Description

Glimepiride Impurity 19 is a specified impurity of the antidiabetic pharmaceutical agent Glimepiride, identified by CAS NO 32175-01-2. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the production and analysis of Glimepiride and related formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Glimepiride Impurity 19 in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor this specific impurity as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Stability Studies: Used in routine QC testing and forced degradation studies to establish impurity profiles and ensure batch-to-batch consistency and product stability.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug approval processes.
• Research & Development: Utilized in synthetic chemistry research to study the formation pathway and to develop purification processes to minimize this impurity in the final API.

Basic Information

Item	Detail
Product Name	Glimepiride Impurity 19
CAS No.	32175-01-2
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; Glimepiride Related Compound 19; Glimepiride EP Impurity G; Glimepiride USP Related Compound G; 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

Our Glimepiride Impurity 19 is manufactured and tested under strict quality systems. Each batch is characterized and qualified using advanced analytical techniques to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity (by HPLC), and related substances. Our quality commitment aligns with cGMP principles and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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