Bioequivalence and Bioavailability Forum • EMA GL: Batch size in validation

EMA GL: Batch size in validation [Bioanalytics]

posted by vajra123 – India, 2010-09-08 15:19 (5774 d 12:18 ago) – Posting: # 5893
Views: 6,415

Hi HS,

❝ Additional question: The method is GC/MS - only 2 µl are injected. Since the idea of the 'batch validation' is essentially to show stability of the column (RT shift, peak shape, etc.) if loaded with extracted matrix, would it be sufficient to repetitively inject from a single vial?

sorry i am not able to get the point of question for the above said.

regards,
Vajra.

—
Vajra

Complete thread:

EMA GL: Batch size in validation Helmut 2010-06-10 14:43
- EMA GL: Batch size in validation Helmut 2010-09-07 12:54
- EMA GL: Batch size in validation vajra123 2010-09-08 05:34
  - EMA GL: Batch size in validation Helmut 2010-09-08 12:36
    - EMA GL: Batch size in validationvajra123 2010-09-08 13:19
      - EMA GL: Batch size in validation Helmut 2010-09-08 13:32
        
        EMA GL: Batch size in validation Ohlbe 2010-09-08 18:03
        
        EMA GL: Batch size in validation Helmut 2010-09-08 18:16
        
        EMA GL: Batch size in validation Ohlbe 2010-09-08 19:03
        
        EMA GL: Batch size in validation Helmut 2010-09-08 19:07