Description

Alosetron n-β-D-Glucuronide is a major, pharmacologically inactive metabolite of the selective 5-HT3 receptor antagonist Alosetron. This compound is of critical importance for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK) studies. It serves as a vital reference standard for analytical method development, validation, and bioanalytical testing. Researchers and quality control laboratories in the global pharmaceutical and contract research organization (CRO) sectors require this high-purity metabolite to ensure accurate quantification and understanding of Alosetron's metabolic profile.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantifying Alosetron and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to elucidate the metabolic pathways and clearance mechanisms of Alosetron.
• Bioanalytical Method Development: Used to develop and validate sensitive LC-MS/MS or HPLC-UV methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling: Acts as a known impurity or degradation product standard for the quality control of Alosetron active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Submissions: Supports investigational new drug (IND) and new drug application (NDA) filings by providing definitive metabolite identification and quantification data.
• Toxicology Studies: Employed in safety assessment studies to understand the distribution and potential effects of Alosetron metabolites.

Basic Information

Product Name	Alosetron n-β-D-Glucuronide
CAS No.	863485-56-7
Molecular Formula	C23H29N5O8
Molecular Weight	503.51 g/mol
Synonyms	Alosetron Glucuronide; Alosetron N-Glucuronide; 2,3,4,5-Tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one β-D-Glucopyranosiduronic Acid; Lotronex Glucuronide; GR 68755C Glucuronide; (2S,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-((5-methyl-2-((5-methyl-1H-imidazol-4-yl)methyl)-2,3-dihydro-1H-pyrido[4,3-b]indol-1-yl)oxy)tetrahydro-2H-pyran-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Alosetron n-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results and specifications. Our quality commitment ensures the material is suitable for use as a high-purity reference standard in regulated pharmaceutical research environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. 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 (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
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.