Global GMP-Compliant Technical Dossier

High-Quality Cas 94-09-7 Manufacturers & Factory

Precision Synthesis, Enterprise-Grade Scalability, and Global Regulatory Compliance for Benzocaine API (CAS 94-09-7) Industrial Sourcing.

Procurement Catalog

High-Purity Reference APIs & Peptides

Direct supply line access with standardized HPLC/MS chromatographic verification and third-party validation.

Industrial Monograph

Cas 94-09-7: Chemistry, Kinetics, and Global Sourcing Standards

An authoritative technical evaluation for procurement directors, QA specialists, and formulation chemists.

Structural Profiling

CAS 94-09-7 (Ethyl 4-aminobenzoate, molecular formula C9H11NO2, MW: 165.19 g/mol) is an ester local anesthetic. It features an aromatic amine conjugated with a carboxyl ester, yielding a pKa of 2.51. This unique chemical profile renders the molecule primarily non-ionized at physiological pH, allowing immediate, non-systemic lipid-membrane partition.

Pharmacodynamics

Benzocaine acts through direct, reversible voltage-gated sodium channel (VGSC) blockade on afferent neuronal axons. By mitigating intracellular sodium influx across neuronal membranes, it depresses action potential propagation, effectively eliminating localized sensory conduction without disrupting vasomotor balance or causing involuntary smooth-muscle relaxation.

Impurity Thresholds

Manufacturing excellence hinges on impurity mitigation. Residual precursors such as 4-nitrobenzoic acid and intermediate volatile halogenated solvents must remain below strict ICH Q3A/B limits. Advanced crystallization protocols guarantee low heavy metal residues (<10 ppm) and an assay result exceeding 99.5% by validated HPLC-UV.

Analytical Parameter USP/EP Regulatory Standard Factory In-House Release Specification Testing Methodology
Chemical Identification Positive for Aminobenzoate & Infrared absorption Conforms to Reference Standard Spectrum FTIR / ATR-IR (USP <197K>)
HPLC Chromatographic Assay 98.0% - 102.0% (dried basis) ≥ 99.50% Area Normalization Reversed-Phase HPLC-DAD (λ=227nm)
Melting Range 88.0°C - 92.0°C 89.0°C - 90.5°C (Narrow band) Capillary Thermal Gradient Method
Loss on Drying ≤ 1.0% ≤ 0.25% Vacuum Desiccation over P2O5
Related Substances (Individual) ≤ 0.10% individual impurities ≤ 0.05% 4-Nitrobenzoic acid Gradient RP-HPLC (USP Impurity Profile)
Residual Solvents (ICH Q3C) Ethanol < 5000 ppm, Toluene < 890 ppm Class 2 < 100 ppm, Class 3 < 500 ppm Headspace Gas Chromatography (HS-GC-FID)
Macro Industry Dynamics

Global Enterprise Procurement & Market Drivers

Strategic analysis of CAS 94-09-7 commercial applications, supply elasticity, and global volume forecasts.

Topical Anesthetics

The global OTC healthcare sector demands consistent CAS 94-09-7 for transdermal pain relief, oral ulcer treatments, dental sprays, and burn formulations. Sourcing teams prioritize ultra-fine micronization (d90 < 20μm) for smooth suspension delivery.

Aquaculture & Veterinary

CAS 94-09-7 plays a pivotal role globally in aquatic anesthesia, minimizing handling-induced cortisol elevation during transport and medical intervention. Enterprise buyers require high solubility profiles and non-toxic aquatic degradation pathways.

Supply Chain Resilience

Post-pandemic disruptions highlight the vulnerability of single-region raw chemical supply. Enterprise buyers demand manufacturers with integrated back-integration into basic feedstocks (PABA) to insulate pricing against market shocks.

Contract Pricing Models

Sustained volatile container shipping rates and raw fuel charges require flexible contract manufacturing arrangements. We offer transparent multi-quarter indexing on bulk drum allocations (FOB, CIF, and DDP terms).

Compliance Architecture

Regulatory Assurances & Global Logistics Protocols

Bridging Chinese manufacturing with global destination compliance: FDA, EU REACH, and PIC/S readiness.

Complete Regulatory Dossiers

Each batch release is accompanied by comprehensive audit-ready documentation, including complete DMF access, ISO 9001/14001 certificates, BSE/TSE declaration, elemental impurity assessments, and confirmed absence of nitrosamine risks.

Secondary Packaging Containment

Transporting pure fine chemicals requires active barrier defense against humidity and oxidation. We employ food/pharma-grade double-layer polyethylene liners placed inside nitrogen-purged hermetically sealed fiber drums (25kg Net Weight).

Customs Clearance Integration

Export teams handle localized documentation clearing with HS Code classification 2922499990. We guarantee seamless customs clearance across the EU (REACH Registration verified), North America (TSCA-compliant), and the Asia-Pacific territory.

Future Roadmap

Continuous Synthesis & Green Engineering Evolution

Pioneering the transformation from conventional batch esterification to advanced microchannel flow synthesis.

Continuous Microflow Reactors

Transitioning from 5,000L glass-lined batch reactors to micro-reaction flow arrays improves mass transfer and maintains tight residence-time distributions. This cuts unwanted poly-substitution side reactions and guarantees 99.8% raw product consistency.

Green Solvent Recycling

Modern sustainability requirements prioritize atom economy. Our closed-loop fractional recovery systems achieve a >96% operational recycle rate for solvent-phase alcohols and crystallizing liquors, minimizing VOC emissions across all factory operations.

AI Process Analytical Tech (PAT)

Online Near-Infrared (NIR) and Raman spectroscopy sensors continuously monitor batch conversion rates during catalytic hydrogenation. Automated AI loops dynamically calibrate thermal inputs, reducing energy expenditures per ton by 22%.

Procurement Inquiries

Frequently Asked Questions: Cas 94-09-7 Sourcing

Clear, direct answers for QA heads and chemical procurement teams.

What is the standard purity threshold guaranteed for CAS 94-09-7?

Every commercial batch released from our factory guarantees a minimum assay of 99.0% by HPLC. For demanding applications, batches consistently test at ≥99.5% with no single unspecified impurity exceeding 0.05%.

Can you provide customized particle size distribution (PSD)?

Yes. In addition to standard needle-crystal and granular formulations, our cleanroom operations feature dynamic air-jet micronization systems. We supply D90 < 50μm, D90 < 20μm, or custom particle profiles for direct compressible tableting and sprays.

What documentation accompanies commercial shipments?

Each delivery includes an authenticated, batch-specific Certificate of Analysis (COA) containing raw HPLC traces, a Safety Data Sheet (SDS) compliant with GHS Rev 8, an origin declaration, an animal-free declaration, and packing inspection sheets.

How do you address international logistics stability?

Materials are securely protected inside hermetically sealed moisture-barrier bags within impact-resistant corrugated drums. We provide real-time temperature tracking tags for sensitive, long-haul ocean routes, ensuring materials arrive free of agglomeration.

Factory Inventory

Specialty Compounds & Research Materials

Reliable bulk-scale delivery channels for research laboratories, university research centers, and manufacturing partners.