Description

Ifosfamide Impurity F is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anticancer drug Ifosfamide by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and regulatory bodies engaged in method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ifosfamide and its related products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity identification data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ifosfamide drug substance and drug products to track impurity formation over time.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and pharmacokinetics of Ifosfamide.

Basic Information

Product Name	Ifosfamide Impurity F
CAS No.	81485-04-3
Molecular Formula	C7H15Cl2N2O2P
Molecular Weight	261.09 g/mol
Synonyms	3-(2-Chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide; Ifosfamide Impurity 6; Ifosfamide EP Impurity F; Ifosfamide Related Compound F; Ifosfamide USP Related Compound F; Isofosfamide Impurity F; NSC-109724 Impurity F; Holoxan Impurity F.
EINECS	Contact for details

Quality Control

Every batch of Ifosfamide Impurity F is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with pharmacopeial standards (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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