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CAS 136-47-0 defines Tetracaine Hydrochloride, a long-acting ester-type local anesthetic renowned for exceptional lipophilicity and sustained blockade of voltage-gated sodium channels. Designed for pharmaceutical contract manufacturing organizations (CMOs), analytical testing facilities, and commercial fine-chemical synthesis.
| Analytical Parameter | Monograph Standard (USP / Ph. Eur.) | Hebei Miaoou Tech Factory Batch Release | Testing Methodology |
|---|---|---|---|
| Chemical Name (IUPAC) | 2-(dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride | Confirms strictly to IUPAC structure | 1H-NMR, 13C-NMR Spectrometry |
| CAS Registry Number | 136-47-0 | 136-47-0 (Free base: 94-24-6) | Chemical Identity Audit |
| Molecular Formula & Weight | C15H24N2O2 · HCl (300.82 g/mol) | 300.82 g/mol verified | High-Resolution Mass Spec (HRMS) |
| Physical Appearance | Fine white crystalline powder, odorless | Conforms (microcrystalline white powder) | Visual / Microscopic Inspection |
| Melting Point Range | 147.0 °C – 151.0 °C | 148.5 °C – 149.8 °C | Capillary Melting Method (EP 2.2.14) |
| Chromatographic Purity (HPLC) | ≥ 99.0% | ≥ 99.65% (Single Impurity ≤ 0.10%) | Reverse-Phase HPLC-UV (254 nm) |
| Loss on Drying (Moisture) | ≤ 1.0% | ≤ 0.35% | Thermogravimetric Analysis / Karl Fischer |
| Residue on Ignition (Sulfated Ash) | ≤ 0.1% | ≤ 0.04% | Muffle Furnace Ashing (600 °C) |
| Heavy Metals / Elemental Impurities | ≤ 10 ppm total heavy metals | Conforms to ICH Q3D Guidelines | ICP-MS Inductively Coupled Plasma |
| Residual Solvents (Ethanol, Acetone) | ICH Q3C Class 2/3 limits | Ethanol < 500 ppm, Acetone < 200 ppm | Headspace Gas Chromatography (GC-HS) |
Tetracaine Hydrochloride (CAS 136-47-0) occupies a vital commercial niche within the worldwide market for synthetic local anesthetics and pharmaceutical intermediates, demonstrating a resilient compound annual growth rate (CAGR) exceeding 5.4% through 2032.
The FDA’s intensified oversight regarding active pharmaceutical ingredient (API) pedigree and drug supply chain security (DSCSA) has driven American formulations away from unvetted broker syndicates. Industrial pharmaceutical manufacturers mandate direct factory COAs featuring comprehensive trace-solvent testing and nitrosoamine screening for all imported lots.
Within the EU, EMA requirements for local anesthetics enforce stringent limits on hydrolysis degradants—predominantly 4-(butylamino)benzoic acid and 2-dimethylaminoethanol. Importers prioritize primary manufacturers capable of delivering batch-specific stability data and low-temperature moisture barrier packaging.
The Asia-Pacific region, spearheaded by high-volume contract compounding organizations in China, India, and Southeast Asia, dominates global consumption for ophthalmic procedures, dental anesthetics, and transdermal numbing preparations, relying on scalable bulk supply chains.
The production of CAS 136-47-0 is undergoing a profound paradigm shift driven by green chemistry principles, continuous flow reaction engineering, and automated crystallization optimization.
Transitioning from legacy batch reactors to continuous flow esterification of 4-butylaminobenzoic acid with 2-diethylaminoethanol. Reduces reaction contact time from 12 hours to 4 minutes while suppressing unwanted thermal side reactions.
Replacing toxic benzene/halogenated extraction solvents with bio-derived 2-methyltetrahydrofuran (2-MeTHF) and supercritical CO2 crystallization, yielding ultra-low VOC residues well beneath ICH Class 3 safety limits.
Incorporation of Focused Beam Reflectance Measurement (FBRM) and real-time Raman spectroscopy during the hydrochloric acid addition phase to tightly govern crystal habit, particle size distribution, and dissolution kinetics.
Development of lipid nanoparticles (LNPs), liposomal encapsulation, and hydrogel composite matrices that extend anesthetic release from conventional 45-minute windows to over 12 hours for post-operative management.
Because of its tenfold higher potency and significantly elevated lipid membrane solubility compared to procaine, Tetracaine HCl CAS 136-47-0 is utilized across distinct pharmaceutical and laboratory disciplines.
0.5% sterile topical ophthalmic solutions for intraocular pressure tonometry, corneal foreign body removal, and diagnostic gonioscopy, demanding sterile non-pyrogenic grade powder.
Hyperbaric (with 6% or 10% dextrose) or isobaric formulations for major orthopedic and subarachnoid surgical interventions, providing 2 to 3 hours of robust motor and sensory nerve block.
Formulation of dermal numbing creams, gels, and sprays in combination with lidocaine or prilocaine for superficial dermatological procedures, laser tattooing removal, and venipuncture.
Active reference material for studying voltage-gated ion channels, calcium influx regulation in ryanodine receptors, and customized animal surgery analgesia compounding.
B2B chemical purchasing managers face mounting challenges regarding adulterated batches, cross-border customs seizures, and regulatory delays. Hebei Miaoou Technology Co., Ltd. resolves these operational bottlenecks through structured institutional mechanisms.
Every commercial batch is serialized with corresponding HPLC chromatograms, mass spectrometry molecular weight verification, and infrared absorption spectra. We eliminate counterfeit dilution risks by guaranteeing 100% batch-to-COA verification before shipment release.
Tetracaine HCl exhibits mild ester bond hydrolysis when exposed to elevated ambient moisture. We utilize nitrogen-flushed pharmaceutical-grade aluminum foil barrier pouches vacuum-sealed within fiber drums equipped with continuous desiccating silica packs.
Operating since 2010, our specialized logistics team delivers comprehensive export documentation including MSDS according to GHS standards, commercial invoices, packing lists, and certified customs declarations, ensuring seamless clearance in North America, Europe, and the Middle East.
Direct answers for research coordinators, chemical procurement directors, and industrial laboratory technicians.
Established in 2010, Hebei Miaoou Technology Co., Ltd. is a benchmark enterprise in fine chemical synthesis, pharmaceutical raw materials, research peptides, and custom active compounds. Our factory in Shijiazhuang, Hebei combines modern chemical synthesis workshops, cleanroom lyophilization equipment, and an advanced analytical testing hub.
Pair your CAS 136-47-0 orders with laboratory reference compounds, metabolic agonists, and fine hormone synthesis intermediates manufactured to exacting analytical specifications.
