Description

Rivastigmine Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Rivastigmine, a cholinesterase inhibitor used in the treatment of dementia. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and routine quality control testing. The compound is supplied with comprehensive analytical data to support its use in regulated environments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Rivastigmine-related substances in API and finished drug products.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control laboratories to monitor and control impurity levels during Rivastigmine manufacturing.
• Stability Studies: Employed as a marker to track the formation of degradation products in Rivastigmine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Rivastigmine Impurity 9
CAS No.	1369779-38-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivastigmine Related Compound 9; Rivastigmine EP Impurity J; Rivastigmine USP Impurity; (S)-3-[1-(Dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate Impurity; Carbamic acid, N-ethyl-N-methyl-, 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (Impurity); Rivastigmine Degradant; Rivastigmine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rivastigmine Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods, including HPLC and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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