Bulk DHEA Powder - Premium Quality Dehydroepiandrosterone Raw Material

Shaanxi Hongda Phytochemistry stands as a driving producer and provider specializing in pharmaceutical-grade DHEA crude materials. Our bulk DHEA powder conveys remarkable virtue at ≥99% (HPLC), including reliable molecule measure dissemination and predominant flowability characteristics fundamental for pharmaceutical and nutraceutical applications. With progressed amalgamation capabilities and exacting quality control conventions, we give producers with dependable supply chain arrangements that address basic definition challenges. Our state-of-the-art 20,000-square-meter office forms over 3,000 tons every year, guaranteeing versatile generation capacity whereas keeping up pharmaceutical benchmarks all through the fabricating process.

DHEA powder

Bulk DHEA Powder Specifications

Specification	Qualified Testing Result	Actual Testing Result	Test Method
Part 1. Physical & Chemical Analysis
Appearance	White crystalline powder	Complied	Visual
Assay (HPLC)	≥99.0%	99.2%	HPLC
Identification	Positive	Complied	IR, HPLC
Melting Point	148–152 °C	150.1 °C	USP
Loss on Drying	≤0.5%	0.08%	USP <731>
Residue on Ignition	≤0.1%	0.03%	USP <281>
Part 2. Heavy Metal Analysis & Control
Total Heavy Metals	≤10 ppm	Complied	AAS
Lead (Pb)	≤3 ppm	<1 ppm	ICP-MS
Arsenic (As)	≤1 ppm	<0.1 ppm	ICP-MS
Cadmium (Cd)	≤1 ppm	<0.05 ppm	ICP-MS
Mercury (Hg)	≤0.1 ppm	<0.01 ppm	ICP-MS
Part 3. Microbiological Analysis & Control
Total Plate Count (cfu/g)	≤1,000	<100	USP <61>
Yeast & Mold (cfu/g)	≤100	<10	USP <61>
E. coli	Negative	Negative	USP <62>
Salmonella (per 25 g)	Negative	Negative	USP <62>

Manufacturing Process

Our generation office utilizes progressed semi-synthesis innovation beginning with high-purity diosgenin sourced from confirmed providers. The multi-stage prepare includes:

Raw Fabric Handling: Cautious choice and confirmation of beginning materials through comprehensive expository testing.

Chemical Amalgamation: Controlled change responses performed in sterile situations with ceaseless observing of temperature and response parameters.

Purification: Multi-step crystallization and recrystallization forms to accomplish pharmaceutical-grade immaculateness levels.

Micronization: Progressed molecule estimate decrease utilizing specialized hardware to upgrade bioavailability and disintegration characteristics.

Quality Testing: Each clump experiences thorough testing counting HPLC virtue investigation, remaining dissolvable testing, overwhelming metals screening, and microbiological evaluation.

Packaging: Last item bundling happens in our 100,000-level refinement workshop utilizing double-lined polyethylene sacks inside fiber drums.

Key ApplicationsPharmaceutical Formulations

Bulk DHEA powder serves as a basic dynamic fixing in hormone substitution treatments and pharmaceutical arrangements. The steady molecule estimate and tall immaculateness guarantee dependable bioavailability over diverse detailing matrices.

Nutraceutical Products

Supplement producers utilize our powder for making capsules, tablets, and specialized conveyance frameworks. The micronized variation offers improved disintegration rates fundamental for ideal absorption.

Research Applications

Academic and clinical investigate teach depend on our pharmaceutical-grade fabric for thinks about examining hormonal adjust and metabolic function.

DHEA benefits

Quality Assurance

Our comprehensive quality control system encompasses every production stage. The SGS-standardized laboratory equipped with HPLC, GC, and spectrophotometric analysis ensures each batch meets international standards.

Testing Protocols Include:

Purity verification through high-performance liquid chromatography
Residual solvent analysis via gas chromatography
Heavy metals screening using ICP-MS technology
Microbiological testing for pathogen detection
Particle size distribution analysis

We maintain strict compliance with cGMP, FSSC22000, and ISO9001 standards while working with third-party testing agencies like SGS and Eurofins for additional verification.

laboratory

Why Choose Hongda

With over two decades of encounter, Shaanxi Hongda combines specialized mastery with fabricating brilliance. Our 150+ talented specialists and 20+ PhD-level analysts guarantee reliable item quality and inventive arrangements.

team

Competitive Advantages:

Pharmaceutical-grade manufacturing facility
Advanced analytical laboratory capabilities
Flexible packaging and customization options
Reliable supply chain with substantial inventory
Comprehensive regulatory compliance

certifications

Our advanced distribution center framework keeps up ideal capacity conditions whereas our coordinations arrange guarantees convenient conveyance around the world. Whether you require standard details or custom details, our group gives specialized back all through your item advancement prepare.

Frequently Asked Questions

Q: What distinguishes micronized from standard product?

A: Micronized versions feature particle sizes below 20 microns, significantly improving dissolution rates and bioavailability compared to standard 80-mesh powder. This enhanced surface area results in superior absorption characteristics.

Q: How do you ensure consistent flowability for encapsulation processes?

A: Our manufacturing process optimizes particle morphology and size distribution. For high-speed encapsulation, we recommend appropriate excipients to enhance flow properties and ensure uniform capsule filling.

Q: What storage conditions prevent degradation?

A: Store in sealed containers away from light and moisture below 25°C. Our double-barrier packaging system protects against oxidation and environmental factors that could compromise product integrity.

Q: Does your powder comply with pharmaceutical regulations?

A: Yes, our manufacturing facility maintains cGMP certification and follows USP/EP monograph requirements. Each batch includes comprehensive documentation supporting regulatory compliance.

Q: What analytical methods verify product quality?

A: We employ HPLC for purity analysis, GC for residual solvents, ICP-MS for heavy metals, and laser diffraction for particle size verification. Third-party testing provides additional quality assurance.

Contact Information

Prepared to talk about your bulk DHEA powder prerequisites? Our specialized group stands prepared to bolster your definition needs with customized arrangements and competitive pricing.