Diethyl Sebacate

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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CH₃CH₂OOC(CH₂)₈COOCH₂CH₃

C14H2604 258.35 Decanedioic acid, 1,10-diethyl ester;

Diethyl 1,10-decanedioate CAS RN^®: 110-40-7.

1 DEFINITION

Diethyl Sebacate consists of the diester of alcohol (Ethanol) and sebacic acid. It contains NLT 98.0% and NMT 102.0% of diethyl sebacate (C₁₄H₂₆O₄).

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197FA (CN 1-MAY-2020)

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

3 ASSAY

3.1 PROCEDURE

Internal standard solution: 0.9 mg/mL of methyl heptadecanoate in n-heptane

Standard solution: 1.0 mg/mL of USP Diethyl Sebacate RS in the Internal standard solution

Sample solution: 1.0 mg/mL of Diethyl Sebacate in the Internal standard solution

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: GC

Detector: Flame ionization

Column: 0.53-mm x 30-m fused silica capillary; 1.5-µm layer of phase G1

Temperatures

Injection port: 300°

Detector: 300°

Column: See Table 1.

Table 1

Carrier gas: Helium

Linear velocity: 50 cm/s

Injection volume: 1 µL

Injection type: Split injection; split ratio, 3:1

3.3 System suitability

Sample: Standard solution

[NOTE-The relative retention times for diethyl sebacate and methyl heptadecanoate are 1.0 and 1.2, respectively.]

Suitability requirements

Resolution: NLT 2.0 between diethyl sebacate and methyl heptadecanoate

Relative standard deviation: NMT 2.0%, ratio of the peak response of diethyl sebacate to that of methyl heptadecanoate

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of diethyl sebacate (C₁₄H₂₆O₄) in the portion of Diethyl Sebacate taken:

Result = (R_U/R_S) x (C_S/C_U) x 100

R_U = peak response ratio of diethyl sebacate to methyl heptadecanoate from the Sample solution

R_S = peak response ratio of diethyl sebacate to methyl heptadecanoate from the Standard solution

C_S = concentration of USP Diethyl Sebacate RS in the Standard solution (mg/mL)

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

Acceptance criteria: 98.0%-102.0%

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.10%

5 SPECIFIC TESTS

5.1 SPECIFIC GRAVITY (841)

0.958-0.968 at 20°

5.2 REFRACTIVE INDEX (831)

1.435-1.437 at 20°

5.3 FATS AND FIXED OILS (401), Procedures, Acid Value

NMT 0.5

5.4 FATS AND FIXED OILS (401), Procedures, s (401), Procedures, lodine Value

NMT 0.5

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE

Preserve in tight containers, and store in a cool, dry, and well-ventilated place.

6.2 USP REFERENCE STANDARDS (11)

USP Diethyl Sebacate RS