SensaPharm Ltd makes key reference standards, 9- epi artemisinin and artemisitene, available for artemisinin quality assessment

26th May 2011

In the past few years there has been considerable debate over the quality requirements applicable to the Artemisinin which is to be used as a starting material for the production of the Artemisinin derivatives and hence for ACT formulations.

The major concern is in the presence and level of certain defined impurities, which have the ability to affect the purity of the APIs.  It is known that artemisinin quality varies according to for example, agricultural conditions, the extraction steps and the purification conditions. The impurities may carry forward to impact the purity of the final API and as such, their measurement is of critical importance. These impurities have been identified as 9- epi artemisinin and artemisitene.

With the support of MMV, Sensapharm Ltd has produced these compounds as validated reference standards, together with specific assays for both molecules, which can also be part of a full pharmacopoeial assay.  These assays are based upon HPLC and LCMSMS and are available as a service from SensaPharm Ltd if required.

In addition, the company has produced reference grade deoxy-artemisinin. The latter has been suggested to appear if artemisinin storage conditions are poor.

SensaPharm Director Neil Sullivan said, “We are pleased to support the industry by supplying reference standards and definitive assays for these known impurities. Ensuring high quality artemisinin for API production is absolutely vital in the fight against malaria.

Dr Ian Bathurst, Director of Drug Discovery at Medicines for Malaria Venture  in Geneva said, “These reference materials will be critical to ensuring that quality guidelines for starting materials are met and will help considerably in securing the high quality supply of APIs.”
http://www.who.int/medicines/services/expertcommittees/pharmprep/Rev1-ArtemisininStartingMaterialQAS10-349_31082010.pdf

For further information regarding supply of these , please contact;
Dr Neil Sullivan, Director, SensaPharm Ltd
+44 (0) 191 516 6969 / neil@sensapharm.eu