Bioequivalence and Bioavailability Forum • What’s the problem?

What’s the problem? [Bioanalytics]

posted by auditor – India, 2012-02-16 13:23 (4859 d 14:50 ago) – Posting: # 8129
Views: 7,041

❝ In European Pharmacopea and / or USP is a statement that it is allowed to maximum deviate 5% from the stated weight in the monographs.

I do agree with you. but here the topic is what to do if some thing is prepared high then the establish one.

I just want to say we need to inject one P&A to justify slightly increased ULOQ. Here we are not changing the range but using of ULOQ which is just slightly beyond the establish one in method validation.

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