Description

Rac-Melphalan Ep Impurity A Dihydrochloride (Dihydroxy Melphalan Dihydrochloride) is a critical reference standard and impurity used in the pharmaceutical development and quality control of the chemotherapeutic agent Melphalan. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors focused on oncology drug manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) in method development and validation.
• Impurity Profiling and Control: Used for the identification and quantification of Rac-Melphalan Ep Impurity A during the stability testing and release of Melphalan Active Pharmaceutical Ingredient (API) and finished drug products.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Employed in pharmacokinetic and metabolic studies to understand the degradation pathways and stability profile of Melphalan.
• Quality Control (QC) Testing: Integral to in-process control and final release testing in GMP manufacturing environments to ensure batch-to-batch consistency and purity.

Basic Information

Product Name	Rac-Melphalan Ep Impurity A Dihydrochloride (Dihydroxy Melphalan Dihydrochloride)
CAS No.	18316-80-8
Molecular Formula	C13H18Cl2N2O4
Molecular Weight	337.20 g/mol
Synonyms	Dihydroxy Melphalan Dihydrochloride; Melphalan Impurity A (EP); Melphalan Related Compound A; rac-3-[4-[Bis(2-chloroethyl)amino]phenyl]-2,3-dihydroxypropanoic Acid Dihydrochloride; 3-(p-[Bis(2-chloroethyl)amino]phenyl)-2,3-dihydroxypropionic Acid Dihydrochloride; DL-Dihydroxymelphalan Dihydrochloride; L-Phenylalanine, 4-[bis(2-chloroethyl)amino]-β,γ-dihydroxy-, hydrochloride (1:2), (±)-
EINECS	Contact for details

Quality Control

Our Rac-Melphalan Ep Impurity A Dihydrochloride is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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