Ascorbyl Palmitate
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L-Ascorbic acid,6-hexadecanoate.
L-Ascorbic acid 6-palmitate [137-66-6].
»Ascorbyl Palmitate contains not less than 95.0percent and not more than 100.5percent of C22H38O7,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers,in a cool,dry place.
Identification—
Dissolve 1g in 25mLof alcohol,and add 1mLof a 1in 1000solution of 2,6-dichlorophenol-indophenol sodium in alcohol:the blue color of the 2,6-dichlorophenol-indophenol sodium solution is discharged immediately.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 1hour:it loses not more than 2.0%of its weight.
for 1hour:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay—
Dissolve about 300mg of Ascorbyl Palmitate,accurately weighed,in 50mLof alcohol,add 30mLof water,and immediately titrate with 0.1Niodine VSto a yellow color that persists for not less than 30seconds.Each mLof 0.1Niodine is equivalent to 20.73mg of C22H38O7.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2959
Phone Number:1-301-816-8143