Cyclophosphamide Powder Cas No.50-18-0
Product Source: Synthetic
Specification: ≥99%
CAS No.: 50-18-0
Molecular Formula: C₇H₁₅Cl₂N₂O₂P
Molecular Weight: 261.09 g·mol⁻¹
Testing Method: HPLC
Active Ingredient: Cyclophosphamide
Product Characteristics: White crystalline powder
Product Packaging: 1kg/bag; 25kg/drum; Customizable
Storage Conditions: Store in a cool, dry place under sealed conditions.
Shelf Life: 24 months
Cyclophosphamide API Powder CAS 50-18-0
High-Purity Oxazaphosphorine Alkylating Agent For Cytotoxic & Immunosuppressive Formulations
1. API Characterization & Manufacturing Value
Cyclophosphamide (CAS No. 50-18-0), commonly designated as CTX, is a synthetic nitrogen mustard derivative belonging to the oxazaphosphorine class of alkylating agents. Operating as a pharmacologically inactive prodrug, it relies on hepatic biotransformation to exert its potent antitumor and immunosuppressive therapeutic effects. Manufactured under strict cGMP protocols at Xi'an Tihealth, our Cyclophosphamide crystalline powder achieves a validated HPLC purity of ≥99.0%.
This pharmaceutical-grade API serves as a cornerstone in the formulation of cytotoxic chemotherapy and specialized immunosuppressive regimens, meeting the exacting standards of global pharmacopoeias for managing lymphoproliferative disorders and severe autoimmune pathologies. We ensure low residual solvent levels and optimized crystalline consistency, making it an ideal starting material for both liquid injectables and lyophilized parenteral powders.
2. Technical Data Sheet (TDS) & Specifications
| Quality Parameter | Specification Limit (USP / EP Grade) |
|---|---|
| Physical Appearance | White crystalline powder or fine crystal aggregates |
| Assay (HPLC, Anhydrous Basis) | 99.0% – 101.0% |
| Related Substances (HPLC) | Single Impurity ≤ 0.10%; Total Impurities ≤ 0.50% |
| Water Content (Karl Fischer) | ≤ 3.0% (Monohydrate form verified) |
| Heavy Metals (ICP-MS) | ≤ 10 ppm (Compliant with ICH Q3D) |
| Residual Solvents | Strictly controlled within ICH Q3C limits |
| Lyophilization Suitability | Optimized for rapid reconstitution and cake integrity |
3. Pharmacodynamics & Metabolic Mechanism of Action
Hepatic Biotransformation
As a specialized prodrug, CTX is hydroxylated in the liver by cytochrome P450 enzymes (predominantly CYP2B6 and CYP3A4) to form 4-hydroxycyclophosphamide. This active intermediate exists in dynamic equilibrium with its tautomer, aldophosphamide.
DNA Alkylation & Cross-Linking
Aldophosphamide spontaneously cleaves into the primary effector, phosphoramide mustard. This highly reactive alkylating moiety induces interstrand and intrastrand DNA cross-links at the N-7 position of guanine residues, irreversibly disrupting the double helix.
Cellular Apoptosis Induction
The resulting cross-linkage inhibits DNA replication and RNA transcription, triggering targeted apoptosis in rapidly proliferating malignant tumor clones and hyperactive autoimmune lymphocytes (T and B cells).
4. Core Pharmaceutical Applications
- Oncology Formulations: The foundational active pharmaceutical ingredient for manufacturing parenteral injectables and oral solid dosages indicated for Hodgkin's lymphoma, multiple myeloma, and breast carcinomas.
- Immunology Therapeutics: Deployed extensively in the industrial production of high-specification treatments targeting severe lupus nephritis and systemic necrotizing vasculitis.
- Transplantation Research: Utilized as a critical raw material by research institutions investigating conditioned immunosuppressive protocols in hematopoietic stem cell transplantation.
HPAPI SAFETY & SOURCING DIRECTIVE
Cyclophosphamide is classified as a highly potent cytotoxic active pharmaceutical ingredient (HPAPI) intended strictly for industrial pharmaceutical manufacturing and authorized scientific research under containment conditions. Because the powder is sensitive to ambient moisture (which induces hydrolysis of the chloroethyl groups and diminishes alkylating potency), strict storage in moisture-barrier packaging is mandatory to preserve the validated 24-month shelf life.
5. Frequently Asked Formulation Questions
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