Impurity profile tracking for active pharmaceutical ingredients: case reports.

Lili Zhou; Bing Mao; Robert Reamer; Tom Novak; Zhihong Ge

doi:10.1016/j.jpba.2006.11.004

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PubMed · 17142001

Impurity profile tracking for active pharmaceutical ingredients: case reports.

Lili Zhou·Bing Mao·Robert Reamer·Tom Novak·Zhihong Ge

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Abstract

Tracking the impurity profile of an active pharmaceutical ingredient (API) is a very important task for all stages of drug development. A systematic approach for tracking impurity profile of API is described. Various real pharmaceutical applications are presented through successful examples of impurity profile tracking for three different novel APIs. These include MK-0969, an M3 antagonist; MK-0677, an oral-active growth hormone secretagogue and API-A, a cathepsin K inhibitor. A general strategy including selection of a reversed phase high performance liquid chromatographic (RP-HPLC) impurity profile method based on screening various stationary phases and changing the pH of the mobile phase and elucidation of impurity structures through the utilization of LC-MS, preparative-LC and NMR is demonstrated. A series of studies were conducted on the peak purity check by using the LC-UV diode-array and LC-MS detections. The advantages and disadvantages of each technique in the evaluation of peak purity are discussed.

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Cathepsin K Cathepsins Chromatography, High Pressure Liquid Drug Contamination Drug Industry Enzyme Inhibitors Human Growth Hormone Hydrogen-Ion Concentration Indoles Muscarinic Antagonists Pharmaceutical Preparations Receptor, Muscarinic M3 Spectrophotometry, Ultraviolet Spiro Compounds Journal Article

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Lili Zhou, Bing Mao, Robert Reamer, Tom Novak, Zhihong Ge. 2006-12-04. Impurity profile tracking for active pharmaceutical ingredients: case reports.. https://doi.org/10.1016/j.jpba.2006.11.004

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