Description

Rivastigmine Ep Impurity E CAS NO 923035-05-6 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Rivastigmine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research scientists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific impurity in Rivastigmine drug substance and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Rivastigmine batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Used in R&D to study the synthesis pathway of Rivastigmine and to develop improved manufacturing processes with lower impurity levels.

Basic Information

Product Name	Rivastigmine Ep Impurity E
CAS No.	923035-05-6
Molecular Formula	C14H22N2O2
Molecular Weight	250.34 g/mol
Synonyms	(S)-3-[1-(Dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate; Rivastigmine Related Compound E; Rivastigmine Impurity E; UNII-9M3C5WJ6IT; Exelon Impurity E; ENA 713 Impurity E; S-Rivastigmine Impurity; (S)-Rivastigmine Carbamate Impurity
EINECS	Contact for details

Quality Control

Every batch of Rivastigmine Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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