Description

Cyclophosphamide Impurity CAS NO 78149-83-4 is a high-purity reference standard critical for analytical research and pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in the active pharmaceutical ingredient (API) Cyclophosphamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Cyclophosphamide API and its formulations.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods.
• Quality Control & Assurance (QC/QA): Enables in-house testing and batch release testing to ensure API purity meets pharmacopeia (USP, EP, JP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in Cyclophosphamide drug products under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research, metabolism studies, and the development of impurity control strategies.

Basic Information

Product Name	Cyclophosphamide Impurity
CAS No.	78149-83-4
Molecular Formula	C7H15Cl2N2O2P
Molecular Weight	261.09 g/mol
Synonyms	2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide; Cyclophosphamide Monohydrate Impurity; Cyclophosphamide Related Compound; NSC-26271 Impurity; N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide
EINECS	Contact for details

Quality Control

Our Cyclophosphamide Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and IR for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and quality needs. The material is suitable for use as a reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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