Answer Posted / ch.h.n.prasad reddy
Specificity is one most important parameter in validation,
in this parameter we inject all specified impurities/known
impurities mentioned in that method in specification level,
with the help of this we can check peak purity of specified
impurities /known impurities and Retention time of
impurities. Separation of specified impurities /known
impurities from main API.
Thanks
CH.H.N.PRASAD REDDY
RESEARCH SCIENTIST
Prasadreddy19@gmail.com
| Is This Answer Correct ? | 9 Yes | 0 No |
Post New Answer View All Answers
What is control room temperature and which guide line says?
A ha tc is actual defination of retention time?
what is procedure of actual procedure for registration of drug?
we are performed SOR for a particular product the limit is -6 to -10.We face particular bathes it is not meeting the specification.we performed diffrent instrument diffrent analyst we are getting diffrent diffrent results.solvent is dimethyl sulfoxide what could be the reasion
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
what are the standard methods for HPLC?
what is the origin to prepare standard operating procedure
if rsd failed then what require to do?
What is the difference between chromatographic purity and related substances?
if you have given one product then how you determine the impurity in that?
what is mean by dissolution biowaiver study?
Which type of column should i use to check the purity of high molecular weight protein using HPLC reverse phase column chromatography? Hi everyone. I wanna to check the purity of high molecular weight protein (collagen) with MW of ~130 kDa using a HPLC. I know C18
If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
i want model written test paper for the post of analyst in IOCL(indian oil corporation ltd) any one pls help me
we can use expired sample for validation and analyst qualification?