DHEA

DHEA (Dehydroepiandrosterone) Powder – 99.5%+ High-Purity

(Powder, Tablets, Capsules)

Specification Detail
Item Number SR-DHEA-01
Chemical Name Dehydroepiandrosterone (3β-Hydroxyandrost-5-en-17-one)
CAS Number 53-43-0
Key Specifications ≥99.5% Purity (HPLC-UV); Key Impurities: Androstenedione <0.5%, Epi-DHEA <0.3%
Test Methods HPLC-UV (Purity/Impurities), GC-FID (Residual Solvents), ICP-MS (Heavy Metals)
Appearance White to off-white, free-flowing crystalline powder
Packaging 25kg/drum, nitrogen-flushed foil bags with oxygen absorbers. Custom packaging available.
Main Benefits Supports healthy aging by restoring youthful hormone levels; boosts energy and vitality; enhances muscle strength and physical function; promotes cognitive and emotional well-being.
Application Anti-aging formulas, hormone support supplements, sports nutrition, men’s and women’s health.

Restore Vitality with Premium DHEA: SRBio’s Pharma-Grade Standard

(99.5%+ Purity · Plant-Derived Diosgenin · GMP Certified)

SRBio’s DHEA (Dehydroepiandrosterone) is not a simple bulk hormone; it is a pharma-grade, high-purity steroid hormone precursor. Sourced from non-GMO wild yam (Dioscorea species) and produced through a proprietary semi-synthesis with stringent impurity control, it delivers a consistent, stable, and highly bioavailable ingredient. As endogenous DHEA levels naturally decline with age, our ≥99.5% pure powder provides supplement formulators with the scientific foundation for products targeting healthy aging, hormonal balance, and physical vitality.

Uncompromising Quality: SRBio’s Manufacturing Excellence

  1. Precision Purity & Impurity Control

    • High-Purity Verification: HPLC-UV analysis confirms purity of ≥99.5%, consistently meeting and exceeding USP/EP/Ph. Eur. pharmacopoeia monographs.

    • Stringent Related Substances Control: We tightly regulate process-related steroidal impurities to ensure predictable bioactivity and safety:

      • Androstenedione: <0.5%

      • 4,6-Androstadien-17-one: <0.1%

      • Epi-DHEA: <0.3%

    • Uncompromised Safety:

      • Heavy Metals: Arsenic, Lead, Cadmium each <0.5 ppm; Mercury <0.1 ppm (ICP-MS validated).

      • Residual Solvents: Fully compliant with ICH Q3C guidelines; Class 2 solvents below 50 ppm (GC-FID).

  2. Advanced & Sustainable Synthesis from Plant Sources

    • Proprietary Semi-Synthesis: Our process begins with high-purity diosgenin, sourced from non-GMO, sustainably farmed wild yam. This ensures a pure, plant-derived starting material, eliminating animal-derived inputs (TSE/BSE free).

    • Closed-Loop Chemical Processing: State-of-the-art reactors precisely control temperature, pressure, and reaction time, guaranteeing consistent, high-yield output batch after batch.

    • Green Purification Technology:

      • Multi-Stage Crystallization: Solvent-specific recrystallization (e.g., ethanol/water mixtures) achieves >99.5% purity while minimizing solvent use.

      • Low-Temperature Drying: Vacuum drying at <60°C preserves the crystalline structure and prevents thermal degradation.

      • Eco-Impact: Solvent recovery and recycling systems reduce waste by >85% compared to traditional processes.

  3. Superior Stability & Shelf Life

    • Long-Term Stability: Accelerated stability studies (ICH Q1A guidelines) confirm ≥98% potency retention after 36 months when stored in sealed, original packaging at 25°C/60% RH.

    • Advanced Protection: Packaged with oxygen absorbers in light-resistant, nitrogen-flushed foil bags to prevent oxidation and ensure long-term stability from our facility to your production line.

Scientific Evidence: Mechanism & Efficacy

  1. Hormonal Modulation & Healthy Aging

    • Precursor to Sex Hormones: DHEA acts as a crucial prohormone, converting peripherally into androgens (like testosterone) and estrogens via tissue-specific enzymes. This supports endocrine balance as endogenous production declines with age (J. Clin. Endocrinol. Metab.).

    • Clinical Outcome: Supplementation in aging adults has been shown to increase serum DHEA-S and bioavailable testosterone levels, contributing to improved well-being and vitality (N. Engl. J. Med.).

  2. Muscle Strength & Physical Function

    • Supports Lean Mass: By restoring a more “youthful” hormonal environment, DHEA helps counteract age-related muscle loss (sarcopenia). Studies indicate improvements in muscle strength and physical function, particularly in individuals with low baseline DHEA levels.

    • Mechanism: Enhances IGF-1 signaling and promotes protein synthesis in skeletal muscle.

