Description

Lidocaine Impurity 6 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing lidocaine. It is primarily required by analytical laboratories, quality control units, and research institutions within the pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in lidocaine API and finished drug products.
• Essential for pharmaceutical research and development (R&D) during formulation studies and stability testing.
• Critical component in analytical method development and validation (HPLC, LC-MS, GC) to meet ICH guidelines.
• Used in quality control (QC) laboratories for routine batch release testing and impurity monitoring.
• Serves as a key material for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and specifications.
• Supports pharmacopoeial testing to verify compliance with USP, EP, or other pharmacopoeia monographs.
• Valuable for academic and clinical research investigating the metabolism and degradation pathways of lidocaine.

Basic Information

Product Name	Lidocaine Impurity 6 Hcl
CAS No.	857170-05-9
Molecular Formula	C14H23ClN2O
Molecular Weight	270.80 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Hydrochloride Impurity 6; Lidocaine EP Impurity G Hydrochloride; Lidocaine Related Compound G HCl; 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide HCl Impurity; Lidocaine Degradant HCl; Lidocaine Process Impurity HCl; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity 6 Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications and typical pharmacopoeial requirements. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to support your regulatory and quality assurance needs.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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