Description

Lidocaine Impurity 40 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of lidocaine-based drug products by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs. The compound is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of lidocaine API and finished drug products.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, and GC analytical methods to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC testing of lidocaine batches to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to identify and track degradation products in lidocaine formulations under various stress conditions.
• Regulatory Compliance and Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Supports impurity profiling and route scouting during the synthetic process development of lidocaine.

Basic Information

Product Name	Lidocaine Impurity 40
CAS No.	457925-74-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lidocaine Related Compound 40; Lidocaine EP Impurity 40; Lidocaine USP Impurity 40; 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity 40; Lignocaine Impurity 40; Xylocaine Impurity 40; (2,6-Dimethylphenyl)carbamoylmethyl-diethylammonium Impurity; Process Impurity of Lidocaine
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and GC to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual and total limits
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.