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