Direct from our state-of-the-art Chinese manufacturing facilities. Fully documented with HPLC, LC-MS, and third-party laboratory verification for international B2B procurement.
An exhaustive scientific breakdown designed for process chemists, analytical quality control managers, and institutional procurement specialists evaluating Stanozolol fine-chemical raw materials.
CAS 10418-03-8, systematically designated under IUPAC conventions as 17β-hydroxy-17α-methyl-5α-androstano[3,2-c]pyrazole (molecular formula: C21H32N2O; molecular weight: 328.49 g/mol), represents an iconic synthetic heterocyclic steroid derivative structurally distinguished by the fusion of a pyrazole ring onto the A-ring of the saturated 5α-androstane steroid skeleton. In the realm of specialty fine chemicals, reference analytical materials, and veterinary endocrine research, the integrity of this molecule hinges upon strict stereochemical precision, specifically the 5α-dihydro configuration and the 17α-methyl / 17β-hydroxyl stereocenter.
| Analytical Parameter | Pharmacopeial Specification (USP / EP Reference) | In-House Factory Release Limits | Testing Methodology | Compliance Status |
|---|---|---|---|---|
| Appearance & Physical State | White to light cream crystalline powder | Conforms; odorless, crystalline micro-granulate | Visual & Organoleptic Inspection | PASSED |
| Identity Confirmation (FT-IR) | Concordant with reference standard spectrum | Fingerprint match across 4000 to 400 cm⁻¹ | Attenuated Total Reflectance (ATR-FTIR) | CONFIRMED |
| Chromatographic Purity (HPLC) | ≥ 98.0% (area percentage) | ≥ 99.0% to 99.5% (custom ultra-grade) | Reverse-Phase UHPLC (C18, UV 224nm) | PREMIUM |
| Individual Related Impurities | ≤ 1.0% single largest impurity | ≤ 0.5% (typically < 0.2% unreacted intermediates) | High-Resolution LC-MS/MS Gradient | PASSED |
| Melting Point Range | 235.0 °C to 242.0 °C (decomposes) | 238.5 °C to 241.0 °C sharp onset | Capillary Melting & DSC Enthalpy Curve | PASSED |
| Loss on Drying (LOD) / Water | ≤ 1.0% | ≤ 0.5% w/w moisture content | Coulometric Karl Fischer Titration | PASSED |
| Residual Solvents (ICH Q3C) | Ethanol < 5000ppm, Methanol < 3000ppm | Class 2 & 3 solvents strictly < 10% of ICH limits | Headspace Gas Chromatography (GC-FID/MS) | PASSED |
| Heavy Metals & Catalyst Residues | ≤ 20 ppm total heavy metals | ≤ 10 ppm (As, Cd, Pb, Hg each < 1 ppm) | Inductively Coupled Plasma (ICP-MS) | PASSED |
Our synthetic pathway utilizes high-yield condensation of 17α-methyl-17β-hydroxy-5α-androstan-3-one with ethyl formate under basic sodium ethoxide catalysis, yielding the 2-hydroxymethylene intermediate. Subsequent cyclization with hydrazine hydrate produces the fused pyrazole moiety with exceptional regiospecificity, eliminating toxic byproduct isomers at the source.
CAS 10418-03-8 exhibits polymorphic behaviors that dictate dissolution rates, bioavailability in veterinary formulations, and stability during dry micronization. Our engineering team controls supersaturation and cooling trajectories in anhydrous ethanol-water systems, securing Form I crystalline structures verified via Powder X-Ray Diffraction (PXRD).
Every synthesized lot is scrutinized for process-related impurities, notably 17α-methyltestosterone derivatives, unreacted 2-hydroxymethylene intermediates, and hydrazine residues. Utilizing high-sensitivity LC-MS/MS and chemical derivatization assays, hydrazine concentrations are documented below 0.1 ppm, well beneath international safety thresholds.
Combining complete domestic precursor integration, multi-ton glass-lined reactor clusters, and relentless Western-aligned quality management systems.
