Enterprise Synthesis & Primary Manufacturing

Buy CAS 521-12-0 Supplier & Factory: Technical Procurement Dossier

Direct manufacturer source for high-assay Drostanolone Propionate (CAS 521-12-0). High-performance synthesis, multi-tier HPLC/LC-MS purity verification, and robust global cold-chain & standard export logistics.

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Industry Whitepaper Technical Core

CAS 521-12-0 (Drostanolone Propionate): Chemical Integrity & Production Architecture

A rigorous industrial perspective on the synthesis pathways, quality control matrices, and commercial supply guarantees governing global procurement of pure steroid reference standards and API intermediates.

≥99.2%
Batch HPLC Purity
<0.1%
Single Individual Impurity
100%
NMR / LC-MS Traceability
Class 100k
Cleanroom Crystallization
Analytical Parameter Monograph Standard (EP / USP Specs) Factory Realized Value (Batch In-House) Test Protocol
Chemical Nomenclature 17β-Hydroxy-2α-methyl-5α-androstan-3-one propionate CAS 521-12-0 Certified Identity 1H / 13C Nuclear Magnetic Resonance (NMR)
Molecular Formula & MW C23H36O3 · 360.53 g/mol Conforms exactly to molecular weight High-Resolution Mass Spectrometry (HRMS)
Appearance White to creamy white crystalline powder Ultra-fine white crystalline solid Organoleptic Inspection / Visual USP <631>
Chromatographic Purity (HPLC) Not less than 98.0% (w/w) 99.15% - 99.45% RP-HPLC (C18 Column, UV 240nm / DAD)
Specific Optical Rotation [α]D +24.0° to +29.0° (c=1, chloroform) +26.8° Automatic Polarimetry at 20°C
Melting Point Range 114.0°C – 120.0°C 116.5°C – 118.2°C Capillary Differential Scanning Calorimetry (DSC)
Loss on Drying & Moisture ≤ 0.50% 0.18% Karl Fischer Volumetric Titration
Heavy Metals & Elemental Impurities ≤ 10 ppm total < 2 ppm (Cd, Pb, As, Hg undetectable) ICP-MS (ICH Q3D Compliant)
Residual Solvents Within ICH limits (Class 2 & Class 3) Methanol < 50ppm, Ethanol < 200ppm Headspace Gas Chromatography (HS-GC-FID)
Global Trends & Sector Trajectory

CAS 521-12-0 Industry Evolution: Shifts in Synthesis, Traceability, & Compliance

How stringent biopharmaceutical quality standards and microfluidic synthesis revolutions are redefining the steroid derivative procurement market for enterprise buyers worldwide.

Catalytic Chemistry

Stereoselective 2α-Alkylation

Traditional manufacturing suffered from poor epimeric selectivity at the C-2 carbon, leading to 2β-isomer contamination. Next-generation production integrates organometallic catalysts and enantioselective hydrogenation, driving diastereomeric purity well beyond 99.5% with zero cross-stereoisomer baggage.

Elimination of 2β-Epimer
Regulatory Mandates

ICH Q3D Elemental Scrutiny

Global pharmaceutical purchasers no longer accept standard generic assay reports. The integration of ICP-MS metal tracking ensures zero heavy metal catalyst bleed-through (such as palladium or platinum from deprotection sequences), aligning bulk commercial supplies directly with clinical research baselines.

Ultra-Low Elemental Impurities
Green Engineering

Solvent Closed-Loop Recovery

Driven by dual-carbon mandates and sustainable manufacturing objectives, modern factory processes eliminate toxic chlorinated solvents during 17β-esterification, transitioning to super-critical extraction and high-recovery cyclic ethyl acetate/heptane crystallization systems that diminish environmental footprint.

Zero-Halogenated Solvents
Smart Manufacturing 4.0

China Factory 4.0: End-to-End Resilience, Scale, & Efficiency Multipliers

Combining backward integration of steroid phytosterol precursors with automated distributed control systems (DCS) to guarantee supply continuity and unmatched cost-to-purity ratios.

Upstream Precursor Sovereignty

While Western chemical suppliers rely heavily on fractured, multi-tiered subcontracted intermediate suppliers, China's centralized industrial chemical parks maintain continuous synthesis chains from crude phytosterols (soy/pine origin) directly into 4-Androstenedione (4-AD) and Dihydrotestosterone (DHT) skeletons. This uninterrupted backward integration completely shields downstream B2B procurement partners from geopolitical tariff spikes, logistical ocean-freight shocks, and raw material shortages.

