WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
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<strong>WHO</strong> Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report<br />
parenteral preparations. The Expert Committee adopted the text subject to the<br />
amendments proposed.<br />
3.4.4 Proposal for revision of high-performance liquid chromatography<br />
A preliminary draft of the revision of the document on high-performance<br />
liquid chromatography (HPLC) was reviewed at the consultation in May 2012.<br />
The document was then sent out for public consultation in July 2012 and the<br />
comments received were subsequently collated by the secretariat. It was pointed<br />
out that it was proposed to revise the chapter of The International Pharmacopoeia<br />
on HPLC to include, among other additions, a description of the dwell volume<br />
and the peak-to-valley ratio.<br />
The Expert Committee adopted the text, subject to the amendments<br />
proposed.<br />
<strong>WHO</strong> <strong>Technical</strong> <strong>Report</strong> <strong>Series</strong>, <strong>No</strong>. <strong>981</strong>, 2013<br />
12<br />
3.4.5 General method for the supplementary information<br />
section of the Fourth Edition of The International<br />
Pharmacopoeia: Resistance to crushing of tablets<br />
At its meeting in October 2007 the Expert Committee recommended that a<br />
general method text on the resistance to crushing of tablets should be included<br />
in the supplementary information section of The International Pharmacopoeia.<br />
Subsequently, at the Committee's meeting in October 2009, a revision of the general<br />
monograph on tablets was adopted in which, in the section on “Manufacturing”,<br />
reference is made to a general method for resistance to crushing of tablets.<br />
The draft text on resistance to crushing of tablets, which is based on the<br />
text in the European Pharmacopoeia, was discussed at the May 2012 consultation<br />
and was subsequently circulated for public consultation, with comments received<br />
being collated in September and October 2012. This test is intended to determine,<br />
under defined conditions, the resistance to crushing of tablets, measured by<br />
the force needed to disrupt them by crushing. It was noted that the European<br />
Pharmacopoeia had granted permission for the text to be reproduced in The<br />
International Pharmacopoeia.<br />
The Expert Committee adopted the text as proposed.<br />
3.4.6 General method for the supplementary information section<br />
of the Fourth Edition of The International Pharmacopoeia:<br />
Measurement of consistency by penetrometry<br />
In October 2007 the Expert Committee recommended that a general method<br />
text on the measurement of consistency by penetrometry should be included in<br />
the supplementary information section of The International Pharmacopoeia. A<br />
preliminary draft text was discussed at the May 2012 consultation. Following<br />
that discussion, a further draft was circulated for public consultation, and the
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