Validation Parameters of Analytical Methods as per ICH guidelines: PART-2

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  • เผยแพร่เมื่อ 5 ต.ค. 2024
  • This video gives an overviews about the parameters of analytical method validation:
    1. Range
    2. Accuracy of experimental value
    3. API Detection Process
    4. Placebo Matrix
    5. Percentage recovery data of API
    6. Precision of results
    7. Relative Standard Deviation
    8. LOD & LOQ
    9. Robustness
    10. Systems stability tests
    Link of Part-1: • Validation Parameters ...

ความคิดเห็น • 2

  • @sathish-USA
    @sathish-USA 10 หลายเดือนก่อน

    If I understand correctly, you said that determination of impurity range from reporting level to 120% of reporting level, is it accurate? I think it should be reporting to 120% of spec level, right?

  • @BappaHamid-kx9qt
    @BappaHamid-kx9qt 11 หลายเดือนก่อน

    nice explanation