Bioequivalence and Bioavailability Forum • What’s the problem?

What’s the problem? [Bioanalytics]

posted by Aceto81 – Belgium, 2012-02-16 11:50 (4855 d 12:12 ago) – Posting: # 8128
Views: 6,918

In European Pharmacopea and / or USP is a statement that it is allowed to maximum deviate 5% from the stated weight in the monographs.
eg if you have to weigh 50mg, you are allowed to weigh 45–55mg.

We use this rule for all our analysis, and never had problems with regulatories (at least not on this topic).

Ace

Complete thread:

Extrapolation of Calibration Curve auditor 2012-02-10 06:45
- Exact weight Ohlbe 2012-02-10 12:05
  - Exact weight auditor 2012-02-10 15:54
    - Exact weight: impossible Helmut 2012-02-10 17:33
    - Exact weight Ohlbe 2012-02-10 18:10
      - Exact weight Helmut 2012-02-10 19:15
        
        Exact weight auditor 2012-02-11 06:49
        
        What’s the problem? Helmut 2012-02-11 12:59
        
        What’s the problem? ElMaestro 2012-02-11 20:20
        What’s the problem? auditor 2012-02-13 05:35
        
        Adjusted dilution? Helmut 2012-02-13 13:29
        What’s the problem?Aceto81 2012-02-16 10:50
        
        What’s the problem? auditor 2012-02-16 12:23
        ±5%? Helmut 2012-02-16 13:24
        
        weight pharmino 2012-02-17 21:24
        
        API/formulation Helmut 2012-02-18 13:34