Pharmaceutical composition and quality control method therefor
By adding an antioxidant to the drug composition of compound A, the problem of nitrosamine impurity formation is solved, and the stability and safety of the drug under high temperature and high humidity conditions are achieved, ensuring the safe use of the drug within its shelf life.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- WUHAN WUYAO SCI & TECH CO LTD
- Filing Date
- 2025-12-02
- Publication Date
- 2026-06-11
AI Technical Summary
In the prior art, compound A drugs gradually generate nitrosamine impurities during storage, causing their content to exceed acceptable limits, and there is currently a lack of effective control methods.
By adding antioxidants, such as water-soluble antioxidants like cysteine or cysteine hydrochloride, to the pharmaceutical composition of Formula A, mixing and preparing it into an oral solid dosage form, the formation of nitrosamine impurities is controlled, ensuring that its content is less than 0.375-0.500 ppm within 3-6 months under 40℃/75%RH conditions.
The formation of nitrosamine impurities was effectively controlled, ensuring that the impurity content of the drug composition remained within a safe range during its shelf life, thus avoiding carcinogenic risks and improving the stability and safety of the drug.
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