Description

4-Hydroxy-2-(10-Hydroxydecyl)-5,6-Dimethoxy-3-Methylphenyl β-D-Glucuronide Monosodium Salt is a high-purity, synthetically derived glucuronide conjugate, primarily utilized as a critical reference standard and metabolite in advanced pharmaceutical research and development. This compound is essential for ensuring the accuracy and reliability of analytical methods, particularly in drug metabolism and pharmacokinetics (DMPK) studies. It is a vital material for pharmaceutical companies, contract research organizations (CROs), and academic institutions focused on metabolic pathway elucidation, bioanalytical method validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of drug metabolites in complex biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Used in in vitro and in vivo studies to identify, characterize, and quantify Phase II glucuronidation metabolites.
• Bioanalytical Method Development: Critical for developing and validating sensitive LC-MS/MS, HPLC, or UPLC methods for metabolite detection and quantification.
• Impurity Profiling & Characterization: Employed as a known impurity or degradation product standard to ensure drug substance and product purity according to ICH guidelines.
• Toxicology Studies: Used to assess the metabolic fate and potential toxicological implications of new chemical entities (NCEs).
• Clinical Research: Supports pharmacokinetic studies in clinical trials by enabling precise measurement of metabolite levels in patient samples.

Basic Information

Product Name	4-Hydroxy-2-(10-Hydroxydecyl)-5,6-Dimethoxy-3-Methylphenyl β-D-Glucuronide Monosodium Salt
CAS No.	153010-32-3
Molecular Formula	C26H41O12Na
Molecular Weight	568.59 g/mol
Synonyms	Monosodium 4-Hydroxy-2-(10-Hydroxydecyl)-5,6-Dimethoxy-3-Methylphenyl β-D-Glucopyranosiduronate; 4-Hydroxy-2-(10-Hydroxydecyl)-5,6-Dimethoxy-3-Methylphenyl Glucuronide Sodium Salt; Sodium (2R,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-[4-hydroxy-2-(10-hydroxydecyl)-5,6-dimethoxy-3-methylphenoxy]oxane-2-carboxylate; Glucuronide Metabolite Standard; Drug Metabolite Sodium Salt; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of 4-Hydroxy-2-(10-Hydroxydecyl)-5,6-Dimethoxy-3-Methylphenyl β-D-Glucuronide Monosodium Salt is manufactured under a strict quality management system and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Specifications are aligned with the rigorous requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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