Ifosfamide is a synthetic alkylating antineoplastic active pharmaceutical ingredient (API) belonging to the oxazaphosphorine class of nitrogen mustard compounds. It is used in oncology formulations for the treatment of several malignant diseases and is structurally related to cyclophosphamide.
Ifosfamide has the molecular formula C7H15Cl2N2O2P and a molecular weight of 261.09 g/mol. Its CAS Number is 3778-73-2.
Ifosfamide is a prodrug that requires metabolic activation in the liver to produce active metabolites capable of interacting with DNA. It is primarily used as an antineoplastic agent in combination chemotherapy regimens.
The API is particularly relevant to pharmaceutical formulations used in the management of sarcomas, testicular cancer and certain other solid tumors and hematological malignancies.
Ifosfamide undergoes hepatic metabolic activation to form active metabolites, including isophosphoramide mustard.
These metabolites form covalent bonds with DNA, resulting in DNA cross-linking and inhibition of DNA replication and transcription. This ultimately interferes with the proliferation of rapidly dividing cancer cells.
Ifosfamide API is used in the development and manufacture of:
Ifosfamide is manufactured through controlled chemical synthesis followed by purification, crystallization and drying. Pharmaceutical quality testing is performed to establish identity, assay, purity and other critical quality attributes.
Quality control may include identification, assay, related substances, water content, residue on ignition, elemental impurities and residual solvents according to the applicable approved specification.
Ifosfamide is generally supplied as a white crystalline powder. It is soluble in water and is commonly formulated as a sterile pharmaceutical preparation for parenteral administration.
Ifosfamide should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
As a cytotoxic antineoplastic API, appropriate occupational handling and containment procedures should be followed during manufacturing and formulation.
Depending on the intended pharmaceutical application, documentation may include:
Ifosfamide is an important alkylating antineoplastic API used in combination chemotherapy for several types of cancer. Through its active metabolites, it produces DNA cross-links that inhibit cancer-cell proliferation, making it an established ingredient in oncology pharmaceutical development.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 48–52°C |