Description

(Glyburide Impurity) CAS NO 57334-89-1 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 Glyburide, an important sulfonylurea medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Glyburide API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Glyburide to understand impurity formation pathways and establish shelf-life specifications.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA, ICH) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for calibrating equipment to ensure batch-to-batch consistency of Glyburide products.
• Research & Development: Supports R&D efforts in studying the metabolism, pharmacokinetics, and degradation chemistry of sulfonylurea drugs.

Basic Information

Product Name	(Glyburide Impurity) CAS NO 57334-89-1
CAS No.	57334-89-1
Molecular Formula	C23H28ClN3O5S
Molecular Weight	494.00 g/mol
Synonyms	Glyburide Related Compound; 5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide; Glyburide Impurity A; Glibenclamide Impurity; Glyburide EP Impurity A; N-[2-[4-[[[(Cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-5-chloro-2-methoxybenzamide; 1-[[p-[2-(5-Chloro-2-methoxybenzamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea
EINECS	Contact for details

Quality Control

Every batch of this impurity standard is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for assay and related substances. Production can adhere to current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial standards (USP, EP) upon request.

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 absorption of moisture. For long-term storage under inert atmosphere, please contact us.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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