Description

Glipizide Impurity H is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization, method validation, and quality control of the antidiabetic drug Glipizide, ensuring product safety and regulatory compliance. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis and quality assurance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Glipizide Impurity H in drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure Glipizide API meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker to track the formation of degradation products during forced degradation and long-term stability testing of Glipizide formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Glipizide Impurity H
CAS No.	10080-05-4
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 H; Glipizide EP Impurity H; Glipizide USP Impurity H
EINECS	Contact for details

Quality Control

Our Glipizide Impurity H is manufactured under strict quality control protocols to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically verified by advanced techniques including HPLC, LC-MS, and NMR. We support compliance with major pharmacopeial standards such as USP and EP.

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 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%
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.