Description

Ambroxol o-Glucuronide is a key metabolite of the widely used mucolytic agent, ambroxol. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It serves as a critical reference standard for laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors requiring high-purity materials for analytical and developmental purposes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative and qualitative analysis in drug development.
• Metabolite Identification & Profiling: Essential for in-vitro and in-vivo studies to understand the metabolic pathways of ambroxol.
• Bioanalytical Method Development: Used to develop and validate HPLC, LC-MS, and LC-MS/MS methods for the detection of ambroxol and its metabolites in biological matrices.
• Pharmacokinetic (PK) Studies: Crucial for calibrating assays that measure metabolite concentration in plasma, serum, or urine during PK/PD studies.
• Quality Control & Impurity Testing: Acts as a known impurity or degradation product standard to ensure the purity and stability of ambroxol active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Submissions: Supports investigational new drug (IND) and new drug application (NDA) filings by providing definitive characterization data.

Basic Information

Product Name	Ambroxol o-Glucuronide
CAS No.	1241045-91-9
Molecular Formula	C22H30Br2N2O7
Molecular Weight	610.29 g/mol
Synonyms	Ambroxol Glucuronide; Ambroxol O-Glucuronide; trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol Glucuronide; Ambroxol Metabolite; Ambroxol-β-D-Glucuronide; Ambroxol D-Glucuronide; NA-872 Glucuronide
EINECS	Contact for details

Quality Control

Our Ambroxol o-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) detailing all test results, including assay, related substances, and identification, is provided to ensure compliance with research and development standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider desiccant and under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	≤ 5.0% total
Water Content (KF)	≤ 5.0%
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.