Packaging and storage
Preserve in well-filled, tight, glass containers.
Identification
To 2 mL of cupric sulfate solution (1 in 100) add 3 drops of a solution of Ethylenediamine (1 in 6), and shake: a purplish blue color is produced.
Heavy metals, Method I 231
Evaporate 5.0 mL on a steam bath to dryness, add to the residue 1 mL of hydrochloric acid and 0.5 mL of nitric acid, and evaporate again to dryness. Dissolve the residue in 20 mL of warm water, cool, dilute with water to 100 mL, mix, and use 20 mL of this solution for the test: the limit is 0.002%.
Assay
Weigh accurately about 1 mL of Ethylenediamine in a tared, glass-stoppered flask containing about 25 mL of water. Dilute with water to about 75 mL, add a mixed indicator of
bromocresol green TS and methyl red TS (5 in 6), mix, and titrate with 1 N hydrochloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 1 N hydrochloric acid is equivalent to 30.05 mg of C
2H
8N
2.
Auxiliary Information
Staff Liaison :
Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29NF24 Page 870
Pharmacopeial Forum : Volume No. 28(6) Page 1789
Phone Number : 1-301-816-8251