2.9.5. UNIFORMITY OF MASS OF SINGLE-DOSE PREPARATIONS

1 UNIFORMITY of mass of SINGLE-DOSE preparationsEUROPEAN pharmacopoeia UNIFORMITY OF MASS OFSINGLE-DOSE PREPARATIONSW eigh individually 20 units taken at random or, forsingle-dose PREPARATIONS presented in individual containers,the contents of 20 units, and determine the average more than 2 of the individual masses deviate from theaverage mass by more than the percentage deviation shownin Table and none deviates by more than twice capsules and powders for parenteral use, proceed asdescribed possible. For soft shell capsules, wash the shell with asuitable solvent and allow to stand until the odour of thesolvent is no longer perceptible.

2 Weigh the shell. The the procedure with another 19 FormAverage MassPercentagedeviation80 mg or less10 More than 80 mg andless than 250 (uncoated andfilm-coated)250 mg or more5 Less than 300 mg10 Capsules, granules(uncoated, SINGLE-DOSE )and powders ( SINGLE-DOSE )300 mg or for parenteral use*( SINGLE-DOSE )More than 40 mg10 Suppositories and pessariesAll masses5 Powders for eye-drops andpowders for eye lotions( SINGLE-DOSE )Less than 300 mg300 mg or * When the average mass is equal to or below 40 mg, the preparationis not submitted to the test for UNIFORMITY of mass but to the test foruniformity of content of SINGLE-DOSE PREPARATIONS ( ).

3 POWDERS FOR PARENTERAL USER emove any paper labels from a container and wash and drythe outside. Open the container and without delay weighthe container and its contents. Empty the container ascompletely as possible by gentle tapping, rinse it if necessarywithwater Rand then withalcohol Rand dry at 100-105 Cfor 1 h, or, if the nature of the container precludes heatingat this temperature, dry at a lower temperature to constantmass. Allow to cool in a desiccator and weigh. The mass ofthe contents is the difference between the weighings. Repeatthe procedure with another 19 UNIFORMITY OF CONTENT OFSINGLE-DOSE PREPARATIONSThe test for UNIFORMITY of content of SINGLE-DOSE preparationsis based on the assay of the individual contents of activesubstance(s) of a number of SINGLE-DOSE units to determinewhether the individual contents are within limits set test is not required for multivitamin and trace-elementpreparations and in other justified and Using a suitable analytical method, determine theindividual contents of active substance(s)

4 Of 10 dosage unitstaken at the criteria of test A, test B or test C as specified in themonograph for the dosage form in ATablets, powders for parenteral use, ophthalmic inserts,suspensions for injection. The preparation complies withthe test if each individual content is between 85 per cent and115 per cent of the average content. The preparation fails tocomply with the test if more than one individual content isoutside these limits or if one individual content is outside thelimits of 75 per cent to 125 per cent of the average one individual content is outside the limits of 85 percent to 115 per cent but within the limits of 75 per cent to125 per cent, determine the individual contents of another20 dosage units taken at random.

5 The preparation complieswith the test if not more than one of the individual contentsof the 30 units is outside 85 per cent to 115 per cent of theaveragecontentandnoneisoutsidethelimi tsof75percentto 125 per cent of the average BCapsules, powders other than for parenteral use, granules,suppositories, pessaries. The preparation complies with thetest if not more than one individual content is outside thelimits of 85 per cent to 115 per cent of the average of 85 per cent to 115 per cent of the average contentor if one or more individual contents are outside the limits of75 per cent to 125 per cent of the average 2 or 3 individual contents are outside the limits of 85 percent to 115 per cent but within the limits of 75 per cent to125 per cent, determine the individual contents of another20 dosage units taken at random.

6 The preparation complieswith the test if not more than 3 individual contents of the30 units are outside the limits of 85 per cent to 115 percent of the average content and none is outside the limits of75 per cent to 125 per cent of the average CTransdermal patches. The preparation complies with thetest if the average content of the 10 dosage units is between90 per cent and 110 per cent of the content stated on thelabel and if the individual content of each dosage unit isbetween 75 per cent and 125 per cent of the average FRIABILITY OF UNCOATEDTABLETSThis chapter provides guidelines for the friabilitydetermination of compressed, uncoated tablets.

7 The testprocedure presented in this chapter is generally applicableto most compressed tablets. Measurement of tablet friabilitysupplements other physical strength measurements, such astablet breaking a drum, with an internal diameter between 283-291 mmand a depth between 36-40 mm, of transparent syntheticpolymer with polished internal surfaces, and subject tominimumstaticbuild-up( ).Onesideof278 See the information section on general monographs (cover pages)