Description

Lidocaine Impurity CAS NO 35891-84-0 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a key impurity profile marker for the widely used local anesthetic, Lidocaine, ensuring the safety and efficacy of the final drug product. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on meeting stringent pharmacopeial standards for impurity identification and quantification.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Lidocaine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug manufacturing process.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Lidocaine to understand degradation pathways and establish shelf-life.
• Quality Control & Release Testing: A critical component in the QC laboratory for routine batch analysis to ensure Lidocaine API and drug products comply with ICH, USP, or EP impurity limits.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Pharmacopeial Testing: Supports testing procedures as required by United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or other international pharmacopeias.

Basic Information

Product Name	Lidocaine Impurity
CAS No.	35891-84-0
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide; Lidocaine EP Impurity C; Lidocaine Related Compound C; Xylocaine Impurity C; Lignocaine Impurity; α-Diethylamino-2,6-acetoxylidide; Diethylglycinexylidide; DEG
EINECS	Contact for details

Quality Control

Our Lidocaine Impurity CAS NO 35891-84-0 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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