Isopropyl Rubbing Alcohol
»Isopropyl Rubbing Alcohol contains not less than 68.0percent and not more than 72.0percent of isopropyl alcohol,by volume,the remainder consisting of water,with or without suitable stabilizers,perfume oils,and color additives certified by the FDAfor use in drugs.
Packaging and storage— Preserve in tight containers,remote from heat.
Labeling— Label it to indicate that it is flammable.
Specific gravity á841ñ: between 0.872and 0.883at 20.
Acidity— Transfer 50mLto a suitable flask,and add about 75mLof carbon dioxide-free water.Titrate potentiometrically to a pHof 8.5:not more than 1.0mLof 0.020Nsodium hydroxide is required for neutralization.
Limit of nonvolatile residue— Evaporate 50mLto dryness in a tared porcelain dish on a steam bath,and dry at 105for 1hour:the weight of the residue does not exceed 5mg (0.01%).
Assay— Transfer 50.0mLof Isopropyl Rubbing Alcohol to a 250-mLdistilling flask,and add 100mLof water.Arrange the flask for distillation,distil,and collect 95mLof distillate in a 100-mLvolumetric flask.Dilute to volume with water,mix,and determine the specific gravity of the distillate at 25(see Specific Gravity á841ñ).The specific gravity is between 0.955and 0.950,corresponding to between 68.0%and 72.0%of isopropyl alcohol in the specimen taken.
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