How to develop the method when we have very low amount of
impurity?
Answer Posted / balaji
IN THIS CASE INCRESE SAMPLE CONCENTRATION EG; MY DRUG KNOW
IMPURITES LIMIT IS 0.05% UNKNOW IMP LIMIT IS 0.03% INTHIS
CASE STD PREPARATION IS 5MG/100 FURATHER 1/100 THIS IS KNOW
IMPURITES CONCENTRATION 3/100 AND 1/100 THIS UNKNOW IMP
MEANS API, SAMPLE CONCENTRATION IS 1MG/ML IF STD AREA IS
NOT COME INCRESE THE SAMLE CONCENTRTION MEANS
10/100*1/100*10/20*100=0.05% SAMLE CONCENTRATION IS 2MG/ML
| Is This Answer Correct ? | 1 Yes | 3 No |
Post New Answer View All Answers
How to determine water content of bis tetrazole amine mono ammonium salt
please explain about aluminium hydroxide assay
WHAT IS THE CRITERIA FOR SELECTION OF TIME OF DISSOLUTION AND THE MEDIUM OF DISSOLUTION?
can i use hplc detector to uplc and why?
how to set sample and standard concentration in RS method?
why xterra column require to use at higher ph?
What is the difference between purge septum flow and column flow in gas chromatography?
USP methodology, EP methodology, IP methodology, among three if possible to use one methodology for qualify working standard to use USP, EP, IP ? Please explain...
What is the diffrence in japan mkt requirement in analytical method validation over US?
In which situation we require to analytical method validation of excipient?
Qc interview questions
How do we get end points and how many end points are possible for citric acid and di-acid not theorotically answer should be given practically.
What is shaking level in GC?
Why we check moisture,ash & AIA in product
What is split ratio in Gc? Splitless? how requirr to select?