Description

Ortho-Glimepiride Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the anti-diabetic drug Glimepiride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Glimepiride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical tool for in-process testing and release testing of Glimepiride batches to meet ICH, USP, and EP guidelines.
• Stability Studies: Employed to track the formation of degradation impurities in Glimepiride under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and submission packages.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and impurity profiling during the drug discovery and development lifecycle.

Basic Information

Product Name	Ortho-Glimepiride Impurity
CAS No.	878480-70-7
Molecular Formula	C24H34N4O5S
Molecular Weight	490.62 g/mol
Synonyms	Glimepiride Ortho Impurity; Glimepiride Impurity O; 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; Ortho Impurity of Glimepiride; Amaryl Impurity O; CAS 878480-70-7.
EINECS	Contact for details

Quality Control

Our Ortho-Glimepiride Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and quality requirements.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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