Jm. Martins et A. Farinha, Uniformity of dosage units - comparative study of methods and specifications between Eur. Pharm. 3rd and USP 23, J PHARM B, 18(4-5), 1998, pp. 487-495
Methods and specifications of fur. Ph. 3rd Ed.;Ind USP 23 for the evaluatio
n of the uniformity of dosage units were compared, in relation to: (i) allo
wed dispersion of the sample; and (ii) adequability to control the individu
al contents of active ingredient in relation to the labelled amount. Using
the characteristics of the normal distribution curve, we calculate: (1) the
highest dispersion allowable, represented by the relative standard deviati
on of the uniformity of mass of single-dose preparations of fur. Ph. 3rd Ed
., (results were 3.4, 5.1 and 6.8% for L1 = 5, L = 7.5 and L = 10, respecti
vely); and (2) for all the methods studied the allowable units frequency fo
r different intervals of the labelled amount. Differences between the tests
of fur. Ph. 3rd Ed. and USP 23 can lead to acceptance samples with very di
fferent individual contents variability, namely if the limit specifications
for the strength was +/- 10%. The main reasons for that are: (1) in fur. P
h. 3rd Ed., the limits are set with reference to the average content of the
sample, and in USP 23, they are set with reference to the labelled amount
of the active ingredient; and (2), the USP 23 calculates the content of act
ive ingredient in each tablet from the result of the assay, when the weight
variation method was used. Taking +/- 5% of label claim as the specificati
on for the strength of the product, according EEC requirements, the maximum
percentage of units outside the range 95-105% of label claim allowed by fu
r. Ph. 3rd Ed. and USP 23 tests are similar. (C) 1998 Elsevier Science B.V.
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