Description

Rac cis-3-Hydroxy Glyburide is a key intermediate and reference standard in the synthesis and analytical profiling of the antidiabetic drug glyburide (glibenclamide). This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, impurity characterization, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on metabolic disorders and drug development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of glyburide and its related substances in drug products and raw materials.
• Metabolite Research: Serves as a critical standard in pharmacokinetic and metabolic studies to understand the biotransformation pathways of glyburide.
• Impurity Profiling: Essential for the development and validation of analytical methods (e.g., HPLC, LC-MS) to monitor and control process-related impurities and degradation products in glyburide API manufacturing.
• Chemical Synthesis Intermediate: Acts as a building block in the organic synthesis of glyburide and its structural analogs for research purposes.
• Quality Control & Assurance: Employed in in-house QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (USP, EP).

Basic Information

Product Name	Rac cis-3-Hydroxy Glyburide
CAS No.	23074-02-4
Molecular Formula	C23H28ClN3O5S
Molecular Weight	494.00 g/mol
Synonyms	3-Hydroxy Glyburide; 3-Hydroxy Glibenclamide; 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-(cis-3-hydroxycyclohexyl)urea; Glyburide Impurity C (cis-3-Hydroxy); cis-3-Hydroxy-1-[[p-[2-(5-chloro-2-methoxybenzamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea; Rac-3-Hydroxy Glybenclamide
EINECS	Contact for details

Quality Control

Our Rac cis-3-Hydroxy Glyburide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory requirements.

Storage

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

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%
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.