CAS Registry: 5086-74-8 · Industrial & Analytical Monograph

China 5086-74-8 s Manufacturers & Product Portfolio

Strategic B2B procurement technical guide, synthesis methodologies, GMP analytical purity parameters, and verified industrial supply infrastructure for Tetramisole Hydrochloride & advanced organic peptide derivatives.

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Industrial Monograph

Technical Profile of CAS 5086-74-8 (Tetramisole Hydrochloride)

Chemical attributes, racemic characterization, and core analytical benchmarks for chemical synthesis engineers and pharmaceutical raw material buyers.

240.75
Molecular Mass (g/mol)
≥99.2%
Standard Purity (HPLC)
260-264°C
Melting Point Range
<0.5%
Loss on Drying Max

Molecular Architecture

CAS 5086-74-8 defines (RS)-6-Phenyl-2,3,5,6-tetrahydroimidazo[2,1-b][1,3]thiazole monohydrochloride. It features a fused bicyclic imidazothiazole core with an empirical formula of C11H12N2S·HCl. As an equimolar racemic mixture of D- and L-enantiomers, its crystalline lattice exhibits strong stability against atmospheric degradation under controlled moisture thresholds.

Solubility & Physical Matrix

The compound precipitates as a white to pale cream crystalline powder, freely soluble in water (approx. 21 g/100 mL at 20°C), readily soluble in methanol, sparingly soluble in ethanol, and essentially insoluble in non-polar organic solvents like ether and benzene. This distinct partition coefficient allows robust crystallization optimization in automated production environments.

Pharmacological Specificity

While the L-isomer (Levamisole, CAS 16595-80-5) is responsible for the predominant stereospecific anthelmintic activity through ganglionic stimulation of nematode somatic muscle cells via L-subtype nicotinic acetylcholine receptors, the racemic hydrochloride CAS 5086-74-8 serves as an essential, cost-effective veterinary therapeutic and high-volume synthetic precursor.

Technical Quality Benchmark Note: Chinese primary manufacturers synthesize CAS 5086-74-8 primarily using condensation cycles starting from 2-amino-2-thiazoline or phenacyl bromide derivatives. In advanced production clusters, residual raw materials such as 2-chloro-1-phenylethanone and related synthesis intermediates are tightly capped at sub-ppm limits via validated GC-MS/LC-MS detection systems, fully meeting BP, USP, and EP compendial monographs.

Analytical Parameter USP / BP Compendial Specification Factory 4.0 Standard Delivery Spec Methodology
Assay (Anhydrous Basis) 98.5% – 101.5% 99.3% – 100.2% Potentiometric Titration / HPLC
Individual Impurity ≤ 0.5% ≤ 0.15% Reverse Phase HPLC (215 nm)
Total Impurities ≤ 1.0% ≤ 0.35% Gradient RP-HPLC
Loss on Drying ≤ 0.5% ≤ 0.22% Vacuum Drying at 105°C
Sulfated Ash / Residue ≤ 0.1% ≤ 0.04% Thermogravimetric Muffle 600°C
Heavy Metals (Pb, As, Cd, Hg) ≤ 10 ppm ≤ 2 ppm ICP-MS (ICH Q3D Compliant)
Chemical Engineering & Future Outlook

Technical Roadmap: Synthesis Evolution & Continuous Flow

The transition from legacy batch reactors to continuous microchannel flow, enzymatic resolution, and closed-loop solvent recovery in China's fine chemical sector.

Continuous Microchannel Synthesis

Traditional batch bromination and cyclization of 6-phenyl-2,3,5,6-tetrahydroimidazo[2,1-b]thiazole suffered from localized thermal spikes, driving byproduct formation like 2-amino-3-(2-chloro-2-phenylethyl)thiazolium chloride. Tier-1 Chinese chemical manufacturing facilities have deployed continuous micro-reactors. The precise heat transfer (surface area-to-volume ratio > 10,000 m²/m³) ensures quantitative conversion with reaction dwell times compressed from 4 hours to 45 seconds.

Enzymatic & Chiral Resolution

For applications where CAS 5086-74-8 is utilized as the raw material to derive enantiopure Levamisole, older routes employed expensive D-camphorsulfonic acid resolution with extensive manual mother-liquor crystallization. Contemporary 2026-generation roadmaps utilize engineered immobilized biocatalysts and continuous simulated moving bed (SMB) chromatography. This enhances chiral separation recovery rates above 96% while reducing waste solvent volume by 70%.

