Description

Lidocaine Impurity CAS NO 70336-49-1 is a high-purity reference standard used in the analytical profiling and quality control of the widely used local anesthetic, Lidocaine. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and control related substances, ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is an essential material for professionals in pharmaceutical R&D, quality assurance, and analytical chemistry who require reliable and well-characterized impurities for method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lidocaine HCl API and finished pharmaceutical products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or GC methods in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure every batch of Lidocaine meets stringent pharmacopeial (USP, EP, JP) specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the drug substance impurity profile.
• Research & Synthesis Monitoring: Serves as a benchmark in chemical synthesis to optimize reaction pathways and minimize the formation of this specific impurity during Lidocaine production.

Basic Information

Product Name	Lidocaine Impurity
CAS No.	70336-49-1
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide; Lidocaine Related Compound; Lidocaine EP Impurity; Lidocaine USP Related Substance; Diethylglycinexylidide; Xylocaine Impurity; Lignocaine Impurity; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity (CAS 70336-49-1) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and residual solvent content, is provided with each shipment to support your regulatory and quality requirements.

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); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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