Method for detecting colatriol intermediates and colatriol intermediate related substances
By separating the intermediates of cloterone and related substances using reversed-phase high-performance liquid chromatography, the problem of the lack of detection methods in the existing technology is solved, and high-precision quality control and improved drug safety are achieved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- JIANGSU JIAERKE PHARMA GRP CORP
- Filing Date
- 2026-05-22
- Publication Date
- 2026-07-17
AI Technical Summary
The lack of analytical and detection methods for the intermediates of cloterone active pharmaceutical ingredient in the current technology leads to low quality control accuracy, which affects the controllability of drug quality and the safety of medication.
Reversed-phase high-performance liquid chromatography (RP-HPLC) was used to separate the cloterone intermediate and related substances on a C18 column by gradient elution. Detection was performed using a specific mobile phase and gradient elution program, combined with an ultraviolet detector.
This study achieved high-precision quality control of the croceton intermediate, confirmed the structure of the new impurity, optimized the synthesis process, improved production stability and drug safety, and complied with the guidelines for drug impurity analysis.
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Figure CN122409909A_ABST