Wholesale Hydroxychloroquine Sulphate Raw Powder Exporter & Product

cGMP-Certified Hydroxychloroquine Sulfate Active Pharmaceutical Ingredient (API) Manufacturing, Comprehensive DMF Technical Documentation, and Global B2B Supply Chain Infrastructure.

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Technical Monograph: Hydroxychloroquine Sulphate API

Comprehensive chemical profile, structural characterization, and analytical standards for enterprise pharmaceutical manufacturing.

Chemical Identity & Structural Overview

Hydroxychloroquine Sulphate (CAS Number: 747-36-4) is a white or practically white, crystalline powder chemically designated as 2-[[4-[(7-chloroquinolin-4-yl)amino]pentyl](ethyl)amino]ethanol sulfate. As an 4-aminoquinoline derivative, it acts as a potent lysosomotropic agent with wide-ranging applications in rheumatology, immunology, and infectious disease therapies.

Our raw powder material is synthesized via optimized green chemical pathways, ensuring exceptionally low organic impurity levels and precise control over particle size distribution (PSD). Designed specifically for oral solid dosage (OSD) formulations, our active pharmaceutical ingredient (API) meets and exceeds all criteria outlined in current USP, EP, BP, and IP monographs.

Pharmacological Mechanism of Action

Hydroxychloroquine Sulphate exerts multi-factorial cellular actions:

Endosomal pH Elevation: Accumulates within acidic intracellular vesicles, suppressing antigen processing and presentation by dendritic cells.
Cytokine Production Suppression: Downregulation of pro-inflammatory cytokines including IL-1, IL-6, and TNF-alpha.
Toll-like Receptor Inhibition: Blocks TLR-7 and TLR-9 signaling pathways, blunting autoimmune cascades in SLE and rheumatoid arthritis.

Analytical Parameter	Specification Standard	Testing Methodology
Chemical Name	Hydroxychloroquine Sulfate / Hydroxychloroquine Sulphate	IUPAC Nomenclature
CAS Registry Number	747-36-4	CAS Chemical Index
Molecular Formula / Weight	C18H26ClN3O · H2SO4 / 433.95 g/mol	Mass Spectrometry (MS)
Assay (Purity Standard)	99.0% – 101.0% (Dried Basis)	HPLC / Volumetric Titration
Appearance	White to Off-White Crystalline Powder	Visual Inspection
Related Substances / Impurities	Individual Impurity ≤ 0.10%, Total Impurities ≤ 0.50%	High-Performance Liquid Chromatography
Heavy Metals & Residue on Ignition	Heavy Metals ≤ 10 ppm, Ignition Residue ≤ 0.1%	ICP-MS / Gravimetric
Particle Size Distribution	Standard: d90 < 100μm \| Micronized Grade Available	Laser Diffraction (Malvern)

99.8%

Average HPLC Purity

250,000 m²

cGMP Production Base

50+

Global Export Markets

100%

Batch Traceability

Global Market Trends & Strategic API Procurement Solutions

Navigating regulatory shifting parameters, raw material security, and green chemistry innovation in antimalarial and autoimmune APIs.

1. Supply Chain Resilience & Raw Material Backward Integration

The global pharmaceutical supply chain requires absolute reliability. Volatility in intermediate precursor chemical markets can trigger severe API shortages. Gentolex addresses this by enforcing complete backward integration—synthesizing key starting materials (KSMs) in-house. This strategy isolates our global enterprise clients from pricing surges and material bottlenecks.

2. Escalating Regulatory Quality Expectations

Global health authorities (US FDA, EMA, PMDA, NMPA) have heightened scrutiny over nitrosamine impurities, elemental impurities (ICH Q3D), and residual solvents (ICH Q3C). Our Hydroxychloroquine Sulphate raw powder is subjected to state-of-the-art LC-MS/MS and ICP-MS testing, guaranteeing zero detectable nitrosamine contamination.

