Diluted Acetic Acid
»Diluted Acetic Acid is a solution containing,in each 100mL,not less than 5.7g and not more than 6.3g of acetic acid (C2H4O2).Prepare Diluted Acetic Acid as follows (see Pharmaceutical Compounding—Nonsterile Preparations á795ñ):
Acetic Acid 158mL
Purified Water,a sufficient quantity
to make
Mix the ingredients.
Packaging and storage— Preserve in tight containers.
Identification— It meets the requirements of the tests for Acetate á191ñ.
Heavy metals,Method Iá231ñ Evaporate 5mLin a porcelain dish on a steam bath to dryness.Warm the residue with 2mLof 1Nacetic acid,and dilute with water to 50mL.Dilute 20mLof this solution with water to 25mL:not more than 0.001%is found.
Readily oxidizable substances— To 20mLin a glass-stoppered flask add 0.30mLof 0.10Npotassium permanganate:the pink color is not changed to brown immediately,and the liquid does not become entirely brown or free from a pink tint in less than 30seconds.
Limit of nonvolatile residue— Evaporate 20mLin a tared porcelain dish on a steam bath,and dry it at 105for 1hour:the weight of the residue does not exceed 1.0mg.Not more than 0.005%is found.
Limit of chloride— Add 5drops of silver nitrate TSto 10mLof a solution (6in 10):no opalescence is found.
Limit of sulfate— Add 5drops of barium chloride TSto 10mLof a solution (6in 10):no turbidity is produced.
Assay— Transfer 25.0mLof Diluted Acetic Acid to a flask,and add 15mLof carbon dioxide–free water.Add phenolphthalein TS,and titrate with 1Nsodium hydroxide VS.Each mLof 1Nsodium hydroxide is equivalent to 60.05mg of C2H4O2.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 2949
Pharmacopeial Forum:Volume No.27(4)Page 2788
Phone Number:1-301-816-8389