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 />
were collated by the secretariat prior to discussion at the consultation in May<br />
2012, where it was proposed to align the conditions for the dissolution testing<br />
to the respective test described in the monograph on levonorgestrel tablets. The<br />
collaborating centre investigated the possibility and subsequently revised the<br />
proposal.<br />
The Expert Committee adopted the monograph, subject to the<br />
amendments proposed.<br />
Zinc acetate and zinc gluconate<br />
Draft proposals for the monographs on zinc acetate and zinc gluconate were<br />
first discussed at the consultation in May 2012. The documents were sent out for<br />
public consultation in August 2012 and were subsequently revised taking into<br />
account the comments received.<br />
It was agreed that limits to microbial contamination should be included<br />
in the monograph on zinc gluconate.<br />
The Expert Committee adopted the monographs on zinc acetate and zinc<br />
gluconate subject to the amendments proposed.<br />
<strong>WHO</strong> <strong>Technical</strong> <strong>Report</strong> <strong>Series</strong>, <strong>No</strong>. <strong>981</strong>, 2013<br />
10<br />
3.3 Harmonized texts<br />
3.3.1 Revision of monograph on General method 5.5<br />
Dissolution test for solid oral dosage forms<br />
In October 2010 the Expert Committee recommended revision of the dissolution<br />
test for solid oral dosage forms. Following discussion of a draft with comments<br />
by the Expert Committee in October 2011 and at the consultation in May 2012,<br />
a revised draft was circulated for public consultation in July 2012. Comments<br />
received were collated by the secretariat for consideration by the Expert<br />
Committee.<br />
The Expert Committee noted that the text was based on the internationally<br />
harmonized texts developed by the PDG. It was developed in line with the style<br />
and requirements used in The International Pharmacopoeia, and the chapter on<br />
“Test conditions and dissolution media” was added to the original PDG text.<br />
In its review of the draft text, the Expert Committee made a number<br />
of further proposals for change. The monograph was adopted subject to<br />
implementation of the amendments proposed.<br />
3.4 Preface, general notices and supplementary information<br />
sections of The International Pharmacopoeia<br />
3.4.1 Proposal for revision of monograph on capsules<br />
The draft of a revised monograph on capsules was considered in May 2012 at<br />
the Consultation on specifications for medicines and quality control laboratory
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