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%
Answer Posted / 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%
Is This Answer Correct ? | 15 Yes | 2 No |
Post New Answer View All Answers
what is the difference between potentiometric titration and karl fischer titration?
how require to interprit the method precision data of hptlc?
Loss of linearity in tkn analysis, possible reasons?
What is the acceptance criteria for moisture balance when calibrated with sodium sulfate
Why are use silicon oil mr?
Why sodium hydroxide used for maintain pH of phosphate buffer
can i use hplc detector to uplc and why?
how you start the solubility study?
Why a1% value is used for some product ? What is the criteria for selection a1% value ?
Why six unit used for precision?
Tell me about analytical method validation in QC
what is the principle of UV Vis spectroscopy, AAS, ICP OES,ICPAES, ICP-MS and FTIR
is it nessesary to do solution stability for 7 days?
What is the difference between chromatographic purity and related substances?
Which are the diffrent grades of api in pharma?