Description

Ropivacaine Impurity CAS NO 1543937-58-1 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 drug substances and finished products. It is an essential tool for analytical chemists, quality assurance professionals, and research scientists working in pharmaceutical development and manufacturing to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of specific impurities in Ropivacaine API and formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to quantify impurity levels against established specifications, ensuring every batch meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies and Forced Degradation Studies: Acts as a marker to track impurity formation under various stress conditions (heat, light, humidity, acid/base), supporting drug shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control strategies as per ICH Q3A and Q3B guidelines.
• Research and Process Chemistry: Used by R&D scientists to study the formation pathways of this impurity, aiding in the refinement of synthetic routes to minimize its presence.

Basic Information

Product Name	Ropivacaine Impurity
CAS No.	1543937-58-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ropivacaine Related Compound; Ropivacaine Impurity Standard; Ropivacaine Process Impurity; (S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity; (2S)-N-(2,6-Dimethylphenyl)-1-propyl-2-piperidinecarboxamide Impurity; Ropivacaine Hydrochloride Impurity; Naropin Impurity; LEVA-004 Impurity
EINECS	Contact for details

Quality Control

Our Ropivacaine Impurity is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, identity, and other critical parameters.

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. For long-term storage, keep the container in a cool, dry, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH Q3C

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