Assay Is Failed But Disso Got 98.99%, How is it possible.Behind any particularly reason…?
Please specify the assay value how much and limit for both assy and disso, then I will try to explain the cause.
Disso. means the extent (quantity)of drug released into media from the pellets / tablets in specified time in either acid/buffer media…
Assay means the content of the API in pellets/tablets…
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May be there is problem with content uniformity
Hi Mr. Reddy, kindly mention the assay value you have got, apart from this is there any additional peak in the respective sample chromagogram during the testing, there could be many reasons behind the failure 1st u need to identify that failure is not due to the lab error i.e.dilution error, selection of wrong glass ware, system malfunctioninv, weighing error, sample is hygroscopic or light sensitive which might have led to the degradation, sample preparation error i.e.insufficient sonication time or shaking time , ensure that lamp intensity might not have reduced during this run this can be eliminated by verifying the SST criteria got complied including BkT std. immediately injected after that sample. Ensure sample is filtered using the same filter mentioned in the MOA. During the vial filling sample might have got diluted due to the traces of diluent present at the mouth of the flaks. Injection volume selected is as per MOA. Assay value can be challenged by performing the CU test using the same chromatographic and sample preparation procedure.
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Assay 95 to 105%,
Disso NLT80%(Q)
Yes But if Uniformity Of content is problem than disso 6 bowls how to pass Any chance is there
What a explaination Shailesh sir.
Thanks a lot sir ji.
You have explained too much nformative .