Description

Melphalan Mono-Chloroethyl Impurity is a critical pharmaceutical reference standard and process-related impurity used in the development and quality control of the anticancer drug Melphalan. Its precise identification and quantification are essential for ensuring drug safety, efficacy, and regulatory compliance in pharmaceutical manufacturing. This high-purity compound is primarily required by analytical laboratories, research institutions, and pharmaceutical companies engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of a key process-related impurity in Melphalan API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels.
• Stability Indicating Studies: Employed in forced degradation and stability studies to understand the degradation pathways of Melphalan and establish shelf-life specifications.
• Quality Control & Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in chemical and pharmacological research to study the metabolism and toxicity profile of Melphalan and its related compounds.

Basic Information

Item	Detail
Product Name	Melphalan Mono-Chloroethyl Impurity
CAS No.	573704-41-3
Molecular Formula	C15H21Cl2N3O4
Molecular Weight	378.25 g/mol
Synonyms	4-[Bis(2-chloroethyl)amino]-L-phenylalanine mono-chloroethyl derivative; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, mono-chloroethyl impurity; Melphalan Chloroethyl Impurity; Melphalan Related Compound; Melphalan Degradant; Sarcolysin Mono-Chloroethyl Impurity; Alkeran Impurity
EINECS	Contact for details

Quality Control

Every batch of Melphalan Mono-Chloroethyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Melphalan Content	≤ 1.0%
Water Content (KF)	≤ 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.