Description

Ropivacaine Impurity CAS NO 1786841-18-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Ropivacaine hydrochloride active pharmaceutical ingredient (API) and finished drug products. It is an essential tool for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying specific impurities during Ropivacaine API development and manufacturing.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and GC analytical methods for impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Ropivacaine drug substances and products to ensure they meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry R&D to study impurity formation pathways and develop purer synthesis routes for Ropivacaine.

Basic Information

Product Name	Ropivacaine Impurity
CAS No.	1786841-18-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ropivacaine Related Compound; Ropivacaine Process Impurity; Ropivacaine Specified Impurity; (S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity; Naropin Impurity; LEVA-004 Impurity; 1-Propyl-2',6'-pipecoloxylidide Impurity
EINECS	Contact for details

Quality Control

Our Ropivacaine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with the requirements for pharmaceutical reference standards, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0%
Water Content	≤ 2.0%
Residual Solvents	Meets ICH limits

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