HK Neopharm Limited is one of the most reliable manufacturers and suppliers of dydrogesterone api in China, featured by quality products and good price. Please rest assured to buy dydrogesterone api in stock here and get quotation from our factory. Customized orders are welcome.
Dydrogesterone API (CAS 152-62-5) is a highly selective progestogen API, mainly used for the treatment of female endocrine and reproductive system disorders. It specifically binds to progesterone receptors, gently regulates endometrial growth, shows no significant androgenic or estrogenic effects, and features excellent clinical safety. Often combined with estrogen for hormone replacement therapy, it effectively improves luteal insufficiency and abnormal uterine bleeding, serving as a safe and reliable core raw material in gynecological endocrine therapy. As one of the leading China Dydrogesterone API manufacturers, we ensure stable and consistent quality at all times.
Technical Specifications
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Product Name |
Dydrogesterone API |
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Synonyms |
Dydrogesterone Powder, Dydrogesterone Raw Material |
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Characteristics |
A white to Light Yellow crystalline powder |
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CAS Number |
152-62-5 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C21H28O2 |
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Package |
Technical Package |
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Storage |
Storage conditions: Store in a refrigerator at 2–8°C, tightly sealed, dry and protected from light. Long-term stability: -20°C: Stable for 3 years as powder. 4°C (2–8°C): Stable for 2 years. Room temperature (<30°C): Only for short-term storage (several weeks); long-term storage is not recommended. |
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Structure |
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Dydrogesterone Raw Material is produced in strict accordance with global GMP standards with full-process quality control, featuring high purity, stable crystal form and g reliable raw material support for innovative gynecological endocrine drug projects. Clients can bexcellent batch-to-batch consistency. As a highly selective progestogen API for gynecological use, it is suitable for formulation development, process scale-up and clinical research, providinuy Dydrogesterone Raw Material from us with stable supply and full documentation.
Product Features
Dydrogesterone Raw Material has a purity of ≥99.0% accurately tested by HPLC, complying with international pharmacopoeia standards such as EP and USP. Manufactured by qualified pharmaceutical enterprises under GMP guidelines, it achieves full-chain quality traceability to ensure no impurity exceedance in any batch, laying a pure and reliable foundation for formulation R&D. We have sufficient Dydrogesterone Raw Material in stock for prompt delivery.
It appears as a white or off-white crystalline powder with a stable and exclusive crystal form. Verified by long-term stability tests, its properties remain unchanged during storage. Key indicators including batch purity and particle size distribution show minimal deviation, meeting the continuous stability requirements of industrial production and supporting large-scale preparation of multiple batches. We also supply bulk Dydrogesterone API for commercial production.
As a highly selective Dydrogesterone API, it specifically binds to progesterone receptors without androgenic or estrogenic side effects, delivering precise and single pharmacological action. It efficiently regulates endometrial transformation and improves luteal function, providing a clear target for the treatment of gynecological endocrine disorders with both clinical safety and efficacy.
Our strictly controlled production process supports the development of various dosage forms, including oral preparations such as tablets and capsules as well as compound hormone preparations. It meets the needs of process scale-up, clinical research and commercial production, supported by complete COA documents to accelerate the R&D progress of innovative gynecological endocrine drugs. We also provide customized Dydrogesterone API to meet special technical requirements.
Full-Cycle Quality Control & Consistent Quality
We have established a full-cycle quality control system covering raw material procurement, R&D trial production and industrial manufacturing, with strict testing at each stage. Relying on advanced testing equipment, we monitor purity, impurities and microbial indicators throughout the process to ensure every batch meets international pharmacopoeia standards and guarantee raw material safety from the source. As a professional China Dydrogesterone Powder factory, we implement strict quality control at every step.
We focus on quality control in core production processes and conduct granulation, drying, crushing and other operations in strict compliance with GMP standards. Through standardized process parameters and real-time online monitoring, we effectively avoid batch-to-batch fluctuations and achieve high stability in key indicators such as product content, crystal form and particle size, satisfying continuous production requirements.
We strengthen quality assurance in storage and logistics with a 2–8℃ sealed storage; protect from light & moisture, avoiding light and moisture and controlling temperature and humidity fluctuations. The entire cold-chain transportation is equipped with a temperature control and traceability system to ensure product properties remain unchanged during circulation and maintain stable quality. All Dydrogesterone Raw Material made in China is transported under strictly controlled conditions.
