For pharmaceutical companies working with cardiovascular medicines, Mexiletine Hydrochloride API remains a specialized and important raw material. It is not a high-volume commodity API. Instead, it is typically sourced by manufacturers, formulation developers, CDMOs and distributors that require reliable quality, clear documentation and stable regulatory support.
Huzhou Ureda Pharmaceutical Co., Ltd. supplies Mexiletine Hydrochloride API CAS 5370-01-4 with GMP and DMF support for global pharmaceutical sourcing and formulation projects.
Product Identity
| Item | Information |
|---|---|
| Product Name | Mexiletine Hydrochloride |
| Common Name | Mexiletine HCl |
| CAS No. | 5370-01-4 |
| Molecular Formula | C11H18ClNO |
| Molecular Weight | 215.72 |
| Pharmacological Category | Class IB antiarrhythmic agent |
| Quality Standard | USP |
| Documentation | GMP / DMF available |
| Typical Packing | 20 kg/drum |
| Application | Antiarrhythmic pharmaceutical formulations |
Mexiletine Hydrochloride is the hydrochloride salt form of Mexiletine. It is structurally related to lidocaine and is classified as a Class IB antiarrhythmic agent. Its use is associated with the treatment of documented ventricular arrhythmias under appropriate medical supervision.
Why Buyers Evaluate Mexiletine Hydrochloride API Carefully
Mexiletine Hydrochloride is a cardiovascular API, so buyers usually pay close attention to supplier qualification and documentation. For this type of product, purchasing decisions are rarely based on price alone.
Typical buyer concerns include:
- GMP manufacturing support
- DMF availability
- USP compliance
- Batch-specific COA
- Assay control
- Appearance and solution clarity
- Loss on drying
- Residue on ignition
- pH control
- Reliable export documentation
- Supplier communication and response speed
For companies developing or maintaining finished dosage products, a stable API supplier can help reduce quality, documentation and registration risks.
USP Quality Profile
A recent batch of Mexiletine Hydrochloride API was tested according to USP requirements. The batch showed good compliance across key quality parameters.
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White or almost white crystalline powder | White crystalline powder |
| Identification | IR, HPLC retention time and chemical identification | Complies |
| Appearance of Solution | Clear and colourless | Complies |
| Melting Point | 202–204°C | 201–202°C |
| pH | 3.5–5.5 | 4.9 |
| Residue on Ignition | ≤0.1% | <0.1% |
| Loss on Drying | ≤0.5% | 0.2% |
| Assay | 98.0%–102.0% | 100.3% |
The result indicates that the material meets USP requirements, with assay at 100.3%, low loss on drying and controlled residue on ignition.
GMP and DMF Support
For Mexiletine Hydrochloride API, documentation support is a key part of the sourcing process. Ureda Pharma can support customers with:
- GMP documentation
- DMF support
- COA
- Specification
- MSDS
- Technical documents upon request
- Export and shipping documentation
This documentation package can support supplier qualification, formulation evaluation, registration preparation and commercial sourcing discussions.
What to Confirm Before Purchasing
Before placing an order for Mexiletine Hydrochloride API, buyers should confirm several practical details:
1. Target Market Requirement
Different markets may require different levels of documentation. Customers should confirm whether GMP, DMF, COA, specification or additional regulatory documents are needed.
2. Quality Standard
The referenced batch was tested according to USP. Buyers should confirm whether USP meets their internal or market-specific requirements.
3. Batch Availability
For cardiovascular APIs, customers may require batch reservation, updated COA, retest date confirmation and packaging details before purchase.
4. Intended Use
Customers should clarify whether the material is required for R&D, pilot trial, registration batch, formulation development or commercial production.
Product Summary
| Product | CAS No. | Standard | Documents | Application |
|---|---|---|---|---|
| Mexiletine Hydrochloride API | 5370-01-4 | USP | GMP / DMF available | Antiarrhythmic formulations |
Why Work with Ureda Pharma?
Huzhou Ureda Pharmaceutical Co., Ltd. supplies APIs and pharmaceutical raw materials for international customers. For Mexiletine Hydrochloride API, our role is to help customers evaluate availability, quality documents, commercial quotation and export feasibility.
We support inquiries from:
- Pharmaceutical manufacturers
- Generic drug companies
- CDMOs
- Formulation developers
- API distributors
- Regulatory sourcing teams
Contact Us for Mexiletine Hydrochloride API
If you are looking for Mexiletine Hydrochloride API CAS 5370-01-4 with GMP and DMF support, please contact us for availability, COA, specification and quotation.
Huzhou Ureda Pharmaceutical Co., Ltd.
Contact: Owen Lee
Email: sales@uredapharm.com
Website: www.uredapharm.com
WhatsApp: +86-18270717590
FAQ
What is Mexiletine Hydrochloride API?
Mexiletine Hydrochloride API is a pharmaceutical raw material used in antiarrhythmic formulations.
What is the CAS number of Mexiletine Hydrochloride?
The CAS number of Mexiletine Hydrochloride is 5370-01-4.
Is Mexiletine Hydrochloride an antiarrhythmic API?
Yes. Mexiletine Hydrochloride is classified as a Class IB antiarrhythmic agent.
Is GMP documentation available?
Yes. GMP support is available for Mexiletine Hydrochloride API.
Is DMF support available?
Yes. DMF support is available depending on customer requirements and project evaluation.
What quality standard is available?
The referenced batch was tested according to USP.
