Description

3-Hydroxy Desloratadine B-D-Glucuronide is a major, pharmacologically active metabolite of the non-sedating antihistamine desloratadine. This compound is of critical importance in pharmaceutical research and development, particularly for metabolism and pharmacokinetic studies. It serves as a key reference standard for analytical method development and validation in bioanalytical laboratories. Researchers and quality control professionals in the pharmaceutical and biotechnology industries rely on this high-purity metabolite to ensure accurate drug monitoring and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantifying desloratadine and its metabolites in biological matrices.
• Bioanalytical Method Development: Essential for developing and validating sensitive LC-MS/MS or HPLC methods for pharmacokinetic (PK) and pharmacodynamic (PD) studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used to study the metabolic pathways, clearance, and exposure of desloratadine in preclinical and clinical research.
• Impurity Profiling and Characterization: Serves as a known impurity or degradation product standard for the quality control of desloratadine active pharmaceutical ingredient (API) and finished drug products.
• Clinical Trial Support: Critical for accurate bioanalysis in clinical trials to assess drug safety, efficacy, and metabolism in human subjects.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	3-Hydroxy Desloratadine B-D-Glucuronide
CAS No.	774538-89-5
Molecular Formula	C27H31ClN2O8
Molecular Weight	547.00 g/mol
Synonyms	Desloratadine 3-Hydroxy Glucuronide; Desloratadine B-D-Glucuronide, 3-Hydroxy-; 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-3-ol B-D-Glucopyranosiduronic Acid; 3-Hydroxydesloratadine Glucuronide; Desloratadine Metabolite; 3-OH-Desloratadine Glucuronide; 3-Hydroxy Desloratadine Glucuronide; 3-Hydroxy-Desloratadine-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our 3-Hydroxy Desloratadine B-D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical applications. Each batch undergoes rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and research needs. Our quality system is designed to meet the exacting standards required for reference materials in pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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