Description

Meta-Glimepiride Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Glimepiride. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and monitoring during the manufacturing process. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies focused on method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Glimepiride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure Glimepiride products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to health authorities like the FDA and EMA.
• Research & Development: Supports synthetic route optimization, impurity profiling, and metabolic studies in preclinical and clinical research phases.

Basic Information

Product Name	Meta-Glimepiride Impurity
CAS No.	791104-62-6
Molecular Formula	C24H34N4O5S
Molecular Weight	490.62 g/mol
Synonyms	Glimepiride Impurity; Glimepiride Related Compound; 1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea; 3-Ethyl-4-methyl-2-oxo-N-[2-[4-[[[[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-3-pyrrolinecarboxamide; Meta Impurity of Glimepiride; Glimepiride Metabolite Impurity; Amaryl Impurity
EINECS	Contact for details

Quality Control

Every batch of Meta-Glimepiride Impurity is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and consistency. Our quality protocols are designed to meet the rigorous standards of pharmaceutical impurity analysis, including compliance with ICH guidelines. A detailed Certificate of Analysis (COA) providing batch-specific data from techniques such as HPLC, NMR, and Mass Spectrometry is supplied with each product.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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