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 />
Tenofovir disoproxil fumarate<br />
Following the adoption of the monograph on tenofovir disoproxil fumarate in<br />
October 2009, the secretariat was informed by users about difficulties encountered<br />
with the specific optical rotation test. The collaborating laboratory which was<br />
assigned the development of the monograph investigated the issue, and new<br />
acceptance limits for this test were proposed. A draft revision of the monograph<br />
was discussed at the consultation in May 2012, following which a further draft<br />
of the monograph was sent out for public consultation. The comments received<br />
were subsequently consolidated and the draft was revised accordingly.<br />
The Expert Committee discussed the revised draft. The monograph was<br />
adopted subject to the changes proposed.<br />
3.2.2 Antituberculosis medicines<br />
Cycloserine<br />
Following a request from a user of The International Pharmacopoeia, it had<br />
been proposed to change the system suitability criterion of the test for related<br />
substances in the monograph on cycloserine. A revision of the monograph was<br />
sent out for public consultation and further proposals for changes were received.<br />
The Expert Committee reviewed the proposals for the revision of<br />
the monograph on cycloserine and adopted the monograph, subject to the<br />
amendments proposed.<br />
<strong>WHO</strong> <strong>Technical</strong> <strong>Report</strong> <strong>Series</strong>, <strong>No</strong>. <strong>981</strong>, 2013<br />
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Cycloserine capsules<br />
As in the case of the cycloserine monograph, it was proposed to change the<br />
system suitability criterion of the test for related substances in the monograph<br />
on cycloserine capsules following a request from a user of The International<br />
Pharmacopoeia. A revision of the monograph was sent out for public consultation<br />
and further proposals for changes were received.<br />
The Expert Committee reviewed the proposals for the revision of the<br />
monographs on cycloserine capsules and adopted the monograph, subject to the<br />
amendments proposed.<br />
3.2.3 Antimalarial medicines<br />
Artesunate<br />
The revision of the monograph on artesunate had been adopted by the Expert<br />
Committee in 2011 and included the correction of information related to the<br />
stereochemistry of artesunate impurity A (artenimol). Further to the changes<br />
already agreed, it was proposed to align the conditions for identity tests C and D<br />
to the test descriptions given in the document New basic tests for antimalarials.<br />
The Expert Committee adopted the monograph, subject to the<br />
amendments proposed.
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