Imeglimin Hydrochloride is the hydrochloride salt of imeglimin, an oral antidiabetic pharmaceutical ingredient belonging to the glimin class. It is developed for the management of type 2 diabetes mellitus and has a distinctive mechanism involving mitochondrial function and glucose metabolism.
Imeglimin is structurally related to the thiazolidinedione class but has a different pharmacological profile. Its activity is associated with improving glucose utilization and reducing excessive hepatic glucose production.
Imeglimin Hydrochloride is a synthetic pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization. Quality control generally focuses on identity, assay, related substances, residual solvents, water content, elemental impurities and physical characteristics.
The hydrochloride salt form provides the pharmaceutical form used for formulation and manufacturing of oral dosage forms.
CAS Number: 1036392-44-1
Molecular Formula: C12H21ClN4O2
Molecular Weight: 288.78 g/mol
Chemical Name: Imeglimin Hydrochloride
Drug Class: Antidiabetic Agent
Pharmacological Class: Glimin
Therapeutic Class: Oral Antidiabetic
Therapeutic Area: Endocrinology / Metabolic Disorders
Imeglimin is associated with improvement of mitochondrial function in pancreatic β-cells and insulin-sensitive tissues.
Its pharmacological effects include:
The combined effects can contribute to improved glycemic control in patients with type 2 diabetes.
Imeglimin Hydrochloride is used in pharmaceutical formulations for:
The specific approved indication and combination use depend on the applicable regulatory labeling.
Imeglimin represents a differentiated approach to type 2 diabetes treatment because its pharmacological activity is closely associated with mitochondrial function and glucose metabolism.
It is therefore relevant to pharmaceutical research involving:
Imeglimin Hydrochloride is the hydrochloride salt of imeglimin. Salt formation is commonly used in pharmaceutical development to provide suitable physicochemical characteristics for manufacturing and formulation.
Imeglimin Hydrochloride is a synthetic, nitrogen-containing small molecule supplied as a crystalline solid. Its physicochemical characteristics, including solubility, particle size and solid-state properties, may be important during development of oral dosage forms.
Imeglimin Hydrochloride API quality evaluation may include:
Imeglimin Hydrochloride should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Final storage conditions should be established according to validated stability data.
Imeglimin Hydrochloride is relevant to pharmaceutical research involving type 2 diabetes, mitochondrial metabolism, insulin resistance, β-cell function and oral antidiabetic drug development.
Imeglimin Hydrochloride is an oral antidiabetic pharmaceutical ingredient belonging to the glimin class. It has CAS Number 1036392-44-1, molecular formula C12H21ClN4O2, and molecular weight 288.78 g/mol. It is associated with improved glucose metabolism through effects on mitochondrial function, insulin action and hepatic glucose production.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |