原料药溶剂残留分析方法验证8大项(国外英文资料).doc

原料药溶剂残留分析方法验证8大项(国外英文资料) 1. special attributes: A, retention time and relative retention time, the same test error acceptable range is + 2% (specifically how to do it?) B and the degree of separation (as stated in the Pharmacopoeia) 2., precision (whether take 6 control samples in turn, see the residual solvent chromatography peak RSD 10%) What are the system precision, methods, precision, and so on? Intermediate precision: different instruments, different operators, different times, should take a few instruments, a few operators, a few different times to do? 3. test line 4. limits of quantitation (3, 4, two) samples of different concentration gradients, each concentration should be matched with a few parallel samples 5. linearity (what data requirements should be met?) 6. linear range (5 and 6) whats the difference? The linear range needs several points. How much does it take in the range of residue limits? 7. recovery rate (accuracy) (take 100% concentration into six parallel samples, or take 80%, 100%, 120%, 3 parallel samples per concentration Which scheme is better? 8. durability (GC should be specific to do what parameters, parameter range within the range of the predetermined value to do, the results should be statistically required to meet He Zhong requirements) 1. special attributes: you can use the blank and the sample of the sample, you do not have to use retention time 2., precision: the total sample size is 3 redundant, enough to calculate the RSD value on it 3. detection limit: the signal-to-noise ratio 3:1 can be used as the detection limit 4. limit: dont do it. 5. linear: at least 5, to meet your test, the upper and lower limit on the line 6., the current scope: meet the recovery rate qualified, and applicable 7. recovery: choose 80%, 100%, 120% as well 8. durability: change detector temperature, split ratio, column temperature, sample storage time and temperature Internal standard method What is the internal standard method and how to choose the in