PAT & Automated Crystallization

Process Analytical Technology (PAT), combining in-situ Focused Beam Reflectance Measurement (FBRM) and ParticleTrack probes, monitors chord length distributions during the final hydrochloric acid salt precipitation phase. Controlling crystallization supersaturation ensures a uniform crystal habit, eliminating fine powder dusting and significantly increasing bulk density for automated high-speed formulation lines.

Commercial & Scientific Applications

Macro Solutions Across Veterinary, Biological & Fine Chemical Sectors

Strategic utilization matrices of 5086-74-8 across livestock healthcare, molecular diagnostics, and custom chemical synthesis.

Veterinary Parasitology Formulations

Tetramisole Hydrochloride is widely deployed as an active pharmaceutical ingredient in veterinary oral drenches, feed pre-mixes, and boluses for cattle, sheep, goats, and swine. It acts against gastrointestinal nematodes (such as Haemonchus, Ostertagia, Trichostrongylus) and lungworms (Dictyocaulus viviparus). Sourcing from China guarantees consistent, cost-controlled bulk supplies for livestock farming regions in South America, Africa, and Southeast Asia.

Alkaline Phosphatase Inhibition

In biochemical and histochemical research, CAS 5086-74-8 serves as an inhibitor of non-specific alkaline phosphatases (excluding intestinal and placental isoenzymes). It suppresses background tissue phosphatase signals in in-situ hybridization, immunohistochemistry (IHC), and Western blot staining protocols without interfering with conjugated horseradish peroxidase (HRP) or acid phosphatase pathways.

Intermediate for Advanced Therapeutics

Beyond agricultural and diagnostic use, high-purity crystalline CAS 5086-74-8 acts as a key structural building block in heterocyclic chemistry. Its stabilized bicyclic scaffold is utilized in developing target-specific immunomodulating drugs, specialty cross-linking catalysts, and fine organic synthesis reagents produced in specialized pharmaceutical synthesis units across China.

Manufacturing Infrastructure & Economics

China Factory 4.0: Supply Chain Resilience & Efficiency Advantages

How China’s integrated raw material ecosystems, smart manufacturing clusters, and automated quality infrastructure deliver unmatched supply reliability.

Vertical Integration of Feedstocks

Unlike regional blenders reliant on imported precursors, China’s industrial chemical clusters in Hebei, Shandong, and Jiangsu produce all essential upstream feedstocks in close proximity—including styrene, bromine, cysteamine, and chloroacetonitrile. This upstream integration insulates international buyers from cross-border intermediate shortages, shipping volatility, and unpredictable global raw material surcharges.

SCADA & IoT-Monitored Scale

Modern production plants utilize Distributed Control Systems (DCS) and SCADA networks to track synthesis metrics including pressure drop, exotherm dissipation, pH, and mother-liquor crystallization endpoints. Real-time logging eliminates human error in batch execution, delivering tight batch-to-batch consistency with minimal variances across multi-ton production campaigns.

Green Chemical Industrial Parks

Production is centralized in specialized national-level eco-industrial chemical parks equipped with dedicated wastewater processing, thermal catalytic oxidizers (RTO) for VOC reduction, and continuous online emission monitoring linked to local environmental agencies. This compliance foundation protects global buyers against unexpected plant shutdowns or environmental production caps.

Regulatory Auditing & Quality Management

Localization Support, cGMP Systems & Global Compliance

Full technical dossier preparation (DMF, CEP, EDQM) and thorough analytical testing under ICH Q7/Q11 guidelines.

Complete Regulatory Dossiers

To support pharmaceutical and veterinary marketing authorizations across North America, the European Union, and Australasia, leading Chinese manufacturers provide CTD-format Drug Master Files (DMFs), CEP certification dossiers for EDQM submission, and full technical declarations covering TSE/BSE risks, genotoxic impurity evaluations, and residual solvent limits under ICH Q3C (Class 2 and Class 3 solvents).

Analytical Traceability & Validation

Every commercial consignment is released with an analytical Certificate of Analysis (COA) containing direct, traceable data: raw HPLC chromatograms, 1H-NMR spectra verifying lack of aromatic degradation, high-resolution MS verifying molecular ion [M+H]+ at m/z 205.07 for the free base, and Karl Fischer titrimetric moisture analysis. Uncut third-party re-testing through SGS or Eurofins is fully supported.

