Description

Lidocaine Impurity 44 is a specified impurity of the widely used local anesthetic, Lidocaine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lidocaine-based drug products. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard for Lidocaine quality control.
• Analytical method development and validation (HPLC, GC, LC-MS).
• Identification and quantification of impurities in Lidocaine Active Pharmaceutical Ingredient (API).
• Stability studies and forced degradation studies of Lidocaine formulations.
• Pharmacopeial testing to meet USP, EP, ICH, and other regulatory guidelines.
• Research into the metabolism and degradation pathways of Lidocaine.
• Calibration of analytical instruments for impurity profiling.
• Batch release testing for Lidocaine API and finished dosage forms.

Basic Information

Product Name	Lidocaine Impurity 44
CAS No.	741638-04-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity 44; Lidocaine Related Compound 44; 2,6-Dimethylanilide Impurity; Lidocaine EP Impurity G; Lidocaine USP Impurity; Lidocaine Degradation Product; Lidocaine Process Impurity; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Impurity
EINECS	Contact for details

Quality Control

Our Lidocaine Impurity 44 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and Mass Spectrometry to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and confirms compliance with relevant pharmacopeial standards. Our quality commitment ensures the material is suitable for its intended use as a high-purity reference standard.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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