We are testing a pharmaceutical product FAMOTIDINE
I have a small doubt regarding this pharmacopoeia HPLC methods which are having same parameters, sample preparation ,standard preparation and same column , only difference is In EP pharmacopoeia monograph they are using EP-CRS only. Where as in USP pharmacopoeia monograph they are using USP-RS only.
Please answer my Questions.
1.These two are Monograph methods so as per USP General Chapter <1226> only method verification is required at current facility. My question is for both methods one verification is enough,.
- presently we are doing one batch testing in both methods (EP &USp) separately ,where as both methods and calculation formulas are same?.
It will make two much cost and time waste, is there any guideline to harmonize the both same methods.
3.please guide the correct guidance to comply with current regulatory bodies .
4.how to do verification these two monograph methods by harmonizing .
5.for your reference the comparison table is attached.
I Hope you will guide me in a good way.