3. Micronization & Customized Physical Properties

Modern tablet manufacturing processes demand precise bulk density, particle size distribution (PSD), and powder flowability. We offer customized particle engineering, providing micronized Hydroxychloroquine Sulphate tailored for direct compression formulation lines to maximize dissolution kinetics.

About Gentolex Group: Global Infrastructure & Capabilities

Connecting global healthcare demands with high-standard Chinese chemical synthesis infrastructure.

Enterprise Vision & Operations

Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa.

Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.

Our overall factory construction area spans 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions for clients globally.

Core Service Offerings

Chemicals Products: High-purity bulk chemical synthesis utilizing continuous crystallization and green chemistry processes.
Pharmaceutical Ingredients: Extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
Custom Peptides & APIs: Flexible contract synthesis solutions tailored to strict pharmacological specs.
Procurement Service: For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.

Manufacturing Plant & Quality Control Assurance

Localized Application Scenarios & Formulation Guidelines

Operational insights for drug product developers, pharmaceutical formulators, and generic drug manufacturers.

Autoimmune Disease Therapy (SLE & RA)

Hydroxychloroquine Sulphate is the cornerstone maintenance therapy for Systemic Lupus Erythematosus (SLE) and active Rheumatoid Arthritis (RA). Formulators rely on our high-purity API to ensure consistent bioavailability, minimal gastrointestinal side-effects, and long-term dose stability in film-coated 200mg and 400mg tablet formulations.

Antimalarial Prophylaxis & Treatment

Widely deployed in malaria-endemic regions across LATAM, Africa, and Southeast Asia. Our raw powder meets international WHO pre-qualification standard benchmarks, allowing regional health authorities and generic pharmaceutical vendors to produce affordable, high-efficacy antimalarial treatments.

Specialized Fixed-Dose Combination (FDC)

Emerging clinical trials evaluate Hydroxychloroquine Sulphate in combination with immunosuppressive adjuncts or metabolic regulators. Our custom mesh sizing guarantees excipient compatibility with microcrystalline cellulose, lactose monohydrate, and magnesium stearate during dry granulation.

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Serving pharmaceutical manufacturers across North America, Europe, LATAM, Africa, and Asia-Pacific.

Frequently Asked Questions (FAQ) for Enterprise Procurement

Direct technical and regulatory answers for chemical buyers, Quality Assurance managers, and supply chain directors.

What drug master file (DMF) documentation accompanies Hydroxychloroquine Sulphate API?

We provide full US FDA DMF, EU CEP/COS documentation support, alongside complete CTD Format Dossiers (Modules 1 through 3). Every shipment is delivered with a comprehensive Certificate of Analysis (CoA), HPLC chromatograms, residual solvent analyses (GC-HS), and heavy metals testing data.

Can Gentolex provide customized particle sizes (e.g., micronized powder)?

Yes. We offer specialized jet-milling micronization services to achieve strict particle size specifications (such as d90 < 20μm, d90 < 50μm, or customized sieve distributions) tailored specifically for direct compression or wet granulation tablet manufacturing processes.

What is the minimum order quantity (MOQ) and commercial lead time?

For standard commercial pilot trials, our MOQ starts at 1 kg. For commercial bulk orders, production capacity scales up to multi-ton lots. Standard warehouse dispatch takes 3–5 business days, while custom synthesis orders typically range from 2–4 weeks based on synthesis complexity and regulatory qualification requirements.

How does Gentolex manage international shipping & customs clearing compliance?

Gentolex operates established regional logistics corridors with physical presence and strategic partners in Mexico and South Africa. We manage temperature-controlled, cold-chain, and hazard-compliant shipping with complete customs declaration paperwork (UN packaging standards, MSDS, customs tariff HS code matching).

What stability data is available under ICH guidelines?

Our Hydroxychloroquine Sulphate raw powder has completed rigorous accelerated stability testing (40°C ± 2°C / 75% RH ± 5% RH for 6 months) and long-term stability testing (25°C ± 2°C / 60% RH ± 5% RH for 36 months) in accordance with ICH Q1A(R2) protocols.