Description

Cyclophosphamide Related Compound D (25 Mg) (3-[2-(2-Chloroethylamino)Ethylamino]Propyl Dihydrogen Phosphate Dihydrochloride) is a high-purity analytical reference standard critical for pharmaceutical research and quality control. This compound serves as a key impurity marker and degradation product for the active pharmaceutical ingredient cyclophosphamide, a widely used alkylating agent. It is essential for researchers and quality assurance professionals in pharmaceutical development, analytical laboratories, and regulatory compliance sectors who require precise standards for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of related substances in cyclophosphamide drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accuracy and specificity in testing protocols.
• Stability Indicating Studies: Employed to monitor the degradation pathways of cyclophosphamide under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Pharmacopoeial Testing: Supports compliance testing against monographs in USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopoeias.
• Metabolism and Pharmacokinetics Research: Acts as a reference compound in studies investigating the metabolism and biotransformation of cyclophosphamide.
• Quality Control Laboratory Calibration: Provides a traceable standard for the calibration of analytical instruments and ensuring the reliability of in-house testing procedures.
• Regulatory Documentation and Submissions: Used to generate data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over product impurities.

Basic Information

Product Name	Cyclophosphamide Related Compound D (25 Mg) (3-[2-(2-Chloroethylamino)Ethylamino]Propyl Dihydrogen Phosphate Dihydrochloride)
CAS No.	158401-51-5
Molecular Formula	C9H24Cl2N3O4P
Molecular Weight	364.18 g/mol
Synonyms	3-[2-(2-Chloroethylamino)ethylamino]propyl dihydrogen phosphate dihydrochloride; Cyclophosphamide Impurity D; Cyclophosphamide Related Substance D; Cyclophosphamide Degradation Product; 2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide Related Compound D; Nor-Nitrogen Mustard Phosphorodiamidate Derivative; Cyclophosphamide Metabolite Reference Standard
EINECS	Contact for details

Quality Control

This high-grade reference standard is produced under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and mass spectrometry to confirm identity and purity. We provide full traceability and a detailed Certificate of Analysis (COA) with each unit, which includes batch-specific results for assay, impurities, and other critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept sealed in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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