Description

Cyclophosphamide Monohydrate is a nitrogen mustard alkylating agent and a key pharmaceutical active ingredient. This compound is a prodrug, requiring metabolic activation in the liver to exert its cytotoxic effects, making it a cornerstone in specific therapeutic regimens. It is essential for manufacturers in the pharmaceutical and biotechnology sectors, particularly those developing and producing oncology and immunosuppressive medications.

Application

• Oncological Drug Manufacturing: Primary active pharmaceutical ingredient (API) in chemotherapeutic agents for treating various cancers, including lymphomas, leukemias, and solid tumors.
• Immunosuppressive Therapy: Key component in medications used to prevent organ transplant rejection and to treat severe autoimmune diseases.
• Pharmaceutical Research & Development: Used as a reference standard and building block in R&D for novel anti-cancer therapies and combination treatments.
• Veterinary Medicine: Employed in veterinary oncology for the treatment of certain cancers in animals.
• Biochemical Research: Utilized in laboratory studies to investigate mechanisms of apoptosis, DNA alkylation, and immunosuppression.

Basic Information

Product Name	Cyclophosphamide Monohydrate
CAS No.	6055-19-2
Molecular Formula	C7H15Cl2N2O2P • H2O
Molecular Weight	279.10 g/mol (Monohydrate)
Synonyms	Cyclophosphamide Hydrate; 2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate; CP monohydrate; CPM; CY; Endoxan; Cytoxan; Neosar; Genoxal; Cycloblastin; WR-138719
EINECS	Contact for details

Quality Control

Our Cyclophosphamide Monohydrate is manufactured and tested under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical applications, with potential alignment to pharmacopoeial requirements (e.g., USP, EP). Every batch undergoes comprehensive analytical testing. Certificates of Analysis (COA) documenting purity, identity, and impurity profiles are available upon request to ensure full traceability and compliance for our B2B partners.

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 dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	NMT 20 ppm

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