Description

Glyburide Related Compound B (25 Mg) (Methyl-[[4-[2-[(5-Chloro-2-Methoxybenzoyl)-Amino]Ethyl]Phenyl]Sulfonyl]Carbamate) (As) is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the antidiabetic drug Glyburide. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory testing facilities to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Glyburide-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for stability-indicating assays.
• Pharmacopeial Compliance Testing: Essential for testing to meet the specifications outlined in international pharmacopeias such as USP, EP, and BP for Glyburide drug substances and products.
• Stability Studies and Forced Degradation: Employed in stability testing protocols to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release: A key component in the routine QC testing of Glyburide manufacturing batches to ensure impurity levels are within acceptable limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of product-related impurities.

Basic Information

Item	Details
Product Name	Glyburide Related Compound B (25 Mg) (Methyl-[[4-[2-[(5-Chloro-2-Methoxybenzoyl)-Amino]Ethyl]Phenyl]Sulfonyl]Carbamate) (As)
CAS No.	21165-77-5
Molecular Formula	C18H19ClN2O6S
Molecular Weight	426.87 g/mol
Synonyms	Glyburide Impurity B; Glyburide Related Substance B; 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-methylurea; N-[4-[β-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl]-N′-methylurea; Methyl-[[4-[2-[(5-Chloro-2-Methoxybenzoyl)Amino]Ethyl]Phenyl]Sulfonyl]Carbamate; Glybenclamide Related Compound B; CAS 21165-77-5
EINECS	Contact for details

Quality Control

Our Glyburide Related Compound B is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques, including HPLC for assay and impurity profiling. We ensure compliance with relevant pharmacopeial guidelines for reference standards. Certificates of Analysis (COA) with detailed chromatographic data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities: ≤ 2.0% Any individual impurity: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Loss on Drying	≤ 0.5%

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