Description

Ifosfamide Impurity E is a specified impurity and degradation product of the antineoplastic agent Ifosfamide. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Ifosfamide drug substances and products. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ifosfamide Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Ifosfamide.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Research & Development: Facilitates research into the degradation pathways and metabolism of Ifosfamide, aiding in the development of more stable formulations.

Basic Information

Product Name	Ifosfamide Impurity E
CAS No.	42453-19-0
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 E (EP); Ifosfamide Related Compound E; Ifosfamide Degradant E; Cyclophosphamide Impurity E (related); 1,3,2-Oxazaphosphorinane, 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-, 2-oxide
EINECS	Contact for details

Quality Control

Every batch of Ifosfamide Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

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 light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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