Description

Lidocaine Impurity CAS NO 1374010-02-2 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 the widely used local anesthetic, Lidocaine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Lidocaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods (HPLC, UPLC, GC) to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to verify that Lidocaine batches meet stringent pharmacopeial (USP, EP, JP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Essential for preparing comprehensive Chemistry, Manufacturing, and Controls (CMC) documentation required for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and synthesis by-products of Lidocaine.

Basic Information

Product Name	Lidocaine Impurity
CAS No.	1374010-02-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lidocaine Related Compound; Lidocaine Impurity Standard; Lidocaine Specified Impurity; 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity; Lignocaine Impurity; Xylocaine Impurity; Lidocaine Process-Related Impurity; Lidocaine Degradation Product
EINECS	Contact for details

Quality Control

Our Lidocaine Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, MS, NMR). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines. The material is suitable for use in pharmacopeial testing and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). For long-term stability, storage at 2-8°C is recommended. The container should be kept in a well-ventilated area and protected from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets project requirements
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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