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Thursday, February 21, 2013

Difference Between PURITY, ASSAY & POTENCY

It is calculated by area normalisation method, it can be directly find out by chromatograms obtained from HPLC.
% Purity = (Area of desired peak / Sum of area of all peaks) x 100
It is calculated against standard. It may be of following types:
1) On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x potency or assay of standard
2) On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100
3) On dried basis = (Assay on as is basis / 100 – LOD) x 100
 100 – (moisture or LOD + residual solvents + heavy metals + sulphated ash + impurities)

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