Description

Lidocaine Ep Impurity G is a specified impurity and degradation product of the widely used local anesthetic, Lidocaine. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of Lidocaine-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, reference standard qualification, and impurity profiling.

Application

• Primary use as a certified reference standard (CRS) for pharmacopeial (EP/USP) compliance testing.
• Critical component in analytical method development and validation for Lidocaine and its formulations.
• Essential for impurity profiling and identification in Active Pharmaceutical Ingredient (API) and finished product quality control.
• Used in stability studies to monitor degradation pathways of Lidocaine under various conditions.
• Serves as a key reagent in pharmaceutical research and development for process-related impurity control.
• Supports regulatory submissions by providing identified impurity data for drug master files (DMFs).

Basic Information

Product Name	Lidocaine Ep Impurity G
CAS No.	42459-30-3
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity G; Lidocaine Related Compound G; 2',6'-Xylidide, N-(Diethylglycyl)-; Lidocaine Degradation Product G; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Impurity; Lidocaine EP Impurity G; Lidocaine USP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Ep Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurities, and chromatographic data. We support compliance with EP, USP, and ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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