Bioequivalence and Bioavailability Forum • Quantification of S-amlodipine

Quantification of S-amlodipine [PK / PD]

posted by Helmut – Vienna, Austria, 2016-06-06 22:23 (3313 d 01:20 ago) – Posting: # 16403
Views: 8,818

Dear Mauricio,

we have done that for other drugs where only the racemate is commercially available as a certified standard. You have to assess and quantify the enantiomeric purity (which is not given in the CoA). Had no issues with the EMA (current GL).

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

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Complete thread:

Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2015-10-07 00:24 [PK / PD]
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-03 22:33
  - Quantification of S-amlodipine Mauricio Sampaio 2016-06-06 16:19
    - Quantification of S-amlodipineHelmut 2016-06-06 20:23
      - Quantification of S-amlodipine nobody 2016-06-07 08:29
        
        Quantification of S-amlodipine Mauricio Sampaio 2016-06-07 18:35
        
        Quantification of S-amlodipine Helmut 2016-06-08 01:32
        
        Quantification of S-amlodipine Mauricio Sampaio 2016-06-09 21:48
- Linear Pharmacokinetics of Levamlodipine martin 2016-06-09 15:22
  - Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-09 22:03
    - Linear Pharmacokinetics of Levamlodipine martin 2016-06-12 21:48