API & Fine Chemical Monograph 2026

High-Quality Cas 23076-35-9 Manufacturers & Suppliers

A Comprehensive Industry Whitepaper on Global Supply Chain Architecture, Analytical Assay Validation (HPLC/GC-MS), Chinese Manufacturing Efficiency, and Enterprise Procurement Frameworks.

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Technical Monograph

Chemical Identity, Analytical Characterization & Quality Parameters of CAS 23076-35-9

Comprehensive molecular profiling, purity thresholds, and release criteria for global chemical procurement specialists and regulatory compliance officers.

Executive Monograph: Xylazine Hydrochloride (CAS 23076-35-9)

CAS 23076-35-9 designates Xylazine Hydrochloride (N-(2,6-dimethylphenyl)-5,6-dihydro-4H-1,3-thiazin-2-amine hydrochloride), a well-established non-narcotic compound widely recognized as a potent α2-adrenergic receptor agonist. Originally developed in fine chemical synthesis laboratories for sedative, analgesic, and central muscle relaxant investigations, the chemical entity functions via central presynaptic α2 receptors, significantly decreasing norepinephrine and dopamine release across biological systems.

For industrial chemical manufacturers, custom synthesis houses, and pharmaceutical intermediate formulators, CAS 23076-35-9 presents unique crystallization behavior, hygroscopic characteristics, and thermal stability requirements. Maintaining reproducible batches demands rigid process control throughout condensation, salt-formation, recrystallization, and vacuum-drying operations. Sourcing from certified manufacturers ensures compliance with stringent international analytical standards, eliminating common structural isomer impurities and hazardous process contaminants.

Analytical Parameter Pharmacopeial / Industrial Standard Typical Factory Batch Result Test Methodology
Chemical Name Xylazine Hydrochloride Conforms to Structure IUPAC Systematics
CAS Registry Number 23076-35-9 Validated Match CAS Inventory Registry
Molecular Formula & Weight C12H16N2S · HCl (256.79 g/mol) 256.80 g/mol High-Res Mass Spectrometry (HRMS)
Physical Appearance White to practically white crystalline powder White microcrystalline powder Visual Inspection (USP <630>)
Chromatographic Purity (HPLC) ≥ 98.5% (EP/USP Grade) 99.4% – 99.8% RP-HPLC (UV detection at 254 nm)
Melting Point Range 164.0 °C – 168.0 °C (with decomposition) 165.2 °C – 166.8 °C Capillary Melting Apparatus
Loss on Drying (LOD) ≤ 0.50% 0.18% Thermogravimetric / Vacuum Oven
Residue on Ignition (Sulfated Ash) ≤ 0.10% 0.04% Muffle Furnace (600 °C ± 50 °C)
Heavy Metals Content ≤ 10 ppm < 5 ppm ICP-MS Heavy Metal Screening
Residual Solvents (ICH Q3C) Methanol < 3000 ppm, Acetone < 5000 ppm Non-detected to traces < 100 ppm Headspace Gas Chromatography (HS-GC)

HPLC Chromatographic Assays

Analytical verification is the primary pillar of chemical trustworthiness. Qualified manufacturers implement reverse-phase HPLC systems utilizing C18 silica stationary phases with gradient acetonitrile/water buffers to quantify primary compound concentration and detect trace impurities.

  • Resolution of structurally related degradation intermediates.
  • Calibration against certified USP and EP analytical references.
  • Complete chromatographic raw data integration provided in batch COAs.

Spectroscopic Fingerprinting

Structural confirmation requires multimodal identity verification. High-resolution Proton and Carbon Nuclear Magnetic Resonance (1H-NMR, 13C-NMR) coupled with Fourier-Transform Infrared (FTIR) spectroscopy establishes exact chemical conformation without isomer cross-contamination.

  • FTIR absorption spectrum matches reference standard conformers.
  • Electrospray Ionization Mass Spectrometry (ESI-MS) parent peak [M+H]+ verification.
  • Routine elemental combustion analysis for carbon, nitrogen, sulfur integrity.

Hygroscopic & Physical Stability

As a hydrochloride salt, CAS 23076-35-9 demonstrates marked thermodynamic stability but requires careful moisture protection to avoid crystal agglomeration and polymorphic shifts under elevated relative humidity conditions.

  • Optimized crystal habit engineered for rapid dissolution profiles.
  • Nitrogen-flushed multi-barrier packaging prevents ambient moisture absorption.
  • Validated shelf-life stability exceeding 36 months under controlled storage (15–25 °C).
Market Dynamics

Global Commercial & Industrial Landscape for CAS 23076-35-9

Market segmentation, international import-export flows, regulatory evolution, and macroeconomic drivers governing active substance procurement.

