Description

Ifosfamide Impurity B is a specified impurity of the antineoplastic agent Ifosfamide, identified by the CAS registry number 241482-18-8. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of impurities in Ifosfamide drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in oncology drug manufacturing and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ifosfamide.
• Method Development and Validation: Crucial for developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Ifosfamide batches meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to monitor the formation of degradation products in Ifosfamide formulations under various storage conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates studies on the metabolism, degradation pathways, and toxicological profile of Ifosfamide.

Basic Information

Product Name	Ifosfamide Impurity B
CAS No.	241482-18-8
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; N-(2-Chloroethyl)-N'-(2-chloroethyl)phosphoric diamide cyclic propanol ester; Ifosfamide Impurity 2; Ifosfamide Related Compound B; Isofosfamide Impurity B; Cyclophosphamide analogue; Holoxan Impurity B
EINECS	Contact for details

Quality Control

Every batch of Ifosfamide Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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