Description

Prilocaine Related Compound B (50 Mg) ((Rs)-n-(4-Methylphenyl)-2-(Propylamino)Propana-Mide) is a high-purity analytical reference standard, specifically identified as a known impurity or degradation product of the local anesthetic Prilocaine. This compound is critical for pharmaceutical research and development, enabling precise method validation, impurity profiling, and quality control testing to ensure drug safety and efficacy. It is primarily utilized by analytical chemists, quality assurance laboratories, and regulatory affairs professionals in the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Prilocaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, GC) to meet ICH Q2(R1) guidelines.
• Quality Control & Stability Studies: Employed in routine batch testing and forced degradation studies to monitor impurity levels and assess drug product stability over time.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research on Metabolism and Degradation Pathways: Acts as a chemical standard in studies investigating the metabolic pathways or decomposition mechanisms of Prilocaine.

Basic Information

Product Name	Prilocaine Related Compound B (50 Mg) ((Rs)-n-(4-Methylphenyl)-2-(Propylamino)Propana-Mide)
CAS No.	744961-76-0
Molecular Formula	C13H20N2O
Molecular Weight	220.31 g/mol
Synonyms	(RS)-N-(4-Methylphenyl)-2-(propylamino)propanamide; Prilocaine Impurity B; Prilocaine Related Substance B; 2-(Propylamino)-N-(p-tolyl)propanamide; LAC 43-0044; (RS)-N-(p-Tolyl)-2-(propylamino)propanamide; (±)-N-(4-Methylphenyl)-2-(propylamino)propanamide
EINECS	Contact for details

Quality Control

Every batch of Prilocaine Related Compound B is manufactured and analyzed under strict quality management protocols. The product undergoes rigorous identity confirmation, purity assessment, and impurity screening using advanced analytical techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances is provided with each unit, supporting compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 2.0%
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.