Dehydroepiandrosterone Acetate Powder

Dehydroepiandrosterone Acetate Powder - Premium Pharmaceutical Intermediate Manufacturer

Shaanxi Hongda Phytochemistry is a major manufacturer and supplier of high quality Dehydroepiandrosterone Acetate Powder, with more than 20 years experience in pharmaceutical intermediates production. We are your trusted partner for pharmaceutical-grade materials, employing state of the art extraction technology and rigorous quality-control procedures. Our contemporary 20,000 square meters building with 100,000-level purification workshops and national patent technology guarantees that every batch of our products fulfils the worldwide pharmaceutical requirements. We can manufacture 3,000 tonnes per annum and have full Certifications including cGMP, FSSC22000, ISO22000, HALAL and KOSHER and provide consistent quality to meet your crucial requirements for stable, trustworthy raw materials. More than 20 professor-level academics on our dedicated team means your product will be delivered with full documentation, available stock and technical assistance that will speed up your production schedules and lower the risks of procurement.

Product Introduction

Dehydroepiandrosterone Acetate Bulk Powder is the acetylated version of the naturally occurring DHEA and provides the pharmaceutical makers with a stabilised intermediate with improved handling characteristics. The substance is a white to off white crystalline molecule with molecular formula C21H30O3 with excellent purity levels ≥98% as confirmed through HPLC analysis. The 3β-acetate alteration offers better resistance to oxidation than the free-base DHEA, which makes it well suited for long-term storage and complex synthetic routes. Reduced hygroscopicity and better solubility in organic solvents translate to more consistent reaction yields and easier processing flows for your industrial processes.

Dehydroepiandrosterone Acetate Powder Advantages

Improved Chemical Stability: The acetate protecting group protects against oxidative degradation during storage and shipping, ensuring a shelf life of over 24 months under appropriate storage circumstances with consistent potency.

Improved Processing Characteristics: Reduced hygroscopicity minimises caking concerns commonly seen with free-base DHEA, providing smooth Dehydroepiandrosterone Acetate Powder flow through automated filling equipment and constant dose accuracy throughout your manufacturing runs.

improved Lipophilicity: The improved partition coefficient aids solubilisation in lipid-based formulation vehicles and increases compatibility with solvents for organic synthesis, leading to enhanced reaction efficiency and product yields.

Selective Reactivity: The protected 3β-hydroxyl position enables selective chemical alterations at C-7 and C-17 positions without competing side reactions, providing synthetic paths for downstream pharmaceutical intermediates.

Regulatory Compliance: Our manufacture is cGMP compliant with complete batch traceability and we can provide the documentation package necessary for FDA DMF filing and international regulatory submissions.

Certificate of Analysis (COA)

Production Process

Step 1 - Raw Material Selection: We purchase pharmaceutical-grade DHEA from certified suppliers and perform inbound quality verification including identification confirmation by IR spectroscopy and purity assessment by HPLC to ensure that only materials with ≥98% purity are allowed to proceed to manufacture.

Step 2 - Acetylation Reaction: The purified DHEA is treated with acetic anhydride in the presence of pyridine catalyst under nitrogen environment at controlled temperature to give the protected 3β-acetoxy derivative with >95% conversion efficiency.

Step 3 - Purification and Crystallisation: The crude reaction mixture is purified by solvent extraction and recrystallisation from ethanol-water systems to give a high purity crystalline product with characteristic melting point and optical rotation values.

Step 4 - Drying and Micronization: Purified crystals are dried under vacuum at controlled temperature to achieve <0.5% moisture content, then passed through precision milling equipment to achieve uniform 80-mesh particle size distribution for optimal handling properties.

Step 5 - Quality Testing and Packaging: Each production batch undergoes comprehensive analysis including HPLC assay, heavy metal screening, and microbiological testing before packaging in double-layer PE bags within fiber drums under cleanroom conditions, ensuring product integrity during storage and shipment.

