Dienogest Powder API | Progestin Raw Material ≥99% Purity | Pharmaceutical-Grade & Bulk Supply for Endometriosis Research
Key Features
● High-Purity Dienogest Powder API ≥99% HPLC for pharmaceutical formulations
● Dual Mechanism Progestin: central hormonal regulation + peripheral lesion suppression
● Ideal for endometriosis drug formulations, hormone research, and preclinical studies
● Stable crystalline Dienogest Powder raw material, compatible with tablets, capsules, and oral dosage forms
● GMP-Compliant, USP/EP Certified, ISO9001 production for regulated pharmaceutical use
● Flexible Supply & Bulk Purchase: 10g sample to ton-level orders with competitive pricing
● Fast Global Shipping & Technical Support available for Europe, US, Asia, and worldwide research institutions
Product Overview
Dienogest Powder API (CAS 65928-58-7) Progestin Raw Material is a highly potent synthetic progestin with ≥99% purity (HPLC). Supplied as a white crystalline pharmaceutical-grade powder, it offers stable physicochemical properties, low impurities, and consistent batch-to-batch quality.
It is ideal for pharmaceutical formulation development, endocrine research, and endometriosis drug R&D. Fully GMP, USP/EP compliant, suitable for tablets, capsules, and oral dosage forms, with bulk purchase and sample options available worldwide at competitive pricing.
COA
| Item | Specification | Result | |
| Characteristics | White to yellowish, crystalline powder. | White crystalline powder. | |
| Solubility | The product is almost insoluble in water, a little soluble in dichloromethane, slightly soluble in methanol. | Conform | |
| Identification | Infrared detection shows that the retention time of the main peak is consistent with that of the working control product. | Conform | |
| Specific rotation | -344° ~ -352° | -344.0° | |
| Loss on drying | ≤0.5% | 0.03% | |
| Melting point | 204-214 ℃ | 213.6-214.0℃ | |
| Organic Impurities Any individual unspecified impurity Total impurities |
≤0.10% ≤0.5% |
0.09% 0.18% |
|
| Residue on ignition | ≤0.1% | 0.04% | |
| Assay | 98.0-102.0% | 100.18% | |
| Residual solvents Methanol Acetonitrile Acetone Tetrahydrofuran |
≤3000ppm ≤410ppm ≤5000ppm ≤720ppm |
Not detected Not detected Not detected Not detected |
|
| Micron | 90%≤30μm 100%≤20μm | Conform | |
| Conclusion | The product complies with the requirements of USP Standard. | ||
Mechanism of Action
Dienogest Powder API exerts pharmacological effects via dual central and peripheral pathways:
● Central Regulation: Inhibits hypothalamic-pituitary-ovarian axis, reducing FSH/LH secretion, gently suppressing ovulation, lowering endogenous estrogen levels
● Peripheral Inhibition: Binds uterine progesterone receptors, blocking estrogen-stimulated proliferation of ectopic endometrium, reducing local estrogen synthesis and inflammation
● Anti-Proliferative & Pro-Apoptotic: Blocks ectopic endometrial cell cycle, promotes apoptosis of abnormal cells, reducing lesion and cyst size
● High Receptor Selectivity: Strong affinity for progesterone receptors, minimal impact on estrogen/androgen receptors, wide safety margin
Product Applications
● Pharmaceutical Formulation Production | Dienogest Powder APISupports 2mg Dienogest tablets, capsules, and oral dosage forms for endometriosis treatment and hormone therapy
● Scientific & Preclinical Research ApplicationsIdeal for endocrinology research, progestin receptor mechanism studies, endometriosis pathological model construction, and drug screening
● Combination Drug Development | Hormone Therapy APIUsed in combined oral contraceptives and hormone replacement therapy formulations
● Clinical Trials & Bulk SupplyProvides Dienogest Powder API for consistency evaluation, pharmacodynamics, pharmacokinetics, and bulk pharmaceutical procurement worldwide
Detailed Benefits
● Relief of Endometriosis Pain: Inhibits proliferation of ectopic endometrial tissue; alleviates dysmenorrhea, chronic pelvic pain, and dyspareunia
● Reduction of Ectopic Cysts: Continuous use suppresses ovarian endometriotic cyst growth; lowers surgical intervention needs
● Regulation of Endocrine Balance: Modulates hypothalamic-pituitary-ovarian axis, maintains hormonal homeostasis
● Anti-Proliferative & Anti-Inflammatory: Blocks ectopic endometrial cell proliferation, promotes apoptosis, reduces lesion recurrence
● High Safety Profile: Low daily dose, minimal liver/kidney impact, suitable for long-term therapy and human-use research
Core Advantages
● High Purity & Low Impurities: ≥99% HPLC, strictly controlled heavy metals, residual solvents, microbial content
● Dual Mechanism of Action: Central hormonal regulation + peripheral lesion suppression
● Stable Physicochemical Properties: Mature crystallization, moderate solubility, compatible with tablets/capsules
● Flexible Supply & Bulk Purchase: 10g sample, 1kg small batch, ton-level long-term contracts; competitive pricing and global delivery
● Professional Technical Support
Quality Assurance
● Triple Quality Control: HPLC purity testing, impurity analysis, and microbial limit inspection; fully traceable and reproducible
● Pharmacopoeial Compliance: USP and EP standards, meeting international human-use raw material requirements
● Complete Documentation: COA, HPLC spectrum, MSDS, TDS provided, compliant with global regulations
● Full Traceability: From raw material procurement, production, to finished product shipment, ensuring consistent quality
FAQ
Q1: What is Dienogest human-use raw material used for?
A: Primarily for endometriosis treatment tablets, capsules, and oral formulations; also for progestin drug development, endocrine research, and steroid hormone studies.
Q2: Who can safely use products made from Dienogest raw material?
A: Intended for adult women with endometriosis. Contraindicated in pregnancy, breastfeeding, severe liver/kidney impairment, or hormone-dependent tumors.
Q3: Can Dienogest human-use raw material be used for research purposes?
A: Yes. Suitable for endocrinology research, progestin receptor mechanism studies, endometriosis pathological models, and drug screening experiments.
Q4: What makes Dienogest safe for long-term therapy?
A: Low daily dose requirement, minimal liver/kidney impact, high receptor selectivity; dual mechanism ensures effective therapy with minimal side effects.
factory
Certificates
Shipping & Packing
Order Now | Stable Global Supply
High-purity human-grade Dienogest Powder API (≥99%), fully qualified, stable quality, flexible supply. Suitable for endometriosis formulation production, endocrine research, and drug development.Free samples and bulk quotations available – contact us for tailored procurement solutions.
Contact:
Whatsapp & Mobile: +8619991242181
Email:sales@hdmbio.com
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