Description

Glipizide Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities in Glipizide drug substances and finished products. It is an essential material for analytical laboratories in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies focused on ensuring drug safety and compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of specific impurities in Glipizide Active Pharmaceutical Ingredients (APIs) and formulations.
• Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to ensure product purity meets stringent pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to monitor the formation of degradation products in Glipizide under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research and Development: Facilitates research into the synthesis, metabolism, and degradation pathways of Glipizide and related sulfonylurea compounds.

Basic Information

Product Name	Glipizide Impurity 3
CAS No.	933705-21-6
Molecular Formula	C21H27N5O4S
Molecular Weight	445.54 g/mol
Synonyms	1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea; N-[[(4-[[[[(Cyclohexylamino)carbonyl]amino]sulfonyl]phenyl)ethyl]amino]carbonyl]-5-methyl-2-pyrazinecarboxamide; Glipizide Related Compound; Glipizide Impurity C; Glipizide Sulfonylurea Impurity; Glipizide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Glipizide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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