Description

4-Hydroxyglibenclamide is a key pharmaceutical intermediate and metabolite of the widely used antidiabetic drug glibenclamide (glyburide). This compound is of significant importance for research and development in pharmacology and analytical chemistry, particularly in studies related to drug metabolism, pharmacokinetics, and the development of new therapeutic agents. It serves as a critical reference standard for quality control laboratories in the pharmaceutical industry, ensuring the accuracy and reliability of analytical methods for drug substance and product testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of glibenclamide and its metabolites in drug substances and finished dosage forms.
• Metabolite Research: Essential for in-vitro and in-vivo studies investigating the metabolic pathways, bioavailability, and excretion profiles of glibenclamide.
• Analytical Method Development: Used to develop, validate, and calibrate high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), and other analytical techniques.
• Impurity Profiling: Acts as a specified impurity standard to monitor and control the quality of glibenclamide active pharmaceutical ingredient (API) according to pharmacopeial guidelines (e.g., USP, EP).
• Pharmacological Studies: Utilized in research to understand the structure-activity relationship (SAR) and the role of hydroxylation on the efficacy of sulfonylurea drugs.
• Clinical Trial Support: Employed in bioanalytical testing for clinical studies involving glibenclamide to ensure accurate measurement of drug and metabolite levels in biological samples.

Basic Information

Product Name	4-Hydroxyglibenclamide
CAS No.	23155-04-6
Molecular Formula	C23H28ClN3O6S
Molecular Weight	510.00 g/mol
Synonyms	4-Hydroxy Glyburide; 1-[4-[2-(5-Chloro-2-methoxybenzamido)ethyl]phenylsulfonyl]-3-(4-hydroxyphenyl)urea; 3-(4-Hydroxyphenyl)-1-[[4-[2-[(5-chloro-2-methoxyphenyl)carbonylamino]ethyl]phenyl]sulfonyl]urea; 4-Hydroxyglibenclamide; Hydroxyglibenclamide; 4'-Hydroxyglibenclamide; A metabolite of Glibenclamide
EINECS	Contact for details

Quality Control

Our 4-Hydroxyglibenclamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with your research or quality control requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Single Unknown Impurity	≤ 0.5%
Loss on Drying	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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