Bioequivalence and Bioavailability Forum • Active moiety

Active moiety [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-01-23 01:54 (4531 d 02:51 ago) – Posting: # 12234
Views: 5,372

Hi Ohlbe,

❝ I'm not a specialist…

… nor am I. I found an interesting draft from the FDA: “Naming of Drug Products Containing Salt Drug Substances”

Active moiety - The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester,* salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule responsible for the physiological or pharmacological action of the drug substance.

The USP has announced plans to revise the USP Salt Policy definition of an active moiety so that it will no longer include “esters.”

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Complete thread:

Biowaiver for low-strength (<5%) Melkor 2014-01-20 13:59 [Regulatives / Guidelines]
- API = salt? Helmut 2014-01-20 14:24
  - API = salt? Melkor 2014-01-20 15:28
    - 5 %: both formulations Ohlbe 2014-01-20 16:21
      - 5 %: both formulations Helmut 2014-01-20 17:04
        
        5 %: both formulations Ohlbe 2014-01-20 17:32
        
        5 %: both formulations Melkor 2014-01-22 12:34
        Active moietyHelmut 2014-01-23 00:54
        
        Change of API and fate of biostudy kumarnaidu 2014-06-27 10:54