Guidelines for Antibiotic group drug substances for the limit of Nitrosamine impurities . (Eg. Azithromycin, Erythromycin )

About Nitrosamines Exchange
#1
  1. Is any guidelines for Antibiotic group drug substances for the limit of Nitrosamine impurities . (Eg. Azithromycin, Erythromycin )
  2. Specially those drugs are formed by the fermentation is any specific guidance for Nitrosamine Impurities. (Eg. Vancomycin Hydrochloride).
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#2

In Europe, according to EMA requests:
Nitrosamine impurities

Marketing authorisation holders should complete the confirmatory testing and submit their variation applications by:

1 October 2023 for chemical medicines;
1 July 2023 for biological medicines.

No special indications were given for fermentation APIs. So, in my opinion, antibiotics made by fermentation only should be classified as biological medicines.

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#3

@paliog sir , Thanks for your valuable information.