Product Overview

Androstenedione (Androst-4-ene-3,17-dione, CAS 63-05-8) is an endogenous C19 steroid hormone with the molecular formula C₁₉H₂₆O₂ and a molecular weight of 286.41 g/mol. Structurally, it features the classic Δ⁴-3-keto steroid backbone — the hallmark pharmacophore of all corticosteroid and progestogen drugs — with a double bond between C4 and C5, ketone groups at C3 and C17, and the essential 5α-androstane ring junction stereochemistry. Biologically, androstenedione occupies the critical branch-point position in steroidogenesis: it is the immediate precursor to testosterone (via 17β-hydroxysteroid dehydrogenase type 3/5 reduction of the 17-keto group) and to estrone/estradiol (via aromatase/CYP19A1 aromatization of the A-ring), making it the central metabolic intermediate linking androgen and estrogen biosynthesis pathways. This unique biosynthetic position — equidistant from both major sex steroid classes — gives androstenedione unparalleled importance as a pharmaceutical starting material.

In industrial pharmaceutical manufacturing, androstenedione is the key starting material for the corticosteroid drug class — anti-inflammatory and immunosuppressive agents with global annual sales exceeding $15 billion. Through microbial biotransformation (typically using Mycobacterium or Rhizopus species for regio- and stereoselective hydroxylation) followed by chemical elaboration, the androstenedione scaffold is converted into prednisone, hydrocortisone, dexamethasone, betamethasone, triamcinolone, and other life-saving corticosteroid APIs. The androst-4-ene-3,17-dione scaffold is an ideal starting point because the Δ⁴ double bond, 3-keto group, 17-keto group, and correct stereochemistry at all 6 chiral centers are already in place — dramatically reducing synthetic complexity compared to total synthesis approaches. UPOR Biotech supplies high-purity Androstenedione (≥98% HPLC) to licensed pharmaceutical manufacturers, CROs, and authorized research institutions worldwide. This product is regulated as a Schedule III controlled substance precursor. All purchasers must provide valid regulatory credentials and an end-use declaration.

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Androstenedione vs Diosgenin/Phytosterols — The Steroid Nucleus Already Built

Traditional corticosteroid synthesis starts from plant-derived sapogenins (diosgenin, hecogenin) or phytosterols (stigmasterol, β-sitosterol), requiring 10-15 chemical and/or microbial steps to degrade the side chain and build the Δ⁴-3-keto system before the corticosteroid scaffold is even established. Androstenedione bypasses this entirely: the complete androstane nucleus — with Δ⁴ double bond, 3-keto and 17-keto groups, and correct stereochemistry at all six chiral centers (5α, 8β, 9α, 10β, 13β, 14α) — is already assembled. Starting from androstenedione, corticosteroid synthesis requires only regio- and stereoselective hydroxylation at C11 (β for hydrocortisone/prednisolone, α for dexamethasone/betamethasone) and C21, plus a few additional transformations, reducing the synthetic route by 8-12 steps compared to phytosterol-based approaches. For pharmaceutical manufacturers, this translates to higher overall yield, reduced solvent consumption, shorter cycle times, and improved process mass intensity — a compelling cost-of-goods and sustainability advantage in large-scale corticosteroid API production.