Dehydroepiandrosterone Acetate Powder Application

Advanced Steroid Synthesis: This molecule is the chosen starting material for pharmaceutical development of 7-Keto-DHEA and 4-Androstenedione, where the acetate group is a protective element in multi-step conversions.

Lipophilic Formulation Development: Research laboratories utilize this material in transdermal patch development and topical cream formulations, leveraging its enhanced skin penetration properties for hormone replacement therapy applications.

Controlled Release Systems: This acetylated version is used by pharmaceutical researchers in implantable delivery matrices where slow hydrolysis releases DHEA over time and is appropriate for endocrine research and veterinary uses.

Analytical Reference Standards: Certified reference materials are high purity batches used by quality control laboratories for method validation and stability studies in pharmaceutical production environments.

Independent Quality Verification: We cooperate with internationally recognised testing agencies, like SGS and Eurofins, to independently verify the quality of each batch of goods we produce.

Pesticide Residue Analysis: Comprehensive screening against 500+ pesticide compounds ensures compliance with EU Pharmacopoeia and USP standards, with all results consistently below detection limits of 0.01 ppm.

Heavy Metal Testing: ICP-MS testing shows Lead <0.5 ppm, Arsenic <0.2 ppm, Cadmium <0.1 ppm, Mercury <0.1 ppm, meeting pharmaceutical safety standards.

Microbiological Safety: Total plate count <1000 CFU/g Yeast & Mould <100 CFU/g Salmonella, E. coli and Staphylococcus aureus are not detected in any tested samples.

OEM / ODM Support

Custom Specification Production: Our R&D team works closely with your formulation scientists to develop materials to your exact specifications including alternative particle size distributions, unique polymorphic forms or custom purity grades suited to your application needs.

Flexible Batch Sizing: If you need tiny research volumes from 1 kg for initial development work, or commercial scale production batches of over 500 kg, our flexible manufacturing capabilities can support your project all the way through all stages.

Private Labelling Services: We offer complete packaging customisation with your branding, lot numbering systems and documentation formats, so you receive product ready to be placed directly into your supply chain.

Regulatory Documentation Support: Our quality assurance team creates Certificates of Analysis, Material Safety Data Sheets, Drug Master Files and stability data packages to meet FDA, EMA or other regional regulatory standards for your markets.

Why Choose Us?

You have a manufacturing partner dedicated to your success with consistent quality and timely support. Our world-class facility is internationally certified by several countries to ensure regulatory approval in all worldwide markets. With more than 150 experienced technicians and 20+ PhD level researchers on staff, we have the technical knowledge to help solve your formulation problems. We've a ready stock inventory, so no ready time and might deliver within 2-3 working days from buy affirmation. We buy without delay from the producer at low priced costs. Every batch is examined via a third birthday celebration and we offer non-public customer service. The result is a supply courting based on reliability and confidence.

FAQ

Q: What is the minimum order quantity for your product?

A: We can supply orders from 1 kg and beyond for research use and we give favourable rates for orders above 25 kg.

Q: How do you ensure batch-to-batch consistency?

A: Every production batch is subjected to the same multi-point quality testing with set reference standards and statistical process control monitoring to maintain parameters within ±2% of all essential parameters.

Q: What do you ship with?

A: Certificate of Analysis, MSDS, third party test reports and Certificate of Origin are supplied with each order. Other documents such as Free Sale Certificates or Health Certificates can be provided upon request.

Q: How long does it usually last when stored as recommended?

A: The minimum shelf life is 24 months from date of manufacture, when stored in sealed containers at room temperature, free from light and moisture.

Q: Do you have samples before bulk order ?

A: Yes, we may provide samples for qualification testing, and the sample charge is refundable against your first commercial order.

Contact Us

Do you have more questions about Dehydroepiandrosterone Acetate Powder?

Email: duke@hongdaherb.com