WHO Revision on Rafampicin Monograph and Test Method

WHO following the determination of traces of nitrosamines in some batches of rifampicin active pharmaceutical ingredient, is proposed to revise the corresponding monograph. The revision is based on information found in other pharmacopeias and in the public domain and on laboratory investigations.

The revision include language for the manufacturers:

Manufacture. The production method is validated to demonstrate to the requirements of the responsible regulatory authority that the suspected carcinogenic nitrosamine 1-nitroso-4-methyl piperazine (MeNP) is eliminated or minimized and adequately controlled in the final product. A suitable method to determine MeNP in Rifampicin active pharmaceutical ingredient or Rifampicin tablets can be found in the Supplementary Section of The International Pharmacopoeia under Test methods used during development or manufacture.

19Oct22 Rafampicin WHO revision.pdf (3.2 MB)