Description

Ropivacaine n-Oxide is a key pharmaceutical intermediate and impurity standard, specifically the N-oxide derivative of the widely used local anesthetic Ropivacaine. This compound is essential for analytical research, method development, and quality control processes in pharmaceutical manufacturing. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in the development, production, and regulatory compliance of anesthetic drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ropivacaine-related impurities in drug substances and finished products.
• Analytical Method Development: Used in HPLC, LC-MS, and other chromatographic methods to validate analytical procedures for purity and stability testing.
• Pharmacological Research: Employed in metabolic and degradation studies to understand the biotransformation pathways and stability profile of Ropivacaine.
• Quality Control & Assurance: Critical for ensuring batch-to-batch consistency and compliance with pharmacopoeial standards (e.g., USP, EP) in API manufacturing.
• Regulatory Documentation: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to support drug safety and efficacy profiles.

Basic Information

Product Name	Ropivacaine n-Oxide
CAS No.	1391053-59-0
Molecular Formula	C17H26N2O2
Molecular Weight	290.41 g/mol
Synonyms	(S)-N-(2,6-Dimethylphenyl)-1-propyl-2-piperidinecarboxamide N-Oxide; (S)-Ropivacaine N-Oxide; Ropivacaine Impurity N-Oxide; Ropivacaine Related Compound N-Oxide; 1-Propyl-2',6'-pipecoloxylidide N-Oxide; Ropivacaine N-Oxide Impurity; Ropivacaine Metabolite N-Oxide
EINECS	Contact for details

Quality Control

Our Ropivacaine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to ensure traceability and compliance with research and pharmaceutical standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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