General Information

Glimepiride Impurities and Glimepiride

Daicel Pharma offers worldwide delivery options for a custom synthesis of Glimepiride impurities, including impurities such as Cis Isomer of MCI-Glimepiride, Cyclohexyl carboxyl Glimepiride, and Trans-hydroxy Glimepiride. These impurities play a vital role in evaluating the purity and safety of Glimepiride, an active pharmaceutical ingredient.

Glimepiride [CAS: 93479-97-1] is a long-acting third-generation sulfonylurea medication. It lowers blood sugar levels and stimulates the secretion of insulin. With its extended duration of action and hypoglycemic effects, Glimepiride is an effective option for managing diabetes.

Glimepiride: Use and Commercial Availability  

Approved by the FDA for treating type 2 diabetes mellitus, Glimepiride is a second-generation sulfonylurea medication. It enhances glycemic control in adults. Glimepiride is used in cases where metformin is not tolerated. Amaryl is the brand name under which Glimepiride is available.

Glimepiride Structure and Mechanism of Action  

The chemical name of Glimepiride is 3-ethyl-4-methyl-N-(4-(N-((4-methylcyclohexyl)carbamoyl)sulfamoyl)phenethyl)-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide. Its chemical formula is C₂₄H₃₄N₄O₅S, and its molecular weight is approximately 490.6 g/mol.

Glimepiride stimulates the release of insulin from functioning pancreatic cells.

Glimepiride Impurities and Synthesis

Glimepiride impurities can form during synthesis¹, storage, or usage, resulting from various factors such as side reactions and degradation. Analytical methods like HPLC, LC-MS, NMR, and IR help analyze and quantify these impurities. Control measures include optimizing synthetic conditions, purification steps, and implementing advanced analytical technology. Proper storage conditions and packaging are essential to minimize impurity formation during storage. Stability studies help assess impurity profiles over time. Compliance with regulatory guidelines ensures the quality and safety of Glimepiride.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for synthesizing Glimepiride impurity standards. We provide a range of Glimepiride impurities, such as Cis Isomer of MCI-Glimepiride, Cyclohexyl carboxyl glimepiride, and Trans-hydroxy Glimepiride. Our impurity standards have a detailed Certificate of Analysis (CoA) and a comprehensive characterization report. The CoA encompasses data obtained through techniques, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data, such as 13C-DEPT, on request. We can synthesize unknown Glimepiride impurities or degradation products. Each delivery has a comprehensive characterization report.