Description

Ropivacaine Impurity CAS NO 1786518-57-7 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 related substances in Ropivacaine drug substances and products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance for local anesthetic products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ropivacaine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure specificity, accuracy, and robustness for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to verify that Ropivacaine batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Used to track the formation of degradation products in Ropivacaine formulations under various stress conditions (e.g., heat, light, humidity) as part of ICH stability-indicating methods.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control over the impurity profile of the drug substance and product.
• Research & Development: Supports synthetic chemistry research for understanding degradation pathways and for the synthesis of metabolite standards in preclinical and clinical studies.

Basic Information

Product Name	Ropivacaine Impurity
CAS No.	1786518-57-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ropivacaine Related Compound; Ropivacaine Impurity Standard; Ropivacaine Specified Impurity; (S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity; Ropivacaine Degradation Product; Naropin Impurity; LEVA-041 Impurity; Pharmaceutical Reference Standard
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 identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including retention time and method parameters, to support your regulatory and quality needs. The material is suitable for use in methods compliant 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). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 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.