Question { Neuland, 10612 }

How to establish pKa for a new API molecule ?

Answer

BY HPLC, UV, TITRIMETRIC METHODS

Question { Ranbaxy, 48236 }

whate is difference between calibration and validation

Answer

Calibration means system performnce checking
Validations mens method of analysis performance checking

Question { Vimta Labs, 26237 }

what is the peak purity concept?

Answer

Peak purity analysis is an evaluation technique for
detecting the presence of coeluting impurities in HPLC
data. Running a peak purity check prior to analytical
quantitation helps to ensure accuracy. In the development
of analytical methods, peak purity analysis can reveal the
presence of contamination during standardization and, by
doing so, can prevent the subsequent generation of false
analytical data.

Peak purity analysis is also a useful addition to routine
quality control procedures, especially in the analysis of
pharmaceuticals and food products, for which contamination
and quality of results are critical.

Question { Vimta Labs, 26237 }

what is the peak purity concept?

Answer

A technique is described whereby the purity of an HPLC peak
can be determined by using electrospray liquid
chromatography-electrospray ionization mass spectrometry.
Electrospray mass spectra acquired across an HPLC peak are
summed and examined for co-eluting impurities. The mass
spectrometer is set up to produce solely cationised
molecules and background noise is minimized so that minor
coeluting impurities can be observed down to a level of
<0.1% of the major component. This method offers advantages
over using diode-array UV detection (LC-DAD) for the
determination of HPLC peak purity, namely components with
similar UV spectra can be distinguished, the molecular mass
of the impurity can be determined and structural data can
be obtained by using tandem mass spectrometry (MS-MS). The
effectiveness of the technique is demonstrated with drug
substances of pharmaceutical interest which have been
chromatographed on an HPLC system designed to intentionally
co-elute a number of impurity standards with these
compounds.