Assay Calculation of Tablets (Not Powdered)

[jayroseville58]

What if the USP Monograph states an assay sample preparation wherein five tablets (not powdered) is to be transferred in a 250-ml volumetric flask. Do we still need to incorporate the Average Tablet Weight in the Assay formula of calculation? Any guidelines that can be used as basis?

[Fernando]

Hi

You have to divide by 5 not using the average weight of the sample. Idon't know if there is an official guideline, I use my own judgement:

Best luck

Fernando

[krickos]

In USP monographs, look at the start of the monograph,

"»X Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of X"

That would indicate Lable claim, not weight corrected. Label claim would be standard/first choice nowadays, but some products may still have weight corrected assay, if so clearly stated in specifications.
If your registered specification not only refer to the monograph it is often stated if it is label claim or weight corrected.