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what is deference b/w the working standard and reference
standard

Answer Posted / tushar

Reference std is like USP,EP std , in this std we get COA
including results of Potency by HPLC , NMR & XRPD data.
whenever there is requirement of w.std preparation first we
have get API rawmaterial from warehouse & we check assay ,
water content or LOD & Related substances aganist reference
std . Some times we are doing analysis in duplicate & get
mean value.then we decide final assay or potency value &
it's validity one year

Is This Answer Correct ?    46 Yes 3 No



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