Dehydroepiandrosterone (DHEA, CAS 53-43-0, molecular formula C₁₉H₂₈O₂, molecular weight 288.42 g/mol), also known as prasterone (INN), androstenolone, and 3β-hydroxyandrost-5-en-17-one, is an endogenous C₁₉ steroid hormone and the most abundant circulating steroid in the human body. Synthesized primarily in the adrenal zona reticularis under ACTH regulation from 17α-hydroxypregnenolone via the CYP17A1 17,20-lyase reaction, DHEA is the pivotal Δ⁵ precursor in steroidogenesis — enzymatically converted to androstenedione by 3β-hydroxysteroid dehydrogenase type 2 (3β-HSD2) in peripheral tissues, which then serves as the direct precursor for testosterone (via 17β-HSD3) and estrogens (via CYP19 aromatase). In circulation, DHEA exists predominantly as its sulfate conjugate, DHEA-S (dehydroepiandrosterone sulfate), which circulates at micromolar concentrations — 10-20× higher than any other steroid hormone — and is desulfated to active DHEA by steroid sulfatase (STS) in target tissues. This intracrine mechanism allows each peripheral tissue (brain, bone, skin, adipose, breast, prostate, vaginal mucosa) to independently regulate its local androgen and estrogen milieu without elevating systemic hormone levels. DHEA/S also functions as a neurosteroid, modulating GABA-A, NMDA, and sigma-1 receptors independently of its role as a sex steroid precursor. The FDA-approved pharmaceutical prasterone (brand: Intrarosa, 2016) harnesses this intracrine mechanism via vaginal administration for postmenopausal vulvovaginal atrophy.

As a leading DHEA supplier and manufacturer, UPOR Biotech provides pharmaceutical-grade dehydroepiandrosterone powder (≥99% purity by HPLC) manufactured under c-GMP conditions with full USP and EP monograph compliance. Our DHEA API supports both FDA-regulated pharmaceutical manufacturing — including prasterone (Intrarosa) drug product manufacturing — and the global nutraceutical market for DHEA supplementation (25-100 mg/day oral) targeting age-related adrenopause and hormone precursor support. Bulk DHEA powder is available in kilogram to multi-kilogram quantities with flexible packaging options, competitive pricing, and low minimum order quantities. We provide comprehensive documentation including Certificates of Analysis (COA), Technical Data Sheets (TDS), Material Safety Data Sheets (MSDS), and DMF support for pharmaceutical customers pursuing ANDA/NDA filings. Free evaluation samples are available for qualified B2B buyers to verify purity, identity, and quality before placing bulk orders. Contact UPOR Biotech today to request your DHEA sample or discuss your custom API requirements.

DHEA vs Direct Hormone Replacement — The Intracrine Advantage

DHEA (as DHEA-S) circulates at micromolar concentrations — 10-20× higher than cortisol, testosterone, or estradiol — making it the most abundant steroid hormone in human physiology. Unlike direct hormone replacement therapies (testosterone injections/pellets, estradiol patches/tablets) that flood all tissues indiscriminately with active hormones, DHEA serves as a universal precursor that peripheral tissues convert to androgens and estrogens on demand via the intracrine mechanism. Each tissue independently controls its sex steroid milieu by regulating the expression of 3β-HSD2, 17β-HSD3, 5α-reductase, and CYP19 aromatase — producing exactly the androgens and estrogens needed, where needed, without elevating systemic hormone levels. This tissue-specific, intracrine activation is the fundamental basis for DHEA’s favorable safety profile and the physiological rationale for its FDA approval as Intrarosa (prasterone) for vulvovaginal atrophy — the only steroid hormone therapy that works without raising systemic estradiol or testosterone concentrations.

