Description

Metformin CAS NO 121369-64-0 is a biguanide-class pharmaceutical compound widely recognized as a first-line therapy 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 manufacturers in the pharmaceutical industry formulating oral anti-diabetic medications. Consistent quality and reliable supply are critical for ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic medications for managing type 2 diabetes mellitus.
• Extended-Release Formulations: Used in controlled-release tablets to provide sustained therapeutic effect over a longer period.
• Fixed-Dose Combination Drugs: Combined with other anti-diabetic agents like sulfonylureas, DPP-4 inhibitors, or SGLT2 inhibitors in single-tablet formulations.
• Metformin Hydrochloride Synthesis: Serves as a key intermediate or starting material in the synthesis of metformin hydrochloride, the most common salt form used in pharmaceuticals.
• Research & Development: Utilized in preclinical and clinical research for studying metabolic disorders, insulin resistance, and potential new therapeutic applications.
• Veterinary Medicine: Investigated for use in managing insulin resistance and metabolic syndrome in companion animals.

Basic Information

Product Name	Metformin
CAS No.	121369-64-0
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	Metformin Base; 1,1-Dimethylbiguanide; N,N-Dimethylbiguanide; Dimethylbiguanide; Glucophage (Base Compound); LA 6023; Metformina; Metforminum; N',N'-Dimethylbiguanide
EINECS	Contact for details

Quality Control

Our Metformin is produced and tested under a strict quality management system to meet the exacting standards of the pharmaceutical industry. We ensure compliance with major pharmacopoeial specifications, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality commitment extends to full traceability and documentation support for regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a cool, dry place. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Ensure the storage area is well-ventilated and away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.1% Total impurities: ≤ 0.5%
Microbial Limits	Meets USP <61> and <62> requirements

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