  3. Cognitive & Emotional Well-Being

    • Neurosteroid Activity: DHEA and its sulfate (DHEA-S) are neurosteroids that modulate neurotransmitter receptors (e.g., GABA, NMDA), potentially improving mood, memory, and stress resilience.

    • Clinical Data: Placebo-controlled trials report improvements in mood, fatigue, and cognitive performance in middle-aged to elderly adults with adrenal insufficiency (J. Clin. Endocrinol. Metab.).

Technical Specifications: SRBio vs. Market Standard

Parameter SRBio DHEA Standard Market Grade
Purity (by HPLC) ≥99.5% 97.0% – 99.0%
Androstenedione (Impurity) <0.5% Often uncontrolled (could be >2%)
Epi-DHEA (Impurity) <0.3% Often uncontrolled
Particle Size 100% through 80 mesh; Customizable D50 options Variable; often too coarse
Bulk Density 0.35 – 0.45 g/cm³ (Optimized for blending) Can vary widely, affecting flow
Loss on Drying ≤0.5% ≤1.0%
Residue on Ignition ≤0.1% ≤0.3%
Heavy Metals (Pb) <0.5 ppm Often <1.0 ppm
Shelf Life (25°C) 36 months (ICH verified) 24 months (often unverified)

Formulation-Ready Advantages

Property SRBio DHEA Benefit for Formulators
Particle Size 100% through 80 mesh; custom D50 options Excellent flow and homogeneous blending
Bulk Density Optimized (0.35-0.45 g/cm³) Consistent die fill for tablets/capsules
Micronized Grade Available for enhanced dissolution Ideal for sublingual sprays/suspensions
Stability 36-month data (ICH Q1A) Confident shelf-life for finished products

Application-Specific Benefits:

  • Capsules/Tablets: Excellent flowability and compressibility enable high-dose (e.g., 25mg, 50mg, 100mg) formulations with minimal excipients.

  • Bulk Powders (Multi-Ingredient): Consistent particle size ensures homogeneous blending with vitamins, minerals, and botanicals.

  • Sublingual/Spray Formulations: Micronized grades available for enhanced dissolution and potential absorption.

Supply Chain & Compliance Leadership

  1. Audited Transparency & Global Compliance

    • Full Traceability: Batch-specific Certificate of Analysis (COA) includes full impurity profile, residual solvent analysis, and manufacturing date. Batch records available for audit.

    • Global Regulatory Dossiers: Comprehensive documentation packages to support your filings, including:

      • USA: GRAS, NDI (New Dietary Ingredient) support.

      • EU: Novel Food application support.

      • Canada: Health Canada submissions.

      • TSE/BSE Free Statement: Available.

    • Allergen-Free: Validated to be free from gluten, soy, dairy, egg, peanuts, and crustaceans (ELISA tested).

  2. Ethical & Sustainable Production

    • Non-GMO & Vegan: Verified production process with no animal-derived inputs; derived from plant-based diosgenin.

    • ISO 14001 Certified: Environmental Management System reflects our commitment to sustainable manufacturing.

Competitive Breakdown: SRBio vs. Market Alternatives

Key Deficiencies in Low-Grade DHEA:

  • High Impurity Profile: Presence of related steroidal impurities (e.g., androstenedione) can lead to unpredictable hormonal effects.

  • Poor Stability: Susceptible to oxidation, leading to degradation and loss of potency, especially in humid or poorly packaged conditions.

  • Inconsistent Physical Properties: Poor flow and blending characteristics lead to content uniformity issues in finished products.

SRBio’s Quality Edge:

  • Impurity Control: Stringent specifications ensure minimal related substances, guaranteeing predictable bioactivity and safety.

  • Polymorphic Stability: Controlled crystallization yields the most stable polymorph, ensuring long-term shelf life and consistent dissolution.

  • Lot-to-Lot Consistency: Every batch is QC/QA released against USP reference standards, guaranteeing identical performance every time.

Technical Partnership Program

  1. Co-Development Services

    • Formulation Support: Our lab can assist with stability studies for your specific matrix (e.g., DHEA with other hormones or in various delivery systems).

    • Analytical Method Transfer: We provide validated HPLC methods for accurate quantification in your finished products.

  2. Market-Ready Solutions

    • Custom Blends:

      • Vitality Stack™: DHEA + Pregnenolone for comprehensive prohormone support.

      • AndroSupport®: DHEA + Boron (glycinate) + Stinging Nettle extract for optimized free testosterone pathways.

    • Private Label Kits: Ready-to-market formulas for capsules (25mg, 50mg), tablets, and sublingual sprays.

📦 Partner with SRBio for Pharmaceutical-Grade DHEA

Request samples, impurity profiles, or discuss co-development today.

  • 📞 English Support: +86-13720408392

  • 📧 Email: admin@plantextractssr.com

SRBio DHEA: The New Standard for Purity, Stability, and Predictable Bioactivity.

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