INTRODUCTION
Podophyllotoxin is a non-alkaloid toxin lignan extracted from the roots and rhizomes of Podophyllum species. It is an organic heterotetracyclic compound that has a Furonaphthodioxole skeleton bearing a 3,4,5-trimethoxyphenyl substituent.
Manufacture
The two step manufacturing process involves extraction of crude Podophyllotoxin from harvested root of Podophyllum E.modi using suitable solvent followed by crystallization and oven drying.
| Synonym | 1,3,3a,4,9,9a-Hexahydro-9-hydroxy-6,7-(methylenedioxy)-4-(3′,4′,5′- trimethoxyphenyl)benz[f]isobenzofuran-3-one |
| Plant Source | Podophyllum E. Modi |
| Part of Plant | Root |
| CAS no. | 518-28-5 |
| EINECS no. | 208-250-4 |
| Molecular formula | C22H22O8 |
| Molecular weight | 414.41 |
| Structure |  |
Applications
| APIs |
|---|
| Podophyllotoxin is classified as ATC class: D06BB04 drug and is listed in WHO’s list of Essential Medicines |
| Antineoplastic and antiviral activities are the most pronounced pharmacological effects of Podophyllotoxin. It is a cytotoxic agent that binds to DNA and inhibits protein synthesis |
| Podophyllotoxin has also been shown to have anti-cancer effects in leukemia and other cancers, as well as being a potential anticancer drug for acute leukemia. It has been shown to induce oxidative stress and cell death in cancer cells |
| It is used for the topical treatment of genital warts in children and dermatological conditions caused by Psoriasis vulgaris as well as Molluscum contagisum infections |
| It may also be used as a therapeutic agent to treat genital tumors, Wilms tumors, lung cancer, and lymphomas |
SPECIFICATIONS
| Test | Unit | Specification |
|---|---|---|
| Appearance | Visual | White to off-white powder; no visible evidence of contamination |
| Identification by IR | – | To conform to structure |
| Melting point | °C | 175.0 – 185.0 |
| Assay by HPLC | % | Min 90.0 |
| Heavy Metals | ppm | Max 20.0 |
| % Volatiles by LOD (2 hours, 105°C under vacuum ) | % | Max 3.0 |
| Chromatographic Purity by HPLC | ||
| 4’-Demethylpodophyllotoxin | % | Max 8.0 |
| Specified impurity @ RRT 0.80 | % | Max 0.5 |
| Specified impurity @ RRT 1.34 | % | Max 1.0 |
| Specified impurity @ RRT 2.4 | % | Max 0.5 |
| Picropodophyllin | % | Max 0.5 |
| Individual unknown impurities | % | Max 0.5 |
STORAGE
Stored at 2 °C – 8°C
PACKING
15 kg UN approved cartons
REACH Status
Not registered
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