Explore our primary commercial portfolio manufactured under strict GMP compliance and international quality standards.
Rac 4-Hydroxy Ephedrine Hydrochloride (racemic 4-hydroxy ephedrine HCl) stands as a pivotal sympathomimetic amine intermediate, essential for the formulation and commercial synthesis of advanced cardiovascular, bronchodilatory, and ophthalmic pharmaceutical products. As a substituted phenethylamine derivative possessing dual adrenergic receptor binding capabilities, this active intermediate plays an irreplaceable role in modern chemical synthesis and finished dosage form (FDF) manufacturing.
In global industrial chemistry, securing a reliable, cGMP-certified wholesale supplier for Rac 4-Hydroxy Ephedrine Hydrochloride is crucial. Pharmaceutical enterprise procurement heads face escalating regulatory compliance challenges, solvent residual tracking demands, and stereo-purity enforcement. Gentolex Group bridges this critical supply gap by providing integrated, scalable manufacturing solutions operating out of standard-compliant chemical facilities.
Information Gain Insight: Unlike standard grade intermediates, our proprietary asymmetric reduction and hydrochlorination purification pathways ensure hyper-consistent crystal habit distribution, yielding optimal flowability and batch-to-batch dissolution kinetics for high-throughput downstream formulation.
Our engineering workflow leverages rigorous high-performance liquid chromatography (HPLC), nuclear magnetic resonance (NMR) spectroscopy, and gas chromatography-mass spectrometry (GC-MS) to guarantee precise chemical compliance across commercial batches.
| Analytical Parameter | Specification Criterion | Test Methodology Standard | Commercial Batch Typical Results |
|---|---|---|---|
| Chemical Name | Racemic 4-(1-hydroxy-2-(methylamino)propyl)phenol hydrochloride | IUPAC Standard / Structural Validation | Conforms to Structure |
| CAS Registry Number | 365-26-4 / (Related Active Bases) | CAS Verification Index | Validated CAS Matrix |
| Appearance | White to Off-White Crystalline Powder | Visual Inspection / Colorimetric | Pure White Crystalline Solid |
| Assay (Purity on Dry Basis) | ≥ 98.5% (Target Grade: ≥ 99.5%) | HPLC (Reverse Phase, Gradient Elution) | 99.68% Average Purity |
| Melting Point Range | 204°C - 208°C (Dec.) | Capillary Melting Point Apparatus | 205.5°C - 207.0°C |
| Loss on Drying (LOD) | ≤ 0.5% max | Thermogravimetric Drying at 105°C | 0.18% |
| Heavy Metal Content | ≤ 10 ppm max | ICP-MS / USP <231> Method II | < 3 ppm |
| Residual Solvents (ICH Q3C) | Methanol < 3000ppm, Ethanol < 5000ppm | Headspace GC-FID Analysis | Within ICH Impurity Limits |
Flexibility to adjust stereo-isomerism ratio from racemic mixtures to enantiomerically enriched fractions depending on customer-specific pharmaceutical application requests.
Micronization capabilities achieving d90 < 20μm or customized particle size distribution (PSD) designed for specialized nasal spray and aerosol dry powder inhalers (DPI).
Extensive ICH stability testing data available (accelerated, intermediate, long-term) alongside fully mapped degradation pathway reports for regulatory submissions.
Pharmaceutical enterprises in North America, Europe, Asia-Pacific, and emerging markets face stringent supply chain bottlenecks. Gentolex provides resilient contractual bulk supply frameworks, mitigating geopolitical volatility and price fluctuation risks.
High demand for complete Drug Master Files (DMF), EDQM suitability certifications, and zero nitrosamine contamination guarantees. We support EU-GMP and US-FDA filing protocols seamlessly.
With established corporate hubs in Mexico, Gentolex streamlines customs clearing, localized inventory warehousing, and rapid last-mile technical support across Latin American markets.
Our localized presence in South Africa provides regional pharmaceutical formulators with reliable access to high-purity raw materials without excessive freight markups or delivery lead times.
Gentolex's ultimate goal is to create seamless global opportunities connecting chemical pharmaceutical markets with superior services and guaranteed chemical products. To date, Gentolex Group has proudly served pharmaceutical manufacturers and biotech institutions across more than 10 countries, establishing direct regional representative hubs in Mexico and South Africa.
Our overall factory construction encompasses over 250,000 square meters operating under international standards to deliver flexible, highly scalable, and cost-effective synthesis solutions. Our core enterprise capabilities cover:
cGMP Manufacturing Infrastructure & Advanced Analytic Labs
Stay informed with our latest scientific whitepapers, API development updates, and research-grade peptide manufacturing protocols.
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View DetailsDirect technical and commercial answers for pharmaceutical buyers, QA compliance managers, and synthesis chemical procurement specialists.
Our commercial batch standard guarantees an HPLC assay purity of ≥98.5%, with high-purity pharmaceutical grades exceeding 99.5%. Each wholesale lot is delivered alongside a comprehensive Certificate of Analysis (CoA) containing individual and total impurity quantitative breakdowns, heavy metals analysis, and residual solvent quantification according to ICH Q3C guidelines.
Gentolex provides full regulatory documentation packages to facilitate seamless filing with national health authorities. Available documentation includes Drug Master Files (DMF), Certificates of Suitability (CEP), ISO 9001/14001 certificates, cGMP audit reports, Method of Analysis (MoA), Method Validation protocols, and Nitrosamine Risk Assessment reports.
Standard commercial export packaging consists of 25 kg fiber drums lined with double-layer anti-static low-density polyethylene (LDPE) food/pharmaceutical grade inner bags. For trial orders or specialized lab quantities, we supply sealed aluminum foil pouches ranging from 1 kg to 5 kg with desiccants inserted for moisture stability.
The compound should be stored in tightly closed, light-resistant containers situated in a cool, dry, well-ventilated warehouse environment between 15°C to 25°C (59°F to 77°F). Avoid exposure to excessive humidity, direct light, or strong oxidizing agents to prevent photo-degradation of the hydroxyl phenol moiety.
Yes. Leveraging our 250,000 m² factory capacity and dedicated R&D lab infrastructure, we offer custom synthesis, specific particle micronization, density tuning, and custom stereoisomeric resolution to meet exact downstream formulation criteria.
Browse our extended global exporter list for pharmaceutical intermediates and peptide active ingredients.
