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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Quality control – specifications and tests<br />
Artesunate tablets<br />
A user of The International Pharmacopoeia had reported a problem with the<br />
chromatography described in the dissolution testing of artesunate tablets. A<br />
collaborating centre investigated the issue, advised corrections to the monograph<br />
and recommended aligning the conditions for identity tests C and D to the test<br />
descriptions given in the document New basic tests for antimalarials.<br />
The Expert Committee adopted the monograph subject to the<br />
amendments proposed.<br />
Artesunate for injection<br />
In view of the proposed changes to the monographs on artesunate and artesunate<br />
tablets, it was also proposed to change the monograph on artesunate for injection<br />
accordingly.<br />
The Expert Committee discussed the revised monograph, and adopted<br />
the monograph subject to the amendments proposed.<br />
Artemisinin<br />
In October 2011 the Expert Committee adopted the document Recommendations<br />
for quality requirements when artemisinin is used as a starting material in<br />
the production of antimalarial active pharmaceutical ingredients, including a<br />
specification for artemisinin used as a starting material. The Committee further<br />
advised that the monograph on artemisinin in The International Pharmacopoeia<br />
should be aligned with the new specification of artemisinin used as a starting<br />
material. Consequently a draft revision of the monograph on artemisinin was<br />
discussed at the consultation in May 2012 and circulated for public consultation<br />
in August 2012.<br />
The Expert Committee reviewed the proposed draft of the monograph.<br />
The monograph was adopted subject to the amendments proposed. It was<br />
noted that certain proposed changes would require that the same changes<br />
should be made to the specification on artemisinin used as a starting material.<br />
The Expert Committee therefore requested the secretariat to make the changes<br />
to the specification on artemisinin as a starting material, provided they are<br />
confirmed by one of the <strong>WHO</strong> collaborating centres, and to publish the revised<br />
Recommendations for quality requirements when artemisinin is used as a starting<br />
material in the production of antimalarial active pharmaceutical ingredients as an<br />
annex to the report of the current meeting. 1<br />
1<br />
During the compilation of the report it was unfortunately revealed that further investigations would be<br />
necessary.<br />
7
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