Mechlorethamine Hydrochloride
;)
Ethanamine,2-chloro-N-(2-chloroethyl)-N-methyl-,hydrochloride.
2,2¢-Dichloro-N-methyldiethylamine hydrochloride [55-86-7].
»Mechlorethamine Hydrochloride contains not less than 97.5percent and not more than 100.5percent of C5H11Cl2N·HCl,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Labeling—
The label bears a warning that great care should be taken to prevent inhaling particles of Mechlorethamine Hydrochloride and exposing the skin to it.
Identification—
A:Infrared Absorption á197Kñ.
B:
Transfer 100mg to a test tube containing 1mLof sodium thiosulfate solution (prepared by dissolving 1g of sodium thiosulfate and 100mg of sodium carbonate in 40mLof water),shake,allow to stand for 2hours,then add 1drop of iodine TS:the color of free iodine remains.
and 111
pHá791ñ:
between 3.0and 5.0,in a solution (1in 500).
Water,Method Iá921ñ:
not more than 0.4%.
Ionic chloride content—
Dissolve about 30mg,accurately weighed,in 30mLof water contained in a beaker.Add 5mLof nitric acid and stir.Titrate with 0.02Nsilver nitrate VSto a potentiometric endpoint,using a silver combination electrode.Perform a blank determination (see Titrimetry á541ñ),and make any necessary correction.Each mLof 0.02Nsilver nitrate is equivalent to 0.709mg of ionic chloride:not less than 18.0%and not more than 19.3%of ionic chloride is found.
Assay—
Transfer about 100mg of Mechlorethamine Hydrochloride,accurately weighed,to a 125-mLconical flask.Add 100mg of sodium bicarbonate and 20.0mLof 0.1Nsodium thiosulfate VS.Allow to stand for 2½hours,add 3mLof starch TS,and titrate the excess sodium thiosulfate with 0.1Niodine VS.Each mLof 0.1Nsodium thiosulfate is equivalent to 9.626mg of C5H11Cl2N·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1192
Pharmacopeial Forum:Volume No.29(3)Page 636
Phone Number:1-301-816-8389