Description

Cyclophosphamide Impurity 8 is a specified impurity of the antineoplastic and immunosuppressive agent Cyclophosphamide. 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 primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Cyclophosphamide drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Cyclophosphamide Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and detect related substances.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Cyclophosphamide formulations under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Facilitates studies on the metabolism, degradation pathways, and toxicological profile of Cyclophosphamide.

Basic Information

Product Name	Cyclophosphamide Impurity 8
CAS No.	90632-33-0
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 8; Cyclophosphamide Related Compound 8; 2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide; Carboxyphosphamide Impurity; Cyclophosphamide Carboxylic Acid Impurity; Peroxyphosphamide Impurity
EINECS	Contact for details

Quality Control

Our Cyclophosphamide Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. We adhere to relevant ICH guidelines and can support compliance with pharmacopeial standards (USP, EP) for pharmaceutical impurity reference materials.

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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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