Description

Lidocaine Impurity 43 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in lidocaine API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure lidocaine batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Aids in metabolic studies, synthesis pathway research, and understanding the degradation pathways of lidocaine.

Basic Information

Product Name	Lidocaine Impurity 43
CAS No.	131081-28-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity 43; Lidocaine Related Compound 43; 131081-28-2; Lidocaine EP Impurity C; Lidocaine USP Impurity; Xylocaine Impurity 43; Lignocaine Impurity 43
EINECS	Contact for details

Quality Control

Our Lidocaine Impurity 43 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Meets ICH limits

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