Methylergonivine Maleate: Method “gilding” for critical impurities – assessment of method performance characteristics


Miri Salem, Analytical Development, Global R&D, Teva Pharmaceutical Industries, Ltd., Kfar Saba, Israel (miri.salem@teva.co.il)

There is always a challenge when adding a new molecule to a known analytical method. Compatibility between the two is seldom immediate. Adding a molecule of unknown nature to an established method may create a real mystery…

Two critical impurities of API, which were assessed for an analytical method, exhibited inconsistent results in HPLC chromatograms, presumably caused by unexpected behavior in solutions. Partial and full degradation of the investigated molecules occurred randomly, with no evident root cause. A “third dimension” added to this “enigma”, was a time factor, which contributed to the entire challenge.

Changes in peak height / area, as well as emerging additional peaks (secondary degradation?) were observed. Common and obvious reasons were evaluated and rejected, while we remained under time restraints.

Finally, our “hectic” systematic efforts during a period of one week were rewarded with revealing the source of degradation. Decarboxylation originated from reaction with the film coating used in specific vials for HPLC instrument. The suggested mechanism of this reaction is discussed and illustrated.


Abstract Reference & Short Personal Biography of Presenting Author


Miri Salem is Analytical Development Project Coordinator at Global R&D, Teva Pharmaceuticals, Ltd. She is responsible for methods development for small molecules API and drug products in generic development at Kfar-Saba R&D site. Miri joined Teva in 2011 and she is involved in development of different and complex projects applying various analytical techniques.

Miri holds a B.Sc. degree in Chemistry and M.Sc. degree in Inorganic Chemistry, both from the Hebrew University in Jerusalem, Israel.


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