WHO Technical Report Series, No. 981 - World Health Organization

Quality control – specifications and tests
comments received were collated by the secretariat. This test is intended to
measure, under determined and validated conditions, the penetration of an
object with a specified shape and size into the product to be examined.
The draft text on the measurement of consistency is based on the text
in the European Pharmacopoeia, from which permission had been granted to
reproduce the text in The International Pharmacopoeia.
The Expert Committee adopted the text as proposed.
3.4.7 General method for the supplementary information section
of the Fourth Edition of The International Pharmacopoeia:
Softening time determination of lipophilic suppositories
In October 2007 the Expert Committee recommended that a general method
text on the determination of softening time of lipophilic suppositories should
be included in the supplementary information section of The International
Pharmacopoeia. A preliminary draft text was discussed at the consultation
in May 2012. Following the consultation a revised text was sent out for public
consultation and the comments received were collated by the secretariat prior to
the meeting of the Expert Committee.
The test is intended to determine, under defined conditions, the time that
elapses before a suppository maintained in water softens to the extent that it no
longer offers resistance when a defined weight is applied. The proposed text is
based on the text in the European Pharmacopoeia from which permission had
been received to reproduce the text in The International Pharmacopoeia.
The Expert Committee adopted the text as proposed.
3.4.8 Bacterial endotoxin
The Expert Committee was informed that the establishment of a primary reference
standard for endotoxin would be considered by the WHO Expert Committee for
Biological Standardization.
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