Packaging and storage
Preserve in well-filled,tight,glass containers.
Identification
To 2mLof cupric sulfate solution (1in 100)add 3drops of a solution of Ethylenediamine (1in 6),and shake:a purplish blue color is produced.
Heavy metals,Method Iá231ñ
Evaporate 5.0mLon a steam bath to dryness,add to the residue 1mLof hydrochloric acid and 0.5mLof nitric acid,and evaporate again to dryness.Dissolve the residue in 20mLof warm water,cool,dilute with water to 100mL,mix,and use 20mLof this solution for the test:the limit is 0.002%.
Assay
Weigh accurately about 1mLof Ethylenediamine in a tared,glass-stoppered flask containing about 25mLof water.Dilute with water to about 75mL,add a mixed indicator of bromocresol green TSand methyl red TS(5in 6),mix,and titrate with 1Nhydrochloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 1Nhydrochloric acid is equivalent to 30.05mg of C2H8N2.
Auxiliary Information
Staff Liaison:
Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28NF23Page 796
Pharmacopeial Forum:Volume No.28(6)Page 1789
Phone Number:1-301-816-8251