Description

Melphalan Impurity B is a specified impurity of the chemotherapeutic agent Melphalan, identified by the CAS registry number 1270153-04-2. 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 pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Melphalan API and finished dosage forms.
• Essential for Analytical Method Development and Validation (e.g., HPLC, UPLC, GC) in quality control laboratories.
• Critical component in Stability Studies and forced degradation studies to understand the degradation pathways of Melphalan.
• Used in Regulatory Submissions (e.g., ANDA, NDA) to establish impurity profiles and specifications as per ICH guidelines.
• Supports Research and Development of generic Melphalan formulations by providing a benchmark for impurity control.
• Employed in Pharmacopeial Testing to verify compliance with USP, EP, or other international monographs.

Basic Information

Product Name	Melphalan Impurity B
CAS No.	1270153-04-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-; 4-[Bis(2-chloroethyl)amino]-L-phenylalanine; L-Melphalan Impurity B; Impurity B of Melphalan; Melphalan Related Compound B
EINECS	Contact for details

Quality Control

Our Melphalan Impurity B is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each lot undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods and purity determination by chromatographic techniques. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

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 Certificate of Analysis. The product should be kept in a dry environment and handled with appropriate precautions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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