Enzacamene

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

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

DOWNLOAD PDF HERE

Bicyclo[2.2.1]heptan-2-one, 1,7,7-trimethyl-3-[(4-methylphenyl)methylene]-;

(±)-3-(p-Methylbenzylidene)camphor;

4-Methylbenzylidene camphor;

1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one CAS RN®: 36861-47-9; UNII: 8I3XWY40L9.

1 DEFINITION

Enzacamene contains NLT 98.0% and NMT 102.0% of enzacamene (C₁₈H₂₂O), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscop) 197A or (USP 1-Dec-2022) 197K

B. SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 197U

Sample solution: 10 µg/mL in methanol

Acceptance criteria: Meets the requirements

3 ASSAY

Change to read:

PROCEDURE

Standard solution: 250 µg/ml. each of Camphor and USP Enzacamene Enzacamene RS (USP 1-Dec-2022) in methylene chloride (USP 1-Dec-2022)

Sample solution: 250 µg/ml, of Enzacamene in methylene chloride (USP 1-Dec-2022)

Chromatographic system

(See Chromatography (621), System Suitability)

Mode: GC

Detector: Flame ionization

Column: 0.32-mm × 30-m fused-silica capillary; coated with a 0.25-μm layer of phase G1

Temperatures

Injection port: 295°

Detector: 305°

Column: See Table 1. The column temperature is maintained at 300" until the end of the procedure.

Carrier gas: Helium

Flow rate: 1.2 ml/min

Injection volume: 1μL

System suitability

Bample: Standard solution

Suitability requirements

Tailing factor: NMT 10 for encacamene

Relative standard deviation: NMT 2.0% for tamete

Analysis

Samples: Standee solution and Sample solution

Calculate the percentage of eczacamene (C₁₈H₂₂O) in the portion of Exzacamere taken

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

r_U = peak response of enzacamene from the sample solution

r_S = peak response of enzacamene from the Standard solution

C_S = concentration of USP Escocamins RS the Standardson solution (mg/ml)

C_U = concentration of ncacamene in as the 2022) the Sample solution (mg/m)

Acceptance criteria: 98.0%-102.01% on the dined basis

4 IMPURITIES

Change to read:

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

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Enzacamene taken

Result = (r_U/(r_S) x 100

r_U = peak response of each impurity from the sample solution

r_S = peak response of enzacamene from the Standard solution

Acceptance criteria: See Table 2

^a (1R,4R)-1,7,7-Trimethylbicyclo[2.2.1]heptan-2-one.

5 SPECIFIC TESTS

Loss on Drying (731)

Analysis: Dry under vacuum at 50° to constant weight.

Acceptance criteria: NMT 0.2%

6 ADDITIONAL REQUIREMENTS

PARAD Sto: Preserve in tight containers.