Description

Ropivacaine Impurity CAS NO 1786560-34-6 is a high-purity chemical reference standard used in the analytical profiling of the local anesthetic Ropivacaine. This compound is critical for pharmaceutical quality control and regulatory compliance, enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development, manufacturing, and regulatory affairs to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Ropivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating stability-indicating HPLC, UPLC, or GC methods for Ropivacaine.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Ropivacaine.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research and Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the Ropivacaine synthesis process.

Basic Information

Item	Detail
Product Name	Ropivacaine Impurity
CAS No.	1786560-34-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ropivacaine Related Compound; Ropivacaine Process Impurity; Specific Ropivacaine Degradant; (2S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity; LEA-103 Impurity; Naropin Impurity; Pharmaceutical Secondary Standard
EINECS	Contact for details

Quality Control

Every batch of Ropivacaine Impurity CAS 1786560-34-6 is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity content. Our quality standards align with the requirements for pharmaceutical reference materials.

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 absorption of water vapor. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report single unknown impurity and total impurities
Water Content (KF)	≤ 5.0%
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.