Description

Lidocaine Impurity 45 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing lidocaine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in lidocaine API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and investigational new drug applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in lidocaine formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of lidocaine-related compounds.
• Quality Control Testing: Acts as a system suitability standard and for calibrating equipment to ensure accuracy in routine batch release testing.

Basic Information

Product Name	Lidocaine Impurity 45
CAS No.	1247567-34-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lidocaine Related Compound 45; Lidocaine EP Impurity G; Lidocaine USP Impurity; 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity 45; Lignocaine Impurity 45; Xylocaine Impurity 45; Lidocaine Degradation Product; Lidocaine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Impurity 45 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. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use under GMP conditions.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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