MASS VARIATION
Carry out an assay for the active substance(s) on a
representative sample of the batch using an appropriate
analytical method. This value is result A, expressed as
percentage of label claim (see Calculation of Acceptance
Value). Assume that the concentration (mass of active
substance per mass of dosage unit) is uniform. Select not
less than 30 dosage units, and proceed as follows for the
dosage form designated.
Uncoated or film-coated tablets. Accurately weigh 10 tablets
individually. Calculate the active substance content,
expressed as percentage of label claim, of each tablet from
the mass of the individual tablets and the result of the assay.
Calculate the acceptance value.