Description

Rivastigmine Usp Rc E CAS NO 1800020-46-5 is a high-purity pharmaceutical reference standard and intermediate, meeting the stringent requirements of the United States Pharmacopeia (USP). This compound is critical for ensuring the quality, safety, and efficacy of finished drug products in the pharmaceutical industry. It is primarily utilized by manufacturers and research institutions involved in the development, production, and quality control of acetylcholinesterase inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the identification, assay, and impurity profiling of Rivastigmine in finished dosage forms and active pharmaceutical ingredients (APIs).
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a key intermediate or starting material in the multi-step synthesis of Rivastigmine tartrate and other Rivastigmine salts.
• Analytical Research & Development: Essential for method development, validation, and calibration of analytical instruments like HPLC, UPLC, and GC in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing certified material for stability studies, batch release testing, and comparative analyses.
• Pharmacological Research: Employed in preclinical and clinical studies to investigate the pharmacokinetics, metabolism, and therapeutic mechanisms of cholinesterase inhibitors.
• Generic Drug Manufacturing: A vital component for generic pharmaceutical companies to demonstrate bioequivalence and ensure product consistency with the innovator drug.

Basic Information

Product Name	Rivastigmine Usp Rc E
CAS No.	1800020-46-5
Molecular Formula	C14H22N2O2
Molecular Weight	250.34 g/mol
Synonyms	(S)-3-[1-(Dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate; (S)-Rivastigmine; Rivastigmine free base; SDZ ENA 713; Exelon base; ENA 713; (S)-N-Ethyl-N-methyl-3-[(1-dimethylamino)ethyl]phenyl carbamate; (S)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate
EINECS	Contact for details

Quality Control

Our Rivastigmine Usp Rc E is manufactured and tested to comply with current United States Pharmacopeia (USP) monograph standards. Every batch undergoes rigorous analytical testing, including identification, assay, and detailed impurity profiling, to ensure it meets the high-purity requirements for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) documenting all test results and specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Optical Rotation	[α]20/D: Specific range provided on COA
Residual Solvents (GC)	Complies with USP <467>
Water Content (KF)	NMT 1.0%

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