Technical Specifications

PropertySpecification
Product NameAndrostenedione (Androst-4-ene-3,17-dione)
CAS Number63-05-8
Molecular FormulaC₁₉H₂₆O₂
Molecular Weight286.41 g/mol
IUPAC NameAndrost-4-ene-3,17-dione
Common Synonyms4-Androstene-3,17-dione, Δ⁴-Androstenedione, Andro, 17-Ketotestosterone
AppearanceWhite to off-white crystalline powder
Assay (HPLC)≥98.0%
Melting Point170 – 175°C
Specific Optical Rotation [α]D²⁰+190° to +198° (c=1.0, dioxane)
Identification (IR)Characteristic absorptions at 1735 cm⁻¹ (C17 C=O), 1660 cm⁻¹ (C3 conjugated C=O), 1615 cm⁻¹ (Δ⁴ C=C)
Identification (¹H-NMR)δ 5.75 (s, 1H, C4-H), δ 1.22 (s, 3H, C19-CH₃), δ 0.93 (s, 3H, C18-CH₃)
Identification (MS)m/z 286.4 [M]⁺; characteristic fragments at m/z 244 (M−CH₂CO), m/z 201 (M−C₅H₉O₂)
Loss on Drying≤0.5%
Residue on Ignition≤0.1%
Related Substances (HPLC)Individual impurity ≤0.5%; Total impurities ≤2.0%
Chromatographic Purity (TLC)Single spot, Rf ~0.4 (silica gel, hexane:ethyl acetate 1:1)
Heavy Metals (as Pb)≤10 ppm
Arsenic (As)≤2 ppm
Lead (Pb)≤2 ppm
Mercury (Hg)≤1 ppm
Residual SolventsUSP <467> / ICH Q3C compliant
Microbial LimitsTAMC ≤100 CFU/g; TYMC ≤10 CFU/g
Bacterial Endotoxins≤0.5 EU/mg (pharmaceutical grade)
SolubilitySoluble in dioxane, chloroform, DMSO, ethanol; sparingly soluble in ethyl acetate; practically insoluble in water
GradePharmaceutical Intermediate Grade / Research Grade
Recommended ApplicationsCorticosteroid API synthesis (prednisone, hydrocortisone, dexamethasone, betamethasone), analytical reference standard, steroid biochemistry research
Regulatory StatusSchedule III controlled substance precursor (US DEA); WADA Prohibited List; requires valid license/authorization for purchase
CertificationsISO 9001:2015, c-GMP, FDA-registered
Packaging100 g, 500 g, 1 kg, 5 kg (amber glass or HDPE container, sealed under nitrogen)
StorageStore at -20°C in tightly sealed container, protected from light and moisture; long-term storage under inert gas (argon or nitrogen) recommended
Shelf Life24 months from date of manufacture in unopened original packaging under recommended storage conditions

Key Benefits — Androstenedione

Pre-Assembled Steroid Nucleus

The complete androstane skeleton with correct stereochemistry at all 6 chiral centers, Δ⁴-3-keto pharmacophore, and 17-keto group is already in place. Starting corticosteroid synthesis from androstenedione eliminates 8-12 synthetic steps vs phytosterol routes, dramatically improving yield and reducing cost.

Efficient

Dual Pathway Intermediate

The 17-keto group makes androstenedione uniquely versatile: reduce to 17β-OH for testosterone and androgen-class drugs, or proceed directly to corticosteroid hydroxylation. This dual reactivity supports diverse pharmaceutical manufacturing pipelines from a single qualified starting material.

Versatile

Industrial Scale & Quality

Manufactured under c-GMP with consistent stereochemical purity (optical rotation +190° to +198°) verified batch after batch. Our supply chain supports seamless scale-up from gram-level R&D to multi-kilogram commercial production with full regulatory documentation.

Scalable

Regulatory Compliance & Security

Rigorous KYC protocols, supply chain security, and DEA compliance ensure that this controlled substance precursor is supplied only to authorized licensees. Full audit trail from manufacturing through delivery supports your regulatory filings and supply chain due diligence.

Compliant

Applications

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Corticosteroid API Synthesis

Industrial starting material for prednisone, hydrocortisone, dexamethasone, betamethasone, triamcinolone, and other life-saving anti-inflammatory corticosteroid APIs via microbial biotransformation and chemical elaboration.

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Steroid Biochemistry Research

Key reference compound for studying steroidogenic enzymes (aromatase/CYP19A1, 17β-HSD, 5α-reductase) and steroid receptor biology. Essential for endocrine pharmacology and drug metabolism research.

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Analytical Reference Standard

High-purity material (>98% HPLC, characterized by IR/NMR/MS) suitable for use as a certified reference standard, system suitability standard, or impurity marker in pharmaceutical quality control laboratories.

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Steroid Derivatization & SAR

Scaffold for synthesizing novel steroid analogues for drug discovery. The 3-keto and 17-keto groups provide two independent handles for selective derivatization and structure-activity relationship exploration.

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Biocatalysis & Biotransformation

Substrate for microbial hydroxylation and dehydrogenation reactions in biocatalysis process development. Key feedstock for engineered Mycobacterium and Rhizopus whole-cell biotransformation processes.

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Clinical Trial Material Supply

GMP-grade androstenedione qualified per ICH Q7 for use as a starting material in clinical trial material (CTM) manufacturing. Full DMF support and regulatory documentation package available.

