Description

Melphalan Ep Impurity C is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticancer drug Melphalan. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known marker for a specific impurity profile. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Melphalan and related alkylating agent therapies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Melphalan Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with strict pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Melphalan formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Utilized in R&D to study the degradation pathways and chemical behavior of Melphalan, aiding in the development of more stable formulations.

Basic Information

Product Name	Melphalan Ep Impurity C
CAS No.	896715-19-8
Molecular Formula	C13H18Cl2N2O2
Molecular Weight	305.20 g/mol
Synonyms	L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, (2S)-2-amino-3-(4-hydroxyphenyl)propanoate (salt); Melphalan Impurity C; Melphalan Related Compound C; EP Impurity C of Melphalan; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, compound with (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid (1:1)
EINECS	Contact for details

Quality Control

Our Melphalan Ep Impurity C is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR), 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.