Witepsol® H15 (NF) Pellet Form Suppository Base
Witepsol®H15 is an NF grade, small pastille form hard fat suppository base comprised of glycerides from vegetable origins with a long history of use with a wide range of APIs. Suitable for both rectal and vaginal use.
Solubility: Readily soluble in diethylether, toluene and n-hexane and slightly soluble in anhydrous ethanol and methylene chloride. Practically insoluble in water.
Has a hydroxyl value of 5-15. It is used as a compound for suspension suppositories having a proportion of solid active compounds of less than 25%.
Meets the requirements of USP-NF (Hard Fat) and Ph. Eur. (Hard Fat With Additives)
|
Test |
Specification |
|
Appearance |
Waxy Solid |
|
Odor |
Odorless |
|
Melting Range |
33.5 to 35.5°C (92.3 to 95.9°F) |
|
Hydroxyl Value (NV=25) |
5 to 15 mgKOH/g |
|
Acid Value |
<= 0.50 mgKOH/g |
|
Peroxide Value |
<= 3.0 meq O/Kg |
|
Saponification Value |
<= 230-245 mgKOH/g |
|
Density |
Average relative density at 20 °C = 0.96 g/cm3 |