Octocrylene

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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C₂₄H₂₇NO₂ 361.48

2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2-ethylhexyl ester;

2-Ethylhexyl 2-cyano-3,3-diphenylacrylate

CAS RN^®: 6197-30-4; UNII: 5A68WGF6WM

1 DEFINITION

Octocrylene contains NLT 95.0% and NMT 105.0% of octocrylene (C₂₄H₂₇NO₂).

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U

Sample solution: 25 µg/mL in methanol

Analytical wavelength: 303 nm

Acceptance criteria: Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%. (ERR 1-Sep-2023)

B. The retention time of major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Standard solution: 21 mg/mL of USP Octocrylene RS in acetone

Sample solution: 21 mg/mL of Octocrylene in acetone

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: GC

Detector: Flame ionization

Column: 0.32-mm × 60-m; coated with a 0.25-µm film of phase G1

Temperatures

Injection port: 300°

Detector: 300°

Column: See Table 1.

Table 1

Carrier gas: Helium

Flow rate: 6 mL/min

Injection volume: 1 µL

Injection type: Split ratio, 30:1

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 1.0 between octocrylene and any other adjacent peak

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of octocrylene (C₂₄H₂₇NO₂) in the portion of Octocrylene taken:

Result = (r_U/r_S) × (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 Octocrylene RS in the Standard solution (mg/mL)

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

Acceptance criteria: 95.0%–105.0%

4 IMPURITIES

4.1 Organic Impurities

Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Octocrylene taken:

Result = (r_U/r_T) × 100

r_U = peak response of each impurity from the Sample solution

r_T = sum of all the peak responses from the Sample solution

Acceptance criteria

Individual impurities: NMT 0.5%

Total impurities: NMT 2.0%

5 SPECIFIC TESTS

Specific Gravity 〈841〉: 1.045–1.055

Refractive Index 〈831〉: 1.561–1.571 at 20°

Acidity

Sample: 6 g of Octocrylene

Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 0.1 N sodium hydroxide

Endpoint detection: Visual

Analysis: To 60 mL of alcohol add 1 mL of phenolphthalein TS and sufficient Titrant to obtain a persistent pink color. Transfer 60 mL of this solution to a suitable container, add the Sample, mix, and titrate with Titrant until a persistent pink color is obtained.

Acceptance criteria: NMT 0.18 mL of Titrant/g is required

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Octocrylene RS