Description

Amifostine Impurity 3 CAS NO 41510-53-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug substance Amifostine. It is essential for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable impurity standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Amifostine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC methods to meet ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation and behavior of this specific impurity under various conditions.
• Quality Control & Release Testing: Essential for routine batch analysis in pharmaceutical QC laboratories to ensure impurity levels remain within specified limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop robust purification processes.

Basic Information

Product Name	Amifostine Impurity 3
CAS No.	41510-53-6
Molecular Formula	C5H15N2O3PS2
Molecular Weight	246.29 g/mol
Synonyms	WR-2721 Impurity 3; Ethiofos Impurity 3; S-2-(3-Aminopropylamino)ethyl dihydrogen phosphorothioate Impurity 3; Amifostine Related Compound 3; (3-Aminopropyl)amino]ethanethiol Dihydrogen Phosphate Ester; Gammaphos Impurity 3; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Amifostine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and residual solvent analysis, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to ensure long-term stability.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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