Technical Specifications — DHEA (Prasterone) Pharma/Nutraceutical Grade

PropertySpecification
Product NameDehydroepiandrosterone (DHEA) — CAS 53-43-0, Pharma/Nutraceutical Grade
INN (International Nonproprietary Name)Prasterone
Common SynonymsDHEA, Dehydroepiandrosterone, Androstenolone, 3β-Hydroxyandrost-5-en-17-one, Intrarosa (brand)
CAS Number53-43-0
Molecular FormulaC₁₉H₂₈O₂
Molecular Weight288.42 g/mol
AppearanceWhite to off-white crystalline powder
Assay (HPLC)≥99.0% (anhydrous basis)
IdentificationIR spectrum concordant with USP DHEA Reference Standard; HPLC retention time matches reference standard
Melting Point148 – 152°C
Specific Optical Rotation[α]D²⁰ +10.0° to +14.0° (c=1, ethanol)
Loss on Drying≤0.5%
Residue on Ignition≤0.1%
Related Substances (HPLC)Total impurities ≤1.0%; Any single impurity ≤0.5%; androstenedione ≤0.3%; 3β,17β-androst-5-ene-diol ≤0.3%
Residual SolventsUSP <467> / EP 5.4 / ICH Q3C compliant
Heavy Metals (as Pb)≤10 ppm
Lead (Pb)≤2 ppm
Arsenic (As)≤1 ppm
Mercury (Hg)≤0.1 ppm
Cadmium (Cd)≤1 ppm
Microbial Limits — TAMC≤100 CFU/g (USP <61>)
Microbial Limits — TYMC≤10 CFU/g (USP <61>)
PathogensE. coli, Salmonella spp., S. aureus, P. aeruginosa — absent (USP <62>)
Bacterial Endotoxins≤0.5 EU/mg (USP <85>, pharma grade)
Key Endogenous RoleDHEA is the Δ⁵ precursor: DHEA → androstenedione (3β-HSD2) → testosterone/estrogens. DHEA-S is the sulfated storage form desulfated to active DHEA by steroid sulfatase (STS) in peripheral tissues.
Recommended Usage / DoseNutraceutical: 25 – 100 mg/day oral; Pharmaceutical (Intrarosa): 6.5 mg vaginal insert daily; Adrenal insufficiency: 25 – 50 mg/day oral
GradePharma/Nutraceutical Grade, ≥99% HPLC, USP/EP compliant
Certifications & StandardsUSP, EP, c-GMP, ISO 9001, DMF support available
StorageStore at 2 – 8°C, tightly sealed in original container, protect from light and moisture
Packaging1 kg, 5 kg, 25 kg fiber drums with double PE liner; custom packaging available. MOQ: 1 kg.
Shelf Life36 months from date of manufacture under recommended storage conditions

Key Benefits — Dehydroepiandrosterone (DHEA)

Master Steroid Precursor — The Universal Prohormone for Androgens & Estrogens

DHEA is the body’s most abundant circulating steroid hormone (as DHEA-S at μM concentrations — 10-20× higher than any other steroid). As the Δ⁵ precursor, each peripheral tissue independently converts DHEA to the exact androgens and estrogens it requires through the intracrine mechanism — producing testosterone, DHT, and estradiol locally without systemic hormone elevation.

Master Prohormone

Adrenopause Countermeasure — Restoring Youthful DHEA Levels After Age-Related Decline

DHEA levels peak at age 20-30 and decline approximately 80% by age 70 in the process known as adrenopause. This selective loss of adrenal androgen production (with preserved cortisol) reduces peripheral sex steroid precursor availability. DHEA supplementation restores youthful DHEA/DHEA-S levels, supporting energy metabolism, body composition, immune function, and cognitive health affected by age-related decline.

Anti-Aging & Adrenopause

FDA-Validated Intracrine Therapy — Intrarosa (Prasterone) for Vulvovaginal Atrophy

DHEA received FDA approval in 2016 as Intrarosa (prasterone) 6.5 mg vaginal inserts for postmenopausal vulvovaginal atrophy — a landmark validation of the intracrine mechanism. Vaginally administered DHEA is converted intracellularly to androgens and estrogens within the vaginal mucosa, restoring vaginal cytology, reducing dyspareunia, and normalizing pH without elevating systemic estradiol or testosterone levels.

FDA-Approved 2016

Dual Pharma + Nutraceutical Versatility — One API, Multiple Markets

UPOR Biotech’s DHEA meets both USP/EP pharmaceutical standards and nutraceutical purity requirements (≥99% HPLC), enabling use across FDA-regulated drug manufacturing (prasterone API), dietary supplement formulation (DHEA 25-100 mg capsules/tablets), anti-aging wellness products, and custom pharmaceutical synthesis. One high-purity API serving regulated pharma, nutraceutical, and API intermediate markets with complete documentation for each application.

Pharma + Nutraceutical

Applications

FDA-Approved Pharmaceutical API: Intrarosa (Prasterone)

DHEA as prasterone API for FDA-approved Intrarosa 6.5 mg vaginal inserts (approved 2016) targeting postmenopausal vulvovaginal atrophy. Intracrine conversion within vaginal mucosa to androgens and estrogens restores cytology, reduces dyspareunia, and normalizes pH without elevating systemic hormone levels. DMF support available for ANDA/NDA filers.

