Dimethyl Isosorbide
C8H14O4
174.20
d-Glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-;
1,4:3,6-Dianhydro-2,5-di-O-methyl-d-glucitol [5306-85-4]
d-Glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-;
1,4:3,6-Dianhydro-2,5-di-O-methyl-d-glucitol [5306-85-4]
BRIEFING
Dimethyl Isosorbide. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. The gas chromatographic procedure in the Assay and test for Organic Impurities is based on analyses performed with the Agilent DB-WAX brand of column with G16 phase. The typical retention times for dimethyl isoidide, dimethyl isosorbide, dimethyl isomannide, and monomethyl isosorbide impurity are about 7.5, 9.1, 10.4, and 11.0 min, respectively.
(SE: S. Saladi)
Correspondence Number—C260587