Description

Melphalan Impurity 6 is a designated impurity of the chemotherapeutic agent Melphalan, identified by the CAS registry number 1951445-22-9. This compound is critical for pharmaceutical research and development, specifically for analytical method development, stability studies, and ensuring the purity and safety profile of the active pharmaceutical ingredient (API). It is an essential reference standard for quality control laboratories in the pharmaceutical and biotechnology sectors, enabling compliance with stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Melphalan API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Melphalan under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Essential for setting impurity specifications and ensuring batch-to-batch consistency in pharmaceutical manufacturing under GMP.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Melphalan, aiding in formulation improvement.

Basic Information

Product Name	Melphalan Impurity 6
CAS No.	1951445-22-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, impurity 6; Melphalan Related Compound 6; 4-[Bis(2-chloroethyl)amino]-L-phenylalanine impurity; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-, isomer; Degradation product of Melphalan; Alkeran Impurity 6; L-PAM Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Melphalan Impurity 6 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against predefined specifications. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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. For long-term storage, consider storing desiccated at -20°C. Handle the material in accordance with safe laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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