Through our dedicated 12,000 m² multi-functional synthesis blocks, we sustain raw buffer stocks capable of yielding metric-ton volumes of Drostanolone Propionate on rolling 30-day production cycles, maintaining flawless stability in contract price schedules across annual procurement agreements.

DCS Automated Synthesis & Crystallization

The manual handling of temperature, reagent addition, and crystallization ramps is the primary cause of inter-batch variance in fine chemicals. Our Smart Factory 4.0 implementation utilizes Distributed Control Systems (DCS) with real-time feedback loops controlling reactor temperature jackets within ±0.2°C during exothermic esterification.

Automated inline Process Analytical Technology (PAT) employing in-situ NIR and turbidity sensors monitors the nucleation threshold during crystal growth. This produces exceptionally uniform particle size distributions (PSD), eliminating variable powder density issues and dramatically improving downstream dissolution rates for analytical testing reagents and formulation matrices.

Cleanroom Finishing (ISO Class 7)

Lyophilization, micronization, and primary vacuum packaging operate under ISO Class 7 laminar flow enclosures with continuous air particle counting to prevent bio-burden and foreign particulate entrapment.

Complete Digital Traceability

Every drum is barcoded to its automated synthesis run, providing an auditable batch genealogy link connecting raw esterification reagents, solvent lot numbers, chromatography charts, and packaging chamber logs.

24/7 Rapid Export Despatch

Centrally located near major international cargo hubs (Shanghai, Beijing, Hong Kong) with specialized chemical transport certifications, reducing shipment turnaround times to North America and Europe by 48-72 hours.

Applications & Industrial Realities

Commercial Landscapes & Precision Downstream Utilization

Critical applications in analytical chromatography standards, receptor-binding investigations, anti-doping reference libraries, and high-precision biochemical formulation research.

1. Reference Material & Forensic Standard Calibration

As international testing facilities and reference laboratories (including WADA-accredited and forensic toxicological testing centers) advance high-resolution tandem mass spectrometry (LC-MS/MS and GC-HRMS), the necessity for reference standards with certified traceability and unambiguous isotope profiles is paramount. Drostanolone Propionate (CAS 521-12-0) manufactured under our strict protocol acts as an ultra-pure calibration baseline for urinary metabolite detection, pharmacokinetic quantification curves, and retention time identification.

Each reference sample is packaged under inert argon blanket conditions in light-impervious, amber borosilicate glass ampoules to preserve the integrity of the propionate ester against ambient atmospheric moisture hydrolysis over multi-year storage cycles.

2. Endocrinology & Androgen Receptor Binding Assays

In biomedical academic research and contract research organizations (CROs), Drostanolone represents a unique molecular template: a non-aromatizing androgen exhibiting high selectivity for the androgen receptor (AR) without conversion into estrogens via cytochrome P450 aromatase enzymes. Furthermore, its unique 2α-methyl substitution offers specific metabolic resistance against 3α-hydroxysteroid dehydrogenase inactivation.

Laboratories investigating muscle catabolism models, oncology cell-line responses, and selective androgenic/anabolic dissociation ratios utilize our material to ensure assay outcomes are uncorrupted by trace unreacted androstane intermediates or stereochemical outliers.

3. Synthesis Intermediates for Custom Chemical Modifications

Contract manufacturing facilities utilize bulk CAS 521-12-0 as a high-grade precursor for transesterification, de-esterification to pure drostanolone base (CAS 58-18-4), or further semi-synthetic steroid architecture exploration. The predictable purity curve of our material guarantees that downstream reaction kinetics remain uninhibited by residual carboxylic acids, heavy metal poisoning, or acidic catalyst residues.

4. Stability & Excipient Compatibility Research

Formulation scientists evaluate our high-purity crystalline solid within diverse lipid carrier matrices (such as medium-chain triglycerides, ethyl oleate, and benzyl benzoate co-solvent systems) to document solubility isotherms, crystal polymorphism, and thermodynamic long-term stability under accelerated aging protocols (ICH Q1A guidelines).

Procurement Quality Governance

The B2B Buyer's Verification Matrix: Evaluating CAS 521-12-0 Suppliers

A structured 5-pillar auditing framework for sourcing managers, quality assurance auditors, and chemical importers to differentiate verified primary manufacturers from high-risk brokers.

