Description

Glimepiride CAS NO 93479-97-1 is a potent third-generation sulfonylurea compound used as an oral anti-diabetic agent. It is a critical active pharmaceutical ingredient (API) for the management of type 2 diabetes mellitus, functioning by stimulating insulin release from pancreatic beta cells. This high-purity compound is essential for pharmaceutical manufacturers developing and producing effective, long-acting anti-diabetic medications. Its reliable performance and quality are paramount for ensuring the safety and efficacy of the final drug product.

Application

Glimepiride is a cornerstone API in the global pharmaceutical industry, primarily utilized in the following applications:

• Primary Active Ingredient in oral anti-diabetic tablets and formulations for the treatment of type 2 diabetes.
• Monotherapy Drug Development for blood glucose control in patients where diet and exercise alone are insufficient.
• Combination Therapy development, often paired with other anti-diabetic agents like metformin for enhanced therapeutic effect.
• Pharmaceutical Research & Development for studying insulin secretion mechanisms and new diabetes treatment modalities.
• Reference Standard in analytical laboratories for quality control and method validation of drug products.
• Generic Drug Manufacturing, serving as the key component for cost-effective alternatives to branded medications.

Basic Information

Product Name	Glimepiride
CAS No.	93479-97-1
Molecular Formula	C24H34N4O5S
Molecular Weight	490.62 g/mol
Synonyms	1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea; Amaryl® (Brand Name); HOE 490; Glimepiridum; Glimepirida; UNII-6KY687524K
EINECS	Contact for details

Quality Control

Our Glimepiride is manufactured under strict quality management systems to meet the rigorous standards of the global pharmaceutical industry. We adhere to relevant pharmacopeial specifications, including USP and EP monographs, ensuring identity, purity, strength, and composition. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters. Our commitment to cGMP (current Good Manufacturing Practice) compliance guarantees traceability and consistency for our B2B partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Ensure the container is sealed after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Water (Karl Fischer)	NMT 0.5% w/w
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP <61> and <62>

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