Description

Rasagiline n-β-D-Glucuronide Sodium Salt, 90% is a high-purity reference standard and metabolite of the anti-Parkinson's drug Rasagiline. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by analytical laboratories, CROs, and pharmaceutical manufacturers engaged in drug discovery and regulatory compliance work.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Rasagiline metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Critical for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of Rasagiline.
• Bioanalytical Method Development: Serves as a key calibrator and quality control sample in LC-MS/MS and HPLC methods for therapeutic drug monitoring and clinical trials.
• Impurity Profiling: Employed to identify and quantify glucuronide conjugate impurities in active pharmaceutical ingredient (API) batches of Rasagiline.
• Regulatory Submissions: Supports documentation for regulatory filings (e.g., FDA, EMA) requiring characterization of major human metabolites.

Basic Information

Product Name	Rasagiline n-β-D-Glucuronide Sodium Salt, 90%
CAS No.	1260595-18-3
Molecular Formula	C17H23N2O7•Na
Molecular Weight	390.37 g/mol
Synonyms	Rasagiline N-Glucuronide Sodium Salt; (1R)-N-(2-Propyn-1-yl)-2,3-dihydro-1H-inden-1-amine N-β-D-Glucuronide Sodium Salt; Rasagiline Metabolite Glucuronide Sodium Salt; AGN 1135 N-Glucuronide Sodium Salt; TVP-1012 N-Glucuronide Sodium Salt; 1H-Inden-1-amine, 2,3-dihydro-N-2-propyn-1-yl-, (1R)-, β-D-glucopyranosiduronic acid, sodium salt; Rasagiline β-D-Glucuronide Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Rasagiline n-β-D-Glucuronide Sodium Salt is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure identity, purity, and consistency. Certificates of Analysis (COA) with detailed batch-specific results are provided and available upon request to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Assay (HPLC)	≥ 90.0%
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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