Unlike Western chemical brokers who rely on fragmented third-party imports, our Hebei manufacturing hub maintains backward vertical integration starting directly from phytosterols and 4-androstenedione (4-AD) intermediates. This complete raw material sovereignty insulates our downstream buyers from geopolitical pricing shocks, trade embargoes, and seasonal feedstock deficits.
Equipped with multiple 3,000L and 5,000L cryogenic glass-lined reactors capable of operating across -78°C to +180°C, our industrial facility seamlessly transitions from 100-gram analytical pilot batches to multi-ton commercial production campaigns. Every step features automated distributed control systems (DCS) monitoring temperature, pH, and agitator torque.
Through continuous process intensification, closed-loop solvent recovery units recouping >92% of ethanol and ethyl formate, and advanced modular crystallization skids, we minimize capital burn while exceeding pharmacopeial purity bars. This operational efficiency translates into sustainable, wholesale pricing margins for institutional B2B contract buyers.
Hebei Miaoou Technology operates within an accredited state-level chemical industrial zone possessing comprehensive environmental impact assessments (EIA) and integrated wastewater/VOC thermal oxidizer scrubbers. While non-compliant workshops face environmental shutdowns during regulatory sweeps, our licensed facility guarantees unbroken, year-round contract manufacturing agreements.
Over 16 years of chemical export logistics expertise. We generate compliant dangerous goods (DG) paperwork, air transport safety certifications (DGM), Certificate of Origin (CO), and formal customs clearances ensuring swift transit to North America, Europe, Latin America, and Asia-Pacific ports.
A transparent, audit-ready qualification pipeline ensuring that what is printed on your Certificate of Analysis accurately reflects the molecular contents inside every shipping container.
Incoming raw materials (intermediates, reagents, catalysts) undergo 100% quarantine sampling, FT-IR fingerprinting, and Karl Fischer moisture qualification prior to reactor charging.
Continuous monitoring of reaction kinetics via in-process thin-layer chromatography (TLC) and fast HPLC to confirm complete intermediate conversion before quenching.
Multi-stage decolorization, recrystallization from pharmaceutical-grade solvents, and continuous vacuum agitation filtering inside ISO Class 7 cleanrooms.
Dual-analyst verification featuring UHPLC-UV purity assays, LC-MS molecular weight confirmation (328.5 [M+H]+), 1H-NMR structural assignment, and ICP-MS metal testing.
Vacuum packaging in medical-grade double polyethylene bags, heat-sealed inside aluminum foil barrier pouches and light-impervious fluorinated HDPE drums with tamper-evident seals.
Examining how high-purity CAS 10418-03-8 functions across analytical toxicology, veterinary endocrinology, and diagnostic standard manufacturing worldwide.
In regulated veterinary medicine, CAS 10418-03-8 has long served as an active ingredient for managing catabolic conditions, severe anemia, chronic renal failure, and geriatric muscle wasting in non-food domestic animals (such as equines and canines). Global veterinary formulators require strict powder micronization (D90 < 20 microns) and zero biological pyrogen contamination to ensure rapid absorption and suspension stability in injectable aqueous vehicles.
Anti-doping reference laboratories accredited by the World Anti-Doping Agency (WADA), horse racing integrity authorities, and forensic pathology centers require high-purity CAS 10418-03-8 as primary calibration standards. Labs evaluate primary metabolites such as 3'-hydroxystanozolol, 4β-hydroxystanozolol, and long-term 17-epistanozolol glucuronide. Purity deviations in the primary reference compound cause quantitative baseline shifts in GC-HRMS and LC-MS/MS assays.
Biochemical research laboratories studying steroid receptor dynamics, nuclear translocation kinetics, and non-genomic signaling rely on CAS 10418-03-8 as an AR agonist model. Its specific pyrazole fusion offers unique binding kinetics when contrasted with cyclopentanoperhydrophenanthrene scaffolds, aiding medicinal chemists in decoupling anabolic nitrogen retention pathways from classical androgenic phenotypes.
