Perifosine API Manufacturer in India

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Perifosine API – KRX-0401

Perifosine is a synthetic alkylphospholipid active pharmaceutical ingredient that has been investigated for its antiproliferative and antineoplastic properties. It is also known by the development code KRX-0401 and has been studied in oncology research, including multiple myeloma and solid tumors. Perifosine is structurally classified as an alkylphosphocholine and is associated with modulation of cellular signaling pathways involved in cell growth and survival.

Perifosine has the CAS Number 157716-52-4, molecular formula C25H52NO4P, and molecular weight 461.7 g/mol. Its systematic chemical name is (1,1-dimethylpiperidin-1-ium-4-yl) octadecyl phosphate. PubChem identifies Perifosine as an alkylphospholipid and ammonium betaine.

Chemical Identity of Perifosine

Perifosine contains a long-chain octadecyl phosphate structure linked to a dimethylpiperidinium group. Its molecular structure contributes to its classification as an alkylphospholipid and differentiates it from conventional small-molecule kinase inhibitors.

The molecular formula of Perifosine is C25H52NO4P, with a molecular weight of 461.7 g/mol. PubChem lists UNII 2GWV496552, ChEBI CHEBI:67272, ChEMBL CHEMBL372764, and DrugBank DB06641 among its identifiers.

Pharmaceutical and Research Applications

Perifosine has been investigated as an orally active anticancer compound. Its pharmacological activity has been associated with effects on cellular membrane function and signaling pathways involved in proliferation and apoptosis. It has been studied in areas including multiple myeloma, leukemia, solid tumors, lung cancer and brain cancer.

Perifosine has reached clinical development, including Phase 3 investigation, but it should not be represented as an approved pharmaceutical API for a specific marketed indication unless supported by the applicable regulatory authority. PubChem currently lists its development status and investigated uses rather than an established marketed indication.

Mechanism of Action

Perifosine is an alkylphospholipid that interacts with cellular membranes and signaling pathways. Research has associated its activity with modulation of Akt/protein kinase B signaling, MAPK-related pathways and cellular survival mechanisms. These effects have contributed to its investigation as an antiproliferative and antineoplastic compound.

API Quality and Analytical Considerations

Perifosine is a defined synthetic small molecule with a molecular weight of 461.7 g/mol. API characterization can include identity testing, chromatographic purity, assay, residual solvents, water content, elemental impurities and other quality attributes appropriate to the manufacturing process and intended use.

However, a current publicly accessible USP, Ph. Eur. or Indian Pharmacopoeia monograph containing universal numerical release specifications for Perifosine was not verified in the authoritative sources reviewed for this page. Therefore, numerical values for assay, individual impurities, total impurities, loss on drying, residue on ignition, heavy metals and pH should not be presented as universal pharmacopoeial specifications without a verified source.

For commercial API documentation, the final acceptance criteria should therefore be based on the applicable approved specification, validated analytical methods and regulatory requirements rather than research-grade vendor specifications.

Perifosine API for Pharmaceutical Research

Perifosine is particularly relevant to pharmaceutical research involving alkylphospholipids, cancer biology, cell signaling and investigational oncology compounds. Its well-defined chemical identity and established research history make it a useful compound for pharmaceutical development and analytical research.

For API listings, it is important to distinguish Perifosine (CAS 157716-52-4) from other alkylphospholipids such as miltefosine and edelfosine, which are chemically distinct compounds with different molecular structures and regulatory profiles.

Detailed Specifications

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%
Heavy Metals NMT 10 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.5%
Water Content NMT 1.0%
Melting Point 230–234°C
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