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Home , Arachidyl alcohol, Cetyl alcohol, Fatty alcohol, Oleyl alcohol, Stearyl alcohol

Printed on: Wed Jan 06 2021, 04:38:44 AM Official Status: Currently Official on 06-Jan-2021 DocId: 1_GUID-42E1ACE0-CA6C-42E9-A6FE-7F1057F838A9_1_en-US (EST) Printed by: Jinjiang Yang Official Date: Official as of 01-Dec-2015 Document Type: NF @2021 USPC 1

Liner: Single taper, low pressure drop liner with Cetostearyl deactivated wool Run time: 15 min System suitability Samples: System suitability solution and Standard solution [NOTE—See Table 2 for the relative retention times.]

Cetylstearyl alcohol [67762-27-0]. Table 2 Relative DEFINITION Retention Cetostearyl Alcohol contains NLT 40.0% of Component Time (C H O), and the sum of the stearyl alcohol content and the 18 38 1-Pentadecanol (C16H34O) content is NLT 90.0% and NMT (internal standard) 1.00 102.0%. It is obtained from sources of vegetable, animal, or synthetic origin. Cetyl alcohol 1.09 IDENTIFICATION Stearyl alcohol 1.25 • A. CHROMATOGRAPHIC IDENTITY 1.28 Analysis: Proceed as directed in the Assay. Acceptance criteria: The retention times of the major peaks Suitability requirements of the Sample solution, excluding the and internal Resolution: NLT 30 between the cetyl alcohol and stearyl standard peaks, correspond to the cetyl alcohol and stearyl alcohol peaks; NLT 2.0 between the stearyl alcohol and alcohol peaks of the System suitability solution. oleyl alcohol peaks, System suitability solution ASSAY Tailing factor: 0.8–1.8 for the stearyl alcohol and • PROCEDURE 1-pentadecanol peaks, Standard solution Internal standard solution: 1 mg/mL of 1-pentadecanol Relative standard deviation: NMT 1%, using the area (internal standard) in ratio of stearyl alcohol to 1-pentadecanol, Standard System suitability solution: Prepare 1 mg/mL each of USP solution Cetyl Alcohol RS, USP Stearyl Alcohol RS, and USP Oleyl Analysis Alcohol RS in Internal standard solution. Heat the solution Samples: Standard solution and Sample solution in a sealed container in a 50° water bath until all fatty Calculate the percentages of cetyl alcohol (C16H34O) or are dissolved. Allow the solution to cool to room stearyl alcohol (C18H38O) in the portion of Cetostearyl temperature, and mix well. Alcohol taken: Standard solution: To match the cetyl alcohol and stearyl alcohol ratio in the test sample, prepare the sum of 2.0 mg/ Result = (RU/RS) × (CS/CU) × 100 mL of USP Cetyl Alcohol RS and USP Stearyl Alcohol RS in Internal standard solution. Heat the solution in a sealed RU = peak response ratio of cetyl alcohol (or stearyl container in a 50° water bath until cetyl alcohol and stearyl alcohol) to the internal standard [peak response alcohol are dissolved. Allow the solution to cool to room of cetyl alcohol (or stearyl alcohol)/peak response temperature, and mix well. of the internal standard] from the Sample solution Sample solution: Prepare 2.0 mg/mL of Cetostearyl RS = peak response ratio of cetyl alcohol (or stearyl Alcohol in Internal standard solution, and heat the solution alcohol) to the internal standard [peak response in a sealed container in a 50° water bath until cetostearyl of cetyl alcohol (or stearyl alcohol)/peak response alcohol is dissolved. Allow the solution toOfficial cool to room of the internal standard] from the Standard temperature, and mix well. solution Chromatographic system CS = concentration of USP Cetyl Alcohol RS (or USP (See Chromatography á621ñ, System Suitability.) Stearyl Alcohol RS) in the Standard solution (mg/ Mode: GC mL) Detector: Flame ionization CU = concentration of Cetostearyl Alcohol in the Column: 0.25-mm × 30-m fused-silica capillary; coated Sample solution (mg/mL) with a 0.25-µm layer of phase G7 Temperatures Acceptance criteria Detector: 280° Stearyl alcohol (C18H38O): NLT 40.0% Injection port: 270° Sum of stearyl alcohol (C18H38O) and cetyl alcohol Column: See Table 1. (C16H34O): 90.0%–102.0%

