Metformin Hydrochloride
Pharmaceutical-grade Metformin Hydrochloride (CAS 1115-70-4), min. 99.0%, supplied wholesale by Zyntex to licensed producers. Biguanide API for immediate-release, extended-release and combination antidiabetic tablets. CoA and SDS.
Description
Metformin Hydrochloride Product Overview
Metformin hydrochloride (C4H11N5·HCl) is a white crystalline powder that dissolves freely in water. It is described in the USP, EP and BP. Because tablets contain large doses, typically 500–1000 mg, the API’s compaction and flow properties strongly influence tablet production; producers therefore offer standard, granular and directly compressible grades.
Pharmaceutical companies use it in immediate-release and extended-release tablets for type 2 diabetes, and in fixed-dose combinations with sulfonylureas such as Glibenclamide, Gliclazide and Glimepiride, and with other antidiabetic APIs.
Regulators have paid special attention to nitrosamine impurities such as NDMA in metformin products. Zyntex supplies metformin HCl from qualified producers with lot-specific documentation, including nitrosamine risk information on request, only to licensed pharmaceutical companies.
Key Applications of Metformin Hydrochloride
Main application areas:
💊 Immediate-Release Tablets
High-dose API for conventional antidiabetic tablets.
⏱️ Extended-Release Tablets
API for once-daily extended-release formulations.
🔗 Fixed-Dose Combinations
Combined with sulfonylureas and other antidiabetic APIs.
🔬 Generic Development
Development material for generic dossiers.
Metformin Hydrochloride Technical Specifications
| Parameter | Standard Value |
|---|---|
| Product Name | Metformin Hydrochloride |
| CAS Number | 1115-70-4 |
| Molecular Formula / Weight | C4H11N5·HCl / 165.62 g/mol |
| Assay / Purity | Min 99.0% |
| Appearance | White crystalline powder |
| Documents | CoA and SDS with every lot |
⚠️ Safety & Handling: Pharmacologically active substance; may be harmful if swallowed and may irritate the eyes. Avoid dust formation and inhalation, and wear gloves, eye protection and dust protection. Store in tightly closed containers in a cool, dry place. Always consult the Safety Data Sheet (SDS) for full classification and handling instructions.
Frequently Asked Questions
Do you supply directly compressible metformin?
Standard and granular or directly compressible grades can be quoted on request. Please share your formulation and process requirements.
Can you provide nitrosamine risk documentation?
Yes. Nitrosamine risk assessment information from the producer can be shared on request before ordering.
How can I get a price and documents?
Prices depend on quantity, packaging and destination. Contact us with your required volume to receive a quotation together with the CoA and SDS.
