Description

Ropivacaine Impurity G is a high-purity chemical reference standard, specifically identified as a process-related impurity of the local anesthetic Ropivacaine. 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 an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ropivacaine Impurity G in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies of Ropivacaine to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Facilitates process chemistry research aimed at minimizing the formation of this impurity during the synthesis and purification of Ropivacaine.

Basic Information

Product Name	Ropivacaine Impurity G
CAS No.	98717-16-9
Molecular Formula	C17H26N2O
Molecular Weight	274.40 g/mol
Synonyms	(S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity G; (2S)-N-(2,6-Dimethylphenyl)-1-propyl-2-piperidinecarboxamide Related Compound G; 1-Propyl-2',6'-pipecoloxylidide Impurity G; Ropivacaine EP Impurity G; Ropivacaine Related Compound G; Naropin Impurity G; LE-103 Impurity G
EINECS	Contact for details

Quality Control

Every batch of Ropivacaine Impurity G is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality protocols are designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for tests including identification, assay, and impurity profile by HPLC. Specifications are aligned with current pharmacopeial expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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