Ascorbyl Palmitate
C22H38O7 414.53
l-Ascorbic acid, 6-hexadecanoate;
l-Ascorbic acid 6-palmitate
[137-66-6].
(as kore' bil pal' mi tate).
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C22H38O7 414.53
l-Ascorbic acid, 6-hexadecanoate;
l-Ascorbic acid 6-palmitate
[137-66-6].DEFINITION
Ascorbyl Palmitate contains NLT 95.0% and NMT 100.5% of C22H38O7, calculated on the dried basis.
IDENTIFICATION
• A. Procedure
Sample solution:
40 mg/mL in alcohol
Analysis:
To 25 mL of Sample solution add 1 mL of a 1-in-1000 solution of 2,6-dichlorophenol-indophenol sodium in alcohol.
Acceptance criteria:
The blue color of the 2,6-dichlorophenol-indophenol sodium solution is discharged immediately.
ASSAY
• Procedure
Sample solution:
Dissolve 300 mg of Ascorbyl Palmitate in 50 mL of alcohol, and add 30 mL of water.
Analysis:
Immediately titrate the Sample solution with 0.1 N iodine VS to a yellow color that persists for NLT 30 s. Each mL of 0.1 N iodine is equivalent to 20.73 mg of C22H38O7.
Acceptance criteria:
95.0%–100.5% on the dried basis
IMPURITIES
SPECIFIC TESTS
• Melting Range or Temperature 
741
:
107
–117
741:
107–117
• Loss on Drying 731:
Dry a sample in vacuum at 60 for 1 h: it loses NMT 2.0% of its weight.
731:
Dry a sample in vacuum at 60 for 1 h: it loses NMT 2.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, in a cool, dry place.
• USP Reference Standards 11
11
USP Ascorbyl Palmitate RS
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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1701
Pharmacopeial Forum: Volume No. 36(2) Page 447