Frequently Asked Questions

Androstenedione (Androst-4-ene-3,17-dione, CAS 63-05-8) is an endogenous C19 steroid hormone produced primarily in the adrenal glands and gonads. With the molecular formula C₁₉H₂₆O₂ and molecular weight 286.41 g/mol, it features the classic Δ⁴-3-keto steroid backbone with ketone groups at positions 3 and 17. Biologically, androstenedione is the direct precursor to both testosterone (via 17β-hydroxysteroid dehydrogenase) and estrone/estradiol (via aromatase/CYP19A1), making it the central branch-point intermediate in sex steroid biosynthesis. This unique position in the steroidogenic pathway — equidistant from both androgen and estrogen endpoints — gives androstenedione exceptional commercial importance as a pharmaceutical intermediate and as a research tool for studying steroidogenic enzyme function and regulation.

Androstenedione is the critical starting material for the industrial synthesis of corticosteroid pharmaceuticals — a drug class with global sales exceeding $15 billion annually. Through multi-step biotransformation (typically using Mycobacterium or Rhizopus species for regio- and stereoselective hydroxylation at C11β and C11α) and chemical elaboration, androstenedione is converted into prednisone, hydrocortisone, dexamethasone, betamethasone, triamcinolone, and other life-saving anti-inflammatory and immunosuppressive corticosteroids. The androst-4-ene-3,17-dione scaffold provides the essential steroid nucleus with the correct stereochemistry (5α-androstane configuration) and key functional groups (Δ⁴ double bond, 3-keto, 17-keto) already in place, dramatically reducing the synthetic steps required compared to total synthesis or phytosterol degradation approaches. This translates to higher overall yield and lower manufacturing cost at industrial scale.

Our Androstenedione meets ≥98.0% purity by HPLC with related substances well-controlled (individual impurity ≤0.5%, total impurities ≤2.0%). Key specifications: appearance — white to off-white crystalline powder; melting point 170-175°C; specific optical rotation [α]D²⁰ +190° to +198° (c=1, dioxane) — confirming correct stereochemistry at all 6 chiral centers; identification confirmed by IR (characteristic carbonyl stretches at 1735 cm⁻¹ and 1660 cm⁻¹, Δ⁴ C=C at 1615 cm⁻¹), ¹H-NMR (Δ⁴ C4-H singlet at δ 5.75, C18 and C19 methyl singlets at δ 0.93 and 1.22), and MS (m/z 286.4 [M]⁺ with characteristic fragmentation); loss on drying ≤0.5%; heavy metals ≤10 ppm; residual solvents per ICH Q3C. Each batch includes a comprehensive COA with full analytical data package.

Yes. Androstenedione is classified as an anabolic steroid precursor and is regulated as a Schedule III controlled substance in the United States under the Anabolic Steroid Control Act of 2004 (21 USC §802). It is also included on the World Anti-Doping Agency (WADA) Prohibited List under class S1 (Anabolic Agents). UPOR Biotech supplies this product strictly for licensed pharmaceutical manufacturing, analytical reference standard use, and authorized research purposes only. All purchasers must provide: (1) valid DEA registration (US customers) or equivalent national regulatory authorization (international customers); (2) a completed end-use declaration specifying the intended application; and (3) institutional credentials verifying legitimate pharmaceutical or research purpose. We maintain rigorous Know Your Customer (KYC) and supply chain security protocols including shipment tracking, diversion monitoring, and regulatory reporting. This product is emphatically not intended for human consumption as a dietary supplement or for any performance-enhancing purpose.

Every shipment includes a comprehensive Certificate of Analysis (COA) with HPLC purity data, specific optical rotation, IR/NMR/MS spectra confirming identity and stereochemistry, and a Material Safety Data Sheet (MSDS). Our manufacturing facilities are ISO 9001:2015 and c-GMP certified, FDA-registered. We provide full lot traceability from raw material sourcing through final QC release. For pharmaceutical manufacturing customers, we can provide: residual solvent analysis (GC-HS), elemental analysis, heavy metal testing per USP <231>/<232>/<233>, microbial limits testing (USP <61>/<62>), bacterial endotoxins (USP <85>), ICH Q1A stability data, DMF support documentation, and GMP batch records. A valid DEA registration or equivalent regulatory authorization is required for purchase. All documentation is maintained in our secure quality management system and is available for customer and regulatory audits.