Description

Ropivacaine Ep Impurity D is a high-purity chemical reference standard, specifically identified as an enantiomeric impurity of the local anesthetic Ropivacaine. This compound is critical for pharmaceutical research and development, enabling the precise analysis and control of product quality and enantiomeric purity. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific enantiomeric impurities in Ropivacaine API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating chiral separation methods, particularly in HPLC and UPLC.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical manufacturing to ensure compliance with strict pharmacopeial limits for enantiomeric purity.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity standards for stability and safety studies.
• Research & Development: Employed in pharmacokinetic and metabolic studies to understand the behavior of Ropivacaine and its related substances.

Basic Information

Product Name	Ropivacaine Ep Impurity D
CAS No.	98626-59-6
Molecular Formula	C17H26N2O
Molecular Weight	274.40 g/mol
Synonyms	(S)-1-Butyl-2',6'-pipecoloxylidide; (S)-Ropivacaine; S(-)-Ropivacaine; Ropivacaine S-enantiomer; LEVA-1; (2S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide; Naropin Impurity D; Ropivacaine Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Ropivacaine Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA), detailing results from HPLC, chiral analysis, and other relevant tests, is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.