Ethyl Butyrate

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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C₆H₁₂O₂  116.16 

Ethyl butyrate CAS RN®: 105-54-4. 

1 DEFINITION 

Ethyl Butyrate contains NLT 98.0% of ethyl butyrate (C₆H₁₂O₂). 

2 IDENTIFICATION 

Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A 

Chromatographic Identity 

System suitability solution, Sample solution, and 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 System suitability solution. 

3 ASSAY 

Procedure 

System suitability solution: Mix quantities of USP Ethyl Acetate RS and USP Ethyl Butyrate RS to obtain a solution containing about 5% ethyl acetate and 95% ethyl butyrate. 

Sample solution: Ethyl Butyrate (neat) 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: GC 

Detector: Flame ionization 

Column: 0.53-mm × 30-m capillary column; bonded with a 3.0-μm layer of phase G43 

Temperatures 

Injection port: 225° 

Detector: 250° 

Column: See Table 1. 

Table 1 

Carrier gas: Helium 

Flow rate: 1 mL/min 

Injection volume: 0.2 µL 

Injection type: Splitless 

[Note—A needle wash with the Sample solution is recommended to minimize the carry-over.] System suitability 

Sample: System suitability solution 

[Note—The relative retention times for ethyl acetate and ethyl butyrate are 0.7 and 1.0, respectively.] Suitability requirements 

Tailing factor: NMT 1.8 for the ethyl acetate and ethyl butyrate peaks 

Relative standard deviation: NMT 2.5%, using the area ratio of ethyl butyrate to ethyl acetate Analysis 

Sample: Sample solution 

Calculate the percentage of ethyl butyrate in the portion of sample taken: 

Result = (r_U/r_T) × F 

r_U = peak response of ethyl butyrate from the Sample solution

r_T = sum of relevant peak responses from the Sample solution

Acceptance criteria: NLT 98.0% 

4 SPECIFIC TESTS 

Fats and Fixed Oils 〈401〉, Procedures, Acid Value, Method I 

Analysis: Dissolve about 10 g of Ethyl Butyrate, accurately weighed, in 50 mL of alcohol. 

Acceptance criteria: NMT 1.0 

Refractive Index 〈831〉: 1.391–1.394 at 20° Specific Gravity 〈841〉: 0.870–0.877 at 25° 

5 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight containers, and avoid exposure to excessive heat. 

USP Reference Standards 〈11〉 

USP Ethyl Acetate RS 

USP Ethyl Butyrate RS