Description

Lidocaine Ep Impurity CAS NO 31785-64-5 is a critical reference standard and impurity used in the pharmaceutical development and quality control of the anesthetic drug Lidocaine. This compound is essential for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the Ep impurity in Lidocaine Hydrochloride and related drug substances.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Quality Control & Batch Release Testing: Employed in routine QC testing of active pharmaceutical ingredients (APIs) to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Serves as a key reagent in synthetic chemistry research for studying degradation pathways and developing purification processes for Lidocaine.

Basic Information

Product Name	Lidocaine Ep Impurity
CAS No.	31785-64-5
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity; Lidocaine Ethyl Impurity; Lidocaine Related Compound E; Lidocaine EP Impurity E; 2',6'-Dimethylacetanilide, N-(Diethylglycyl)-; N-(2,6-Dimethylphenyl)-N-(2-diethylaminoethyl)acetamide; Lidocaine Degradant; Lignocaine Impurity E
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Ep Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with USP, EP, ICH, and other relevant pharmacopeial 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 degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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