Description

Lidocaine Impurity 2 CAS NO 1596965-85-3 is a high-purity 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 this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify Lidocaine Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Method Development & Validation: Serves as a critical component in developing and validating stability-indicating assay methods for lidocaine and its related substances.
• Quality Control & Batch Release: Employed in routine QC testing to ensure lidocaine drug substances and products meet stringent pharmacopeial limits for specified impurities.
• Regulatory Submission & Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of product-related impurities as per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.

Basic Information

Product Name	Lidocaine Impurity 2
CAS No.	1596965-85-3
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity 2; Lidocaine Related Compound 2; 2,6-Dimethylacetanilide Diethylglycine Ester; Lidocaine EP Impurity B; Lidocaine USP Related Substance; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Impurity; Lignocaine Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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); the container must be kept tightly sealed 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 102.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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