2.9.5. Uniformity of mass of single-dose preparations EUROPEAN PHARMACOPOEIA 11.

Place the cylinder in the apparatus and immediately rotate nature of the container precludes heating at this temperature,
the cylinder, at 100 r/min for example. At predetermined dry at a lower temperature to constant mass. Allow to cool
intervals, withdraw a sample from the zone midway between in a desiccator and weigh. The mass of the contents is the
the surface of the dissolution medium and the top of the difference between the weighings. Repeat the procedure with
rotating cylinder, not less than 1 cm from the vessel wall. another 19 containers.
Perform the assay on each sample, correcting for any volume
withdrawn, as necessary. Repeat the test with additional
patches. 01/2017:20906
4. INTERPRETATION
The requirements are met if the quantity of active substance(s)
released from the patch, expressed as the amount per surface
area per time unit, is within the prescribed limits at the
defined sampling times. 2.9.6. UNIFORMITY OF CONTENT OF
SINGLE-DOSE PREPARATIONS
The test for uniformity of content of single-dose preparations
01/2008:20905 is based on the assay of the individual contents of active
substance(s) of a number of single-dose units to determine
whether the individual contents are within limits set with
reference to the average content of the sample.
The test is not required for multivitamin and trace-element
2.9.5. UNIFORMITY OF MASS OF preparations and in other justified and authorised
circumstances.
SINGLE-DOSE PREPARATIONS
Method. Using a suitable analytical method, determine the
Weigh individually 20 units taken at random or, for single-dose individual contents of active substance(s) of 10 dosage units
preparations presented in individual containers, the contents taken at random.
of 20 units, and determine the average mass. Not more than Apply the criteria of test A, test B or test C as specified in the
2 of the individual masses deviate from the average mass by monograph for the dosage form in question.
more than the percentage deviation shown in Table 2.9.5.-1
and none deviates by more than twice that percentage. TEST A
For capsules and powders for parenteral administration, The preparation complies with the test if each individual
proceed as described below. content is between 85 per cent and 115 per cent of the average
content. The preparation fails to comply with the test if
CAPSULES more than one individual content is outside these limits or if
Weigh an intact capsule. Open the capsule without losing any one individual content is outside the limits of 75 per cent to
part of the shell and remove the contents as completely as 125 per cent of the average content.
possible. For soft shell capsules, wash the shell with a suitable If one individual content is outside the limits of 85 per
solvent and allow to stand until the odour of the solvent is no cent to 115 per cent but within the limits of 75 per cent to
longer perceptible. Weigh the shell. The mass of the contents 125 per cent, determine the individual contents of another 20
is the difference between the weighings. Repeat the procedure dosage units taken at random. The preparation complies with
with another 19 capsules. the test if not more than one of the individual contents of the
Table 2.9.5.-1 30 units is outside 85 per cent to 115 per cent of the average
content and none is outside the limits of 75 per cent to 125 per
Pharmaceutical Form Average Mass Percentage cent of the average content.
deviation
Tablets (uncoated and 80 mg or less 10 TEST B
film-coated) The preparation complies with the test if not more than one
More than 80 mg and 7.5
less than 250 mg individual content is outside the limits of 85 per cent to
115 per cent of the average content and none is outside the
250 mg or more 5
limits of 75 per cent to 125 per cent of the average content.
Capsules, granules Less than 300 mg 10 The preparation fails to comply with the test if more than
(uncoated, single-dose) 3 individual contents are outside the limits of 85 per cent
and powders (single-dose) 300 mg or more 7.5
to 115 per cent of the average content or if one or more
Powders for parenteral More than 40 mg 10 individual contents are outside the limits of 75 per cent to
administration* 125 per cent of the average content.
(single-dose)
If 2 or 3 individual contents are outside the limits of 85 per
Suppositories and pessaries All masses 5
cent to 115 per cent but within the limits of 75 per cent to
Powders for eye-drops and Less than 300 mg 10 125 per cent, determine the individual contents of another
powders for eye lotions 300 mg or more 7.5 20 dosage units taken at random. The preparation complies
(single-dose) with the test if not more than 3 individual contents of the
* When the average mass is equal to or below 40 mg, the preparation 30 units are outside the limits of 85 per cent to 115 per cent
is not submitted to the test for uniformity of mass but to the test for of the average content and none is outside the limits of 75 per
uniformity of content of single-dose preparations (2.9.6).
cent to 125 per cent of the average content.
POWDERS FOR PARENTERAL ADMINISTRATION TEST C
Remove any paper labels from a container and wash and dry The preparation complies with the test if the average content
the outside. Open the container and without delay weigh the of the 10 dosage units is between 90 per cent and 110 per cent
container and its contents. Empty the container as completely of the content stated on the label and if the individual content
as possible by gentle tapping, rinse it if necessary with water R of each dosage unit is between 75 per cent and 125 per cent
and then with alcohol R and dry at 100-105 °C for 1 h, or, if the of the average content.

358 See the information section on general monographs (cover pages)