Description

Rasagiline 13C3 Mesylate (Racemic) is a stable isotope-labeled internal standard of the active pharmaceutical ingredient Rasagiline, specifically designed for use in quantitative mass spectrometry. This compound is essential for ensuring the accuracy, precision, and regulatory compliance of bioanalytical methods during drug development and pharmacokinetic studies. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in neuroscience and metabolic research.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of Rasagiline and its metabolites in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical trials.
• Method Development and Validation: Used as a reference material to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Drug Metabolism Studies: Facilitates the identification and quantification of metabolite profiles, aiding in understanding the drug's metabolic pathways.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating assays for the active pharmaceutical ingredient (API).
• Forensic and Doping Control Analysis: Provides a reliable reference for detecting and confirming the presence of Rasagiline in forensic or anti-doping contexts.

Basic Information

Product Name	Rasagiline 13C3 Mesylate (Racemic)
CAS No.	1391052-18-8
Molecular Formula	C10H1313C3N•CH4O3S
Molecular Weight	Contact for details
Synonyms	(R,S)-N-(2-propynyl)-2,3-dihydro-1H-inden-1-amine-13C3 methanesulfonate; 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-13C3-, (±)-, methanesulfonate; Rasagiline-13C3 Mesylate; Rasagiline-13C3 (Racemic) Mesylate; AVP-13C3 Mesylate; AGN-1135-13C3 Mesylate; Isotopically Labeled Rasagiline Mesylate; Rasagiline Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Rasagiline 13C3 Mesylate (Racemic) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure high chemical and isotopic purity, identity confirmation, and the absence of interfering impurities. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, isotopic enrichment, and related substances by HPLC and/or LC-MS. Our quality commitment aligns with the standards expected for GMP-grade reference materials used in regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C
Isotopic Purity (by MS)	≥99%
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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