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Dibutyl Sebacate
»Dibutyl Sebacate consists of esters of n-butyl alcohol and saturated dibasic acids,principally sebacic acid.It contains not less than 92.0percent of C18H34O4.
Packaging and storage
Preserve in tight containers.
Specific gravity á841ñ:
between 0.935and 0.939at 20
Refractive index á831ñ:
between 1.429and 1.441.
Acid value á401ñ:
not more than 0.1.
Saponification value á401ñ:
between 352and 357.
Assay
System suitability solution
Add 0.2g of methyl heptadecanoate to 0.3g of Dibutyl Sebacate,and mix to dissolve.
Chromatographic system
(see Chromatography á621ñ)The gas chromatograph is equipped with a flame-ionization detector and a 2-mm ×1.8-m column packed with 10%liquid phase G41on 100-to 120-mesh support S1A.The carrier gas is helium,flowing at a rate of about 30mLper minute.The chromatograph is programmed as follows.Initially,the column temperature is maintained at 150
Procedure
Inject about 1.0µLof Dibutyl Sebacate into the chromatograph,record the chromatogram,and measure the peak responses.Calculate the percentage of C18H34O4in the portion of Dibutyl Sebacate taken by the formula:
100A/B,
in which Ais the peak response for dibutyl sebacate;and Bis the sum of the responses of all the peaks.
Auxiliary Information
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28NF23Page 2997
Phone Number:1-301-816-8143
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