Description

Ifosfamide Impurity A is a critical reference standard used in the pharmaceutical quality control process. This compound is essential for the accurate identification, quantification, and monitoring of a key impurity in the active pharmaceutical ingredient (API) Ifosfamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Ifosfamide Impurity A in drug substances and products.
• Method Development and Validation: Used in developing and validating robust analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against predefined specifications, ensuring batch-to-batch consistency of Ifosfamide API.
• Stability Studies: A crucial component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research and Development: Used in R&D to understand the degradation pathways of Ifosfamide and to synthesize purer batches of the API.

Basic Information

Product Name	Ifosfamide Impurity A
CAS No.	22608-58-8
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; Iso-Ifosfamide; Ifosfamide Isomer; Ifosfamide Related Compound A; Cyclophosphamide Impurity; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Ifosfamide Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants and inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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