Nutraceutical DHEA Supplementation — Anti-Aging & Wellness

DHEA at 25-100 mg/day oral in capsules, tablets, and powder formulations targeting age-related DHEA decline (adrenopause). Supports energy, vitality, body composition, mood, cognitive function, libido, and immune health. The most established nutraceutical application of DHEA. OEM and private label formulations available.

Adrenal Insufficiency & Hormone Replacement Therapy

DHEA supplementation at 25-50 mg/day oral for primary and secondary adrenal insufficiency (Addison’s disease, hypopituitarism) where endogenous DHEA production is deficient despite glucocorticoid and mineralocorticoid replacement. Restores androgen precursor levels and improves quality of life, mood, and libido in adrenal-insufficient patients.

Steroid Hormone Synthesis — Pharmaceutical Intermediate & API Precursor

DHEA as the key Δ⁵ precursor for pharmaceutical steroid synthesis: DHEA → androstenedione (3β-HSD2) → testosterone (17β-HSD3) → estradiol (CYP19 aromatase). Used in the manufacture of testosterone, estradiol, and other steroid hormone APIs requiring a high-purity starting material with well-characterized impurity profiles.

Cognitive Health & Neurosteroid Modulation

DHEA/S functions as a neurosteroid in the CNS, directly modulating GABA-A (negative allosteric modulator), NMDA (positive allosteric modulator), and sigma-1 receptors independently of its role as a sex steroid precursor. DHEA supplementation at 25-100 mg/day has shown benefits for mood, well-being, and cognitive function in aging populations.

Bone Health, Body Composition & Metabolic Support

DHEA-derived estrogens and androgens support bone mineral density maintenance in postmenopausal women and aging men. DHEA supplementation has demonstrated modest improvements in lean body mass, reduced visceral adiposity, and insulin sensitivity in elderly populations, making it a comprehensive metabolic and musculoskeletal support ingredient.

Frequently Asked Questions

Dehydroepiandrosterone (DHEA, CAS 53-43-0) is an endogenous C₁₉ steroid hormone synthesized primarily in the adrenal zona reticularis from 17α-hydroxypregnenolone via the CYP17A1 17,20-lyase reaction under ACTH regulation. DHEA is the most abundant circulating steroid in the human body because it exists predominantly as its sulfated storage form, DHEA-S (dehydroepiandrosterone sulfate), which circulates at micromolar concentrations (1-10 μM) — 10-20× higher than cortisol, testosterone, or estradiol. DHEA-S serves as a stable circulating reservoir: it is desulfated to active DHEA by steroid sulfatase (STS) in peripheral target tissues, where it is then converted to androgens and estrogens via the intracrine mechanism. This sulfation/desulfation cycle allows DHEA to function as a universal prohormone that each tissue independently converts to the specific androgens and estrogens it requires, without altering systemic hormone levels. DHEA/S also functions as a neurosteroid, directly modulating GABA-A, NMDA, and sigma-1 receptors in the CNS. UPOR Biotech supplies pharmaceutical-grade DHEA (≥99% HPLC) meeting USP and EP monograph standards with full documentation.

Adrenopause is the age-related, selective decline in adrenal androgen production — specifically DHEA and DHEA-S — that occurs independently of cortisol and aldosterone secretion. DHEA levels peak at approximately age 20-30 years (serum DHEA-S ~300-500 μg/dL) and decline progressively by approximately 80% by age 70 (serum DHEA-S ~50-100 μg/dL). The mechanism involves a specific reduction in CYP17A1 17,20-lyase activity within the adrenal zona reticularis, while 17α-hydroxylase activity (required for cortisol synthesis) remains intact. This functional uncoupling is driven by: (1) progressive atrophy of the zona reticularis with aging, (2) decreased expression of cytochrome b5 (an allosteric enhancer of 17,20-lyase activity), and (3) altered redox regulation of P450 oxidoreductase electron transfer to CYP17A1. The clinical consequence is a gradual decline in peripheral androgen and estrogen precursor availability, which has been associated with age-related changes in body composition (reduced lean mass, increased visceral adiposity), bone mineral density loss, cognitive decline, diminished immune function, and reduced libido. DHEA supplementation (25-100 mg/day oral) restores circulating DHEA/DHEA-S to youthful physiological levels and is widely used in anti-aging and wellness nutraceutical protocols. The adrenopause phenomenon is unique to humans and some higher primates — laboratory rodents do not produce adrenal DHEA, making human clinical data essential.

