99% Mexiletine Hydrochloride API With GMP
Mexiletine hydrochloride (CAS 5370-01-4) is a Class IB antiarrhythmic agent—a sodium channel blocker structurally similar to lidocaine but with the game-changing advantage of oral activity. It is indicated for the treatment of documented life-threatening ventricular arrhythmias, including sustained ventricular tachycardia.
When your formulation depends on a stable, high-purity supply of Mexiletine HCl API, every detail matters. That is why pharmaceutical manufacturers and compounding pharmacies worldwide are turning to a partner that understands the critical nature of cardiac drug production.
As a GMP-certified manufacturer of Mexiletine Hydrochloride API, we supply pharmaceutical-grade material that meets USP, EP, CP, JP, and IP standards—backed by comprehensive documentation, including Certificates of Analysis (CoA), Drug Master Files (DMF), and stability data.
Why Import Mexiletine HCl API From Us?
Pharma-Grade API Approved With GMP
Our Mexiletine hydrochloride API is from a GMP-certified factory registered and approved by the Chinese FDA. It means our mexiletine is suitable for medicine manufacturing and pharmacy compounding.
Fast Shipment After Your PO
Mexiletine hydrochloride raw material is one of our regular APIs in stock, so we can ship it within 3~4 days after your purchase order with quick repacking and handling.
Furthermore, we can quickly repack 1 KG, 5 KG, or 10 KG within 2 days and provide you with a FedEx tracking number within 4~5 days.
Mexiletine HCl API Applications and Specifications
Manufacturer Documents Download
MSDS (Ask us for it if you need it)
Applications:
For Pharmaceutical Manufacturers
Ventricular Arrhythmia Formulations: The primary indication. Mexiletine suppresses ventricular premature beats and reduces episodes of non-sustained ventricular tachycardia. At doses of 200–400 mg every 8 hours, it delivers a significant antiarrhythmic effect.
Digitalis Intoxication Management: Essential for arrhythmias resulting from glycoside toxicity—a critical emergency care application.
Generic Drug Development: With branded drugs like MEXITIL marketed by multiple companies (Boehringer Ingelheim, Teva, Ingenus, Senores Pharmaceuticals), generic formulations are well-established and in steady demand.
Emerging Applications: Research is expanding into chronic pain syndromes, myotonic dystrophy, and neurological disorders.
For Compounding Pharmacies
Custom Patient-Specific Formulations: Need variable strengths or alternative dosage forms? Our pharmaceutical-grade API supports tailored compounding for patients requiring individualized antiarrhythmic therapy.
Small-Batch Flexibility: Compounding doesn‘t always mean massive volumes. We accommodate smaller quantities with the same rigorous quality documentation as bulk orders.
Regulatory Readiness: Every shipment includes CoA, MSDS, and stability data, ensuring your compounded preparations meet USP standards.
Product Name: Mexiletine Hydrochloride APIs (盐酸美西律)
Appearance: A white crystalline powder
Solubility: Not available
Cas Number: 5370-01-4
Molecular Formula: C11H18ClNO
Molecular Weight: 215.72 g/mol
Chemical Name: 1-(2,6-dimethylphenoxy)propan-2-amine;hydrochloride
HS Code: 2922199090 (Other amino alcohols, their ethers, esters, and their salts, except those amino alcohols containing more than one oxygen group-其他氨基醇及其醚、酯和它们的盐, 但含有一种以上含氧基的除外)
Suitability to be shipped by air/sea/rail as common goods: suitable. It is safe to ship by air as a common good.
Grade: Pharmaceutical Grade
Purity or Assay: 99% (By HPLC)
Standards: CP/EP/USP (CP grade not for export)
Manufacturer Certificates available: GMP/WC
Manufacturer Documents Available: COA/MSDS
Supply Capability: Over 100 KG per month
MOQ: 1KG
Price Ideas In 2024: Contact us by WhatsApp for more updated prices
Lead Time: 3~4 days for quantities less than 25 KG
Stock Status: Over 150 KG
Shipping Temperature: Room temperature
Storage: 2~8 °C (Long-Term)
FAQs About Our Mexiletine Hydrochloride API
Q1. What quality certifications does OctagonChem’s Mexiletine HCl API comply with?
Our Mexiletine HCl API meets EP standards and is manufactured in a GMP-certified facility.
Our optimal manufacturing process and high-quality standards ensure that, when tested per USP, our product meets USP requirements.
Regardless of your location, once we receive your orders, we provide Certificates of Analysis (CoA) and other detailed data to ensure compliance with global regulatory requirements in the relevant countries.
Q2. What packaging options are available for bulk orders?
We offer customizable packaging in moisture-resistant, light-protected containers (e.g., 5 kg cartons).
For smaller quantities, we provide sealed aluminum foil bags of 1 kg or 2 kg, accompanied by desiccants, to maintain stability during transit.
Q3. How does your Mexiletine HCl ensure solubility and stability for compounding?
Our API undergoes rigorous micronization to achieve particle-size uniformity (D90 ≤ 500 µm), thereby enhancing solubility in formulations.
Stability studies confirm a 24-month shelf life under recommended storage conditions (15–25°C, protected from humidity).
Q4. Can you support custom synthesis for specific pharmacopeial standards?
Yes!
We offer tailored synthesis for regional pharmacopeial specifications (e.g., JP, IP) and, upon request, provide impurity profiling (compliant with ICH Q3A/B).
Q5. What documentation is included with shipments?
Every shipment includes:
CoA (purity ≥ 99.5%)
Commercial Invoice
Packing List
MSDS (handling and safety guidelines)
Stability and Residual Solvent Reports
Custom documentation (e.g., TSE/BSE-free statements) is available
Q6. How do you ensure product integrity during transportation?
We can utilize temperature-controlled logistics for international shipments during the summer months or in tropical areas; however, Mexiletine HCL API is usually stable at room temperature.
We can also repack Mexiletine APIs with nitrogen flushing to prevent oxidation and moisture ingress.
Real-time tracking is provided for all orders.
Q7. What technical support do you offer for formulation challenges?
Our team provides:
Solubility and compatibility data for common excipients.
Guidance on pH-sensitive formulations (e.g., avoiding interactions with acidic/basic compounds).
Regulatory assistance for MOH submissions.
Q8. Are there discounts for long-term or bulk contracts?
Yes! We offer Quantity-based pricing and flexible payment terms for repeat orders and regular customers.
Contact our sales team for a tailored quote to get the ball rolling.
Q9. How do you control your Mexiletine HCl impurity?
We employ HPLC-UV/LC-MS for impurity profiling, ensuring compliance with ICH limits (total impurities < 0.5% and single impurities < 0.1%).
Process validation data is available upon request.
Q10. Can you provide references from existing clients in the compounding sector?
We have successfully supplied APIs to 10+ compounding pharmacies in North America and the EU.
Case studies and testimonials are available under NDAs.
Q11. Do you have free samples of Mexiletine Hydrochloride API?
It depends on your sample quantities.
Usually, we have 1~5 grams of free samples for testing purposes, provided you have a courier account to cover the shipping cost.
For sample quantities of 100 grams or more, sample fees will apply. Please get in touch with us for cost details.
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