Description

Amifostine Impurity 5 CAS NO 712255-27-1 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 manufacturing of the cytoprotective agent Amifostine. It is essential for researchers and quality assurance professionals who require precise identification, quantification, and monitoring of impurities to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation in Amifostine API production.
• Quality Control & Assurance (QC/QA): Used in HPLC, LC-MS, and other chromatographic systems for the identification and quantification of specific impurities in drug substance batches.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity profiles.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Amifostine formulations.
• Research & Development (R&D): Serves as a key reagent in metabolic pathway studies and impurity synthesis research related to Amifostine.
• Pharmacopoeial Testing: Applicable for testing against monograph specifications in pharmacopoeias such as USP or EP where impurity limits are defined.

Basic Information

Product Name	Amifostine Impurity 5
CAS No.	712255-27-1
Molecular Formula	C5H15N2O3PS2
Molecular Weight	246.29 g/mol
Synonyms	Ethiofos Impurity 5; WR-2721 Impurity 5; S-2-(3-Aminopropylamino)ethyl dihydrogen phosphorothioate Impurity 5; Amifostine Related Compound 5; (3-Aminopropyl)amino]ethanethiol Dihydrogen Phosphate Ester Impurity; Gammaphos Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Amifostine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 2.0%

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