Description

Melphalan Impurity I is a specified impurity of the chemotherapeutic agent Melphalan, identified by the CAS registry number 573704-40-2. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Melphalan drug substances and products. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Melphalan active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and understand the degradation pathways of Melphalan.
• Quality Control (QC) Testing: A critical component in routine batch release testing within pharmaceutical QC laboratories to ensure impurity levels are within specified limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity data for drug approval processes.
• Research and Development: Used in synthetic chemistry and process development to study and control the formation of this impurity during the manufacturing of Melphalan.

Basic Information

Product Name	Melphalan Impurity I
CAS No.	573704-40-2
Molecular Formula	C13H18Cl2N2O2
Molecular Weight	305.20 g/mol
Synonyms	4-[Bis(2-chloroethyl)amino]-L-phenylalanine; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-; Melphalan Related Compound I; Melphalan Impurity A; Melphalan EP Impurity I; Melphalan USP Related Compound I; 4-[Bis(2-chloroethyl)amino]phenylalanine; L-Melphalan Impurity I
EINECS	Contact for details

Quality Control

Every batch of Melphalan Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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