Ascorbyl Palmitate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₂₂H₃₈0₇    414.53

L-Ascorbic acid, 6-hexadecanoate;

L-Ascorbic acid 6-palmitate CAS RN^®: 137-66-6.

1 DEFINITION

Ascorbyl Palmitate contains NLT 95.0% and NMT 100.5% of ascorbyl palmitate (C₂₂H₃₈O₇), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

2.1 A. ASPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN 1-MAY-2020)

2.2 B. CHROMATOGRAPHIC IDENTITY

Analysis: Proceed as directed in the Assay.

Acceptance criteria: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.

3 ASSAY

3.1 PROCEDURE

Mobile phase: Acetonitrile, methanol, 0.01 M perchloric acid (10:65:25)

Standard solution: 0.5 mg/mL of USP Ascorbyl Palmitate RS in methanol

Sample solution: 0.5 mg/mL of Ascorbyl Palmitate in methanol

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 245 nm

Column: 4.6-mm x 15-cm; 5-µm packing L7

Temperatures

Column: 25°

Autosampler: 5°

[NOTE-If an autosampler is not used, keep the Standard solution and Sample solution at 5° before injection.]

Flow rate: 1.0 mL/min

Injection volume: 10 µL

Run time: 15 min

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 1.0%

Tailing factor: 0.8-2.0

Analysis

Samples: Standard solution and Sample solution

Calculate, on the dried basis, the percentage of Ascorbyl Palmitate taken:

Result = [(r_U/r_S) x (C_S/C_U)] × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Ascorbyl Palmitate RS in the Standard solution (mg/mL)

C_U = concentration of Ascorbyl Palmitate in the Sample solution (mg/mL)

Acceptance criteria: 95.0%-100.5% on the dried basis

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.1%

5 SPECIFIC TESTS

OPTICAL ROTATION, Specific Rotation (781S): +21° to +24°

Sample solution: 100 mg/mL in methanol

LOSS ON DRYING (731).

Analysis: Dry a sample in vacuum at 60° for 1 h.

Acceptance criteria: NMT 2.0%

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers, and store in a cool, dry place.

USP REFERENCE STANDARDS (11)

USP Ascorbyl Palmitate RS