Azeotropic Isopropyl Alcohol
»Azeotropic Isopropyl Alcohol contains not less than 91.0percent and not more than 93.0percent of isopropyl alcohol,by volume,the remainder consisting of water.
Packaging and storage— Preserve in tight containers,remote from heat.
Identification— The IRabsorption spectrum of a thin film of it exhibits a strong broad band at 3.0µm;a strong region of absorption between 3.35µm and 3.5µm,with its highest peak at 3.36µm,and others at 3.41µm and 3.47µm;many weak peaks between 3.6µm and 6.0µm,among the most noticeable being those at 3.68µm,3.77µm,3.97µm,4.17µm,and 5.26µm;a broad band at about 6.2µm;a strong region of absorption between 6.7µm and 7.8µm,the most prominent features being the peaks at 6.80µm,7.09µm,7.25µm (the highest),7.46µm,and 7.63µm;a strong region of absorption between 8.5µm and 9.2µm,peaking at 8.6µm,8.85µm,and 9.0µm;and strong peaks at 10.5µm and at 12.3µm.
Specific gravity á841ñ: between 0.815and 0.810,indicating between 91.0%and 93.0%by volume of C3H8O.
Refractive index á831ñ: between 1.376and 1.378at 20.
Acidity— To 50mLin a suitable flask add 100mLof carbon dioxide-free water.Add 2drops of phenolphthalein TS,and titrate with 0.020Nsodium hydroxide to a pink color that persists for 30seconds:not more than 0.70mLof 0.020Nsodium hydroxide is required for neutralization.
Limit of nonvolatile residue— Evaporate 50mLof Isopropyl Alcohol in a tared porcelain dish on a steam bath to dryness,and heat at 105for 1hour:the weight of the residue does not exceed 2.5mg (0.005%).
Volatile impurities— Inject about 5µLinto a suitable gas chromatograph,equipped with a thermal conductivity detector.Under typical conditions,the gas chromatograph contains a 6.4-mm ×1.8-m stainless steel column packed with 10%liquid phase G20on support S1A,the column is maintained at 55,and helium is used as the carrier gas at a flow rate of 45mLper minute.Relative retention times of some of the possible components,when present,are:air at 0.09,diethyl ether at 0.14,diisopropyl ether at 0.17,acetone at 0.37,isopropyl alcohol at 1.00,2-butanol at 1.64,n-propyl alcohol at 1.86,and water at 3.14.Divide the area under the isopropyl alcohol peak by the sum of the areas under all of the peaks observed,excluding the water peak:the quotient is not less than 0.99.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1077
Phone Number:1-301-816-8394