DHEA (prasterone) has one FDA-approved pharmaceutical indication and several major nutraceutical applications. Pharmaceutical: In 2016, the FDA approved prasterone (Intrarosa) as a 6.5 mg daily vaginal insert for the treatment of moderate-to-severe dyspareunia associated with postmenopausal vulvovaginal atrophy (VVA). Intrarosa works via the intracrine mechanism — vaginally administered DHEA is converted intracellularly to androgens and estrogens within the vaginal mucosa, restoring vaginal cytology, reducing parabasal cells, increasing superficial cells, and normalizing vaginal pH without elevating systemic estradiol levels. Nutraceutical applications (25-100 mg/day oral): (1) Anti-aging and wellness supplementation — the most established use, targeting adrenopause-related decline. (2) Cognitive health and mood support — DHEA/S as a neurosteroid modulating NMDA, GABA-A, and sigma-1 receptors. (3) Libido and sexual function — DHEA-derived androgens support sexual desire in both men and women. (4) Bone health — DHEA-derived estrogens support bone mineral density in postmenopausal women. (5) Immune modulation — studies suggest benefits for autoimmune conditions including SLE. (6) Body composition — modest improvements in lean mass and reductions in visceral adiposity. UPOR Biotech supplies both pharmaceutical-grade DHEA API and nutraceutical-grade DHEA powder.

DHEA is the pivotal Δ⁵ precursor in the steroidogenic pathway. The conversion proceeds through two pathways: (1) The Δ⁵ pathway (predominant in peripheral tissues): DHEA is first converted to androstenedione by 3β-hydroxysteroid dehydrogenase type 2 (3β-HSD2), which oxidizes the 3β-hydroxyl to a 3-keto group and isomerizes Δ⁵ to Δ⁴. Androstenedione then serves as the branch point — converted to testosterone by 17β-hydroxysteroid dehydrogenase type 3 (17β-HSD3) in the reductive direction, or aromatized to estrone by CYP19 aromatase. Testosterone can be further reduced to the more potent androgen 5α-dihydrotestosterone (DHT) by 5α-reductase in androgen-target tissues (prostate, skin, hair follicles), or aromatized to estradiol by CYP19 aromatase. (2) The Δ⁵ alternative pathway: DHEA can be directly converted to androst-5-ene-3β,17β-diol (androstenediol) by 17β-HSD, then converted to testosterone by 3β-HSD. The critical feature of DHEA metabolism is its intracrine nature — the conversion to active androgens and estrogens occurs within peripheral target tissues (brain, bone, skin, adipose, breast, prostate, vaginal mucosa), not in the systemic circulation. Each tissue independently regulates its local sex steroid milieu by controlling expression of 3β-HSD2, 17β-HSD3, 5α-reductase, and CYP19 aromatase, producing exactly the androgens and estrogens needed without elevating systemic hormone levels. This tissue-specific intracrinology is the basis for DHEA’s favorable safety profile compared to direct hormone replacement therapies.

Every DHEA shipment from UPOR Biotech includes a complete documentation package: Certificate of Analysis (COA) with HPLC purity (≥99.0%), full impurity profile (total impurities ≤1.0%, any single impurity ≤0.5%), identification by IR and HPLC retention time against USP reference standard, melting point (148-152°C), specific optical rotation ([α]D²⁰ +10.0° to +14.0°), loss on drying (≤0.5%), residue on ignition (≤0.1%), residual solvents per USP <467>/EP 5.4/ICH Q3C, heavy metals panel (total ≤10 ppm with Pb ≤2 ppm, As ≤1 ppm, Hg ≤0.1 ppm, Cd ≤1 ppm), microbial limits per USP <61>/<62> (TAMC ≤100 CFU/g, TYMC ≤10 CFU/g, pathogens absent), and bacterial endotoxins (≤0.5 EU/mg per USP <85>). Additional documentation: Material Safety Data Sheet (MSDS), signed and dated HPLC Chromatogram, Technical Data Sheet (TDS), BSE/TSE-Free Statement, Allergen Statement, Stability Data (25°C/60%RH long-term and 40°C/75%RH accelerated), and Complete Lot Traceability from synthesis batch to finished product. DMF (Drug Master File) support is available for pharmaceutical customers pursuing ANDA/NDA filings. Our DHEA is manufactured under c-GMP conditions with ISO 9001 quality management. Free evaluation samples are available for qualified B2B buyers. Standard MOQ: 1 kg. Packaging: 1 kg, 5 kg, and 25 kg fiber drums with double PE liner; custom packaging available. All documents provided in English.