Description

Melphalan Dimer Hydrochloride is a high-purity chemical derivative of the alkylating agent melphalan, primarily used as a critical reference standard and impurity control material in pharmaceutical development. Its significance lies in enabling precise analytical method validation and ensuring the quality and safety of melphalan-based drug products. This compound is essential for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on oncology drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used for the identification, assay, and impurity profiling of melphalan active pharmaceutical ingredients (APIs) and finished drug products.
• Impurity Control and Quantification: Serves as a specified impurity marker in stability studies and release testing to monitor drug product degradation.
• Analytical Method Development and Validation (HPLC/LC-MS): A critical component for developing and validating chromatographic methods to separate and quantify melphalan and its related substances.
• Pharmacology and Toxicology Research: Employed in studies investigating the metabolism, stability, and degradation pathways of melphalan.
• Quality Assurance/Quality Control (QA/QC): Integral for in-process testing and final release of melphalan APIs to ensure compliance with pharmacopeial monographs (e.g., USP, EP).
• Regulatory Submission Support: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Melphalan Dimer Hydrochloride
CAS No.	2238824-44-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Phenylalanine mustard dimer hydrochloride; L-Sarcolysin dimer hydrochloride; 4-[Bis(2-chloroethyl)amino]-L-phenylalanine dimer hydrochloride; NSC-8806 dimer hydrochloride; CB-3025 dimer hydrochloride; Alkeran dimer impurity hydrochloride; Melphalan dimer HCl
EINECS	Contact for details

Quality Control

Our Melphalan Dimer Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for use as a reference material. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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