WHEN AN UN KNOWN SAMPLE IS GIVEN TO U,HOW WILL U START THE
ANALYSIS(ie FIRST WHICH TEST TO BE DONE,NEXT,THEN NEXT),HOW
WILL U DECIDE WHICH TYPE OF ANALYSIS TO BE DONE FOR IT?
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Answer Posted / dhananjay s chavan
Pre method development requirements
1 Literature search
2 Published method
3 Availability of Pharmacopiel/Supplier/DMF Impurities
4 Availability of Pharmacopiel/Supplier/DMF Method
5 Workability of Pharmacopiel/Supplier/DMF Method
6 Identify different source of API
7 API degradation data from Supplier/DMF
8 API stability data from Supplier/DMF
9 Calculate imp level as per ICH for FPS
Method development
10 API Solubility in different pH
11 API Solubility in different solvent
12 Placebo interference
13 Main peak recovery/peak shape/response
14 Degradation study in different condition with
autoclave
Achieve degradation between 5 to 20%
Peak purity of all known impuriite(s) and main peak
Peak purity of all unknown impurities above LOQ
level
Check the elution of all degradants by extending
runtime
15 Establish LOD/LOQ
16 Filter study
17 Elution of all source impurities in final method
18 Reproducibility of method in different system and
different column lot
19 Check System suitability requirement (Resolution,
Similarity factor, Std RSD…etc)
Parmeteres to be done on finlized method
20 RRF Development in different system
21 LOQ, 100% and 150% Recovery in duplicate
22 Linearity
23 Stability sample and different batch analysis
24 Solution stability
25 Robustness in final method (Flow/temp./pH variation)
26 Method equivalency between final method and other
method(s)
27 Method evaluation by validation team
| Is This Answer Correct ? | 3 Yes | 9 No |
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