Description

Glimepiride Ep Impurity J is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for ensuring the safety and efficacy of the antidiabetic drug Glimepiride by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the specificity and accuracy of impurity profiling assays.
• Stability Studies: Employed to track the formation of degradation products in Glimepiride under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for drug master files (DMFs), ANDAs, and other regulatory filings to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Used for compliance testing against specifications in pharmacopoeias such as USP, EP, or BP.

Basic Information

Product Name	Glimepiride Ep Impurity J
CAS No.	41176-98-1
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 Impurity J; Glimepiride Related Compound J; Glimepiride EP Impurity J; Amaryl Impurity J; HOE 490 Impurity J; 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 Ep Impurity J is manufactured and tested under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopoeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.