5.8%
Global Compound Market CAGR
≥99.5%
Target Assay Purity Standard
120+
Global Trading Corridors
<24h
Factory Document Release Time

Veterinary Medicine & Animal Husbandry

CAS 23076-35-9 remains an indispensable therapeutic active pharmaceutical ingredient (API) across large-animal veterinary healthcare. Formulated into sterile injectable solutions (typically 20 mg/mL and 100 mg/mL), it is routinely applied in equine medicine, bovine surgery, and companion animal diagnostics for its reliable sedation, muscular relaxation, and visceral analgesia.

Additionally, wildlife conservation programs and zoological field veterinary teams rely on standardized combinations (such as xylazine-ketamine formulations) for the safe handling, tagging, and surgical treatment of wild ungulates and captive species.

Preclinical & Neuroscience Research

In academic institutions, contract research organizations (CROs), and biomedical research centers, high-purity Xylazine Hydrochloride is universally deployed as a reference agonist in rodent neurological and cardiovascular research. Studies evaluating α2A, α2B, and α2C receptor subtypes depend on ultrapure material to eliminate receptor binding noise caused by trace unreacted precursors or side-chain synthesis artifacts.

The compound also acts as a vital benchmark in metabolic studies exploring adrenergic regulation of insulin release and blood glucose modulation.

Regulatory Shifts & Traceability Mandates

Over recent years, international regulatory bodies—including the US FDA, DEA, European EMA, and Asian border control agencies—have instituted enhanced oversight and import surveillance over CAS 23076-35-9 to curb non-veterinary diversion and counterfeit adulteration. For enterprise buyers, this heightened regulatory scrutiny makes working with certified, legally structured chemical suppliers non-negotiable.

Legitimate industrial buyers require verified end-user declarations (EUDs), transparent chain-of-custody documentation, and complete analytical disclosure before entering supply agreements.

Manufacturing Supremacy

China Factory Efficiency Advantages in CAS 23076-35-9 Production

Vertical upstream integration, modern glass-lined automated reactor clusters, and robust economies of scale deliver unmatched cost-performance for global B2B procurement.

Upstream Petrochemical Integration

Chinese fine-chemical production hubs benefit from immediate domestic proximity to core feedstocks, including 2,6-dimethylaniline and isothiocyanate intermediates. Direct pipeline and bulk container access to basic chemical precursors insulates Chinese synthesis plants from the global raw-material supply shocks experienced by European and North American toll manufacturers.

Automated Reaction Clusters

Leading facilities in Hebei and Shandong deploy distributed control systems (DCS) governing multi-stage condensation reactions. Real-time temperature regulation, stoichiometric reagent dosing, and automated pH controllers during the hydrochloric acid addition phase minimize isomer formation and boost one-pass yield to over 91.5%.

Industrial Scale & Cost Leadership

By operating multi-ton synthesis reactors, Chinese manufacturers achieve drastic reductions in energy, labor, and testing amortization per kilogram. Global enterprise buyers leverage this high production capacity to secure stable, multi-year contract pricing shielded from short-term spot market volatility and regional chemical tariff fluctuations.

Export Logistics & Customs Readiness

Export teams stationed at major Chinese maritime hubs (Tianjin, Qingdao, Shanghai) are deeply versed in international chemical clearance protocols. They provide pre-shipment DGM hazardous goods evaluations, certified UN drums, tamper-evident seals, and complete customs documentation packets for swift arrival at destination ports worldwide.

Strategic Sourcing

Enterprise Procurement Frameworks & Quality Risk Mitigation

A systematic audit matrix for chemical procurement directors, quality assurance managers, and global supply chain executives.

Analytical Audit Checklist

Never rely solely on single-page vendor statements. Sourcing teams must demand unredacted, raw analytical instrument readouts before releasing payment or approving customs transit.

  • HPLC Retention Time: Verified against primary standard reference chromatograms.
  • Impurity Fingerprinting: Confirmation that individual unknown impurities remain strictly ≤ 0.10%.
  • Heavy Metals & Ash: Rigorous verification of ICP-MS certificates ensuring complete absence of catalyst traces.
  • Water Content: Karl Fischer titration verifying moisture content under 0.5%.

Packaging & Cold-Chain Integrity

Proper bulk packing determines whether high-purity chemical batches survive long oceanic or air freight without clumping, degradation, or oxidative degradation.

  • Primary Containment: Double pharmaceutical-grade food-contact PE inner bags.
  • Secondary Moisture Barrier: Heavy-gauge vacuum-sealed aluminum composite barrier bags with pharmaceutical-grade silica gel desiccants.
  • Outer Protective Shell: UN-certified fiberboard drums or HDPE airtight drums with tamper-evident security banding.
  • Labeling: GHS-compliant hazardous labeling paired with scannable batch QR tracking codes.

Supply Chain Continuity & Dual Sourcing

In high-demand or legally constrained chemical sectors, reliance on spot-market traders exposes procurement teams to fatal supply interruptions and price gouging.

