Description

4-Ketoifosfamide is a key intermediate metabolite and impurity standard in the synthesis and analysis of the chemotherapeutic agent ifosfamide. Its precise characterization is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product. This compound is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in oncology drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in ifosfamide drug substance and finished products.
• Metabolite Research: Serves as a critical standard in pharmacokinetic and metabolic pathway studies of ifosfamide.
• Process Impurity Monitoring: Essential for monitoring and controlling this specific impurity during the synthesis and purification stages of ifosfamide manufacturing.
• Analytical Method Development: Used in the development and validation of HPLC, LC-MS, and other chromatographic methods for ifosfamide analysis.
• Quality Control & Assurance: A vital component in the QC laboratory for routine batch release testing to comply with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in ifosfamide stability samples under various conditions.

Basic Information

Product Name	4-Ketoifosfamide
CAS No.	42436-20-4
Molecular Formula	C7H15Cl2N2O2P
Molecular Weight	261.09 g/mol
Synonyms	4-Ketocyclophosphamide; 4-Oxoifosfamide; NSC 347187; Ifosfamide Impurity C; Ifosfamide Metabolite; 2-[Bis(2-chloroethyl)amino]-4-hydroperoxy-2-oxo-1,3,2-oxazaphosphorinane; 4-Hydroperoxyifosfamide (related peroxide form)
EINECS	Contact for details

Quality Control

Our 4-Ketoifosfamide is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with your internal specifications and relevant regulatory guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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