Export Packaging & Dangerous Goods Compliance

CAS 5086-74-8 is packed in UN-certified, tamper-evident 25kg fiber drums with double food-grade polyethylene heat-sealed liners, desiccants, and inert nitrogen blankets. Complete DG shipping documentation, GHS compliant Safety Data Sheets (16 sections translated into multiple target languages), and customs HS Code 2933.9900 declarations are systematically provided for seamless clearance.

B2B Procurement Guidelines

Global Strategic Sourcing Framework for Enterprise Buyers

How procurement managers, pharmaceutical formulation directors, and contract manufacturers minimize risk when sourcing CAS 5086-74-8 in commercial quantities.

Tier-1 vs. Tier-3 Supplier Qualification

Auditing teams must distinguish between primary basic chemical synthesizers and secondary packaging traders. True synthesis manufacturers maintain dedicated solvent rectification columns, multi-ton automated crystallizers, and in-house cGMP analytical quality laboratories equipped with Agilent or Waters HPLCs. Sourcing directly eliminates intermediary markups and guarantees clear batch-genealogy tracking from primary raw materials.

Contracting, Hedging & Volume Pricing

Raw material components for 5086-74-8 fluctuate based on energy tariffs, basic petrochemical feeds, and elemental bromine indices. Enterprise buyers should pursue indexed quarterly supply contracts or 6-to-12 month annual allocation agreements. Leading Chinese factories provide structured price-hedging options supported by their dedicated precursor stockpiles, ensuring price stability during shifting market conditions.

Logistics Channels & Cold-Chain Integrity

Although Tetramisole HCl is stable at ambient temperatures, prolonged humidity or temperatures exceeding 40°C during transoceanic shipping can trigger microscopic surface clumping, impeding direct dissolution during high-speed formulation drench manufacturing. Direct factory contracts ensure moisture-barrier inner packaging and maritime shipping routes avoiding excessive vessel engine room heat.

Direct Answers

Frequently Asked Questions: CAS 5086-74-8 Sourcing

Clear, technical guidance addressing quality verification, international regulatory compliance, and industrial production parameters.

What distinguishes CAS 5086-74-8 from CAS 16595-80-5?

CAS 5086-74-8 designates Tetramisole Hydrochloride, which is an optically inactive racemic mixture (50% D-isomer and 50% L-isomer). In contrast, CAS 16595-80-5 designates Levamisole Hydrochloride, the pure, optically active L-enantiomer ([α]D = -120° to -128° in water). For veterinary indications where broader commercial tolerance exists, Tetramisole offers significant manufacturing cost advantages compared to pure Levamisole.

How is residual solvent controlled in automated crystallization?

Chinese GMP-aligned synthesis lines utilize closed-loop rotary vacuum dryers and fluid bed dryers with process automation. Residual solvents such as methanol, ethanol, acetone, and toluene are kept well below ICH Q3C limits (e.g., methanol < 500 ppm, acetone < 800 ppm, toluene < 50 ppm), with results verified via Headspace Gas Chromatography (GC-FID) on every batch COA.

Can Chinese manufacturers provide custom particle micronization?

Yes. While standard production delivers a free-flowing crystalline powder (D90 around 120–250 μm), facilities provide integrated air-jet micronization under inert nitrogen blankets. Buyers can request custom particle distribution profiles, such as ultra-fine grades with D90 < 20 μm, tailored for veterinary suspension formulations and water-soluble pre-mix packages.

What is the standard re-test interval and recommended storage?

When stored in original, unopened factory drums in a cool, dry area away from direct light (below 25°C and <65% RH), CAS 5086-74-8 maintains complete analytical stability for 36 to 48 months. Real-time and accelerated stability study data (25°C/60% RH and 40°C/75% RH) under ICH Q1A guidelines are available for review.

Are third-party analytical audits and facility inspections supported?

Qualified B2B procurement clients are welcome to perform on-site quality audits or hire independent inspectors (such as SGS, Intertek, or BV) prior to dispatch. Facilities provide remote video audits, validation documentation, cleanroom logs, and dynamic SCADA traceability records to verify supply chain transparency.

What are the minimum commercial order quantities (MOQ)?

Evaluation samples (100g to 1kg) for laboratory characterization, dissolution profiling, and analytical pilot testing are available. Standard commercial orders begin at 25kg (one export fiber drum), scaling up to full FCL container loads (10 to 18 metric tons palletized) with customized, tiered quantity pricing.

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