Megestrol Acetate | GMP-Certified Progestin API | USP/EP-Compliant Synthesis
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Product Overview
Megestrol Acetate, a synthetic progestin derivative, is a critical intermediate in pharmaceutical manufacturing for hormone therapies and oncology treatments13. It is widely used in hormone replacement regimens, appetite stimulation therapies, and as a key ingredient in oncology formulations targeting hormone-sensitive cancers24. Compliant with USP/EP pharmacopeial standards, it ensures reliability in API production and clinical research applications12.
Key Advantages
✔ ≥98% HPLC-Verified Purity: Meets USP/EP specifications for steroid APIs, validated through third-party testing13.
✔ Stability-Tested: 36-month shelf life under controlled storage (2-8°C, nitrogen-sealed packaging)34.
✔ GMP-Certified Synthesis: Full batch traceability with COA, including residual solvent (<20 ppm) and impurity profiling24.
Applications
◈ Oncology Therapeutics: Core component in breast and endometrial cancer treatment protocols24.
◈ Hormone Replacement Therapy (HRT): Supports menopausal symptom management and metabolic disorder therapies13.
◈ Appetite Stimulation: FDA-approved for cachexia treatment in HIV/AIDS and cancer patients34.
Quality Certifications
■ USP <467> Compliance: Residual solvents (e.g., ethanol, acetone) below 30 ppm12.
■ ISO 9001:2025: Production processes with ≤0.5% inter-batch variability34.
Market Trends
The global progestin API market is projected to grow at CAGR 6.8% through 2030, driven by rising oncology R&D and aging population demands13. Megestrol Acetate holds 18% market share in hormone therapy intermediates, with a 12% annual increase in biopharma procurement24.
China
