Description

Lidocaine Ep Impurity F 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 pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and regulatory compliance. The precise characterization of such impurities is fundamental to meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurities in lidocaine API and finished drug products.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure lidocaine products comply with pharmacopeial limits for specified impurities (e.g., EP, USP, ICH guidelines).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation and levels of degradation products in lidocaine formulations under various storage conditions.
• Research and Development: Facilitates process chemistry optimization by identifying and quantifying synthetic by-products, aiding in purification route development.

Basic Information

Product Name	Lidocaine Ep Impurity F
CAS No.	142713-08-4
Molecular Formula	C14H22N2O
Molecular Weight	234.34 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide Impurity F; Lidocaine Related Compound F; Lidocaine EP Impurity F; 2',6'-Xylidide, N-(Diethylglycyl)-, Impurity F; Lidocaine Process Impurity; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide Impurity F; Lidocaine Specified Impurity F
EINECS	Contact for details

Quality Control

Every batch of Lidocaine Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your quality and regulatory requirements.

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 under inert atmosphere to ensure maximum stability.

Specification

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

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