Description

trans-Carboxy Glimepiride is a key pharmaceutical intermediate and impurity reference standard used in the development and quality control of antidiabetic medications. Its primary value lies in its role as a critical marker for ensuring the purity and efficacy of the active pharmaceutical ingredient Glimepiride, a widely prescribed sulfonylurea drug. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on metabolic disorder therapeutics. High-purity grades support rigorous compliance with pharmacopeial standards for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC and LC-MS analysis in Glimepiride API and finished dosage form quality control.
• Process Chemistry Research: Used in studying the synthesis pathways, degradation profiles, and metabolic pathways of Glimepiride.
• Analytical Method Development: Critical for developing and validating stability-indicating assay methods (SIAMs) for antidiabetic drug products.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity data.
• Academic & Clinical Research: Utilized in university and institutional research investigating the structure-activity relationships of sulfonylurea derivatives.
• Quality Assurance Laboratories: Employed for routine batch release testing and stability studies of Glimepiride-based medications.

Basic Information

Product Name	trans-Carboxy Glimepiride
CAS No.	127554-90-9
Molecular Formula	C24H34N4O5S
Molecular Weight	490.62 g/mol
Synonyms	trans-1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea-4'-carboxylic Acid; Glimepiride Carboxy Impurity (trans isomer); trans-4'-Carboxy Glimepiride; Glimepiride Impurity F (trans); UNII-7V3E46821S; 3-[[4-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-1-(trans-4-methylcyclohexyl)urea-4-carboxylic Acid
EINECS	Contact for details

Quality Control

Our trans-Carboxy Glimepiride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral methods for isomeric composition, and spectroscopic identification (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications. The product is suitable for use as a reference standard in compliance with ICH Q3B(R2) guidelines for impurities in new drug products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
trans-Isomer Content (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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