Description

Lidocaine Impurity E is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in lidocaine-based drug substances and finished products. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Critical for the structural elucidation and tracking of specific impurities during lidocaine API (Active Pharmaceutical Ingredient) synthesis.
• Method Development & Validation: Serves as a key component in developing and validating HPLC, UPLC, and GC analytical procedures for impurity detection.
• Quality Control & Release Testing: Employed in routine QC testing of lidocaine batches to ensure impurity levels remain within ICH (International Council for Harmonisation) specified limits.
• Regulatory Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Used as a marker to monitor the formation of degradation products in lidocaine formulations under various stress conditions.

Basic Information

Product Name	Lidocaine Impurity E
CAS No.	745798-07-6
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity E; Lidocaine Related Compound E; 2',6'-Xylidine Impurity E; Lidocaine EP Impurity E; Lidocaine USP Impurity E; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Impurity; α-Diethylamino-2,6-dimethylacetanilide Impurity E
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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