Description

Rac trans-4-Hydroxy Glyburide is a key chemical intermediate and reference standard of significant interest in pharmaceutical research and development. This compound is particularly valuable for its role in the study of drug metabolism and the synthesis of related active pharmaceutical ingredients (APIs). It serves as a critical building block for researchers and manufacturers in the life sciences sector, where precise chemical structure and high purity are paramount. The demand for this material is driven by its application in developing and analyzing therapeutic agents, especially within metabolic disease research.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for analytical method development, validation, and quality control testing in API and finished drug product manufacturing.
• Metabolite Research: Serves as a crucial metabolite standard in pharmacokinetic and pharmacodynamic studies to understand the biotransformation pathways of glyburide and related sulfonylureas.
• Active Pharmaceutical Ingredient (API) Synthesis: Acts as a sophisticated intermediate in the multi-step synthesis of novel sulfonylurea-based drug candidates and for producing labeled compounds for tracer studies.
• Biochemical Research: Employed in in-vitro and in-vivo studies to investigate drug-receptor interactions, metabolic enzyme activity, and the mechanisms of action of hypoglycemic agents.
• Impurity Profiling: Essential for identifying, quantifying, and qualifying potential process-related impurities and degradation products in glyburide drug substances and products to ensure safety and compliance.

Basic Information

Item	Detail
Product Name	Rac trans-4-Hydroxy Glyburide
CAS No.	23155-00-2
Molecular Formula	C23H28ClN3O6S
Molecular Weight	510.00 g/mol
Synonyms	4-Hydroxy Glyburide; 1-[4-[2-(5-Chloro-2-methoxybenzamido)ethyl]phenyl]sulfonyl]-3-(trans-4-hydroxycyclohexyl)urea; trans-4-Hydroxy Glibenclamide; Glyburide Hydroxy Metabolite; Glibenclamide Hydroxy Metabolite; 4'-Hydroxy Glyburide; 4-OH-Glyburide; 4-Hydroxyglibenclamide
EINECS	Contact for details

Quality Control

Every batch of Rac trans-4-Hydroxy Glyburide is manufactured and tested under a strict quality management system. We provide comprehensive analytical data to ensure identity, purity, and consistency, meeting the exacting requirements for pharmaceutical research and development. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting key parameters such as assay, related substances, and residual solvents. Our quality commitment supports compliance with cGMP guidelines for advanced intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled and stored accordingly to maintain stability. Keep the container tightly sealed in a dry environment to prevent moisture absorption.

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 single impurity ≤ 1.0%
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.