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 ...
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?
nice explanation