Description

Cyclophosphamide Impurity A CAS NO 1391053-11-4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Cyclophosphamide drug substances and products. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical development, manufacturing, and regulatory compliance. The availability of a well-characterized impurity standard is fundamental to ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC, UPLC, and LC-MS analysis.
• Impurity Profiling: Identification and quantification of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products containing Cyclophosphamide.
• Regulatory Compliance & Filing: Supporting regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data required for ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Monitoring the formation and levels of this impurity during forced degradation and long-term stability testing of Cyclophosphamide formulations.
• Process Chemistry R&D: Used in research to understand and optimize synthesis pathways to minimize the formation of this impurity.
• Quality Control Laboratories: Routine testing in QC labs to ensure batch-to-batch consistency and that impurity levels remain within specified limits.

Basic Information

Product Name	Cyclophosphamide Impurity A
CAS No.	1391053-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cyclophosphamide Related Compound A; Cyclophosphamide EP Impurity A; Cyclophosphamide USP Impurity A; Cyclophosphamide Process Impurity; N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide impurity A; CPA Impurity A; Cyclophosphamide Degradant
EINECS	Contact for details

Quality Control

Our Cyclophosphamide Impurity A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere if specified.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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