  • Direct Contract Manufacturing: Partnering directly with vetted primary synthesis plants rather than unauthorized brokers.
  • Buffer Inventory Agreements: Establishing rolling safety stock in bonded warehouse facilities.
  • Multi-Batch Retention Samples: Dedicated retention samples archived for 36 months to defend against customer inquiries or regulatory inquiries.
Innovation Roadmaps

Synthesis Optimization & Green Chemistry Trends in Fine Chemicals

Continuous flow chemistry, solvent recovery closed loops, and modern crystallization control reshaping the production economics of heterocyclic compounds.

Microchannel & Continuous Flow Synthesis

Conventional batch synthesis of 1,3-thiazine intermediates frequently encounters localized overheating, giving rise to persistent polymeric by-products. Modern Chinese facilities are increasingly transitioning primary reaction pathways into continuous micro-reactors, which offer instantaneous heat dissipation, exact stoichiometric mixing, and dramatically improved atom economy.

Zero-Discharge Solvent Recycling Systems

Under tightening global ESG frameworks and China's national environmental protection guidelines, leading factories incorporate vacuum distillation recovery systems capable of reclaiming over 94% of operational organic solvents (such as ethanol, acetone, and ethyl acetate), sharply curtailing volatile organic compound (VOC) emissions while driving production overhead down.

Digital Traceability & Smart Warehousing

Next-generation suppliers are implementing blockchain-enabled ERP systems linking manufacturing equipment telemetry directly with customer batch certificates. Scanning a drum barcode instantly retrieves real-time reactor run profiles, analytical HPLC spectra, environmental monitoring data during packaging, and authorized warehouse logistics histories.

Expert Answers

Frequently Asked Questions: Sourcing & Technical Specifications

Comprehensive answers addressing common questions regarding CAS 23076-35-9 analytical verification, packaging parameters, storage protocols, and global import compliance.

What is the exact chemical structure and primary application of CAS 23076-35-9?
CAS 23076-35-9 represents Xylazine Hydrochloride, an organic salt having the formula C12H16N2S · HCl. It acts as an α2-adrenergic receptor agonist and is synthesized as a critical active pharmaceutical ingredient for veterinary medicines (providing sedation, analgesia, and muscle relaxation) as well as an essential reference material in neurological, receptor binding, and animal physiology research.
What minimum purity threshold should enterprise buyers demand?
Enterprise and laboratory procurement specifications should demand a minimum HPLC assay purity of ≥ 98.5% on an anhydrous basis. Premium Chinese export batches manufactured for high-end formulation and analytical institutions consistently achieve between 99.2% and 99.8% purity, with individual unknown impurities strictly confined below 0.10%.
What technical documentation is provided alongside commercial orders?
Every shipment includes an authentic, batch-specific Certificate of Analysis (COA) containing exact test results (not just "conforms"), raw HPLC chromatograms, FTIR verification spectra, and a formal GHS-compliant Material Safety Data Sheet (MSDS/SDS). For larger enterprise agreements, TSE/BSE-free statements, Residual Solvent statements, and Heavy Metal ICP-MS data sheets are supplied upon request.
What are the standard industrial packaging specifications available?
Standard laboratory quantities are supplied in 500 g, 1 kg, and 5 kg double-sealed polyethylene bags inside vacuum-sealed aluminum barrier pouches. Commercial and bulk production quantities are packed in 25 kg UN-approved fiber drums with tamper-proof locks and moisture-barrier inner liners. Tailored OEM packaging and private labeling are available for qualified institutional buyers.
What storage parameters prevent compound degradation and caking?
CAS 23076-35-9 powder should be stored in tightly sealed original containers in a cool, dry, and well-ventilated warehouse environment maintained between 15 °C and 25 °C, protected from direct sunlight, heat, and moisture. When maintained under these conditions, the powder retains full analytical integrity for a documented shelf life of at least 36 months.
How are global regulatory clearances and export declarations managed?
Suppliers coordinate directly with freight forwarders specialized in fine chemical compliance. Shipments are classified accurately under internationally accepted HS codes, supported by Dangerous Goods Declarations (DGD), commercial invoices, and packing lists. Qualified buyers are responsible for confirming that the compound is cleared for importation according to their national jurisdiction's regulatory frameworks.
Can independent third-party lab testing (e.g., SGS, Eurofins, Intertek) be requested?
Yes. Transparent manufacturers fully support pre-shipment sampling and testing by accredited independent third-party laboratories. Batch release samples can be dispatched directly from the warehouse to your designated analytical laboratory for blind chromatographic and mass-spectrometry verification prior to dispatch.
What typical lead times can buyers expect for spot vs bulk orders?
Standard inventory batches (1 kg to 50 kg) generally dispatch within 24 to 48 hours following document and payment processing. Custom synthesis runs or large-scale contract orders (100 kg to multi-ton consignments) typically require a 2 to 3 week production cycle to accommodate synthesis, crystallization, analytical batch release, and export packing.
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