Description

Melphalan Ep Impurity H is a high-purity chemical reference standard, specifically identified as an impurity of the antineoplastic agent Melphalan. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, quality control laboratories, and manufacturers engaged in the development and production of Melphalan and related pharmaceutical compounds.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Melphalan Ep Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling of Melphalan.
• Quality Control & Assurance: Essential for routine batch testing in QC labs to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Melphalan.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in academic and industrial R&D for studying the metabolism, pharmacokinetics, and impurity formation mechanisms of alkylating agents.

Basic Information

Product Name	Melphalan Ep Impurity H
CAS No.	88457-23-2
Molecular Formula	C14H20Cl2N2O4
Molecular Weight	351.23 g/mol
Synonyms	4-[Bis(2-chloroethyl)amino]-L-phenylalanine ethyl ester; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, ethyl ester; Ethyl 4-[bis(2-chloroethyl)amino]-L-phenylalaninate; Melphalan Ethyl Ester; Melphalan Impurity H (EP); Melphalan Related Compound H
EINECS	Contact for details

Quality Control

Every batch of Melphalan Ep Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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