Description

Rac trans-2-Hydroxy Glyburide is a key chemical intermediate and reference standard of significant interest in pharmaceutical research and development. This compound is primarily utilized as a metabolite or impurity standard in the analysis and quality control of the antidiabetic drug glyburide (glibenclamide). Its availability is critical for researchers and manufacturers in the pharmaceutical industry who require high-purity analytical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical metabolite standard in pharmacokinetic and drug metabolism studies of glyburide.
• Essential impurity standard for monitoring and controlling related substances in glyburide Active Pharmaceutical Ingredient (API) manufacturing.
• Used in bioanalytical research to study the metabolic pathways and clearance mechanisms of sulfonylurea drugs.
• Serves as a chemical intermediate in advanced organic synthesis for novel compound libraries.
• Supports regulatory compliance and documentation for drug submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Rac trans-2-Hydroxy Glyburide
CAS No.	586414-93-9
Molecular Formula	C23H28ClN3O6S
Molecular Weight	510.00 g/mol
Synonyms	trans-2-Hydroxy Glibenclamide; 1-[4-[2-(5-Chloro-2-methoxybenzamido)ethyl]phenyl]sulfonyl]-3-(trans-2-hydroxycyclohexyl)urea; 2-Hydroxy Glyburide; 2-Hydroxy Glibenclamide; Glyburide Hydroxy Metabolite; Glibenclamide trans-2-Hydroxy Metabolite; Rac-trans-2-Hydroxyglibenclamide; Benzenesulfonamide, N-[4-[2-[[[[(trans-2-hydroxycyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-5-chloro-2-methoxy-
EINECS	Contact for details

Quality Control

Our Rac trans-2-Hydroxy Glyburide is produced under strict quality management systems to ensure the high purity and consistency required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation, purity assay, and impurity profiling via advanced chromatographic techniques. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.