Miltefosine is an alkylphosphocholine pharmaceutical compound with antiprotozoal activity. It is primarily used as an oral treatment for leishmaniasis, including visceral, cutaneous, and mucosal forms caused by susceptible Leishmania species. It is also studied for other antimicrobial and antiparasitic applications.
Miltefosine is chemically classified as a phospholipid/phosphocholine derivative and is also known as hexadecylphosphocholine (HePC).
Miltefosine is a specialized antiprotozoal pharmaceutical API used in the development and manufacture of oral pharmaceutical formulations.
Important quality characteristics include assay, related substances, water content, residual solvents, elemental impurities, identification and physical characteristics, with acceptance criteria established according to the applicable pharmaceutical specification.
CAS Number: 58066-85-6
Molecular Formula: C21H46NO4P
Molecular Weight: 407.57 g/mol
IUPAC Name: Hexadecyl 2-(trimethylazaniumyl)ethyl phosphate
Synonyms: Hexadecylphosphocholine, n-Hexadecylphosphorylcholine, HePC, D-18506
Drug Class: Alkylphosphocholine
Therapeutic Class: Antiprotozoal
Therapeutic Area: Infectious Disease / Tropical Medicine
Molecule Type: Synthetic Phospholipid
Miltefosine is an alkylphospholipid that affects parasite membrane structure and cellular signaling. Its antileishmanial activity is associated with disruption of membrane lipid metabolism and other cellular processes, ultimately contributing to parasite death.
Miltefosine API is associated with:
Miltefosine is an FDA-approved oral treatment for specified forms of leishmaniasis.
Miltefosine is primarily formulated as oral capsules for pharmaceutical administration.
Miltefosine is a solid phospholipid compound. Published chemical references report a molecular weight of 407.57 g/mol. The reported melting behavior varies by source and analytical material; therefore, a supplier-specific melting specification should be based on the applicable validated method.
A controlled Miltefosine API manufacturing process may involve:
Typical Miltefosine API testing may include:
Store Miltefosine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Miltefosine is relevant to research involving:
Miltefosine is an alkylphosphocholine antiprotozoal compound with CAS Number 58066-85-6, molecular formula C21H46NO4P, and molecular weight 407.57 g/mol. It is primarily associated with oral treatment of specified forms of leishmaniasis.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | Conforms by IR / HPLC / LC-MS |
| Assay (HPLC) | 98.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 7.0% |
| Melting Point | 216°C (decomp.) |