Description

Glipizide Impurity CAS NO 1428553-61-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Glipizide, a widely prescribed medication for type 2 diabetes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Glipizide API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and other chromatographic methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Glipizide formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways related to Glipizide.
• Quality Control (QC) Testing: Acts as a system suitability standard and a comparator in routine QC batch release testing of Glipizide.

Basic Information

Product Name	Glipizide Impurity
CAS No.	1428553-61-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Glipizide Related Compound; Glipizide Specified Impurity; Glipizide Degradation Product; 1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea Impurity; Glipizide EP Impurity; Glipizide USP Impurity; Sulfonylurea Impurity
EINECS	Contact for details

Quality Control

Every batch of Glipizide Impurity (CAS 1428553-61-0) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH guidelines and pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.