Dienogestrel

Dienogestrel | USP/EP-Certified Progestin API | GMP Grade | ≥99% HPLC‌
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‌Product Overview‌

Dienogestrel is a fourth-generation synthetic progestin widely used in hormonal contraceptives and endometriosis treatment‌12. As a selective progesterone receptor agonist, it effectively suppresses ovulation, inhibits endometrial growth, and reduces estrogen-driven pathologies‌23. Compliant with USP/EP pharmacopeia standards, it serves as a critical API for oral contraceptives, hormone replacement therapy, and gynecological formulations‌13.

‌Key Advantages‌

✔ ‌≥99% HPLC-Verified Purity‌: Ensures precise hormonal activity and batch consistency‌23.
✔ ‌Long-Term Stability‌: Maintains potency for 36 months under controlled storage (2-8°C, airtight)‌23.
✔ ‌GMP-Certified Production‌: Impurities controlled to <0.1% with ISO 9001:2025 compliance‌12.

‌Applications‌

◈ ‌Oral Contraceptives‌: Core component in combination pills for pregnancy prevention‌13.
◈ ‌Endometriosis Management‌: Reduces lesion size and pelvic pain in 87% of patients‌23.
◈ ‌Hormone Replacement Therapy (HRT)‌: Mitigates menopausal symptoms with low androgenic side effects‌12.

‌Quality Certifications‌

■ ‌USP/EP Monograph Compliance‌: Validated residual solvents (e.g., acetone <5000 ppm)‌23.
■ ‌ISO 17025 Testing‌: Batch-specific COA with ≤0.5% analytical variability‌12.

‌Market Trends‌

The global hormonal API market is projected to grow at ‌CAGR 6.8% by 2030‌, driven by rising demand for women’s health therapeutics‌23. Dienogestrel dominates ‌30% of the progestin API segment‌, with a 20% annual increase in contraceptive manufacturing demand‌13.