Description

Metformin Hydrochloride CAS NO 1115-70-4 is the hydrochloride salt of metformin, a biguanide-class compound widely recognized as a first-line oral medication for type 2 diabetes. Its primary value lies in its ability to effectively lower blood glucose levels by decreasing hepatic glucose production and improving insulin sensitivity. This high-purity active pharmaceutical ingredient (API) is essential for global pharmaceutical manufacturers engaged in the production of solid dosage forms, such as tablets and capsules, for the management of diabetes and related metabolic disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in anti-diabetic medications for the treatment of type 2 diabetes mellitus.
• Tablet Formulation: Direct compression or granulation processes for the manufacture of immediate-release and extended-release oral tablets.
• Fixed-Dose Combination Drugs: Used in combination with other anti-diabetic agents (e.g., sulfonylureas, DPP-4 inhibitors) in single-pill therapies.
• Metabolic Syndrome Research: Serves as a key reference standard and investigational material in preclinical and clinical research for insulin resistance and polycystic ovary syndrome (PCOS).
• Veterinary Medicine: Application in the management of insulin resistance and diabetes mellitus in companion animals.
• GMP Manufacturing: Sourced by contract development and manufacturing organizations (CDMOs) for cGMP-compliant drug production.

Basic Information

Product Name	Metformin Hydrochloride
CAS No.	1115-70-4
Molecular Formula	C4H11N5•HCl
Molecular Weight	165.63 g/mol
Synonyms	Metformin HCl; 1,1-Dimethylbiguanide Hydrochloride; N,N-Dimethylimidodicarbonimidic diamide Hydrochloride; Dimethylbiguanide Hydrochloride; Glucophage (API); Metformin Monohydrochloride; Metformin HCL; Metformin Hydrochloride USP
EINECS	214-230-6

Quality Control

Our Metformin Hydrochloride is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, and potency to ensure it is suitable for pharmaceutical use. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological limits is provided with each shipment, guaranteeing traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and flow properties. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (on dried basis)	98.5% - 101.0%
pH (1% solution)	6.0 - 7.5
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 0.5% Any individual impurity ≤ 0.2%
Microbiological Enumeration	Total aerobic microbial count ≤ 1000 cfu/g Total combined yeasts/molds ≤ 100 cfu/g
Specified Microorganisms	Absence of E. coli, Salmonella

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.