Table 1 IMPURITIES • RESIDUE ON IGNITION á281ñ: NMT 0.1%, determined on 2 g Hold Time at Fi- • LIMIT OF RELATED FATTY ALCOHOLS Initial Temperature Final nal Temperature Ramp Temperature Temperature Solution A: 1 mg/mL of 1-pentadecanol in ethanol (°) (°/min) (°) (min) Resolution solution: Prepare 1 mg/mL each of USP Lauryl Alcohol RS, USP Myristyl Alcohol RS, USP Cetyl Alcohol RS, 60 20 180 — USP Stearyl Alcohol RS, USP Oleyl Alcohol RS, USP Linolenyl 180 10 220 5 Alcohol RS, and USP RS in Solution A. Heat the solution in a sealed container in a 50° water bath until Carrier gas: all fatty alcohols are dissolved. Allow the solution to cool to Flow rate: 2.0 mL/min, constant flow mode room temperature, and mix well. Dilute the solution with Injection volume: 1 µL ethanol to obtain a solution containing 0.05 mg/mL each Injection type: Split injection; split ratio, is 100:1 of USP Lauryl Alcohol RS, USP Myristyl Alcohol RS, USP Cetyl Alcohol RS, 1-pentadecanol, USP Stearyl Alcohol RS, USP

https://online.uspnf.com/uspnf/document/1_GUID-42E1ACE0-CA6C-42E9-A6FE-7F1057F838A9_1_en-US 1/2 Printed on: Wed Jan 06 2021, 04:38:44 AM Official Status: Currently Official on 06-Jan-2021 DocId: 1_GUID-42E1ACE0-CA6C-42E9-A6FE-7F1057F838A9_1_en-US (EST) Printed by: Jinjiang Yang Official Date: Official as of 01-Dec-2015 Document Type: NF @2021 USPC 2

Oleyl Alcohol RS, USP Linolenyl Alcohol RS, and USP Calculate the percentage of each related or Arachidyl Alcohol RS. any unspecified impurity in the portion of Cetostearyl Sample solution: 1 mg/mL of Cetostearyl Alcohol in Alcohol taken: ethanol. Heat the solution in a sealed container in a 50° water bath until cetostearyl alcohol is dissolved. Allow the Result = (rU/rT) × 100 solution to cool to room temperature, and mix well. Chromatographic system: Proceed as directed in the rU = peak response of each related fatty alcohol (or any Assay, except for the split ratio. unspecified impurity) from the Sample solution Injection type: Split injection; split ratio is 5:1 rT = sum of all the peak responses excluding peak System suitability responses due to solvent from the Sample solution Sample: Resolution solution [NOTE—See Table 3 for the relative retention times.] Acceptance criteria: Disregard peaks that are less than 0.05% for any unspecified impurities, and any peaks due to Table 3 solvent. Sum of unspecified impurities: NMT 1% Relative Retention Sum of related fatty alcohols and unspecified impurities: Component Time NMT 10.0% Lauryl alcohol 0.79 SPECIFIC TESTS ATS AND IXED ILS á ñ Myristyl alcohol 0.93 • F F O , Acid Value 401 : NMT 2 • AND FIXED OILS, Hydroxyl Value á401ñ: 208–228 1-Pentadecanol 1.00 • FATS AND FIXED OILS, Iodine Value á401ñ: NMT 4 Cetyl alcohol 1.09 • WATER DETERMINATION, Method I á921ñ: NMT 0.5% Stearyl alcohol 1.25 ADDITIONAL REQUIREMENTS • PACKAGING AND STORAGE: Preserve in well-closed Oleyl alcohol 1.28 containers. Linolenyl alcohol 1.36 • LABELING: Label it to indicate whether it is derived from vegetable, animal, or synthetic sources. Arachidyl alcohol 1.44 • USP REFERENCE STANDARDS á11ñ USP Arachidyl Alcohol RS Suitability requirements USP Cetyl Alcohol RS Resolution: NLT 15 between the myristyl alcohol and USP Lauryl Alcohol RS 1-pentadecanol peaks; NLT 30 between the cetyl alcohol USP Linolenyl Alcohol RS and stearyl alcohol peaks; NLT 2.0 between the stearyl USP Myristyl Alcohol RS alcohol and oleyl alcohol peaks USP Oleyl Alcohol RS Analysis USP Stearyl Alcohol RS Samples: Resolution solution and Sample solution Identify each related fatty alcohol peak in the Sample solution based on that in the ResolutionOfficial solution.

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