2.9.6. Uniformity of content of single-dose preparations EUROPEAN PHARMACOPOEIA 10.

Table 2.9.5.-1 30 units is outside 85 per cent to 115 per cent of the average
Pharmaceutical Form Average Mass Percentage content and none is outside the limits of 75 per cent to 125 per
deviation cent of the average content.
Tablets (uncoated and 80 mg or less 10 TEST B
film-coated)
More than 80 mg and 7.5 The preparation complies with the test if not more than one
less than 250 mg individual content is outside the limits of 85 per cent to
250 mg or more 5 115 per cent of the average content and none is outside the
10
limits of 75 per cent to 125 per cent of the average content.
Capsules, granules Less than 300 mg
(uncoated, single-dose) The preparation fails to comply with the test if more than
and powders (single-dose) 300 mg or more 7.5 3 individual contents are outside the limits of 85 per cent to
115 per cent of the average content or if one or more individual
Powders for parenteral More than 40 mg 10
administration* contents are outside the limits of 75 per cent to 125 per cent
(single-dose) of the average content.
Suppositories and pessaries All masses 5 If 2 or 3 individual contents are outside the limits of 85 per
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
(single-dose) 20 dosage units taken at random. The preparation complies
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
uniformity of content of single-dose preparations (2.9.6). of the average content and none is outside the limits of 75 per
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.
nature of the container precludes heating at this temperature,
dry at a lower temperature to constant mass. Allow to cool
in a desiccator and weigh. The mass of the contents is the 01/2010:20907
difference between the weighings. Repeat the procedure with
another 19 containers.

01/2017:20906
2.9.7. FRIABILITY OF UNCOATED
TABLETS(7)
This chapter provides guidelines for the friability
determination of compressed, uncoated tablets. The test
2.9.6. UNIFORMITY OF CONTENT OF procedure presented in this chapter is generally applicable to
SINGLE-DOSE PREPARATIONS most compressed tablets. Measurement of tablet friability
supplements other physical strength measurements, such as
The test for uniformity of content of single-dose preparations tablet breaking force.
is based on the assay of the individual contents of active Use a drum, with an internal diameter between 283-291 mm
substance(s) of a number of single-dose units to determine and a depth between 36-40 mm, of transparent synthetic
whether the individual contents are within limits set with polymer with polished internal surfaces, and subject to
reference to the average content of the sample. minimum static build-up (see Figure 2.9.7.-1.). One side of
The test is not required for multivitamin and trace-element the drum is removable. The tablets are tumbled at each turn
preparations and in other justified and authorised of the drum by a curved projection with an inside radius
circumstances. between 75.5-85.5 mm that extends from the middle of the
Method. Using a suitable analytical method, determine the drum to the outer wall. The outer diameter of the central
individual contents of active substance(s) of 10 dosage units ring is between 24.5-25.5 mm. The drum is attached to the
taken at random. horizontal axis of a device that rotates at 25 ± 1 r/min. Thus,
Apply the criteria of test A, test B or test C as specified in the at each turn the tablets roll or slide and fall onto the drum
monograph for the dosage form in question. wall or onto each other.
For tablets with a unit mass equal to or less than 650 mg, take
TEST A a sample of whole tablets corresponding as near as possible to
The preparation complies with the test if each individual 6.5 g. For tablets with a unit mass of more than 650 mg, take a
content is between 85 per cent and 115 per cent of the average sample of 10 whole tablets. The tablets are carefully dedusted
content. The preparation fails to comply with the test if prior to testing. Accurately weigh the tablet sample, and place
more than one individual content is outside these limits or if the tablets in the drum. Rotate the drum 100 times, and
one individual content is outside the limits of 75 per cent to remove the tablets. Remove any loose dust from the tablets as
125 per cent of the average content. before, and accurately weigh.
If one individual content is outside the limits of 85 per Generally, the test is run once. If obviously cracked, cleaved, or
cent to 115 per cent but within the limits of 75 per cent to broken tablets are present in the tablet sample after tumbling,
125 per cent, determine the individual contents of another 20 the sample fails the test. If the results are difficult to interpret
dosage units taken at random. The preparation complies with or if the weight loss is greater than the targeted value, the test
the test if not more than one of the individual contents of the is repeated twice and the mean of the 3 tests determined. A
(7) This chapter has undergone pharmacopoeial harmonisation. See chapter 5.8. Pharmacopoeial harmonisation.

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

EUROPEAN PHARMACOPOEIA 10.0 2.9.9. Measurement of consistency by penetrometry

Figure 2.9.7.-1. – Tablet friability apparatus

maximum loss of mass (obtained from a single test or from OPERATING PROCEDURE
the mean of 3 tests) not greater than 1.0 per cent is considered Place the tablet between the jaws, taking into account, where
acceptable for most products. applicable, the shape, the break-mark and the inscription ;
If tablet size or shape causes irregular tumbling, adjust the for each measurement orient the tablet in the same way with
drum base so that the base forms an angle of about 10° with the respect to the direction of application of the force. Carry out
horizontal and the tablets no longer bind together when lying the measurement on 10 tablets, taking care that all fragments
next to each other, which prevents them from falling freely. of tablets have been removed before each determination.
Effervescent tablets and chewable tablets may have different This procedure does not apply when fully automated equipment
specifications as far as friability is concerned. In the case of is used.
hygroscopic tablets, a humidity-controlled environment is
required for testing. EXPRESSION OF RESULTS
A drum with dual scooping projections, or apparatus with Express the results as the mean, minimum and maximum
more than one drum, for the running of multiple samples at values of the forces measured, all expressed in newtons.
one time, are also permitted. Indicate the type of apparatus and, where applicable, the
orientation of the tablets.

01/2008:20908
07/2008:20909

2.9.8. RESISTANCE TO CRUSHING OF

TABLETS 2.9.9. MEASUREMENT OF
CONSISTENCY BY PENETROMETRY
This test is intended to determine, under defined conditions,
the resistance to crushing of tablets, measured by the force This test is intended to measure, under determined and
needed to disrupt them by crushing. validated conditions, the penetration of an object into the
product to be examined in a container with a specified shape
APPARATUS and size.
The apparatus consists of 2 jaws facing each other, one of
which moves towards the other. The flat surfaces of the jaws APPARATUS
are perpendicular to the direction of movement. The crushing The apparatus consists of a penetrometer made up of a stand
surfaces of the jaws are flat and larger than the zone of contact and a penetrating object. A suitable apparatus is shown in
with the tablet. The apparatus is calibrated using a system Figure 2.9.9.-1.
with a precision of 1 newton.

General Notices (1) apply to all monographs and other texts 337