Description

Propitocaine Impurity B is a specified impurity and a critical reference standard used in the quality control of the local anesthetic agent Propitocaine. This high-purity analytical standard is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in research, development, and quality assurance processes within the pharmaceutical industry, particularly for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Propitocaine Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Propitocaine batches.
• Quality Control & Assurance (QC/QA): Employed in routine QC testing to ensure Propitocaine meets stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B) for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of Propitocaine.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Propitocaine.

Basic Information

Product Name	Propitocaine Impurity B
CAS No.	42459-45-0
Molecular Formula	C13H20N2O
Molecular Weight	220.31 g/mol
Synonyms	2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide; N-(2,6-Dimethylphenyl)-2-(diethylamino)acetamide; Prilocaine Impurity B; LAC 43 Impurity B; Citanest Impurity B; Propitocaine Related Compound B; 2',6'-Pipecoloxylidide Impurity B
EINECS	Contact for details

Quality Control

Our Propitocaine Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous 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 in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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