These reference standards will serve to ensure greater consistency in the quality of the natural product artemisinin used to treat malaria.
With the support of Medicines for Malaria Venture (MMV), SensaPharm Ltd of Sunderland, UK, has produced the key impurities which are found during artemisinin production, 9- epi artemisinin and artemisitene. These are now being made available as validated reference standards together with specific assays for both molecules.
In the past few years there has been considerable debate over the quality requirements applicable to the API artemisinin, which is used as the starting material for the production of the highly important artemisinin-based combination therapies (ACTs).
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, extraction steps and purification conditions.
The impurities, identified as 9- epi artemisinin and artemisitene, may carry forward to impact the purity of the final API and as such, their measurement is of critical importance.
These standards are available in various pack sizes for analytical laboratories and the assays, based upon both HPLC and LCMSMS, are available as a service from SensaPharm Ltd.
In addition, and among a range of other relevant standards, the company has produced reference grade deoxy-artemisinin. This compound has been suggested to increase if storage conditions for the artemisinin API are poor.
SensaPharm Ltd 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 and we hope our efforts will in some way make a contribution”.
Dr Ian Bathurst, Director of Drug Discovery at Medicines for Malaria Venture* 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.”