Through assay by hplc(anhydrous basis) product got 100.8% .How much the potency

Through assay by hplc(anhydrous basis) product got 100.8% .How much the potency of that product.Moisture content is 1.7%,Sulfated ash is 0.02%,Total impurities are 0.3%

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Through assay by hplc(anhydrous basis) product got 100.8% .How much the potency of that product.Mois..

Answer / venkata naveen talluri

It is not possible to tell the potency based on the assay value. Impurity profile from the related substances is used to calculate the potency.

potency=100-(moisture content+sulfated ash+total impurities)
=100-(1.7+0.02+0.3)
=100-2.02
=97.98
=98%

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Through assay by hplc(anhydrous basis) product got 100.8% .How much the potency of that product.Mois..

Answer / minal

potency= 100- (Total Impurities in RS +Moisture+Residue on Ignition+Residual Solvent)

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