Description

Glimepiride Related Compound C (20 Mg) (Glimepiride Urethane) is a high-purity chemical reference standard and a key impurity of the anti-diabetic drug Glimepiride. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and fine chemical industries for method validation, impurity profiling, and stability studies. The CAS number for this compound is 119018-30-3.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Glimepiride Urethane impurity in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for Glimepiride and related substances.
• Quality Control (QC) & Quality Assurance (QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with ICH, USP, or EP specifications.
• Stability Studies: Employed to track the formation of degradation products in Glimepiride formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purer synthesis routes for Glimepiride API.

Basic Information

Product Name	Glimepiride Related Compound C (20 Mg) (Glimepiride Urethane)
CAS No.	119018-30-3
Molecular Formula	C25H34N4O5S
Molecular Weight	502.63 g/mol
Synonyms	1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea; Glimepiride Impurity C; Glimepiride EP Impurity C; Urethane of Glimepiride; Amaryl Impurity C; 3-Ethyl-4-methyl-2-oxo-N-[2-[4-[[[[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-3-pyrrolinecarboxamide
EINECS	Contact for details

Quality Control

Every batch of Glimepiride Related Compound C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring full traceability and regulatory readiness for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.