Description

[2H6]-(±)-Rivastigmine CAS NO 194930-04-6 is a deuterium-labeled isotopologue of the acetylcholinesterase inhibitor Rivastigmine, serving as a critical internal standard for precise bioanalytical quantification. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, eliminating variability in mass spectrometry analysis. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS: Primary application for the quantitative bioanalysis of Rivastigmine and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME).
• Metabolite Identification and Profiling: Used as a stable isotope tracer to facilitate the identification and structural elucidation of drug metabolites.
• Method Development and Validation: Critical component in developing and validating robust, GLP-compliant analytical methods for clinical and non-clinical trials.
• Quality Control in API Manufacturing: Can be utilized as a reference standard to monitor the synthesis and purity of non-labeled Rivastigmine active pharmaceutical ingredient (API).
• Forensic and Doping Control Analysis: Supports accurate quantification in specialized testing scenarios requiring high specificity and sensitivity.

Basic Information

Product Name	[2H6]-(±)-Rivastigmine
CAS No.	194930-04-6
Molecular Formula	C14H16D6N2O2
Molecular Weight	254.36 g/mol
Synonyms	(±)-Rivastigmine-d6; Rivastigmine (hexadeuterated); S)-3-[1-(Dimethylamino)ethyl]phenyl-d6 N-ethyl-N-methylcarbamate; Exelon-d6; SDZ ENA 713-d6; ENA 713-d6; (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-d6-phenyl carbamate
EINECS	Contact for details

Quality Control

Every batch of [2H6]-(±)-Rivastigmine is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles, ensuring compliance with the stringent requirements for reference standards used in regulated bioanalysis. Our quality commitment supports GMP/GLP environments and global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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