Accelerating global research and commercial active ingredient pipelines with verified analytical documentation and direct manufacturing traceability.
A rigorous industrial perspective on purchasing CAS 118-42-3 from verified global chemical synthesis manufacturers, navigating regulatory dossiers, purity assays, and supply-chain continuity.
In B2B active pharmaceutical ingredient (API) procurement, precision in chemical nomenclature is paramount. CAS 118-42-3 represents 2-[{4-[(7-chloroquinolin-4-yl)amino]pentyl}(ethyl)amino]ethanol in its free base molecular form (C18H26ClN3O, MW: 335.87 g/mol). While commercial solid oral dosage formulations (tablets) predominantly formulate the sulfate salt (CAS 747-36-4), primary chemical synthesizers, contract manufacturing organizations (CMOs), and advanced research laboratories acquire CAS 118-42-3 as the pristine base for targeted salt engineering, crystal habit modification, and complex intermediate synthesis.
| Analytical Parameter | Pharmacopeial Specification (USP / Ph. Eur.) | Manufacturer In-House Release Standards | Analytical Methodology |
|---|---|---|---|
| Chemical Identification | Conforms to Reference Standard | Positive Concordance via IR & MS | FTIR / LC-MS Verification |
| Assay (Titration / HPLC) | 98.0% – 102.0% (anhydrous basis) | 99.2% – 100.8% (ultra-pure lot release) | Reversed-Phase HPLC / Potentiometry |
| Impurity A (Chloroquine Analog) | ≤ 0.2% | ≤ 0.05% (Controlled threshold) | RP-HPLC (UV detection at 254 nm) |
| Any Individual Unspecified Impurity | ≤ 0.10% | ≤ 0.05% | High-Resolution UPLC-PDA |
| Total Related Substances | ≤ 0.5% | ≤ 0.25% | Gradient HPLC Impurity Profiling |
| Loss on Drying / Moisture | ≤ 2.0% | ≤ 0.50% | Karl Fischer Coulometric Titration |
| Residual Solvents (ICH Q3C) | Meets ICH Class 2 & 3 Thresholds | Ethanol < 500 ppm, Toluene < 50 ppm | Headspace Gas Chromatography (GC-FID) |
| Elemental Impurities (ICH Q3D) | Cadmium, Lead, Arsenic, Mercury within PDE | Class 1 metals < 0.5 ppm each | ICP-MS Inductively Coupled Plasma |
Evaluating vendor stability, raw material key starting materials (KSMs), and multinational regulatory alignment for large-scale CAS 118-42-3 sourcing.
CAS 118-42-3 remains a pillar therapeutic molecule worldwide. Beyond its traditional anti-malarial classification, it is irreplaceable in long-term immunomodulatory therapy regimens for:
Procuring CAS 118-42-3 requires strict auditing of upstream precursor chemicals. Global price volatility and supply shortfalls stem almost exclusively from two Key Starting Materials:
Pharmaceutical enterprise buyers cannot treat CAS 118-42-3 as a commodity chemical. Vendor qualification mandates a four-step compliance review:
From batch vessel nucleophilic substitution to continuous flow microreactors: How next-generation manufacturers drive out impurities and lower the carbon footprint of CAS 118-42-3.
Classical synthesis utilizes direct condensation between 4,7-dichloroquinoline and the side-chain amino alcohol at elevated temperatures (120°C – 140°C). Advanced facilities deploy catalytic phase-transfer agents to suppress thermal decomposition products and reduce reaction time from 18 hours to under 4 hours.
Leading manufacturers are transitioning from 5,000L glass-lined stirred tanks to continuous tubular reactors. Flow chemistry maintains precise residence time distribution, eliminates hot spots, controls exotherms, and restricts bis-quinoline byproduct formation to below 0.03%.
Given stringent FDA and EMA directives on NDMA/NDEA mutagenic impurities, secondary amine precursors are verified under tight controls. Synthetic loops maintain acidic, nitrite-free aqueous washing protocols to guarantee undetectable nitrosamine levels (<1 ppb).
Legacy methods relied heavily on chlorinated solvents (DCM, chloroform) for crystallization. Upgraded synthesis programs utilize green solvent matrices (2-MeTHF, ethyl acetate, bio-derived alcohols), slashing process E-factor from 45 down to 12 kg waste per kg pure product.
Seamless international trade architectures ensuring rapid customs clearance, regulatory dossier defense, and cold-chain integrity from plant to receiving dock.
Every commercial order of CAS 118-42-3 is backed by a complete analytical package, ready for import clearance and health authority inspection:
Navigating global chemical transport requires tailored logistics solutions for air cargo, sea freight, and dedicated door-to-door chemical courier networks:
Eliminating time-zone frictions through dedicated international technical sales representatives and scientific audit support:
Direct answers for sourcing managers, formulation scientists, regulatory specialists, and quality control directors.
Explore our extended synthetic portfolio featuring clinical-grade neuropeptides, endocrine modulators, and small-molecule active raw powders.
Connect directly with our chemical manufacturing division for Hydroxychloroquine (CAS 118-42-3). Receive a comprehensive dossier package including commercial pricing scales, complete Certificate of Analysis (COA), method validation summaries, and Drug Master File (DMF) open-part documentation within 24 hours.
