Description

Cyclophosphamide Impurity D is a critical reference standard used in the analytical profiling and quality control of the pharmaceutical agent Cyclophosphamide. This impurity is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling precise identification and quantification during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cyclophosphamide Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Utilized to track the formation and degradation of this specific impurity under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports investigative studies into the degradation pathways and metabolism of Cyclophosphamide.

Basic Information

Item	Details
Product Name	Cyclophosphamide Impurity D
CAS No.	45164-26-9
Molecular Formula	C7H15Cl2N2O2P
Molecular Weight	261.09 g/mol
Synonyms	N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide; Cyclophosphamide Monohydrate Impurity D; 2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide; Cyclophosphamide Related Compound D; 1,3,2-Oxazaphosphorinane, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide; CPA Impurity D
EINECS	Contact for details

Quality Control

Our Cyclophosphamide Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including HPLC purity, identification (IR, NMR), and residual solvent analysis. We adhere to relevant ICH guidelines and support compliance with USP and EP monograph requirements for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.