Modern procurement directors face critical friction when sourcing specialty steroid APIs and research chemicals: (1) Batch-to-batch chromatographic divergence that triggers regulatory holds, (2) Missing structural elucidation packages (NMR, LC-MS, IR) required by internal QC reviewers, and (3) Customs clearance seizures triggered by improper documentation. Hebei Miaoou Technology neutralizes these vulnerabilities by pairing every shipment with comprehensive lot-specific technical packs, unadulterated analytical raw data, and pre-cleared customs documentation tailored to the jurisdictional laws of the receiving port.
How regulatory shifts, green synthesis technologies, and micro-contaminant surveillance are transforming the steroid manufacturing landscape.
Traditional batch condensation reactions are progressively migrating toward continuous micro-channel reactors. This engineering transformation provides sub-millisecond heat exchange, preventing thermal degradation hotspots during the formylation and cyclization steps. The result is an immediate reduction in tar formation, elevating baseline crude purities beyond 95% before secondary purification even begins.
Under tightening global REACH, EPA, and Chinese ecological protection mandates, factories utilizing hazardous chlorinated solvents (such as dichloromethane or chloroform) for extraction are being phased out. Modern leaders utilize bio-derived 2-methyltetrahydrofuran (2-MeTHF) and supercritical CO2 crystallization systems, virtually eliminating toxic environmental effluents.
With the alarming surge in mislabeled research chemicals and under-dosed materials across global markets, institutional procurement protocols increasingly mandate isotope ratio mass spectrometry (IRMS) and full-scan quadrupole time-of-flight (Q-TOF) validation. This analytical rigor ensures complete traceability from factory batch numbers down to molecular mass signatures.
Immediate answers to the commercial, analytical, regulatory, and logistics queries most frequently submitted to our export sales engineers.
Every shipment includes a lot-specific Certificate of Analysis (COA) containing verified HPLC chromatograms, 1H-NMR spectra, LC-MS molecular weight confirmation, and loss-on-drying metrics. Additionally, we provide fully compliant Safety Data Sheets (SDS) in accordance with GHS revisions, a formal TSE/BSE-free statement, residual solvent declarations (ICH Q3C), and standard proforma commercial invoices.
Yes. Beyond standard crystalline powder, our facility operates sterile air-jet micronization mills capable of producing specific particle size distributions, including D90 < 20 μm and D50 < 8 μm, commonly specified for veterinary aqueous suspensions or dry blend homogeneity. Particle size analysis reports verified by Malvern Mastersizer 3000 laser diffraction are provided upon request.
For standard in-stock inventory, release and dispatch occur within 24 to 48 hours following proforma sign-off. For pilot testing and analytical qualification, our MOQ begins at 100 grams. For bulk commercial contracts (25 kg to 500 kg+), production campaigns operate on a 2 to 3 week delivery schedule directly from our Hebei synthesis workshops.
Our synthesis suits operate under strict cGMP-aligned cleaning validation protocols (swab testing with HPLC residual detection below 1 ppm). Glass-lined reactors are dedicated to specific steroid families to prevent isomeric or chemical cross-contamination. Every commercial batch is blended in sanitary double-cone ribbon blenders to ensure absolute intra-lot homogeneity before cleanroom packaging.
Absolutely. We encourage prospective enterprise buyers to extract pre-shipment samples for independent third-party analysis at internationally accredited testing institutions (such as Janoshik, SGS, or Eurofins). Release terms can be contractually linked to analytical confirmation of purity, residual solvent thresholds, and heavy metal compliance.
CAS 10418-03-8 raw powder exhibits optimal long-term chemical stability when preserved in tightly sealed, light-resistant containers under dry conditions at 20°C to 25°C (controlled room temperature). Avoid prolonged exposure to direct sunlight, high humidity (>65% RH), and excessive thermal stress to prevent pyrazole oxidation or trace moisture uptake.
Explore our accompanying laboratory compounds, signaling peptides, and certified active powders manufactured to identical pharmaceutical standards.
Connect directly with Hebei Miaoou Technology's export chemical synthesis division. Obtain full HPLC chromatograms, 1H/13C-NMR data packs, process impurity profiles, and contract tier pricing within 24 hours.
