Description

Glipizide Impurity 2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Glipizide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Glipizide Impurity 2 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Glipizide.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Glipizide batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control strategies for the drug substance.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during the development of Glipizide and its formulations.

Basic Information

Product Name	Glipizide Impurity 2
CAS No.	73631-58-0
Molecular Formula	C15H21N3O3S
Molecular Weight	323.41 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 EP Impurity B; Glipizide USP Related Compound; Glipizide Sulfonylurea Impurity
EINECS	Contact for details

Quality Control

Every batch of Glipizide Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 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)	Individual 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.