Podofilox, also known as Podophyllotoxin, is a naturally occurring lignan and antimitotic compound identified by CAS No. 518-28-5. It has the molecular formula C₂₂H₂₂O₈ and a molecular weight of 414.41 g/mol. FDA substance records identify PODOFILOX with CAS 518-28-5 and UNII L36H50F353.
Podofilox is used primarily as an active pharmaceutical ingredient for topical preparations. FDA labeling describes podofilox as an antimitotic drug used in topical treatment of external anogenital and perianal warts.
Podofilox is chemically identical to podophyllotoxin, a lignan obtained naturally from Podophyllum species or produced through chemical processes. It acts as an antimitotic compound and causes necrosis of treated wart tissue when applied topically.
The API is a stereochemically defined compound with the molecular formula C₂₂H₂₂O₈, molecular weight 414.41 g/mol, and CAS number 518-28-5.
| Parameter | Details |
|---|---|
| Product Name | Podofilox |
| Synonym | Podophyllotoxin |
| CAS Number | 518-28-5 |
| Molecular Formula | C₂₂H₂₂O₈ |
| Molecular Weight | 414.41 g/mol |
| FDA UNII | L36H50F353 |
| ChEBI | CHEBI:50305 |
| DrugBank | DB01179 |
| Physical Form | White to off-white powder/crystalline solid |
| Melting Point | 183–184°C |
| Solubility | Soluble in alcohol; sparingly soluble in water |
| Storage | 2–8°C recommended for reference/commercial material |
PubChem reports the molecular formula and molecular weight, while Sigma-Aldrich reports an assay of ≥98% and melting point of 183–184°C for its Podophyllotoxin material.
Podofilox is primarily associated with topical pharmaceutical formulations for external anogenital and perianal warts. FDA labeling describes the mechanism as antimitotic and states that treatment results in necrosis of visible wart tissue.
Commercial topical products have been formulated at 0.5% podofilox, including topical solutions and gels. FDA labeling specifies 5 mg of podofilox per mL for the 0.5% solution and 5 mg per gram for the 0.5% gel.
Podophyllotoxin is also an important chemical precursor for semisynthetic derivatives such as etoposide and teniposide.
Podofilox API can be characterized using chromatographic and spectroscopic analytical techniques appropriate for identity, assay, related substances, and stereochemical quality assessment.
Commercial analytical-grade specifications provide ≥98.0% HPLC assay for podophyllotoxin. Glentham Life Sciences also lists ≥98.0% HPLC assay for its Podophyllotoxin material. These values should be understood as commercial/reference-material specifications rather than a universal pharmacopoeial API limit.
Podofilox API is suitable for pharmaceutical development and manufacturing applications requiring controlled-quality podophyllotoxin. API documentation can include analytical testing information, batch-specific certificates, product specifications, safety documentation, and technical documentation as applicable.
Podofilox should be protected from excessive moisture, heat, and light. Commercial/reference materials are commonly stored under refrigerated conditions, with Sigma-Aldrich specifying 2–8°C.
Packaging should be selected according to the material's stability requirements and intended pharmaceutical application.
Typical technical documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 95.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Melting Point | 177–185°C |