Polyoxyl 40 Hydrogenated Castor Oil
(pol'' ee ox' il hye droj' en ay'' ted kas' tor oyl).
» Polyoxyl 40 Hydrogenated Castor Oil contains mainly the tri-hydroxystearate ester of ethoxylated glycerol, with smaller amounts of polyethylene glycol tri-hydroxystearate and of the corresponding free glycols. It results from the reaction of glycerol tri-hydroxystearate with about 40 to 45 moles of ethylene oxide.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Dissolve about 0.1 g in 1 mL of water, add 9 mL of sodium chloride solution (1 in 20), and heat in a water bath: the solution becomes turbid at a temperature between 70
and 85.
and 85.
B:
Dissolve about 0.1 g in 10 mL of alcoholic potassium hydroxide TS, boil for about 3 minutes, and evaporate to dryness. Mix the residue with 5 mL of water: it dissolves, yielding a clear solution. Add a few drops of glacial acetic acid: a white precipitate is formed.
Congealing temperature 
651
:
between 16 and 26.
651:
between 16 and 26.
Acid value 401:
not more than 2.0.
401:
not more than 2.0.
Hydroxyl value 401:
between 60 and 80.
401:
between 60 and 80.
Iodine value 401:
not more than 2.0.
401:
not more than 2.0.
Saponification value 401:
between 45 and 69.
401:
between 45 and 69.
Water, Method I 921:
not more than 3.0%.
921:
not more than 3.0%.
Residue on ignition 281:
not more than 0.3%.
281:
not more than 0.3%.
Heavy metals, Method II 231:
0.001%.
231:
0.001%.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1917