We have built a sustainable quality assurance mechanism by carrying out regular process optimization and quality reviews while tracking customer feedback. By dynamically adjusting quality control details and upgrading testing technologies, we continuously improve batch-to-batch consistency and long-term stability, providing long-term reliable support for formulation R&D. We also offer Dydrogesterone Powder free sample for laboratory evaluation.
Application Scenarios
As a highly selective progestogen raw material, Dydrogesterone API (CAS 152-62-5) is widely used in various clinical scenarios in gynecological endocrinology thanks to its precise pharmacological activity and excellent safety. It provides solid raw material support for the diagnosis and treatment of diseases related to female reproductive health. The specific application scenarios are as follows:
As a core progestogen material, it is widely used in the formulation development for luteal insufficiency, threatened abortion and recurrent miscarriage, effectively improving pregnancy outcomes and supporting reproductive health for women of childbearing age.
It is suitable for hormone replacement therapy in perimenopausal women. When used in combination with estrogen, it accurately protects the endometrium, reduces hyperplasia risk and relieves menopausal symptoms, serving as a key compatible raw material for hormone replacement therapy.
It is used in the R&D of preparations for menstrual disorders such as dysfunctional uterine bleeding, amenorrhea and dysmenorrhea, efficiently regulating cyclic endometrial transformation and normalizing menstrual rhythm, providing a therapeutic option for common gynecological endocrine diseases.
In assisted reproductive technologies such as in vitro fertilization, it is used for the development of luteal support preparations, improving endometrial receptivity and embryo implantation rate, providing safe and reliable raw material support for assisted reproductive projects.
Packaging and Transportation
To ensure the quality stability of high-purity Dydrogesterone Powder during storage and transportation, the company implements standardized packaging and professional logistics solutions in strict accordance with pharmaceutical API specifications. Scientific protection, standardized operation and full-process controllable management ensure safe and intact product delivery. Details are as follows:
The product adopts pharmaceutical-grade double-layer sealed packaging with an inner aluminum foil vacuum bag for moisture isolation and an outer light-proof and moisture-proof hard drum with a leak-proof sealing structure, effectively avoiding the impact of light and humidity on stability and ensuring stable quality during storage.
A variety of standardized packaging specifications are available, and customized packaging is available according to customer production needs. All packages are clearly labeled with product information, batch number, storage conditions and warning signs, complying with global regulatory requirements for the transportation and storage of pharmaceutical raw materials and facilitating production traceability and management.
Strict low-temperature storage standards are followed, and a professional cold-chain logistics system is adopted for transportation, equipped with real-time temperature and humidity monitoring and traceability systems to ensure a stable environment throughout the transportation chain, eliminate quality fluctuations and safely deliver goods to customers' designated locations.
Our Advantages
Stable Production Capacity & Cost-Effective Supply
The company has mature and stable large-scale production technology to continuously supply high-purity Dydrogesterone API. Strict control of key process parameters effectively reduces production costs, providing customers with cost-effective raw materials and ensuring long-term stable supply.
Strict Quality Control & Reliable Quality Assurance
A full-process quality traceability system is established with strict testing from raw material incoming to finished product delivery. Products comply with international pharmacopoeia standards with stable crystal form and controllable impurities, providing reliable data support for formulation R&D and registration.
Professional Technical Support & Customized Services
A professional R&D and after-sales team is available to quickly respond to customer needs in process optimization and formulation development, providing customized technical services to help customers shorten R&D cycles and accelerate project implementation.
Standardized Compliance System & International Recognition
The entire production process strictly follows GMP standards with a complete quality assurance system and compliance documentation, meeting the registration and commercial production requirements of domestic and foreign pharmaceutical companies, giving our products outstanding competitiveness.
FAQ
The company always upholds rigorous pharmaceutical principles, prioritizes clinical medication safety and product quality, and focuses on producing high-purity and stable Dydrogesterone API (CAS 152-62-5). Standardized management is implemented throughout production with traceability for key processes. From scientific research and formulation development to large-scale production, we provide stable and high-quality raw material support for gynecological pharmaceutical projects. We sincerely cooperate with customers worldwide to promote the development of women's health with high-quality raw materials and build a long-term, stable and win-win pharmaceutical cooperation ecosystem.
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