nitrosamine Impurities on a website. But I’m not sure if it is the latest or not. I hope it will be helpful to you.

5-11-nitrosamine-impurities.pdf (1.5 MB)

DAB · September 14, 2022, 2:20pm

Hi Naiffer @Naiffer_Host, @Yosukemino
Am yet to receive the official copy of IP 2022, however the draft version that I reviewed is quite on the lines of what is already known about Nitrosamines.

Attached is the notification that I received from IPC.
Salient_Features_of_IP_2022.pdf (330.7 KB)