Description

Imeglimin Hydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) with the CAS registry number 775351-61-6. This compound is a novel, first-in-class oral anti-diabetic agent that targets mitochondrial bioenergetics, offering a distinct mechanism of action for glycemic control. It is primarily required by pharmaceutical R&D laboratories, contract manufacturing organizations (CMOs), and API producers engaged in the development and production of next-generation treatments for type 2 diabetes.

Application

• Pharmaceutical API Synthesis: Serves as the core active ingredient in the commercial and developmental manufacture of anti-diabetic medications.
• Clinical Research & Development: Used in preclinical and clinical studies to investigate new therapeutic formulations and combination therapies.
• Reference Standard: Employed as a high-purity analytical standard in quality control (QC) and quality assurance (QA) laboratories for method development and validation.
• Process Chemistry & Scale-Up: A key starting material or intermediate for process optimization and pilot-scale production runs.
• Academic & Institutional Research: Utilized in biochemical and pharmacological studies to explore mechanisms of action related to mitochondrial function and glucose metabolism.

Basic Information

Product Name	Imeglimin Hydrochloride
CAS No.	775351-61-6
Molecular Formula	C7H15N3O2 • HCl
Molecular Weight	233.68 g/mol (Hydrochloride salt)
Synonyms	Imeglimin HCl; (1R,2S)-2-(2-Methoxyethyl)-3,4-dihydro-1H-isoindole-1,1(2H)-dicarboximidamide hydrochloride; Imeglimin monohydrochloride; TW-059B; 775351-61-6 (CAS); Imeglimin hydrochloride salt
EINECS	Contact for details

Quality Control

Our Imeglimin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

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 (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤2.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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