Description

Amifostine Impurity 7 is a specified impurity of the cytoprotective agent Amifostine, identified by CAS No. 174397-83-2. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Amifostine drug substance and products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Pharmacopoeial Testing: Supports testing to meet the standards of USP, EP, or other pharmacopoeias where Amifostine monographs are established.

Basic Information

Product Name	Amifostine Impurity 7
CAS No.	174397-83-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2-((Aminocarbonyl)thio)ethyl)phosphonic Acid; S-2-(3-Aminopropylamino)ethylphosphorothioate Impurity 7; Amifostine Related Compound 7; Ethyfos Impurity 7; WR-2721 Impurity 7; Gammaphos Impurity 7; Amifostine Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Amifostine Impurity 7 (CAS 174397-83-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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