1. Raw Chromatographic Data

Never accept a COA that solely presents numerical percentage values. Insist on authentic raw instrument files featuring baseline separation, integrator event logs, injection volume details, retention time symmetry, and full-spectrum UV diode array scans proving absence of co-eluting impurities.

2. Mass Spectrometry Verification

Confirm the parent molecular ion [M+H]+ at m/z 361.3 and characteristic fragmentation pathways via electrospray ionization (ESI-MS). This proves beyond doubt that the propionate side chain is intact and not degraded to the free alcohol or oxidized 3-enol structures.

3. Controlled Packaging Integrity

Steroid propionate esters are sensitive to moisture-catalyzed ester hydrolysis. True industrial suppliers package under dry nitrogen or argon blankets inside multi-layered anti-static aluminum foil bags, shielded within tamper-evident HDPE drums with desiccant seals.

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Knowledge Base & Technical Inquiries

Frequently Asked Questions: CAS 521-12-0 Sourcing & Quality Parameters

Authoritative technical guidance compiled by our senior chemical engineers and analytical release chemists to answer critical enterprise procurement inquiries.

What is the definitive chemical identity and stereochemical structure of CAS 521-12-0?
CAS 521-12-0 corresponds specifically to Drostanolone Propionate (IUPAC: [2α,5α,17β]-2-methyl-3-oxoandrostan-17-yl propanoate). The molecule features a completely reduced 5α-androstane nucleus, a stereospecific 2α-methyl substitution, and an esterified 17β-hydroxyl group with propionic acid. It has a molecular formula of C23H36O3 and an exact molecular weight of 360.53 g/mol. Purity verification must confirm the complete absence of the 2β-epimer, unreacted drostanolone base (CAS 58-18-4), and free propionic acid residues.
What analytical documentation accompanies every industrial batch of CAS 521-12-0?
Every shipment leaves our facility with a comprehensive analytical release dossier including: (1) Certificate of Analysis (COA) specifying batch number, release date, and retest interval; (2) High-Performance Liquid Chromatography (HPLC) chromatogram with peak integration table; (3) Proton and Carbon-13 Nuclear Magnetic Resonance (1H-NMR / 13C-NMR) spectral scans; (4) High-Resolution Mass Spectrometry (HRMS) confirmation; (5) Karl Fischer moisture measurement; and (6) Heavy metals and residual solvents quantification.
How does China Factory 4.0 automation ensure superior batch-to-batch consistency?
Our automated facility utilizes programmable DCS architectures that strictly standardize kinetic reaction times, reagent dosage rates, and crystallization crystallization cooling curves within ±0.2°C tolerance limits. By minimizing human intervention during the 17β-esterification and solvent crystallization stages, we eliminate inter-batch purity drift, guaranteeing that successive lots maintain identical crystal morphology, bulk density, and melting points (114.0°C–120.0°C).
What are the recommended temperature and storage conditions for bulk powder inventory?
Drostanolone Propionate should be stored at controlled room temperature (20°C to 25°C) with excursions permitted between 15°C and 30°C in an airtight container protected from direct light, heat, and moisture. For long-term archival reference storage exceeding 24 months, storage at 2°C to 8°C under nitrogen purging in desiccated amber containers is recommended to completely prevent trace hydrolytic cleavage of the ester bond.
How do you handle custom packaging, contract labeling, and discreet international logistics?
We provide modular B2B packaging options ranging from 100g, 500g, and 1kg vacuum heat-sealed aluminum foil pouches to 25kg UN-certified fiber drums lined with dual polyethylene liners. Full OEM/ODM labeling conforming strictly to commercial buyer shipping declarations is supported. Our logistics division coordinates express air cargo, thermal data logging, and professional export customs clearances with end-to-end waypoint tracking.
Can your factory support independent third-party lab testing (SGS / Intertek / Janoshik)?
Yes. We actively encourage and accommodate blind third-party verification. In addition to our internal QA release protocols, buyers can designate independent analytical laboratories to perform blind pre-shipment sampling. Our manufacturing quality guarantee provides a 100% replacement or refund assurance should any verified third-party laboratory report a deviation from our signed Certificate of Analysis specifications.
Factory Direct Technical Engagement

Request Official Batch COA, Working Standard & Commercial Quotation

Connect directly with our fine chemical export division. Submit your required purity specifications, volume requirements (grams to metric tons), and documentation needs. Receive formal proforma invoices and full analytical data sets within 24 business hours.

Download Analytical Catalog & Sample COA Initiate B2B Procurement Inquiry