Betaine Hydrochloride
;)
Methanaminium,1-carboxy-N,N,N-trimethyl-,chloride.
Betaine hydrochloride.
(Carboxymethyl)trimethylammonium chloride [590-46-5].
»Betaine Hydrochloride contains not less than 98.0percent and not more than 100.5percent of C5H11NO2·HCl,calculated on the anhydrous basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Asolution (1in 20)responds to the tests for Chloride á191ñ.
pHá791ñ:
between 0.8and 1.2,in a solution (1in 4).
Water,Method Iá921ñ:
not more than 0.5%.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals á231ñ:
0.001%.
Assay—
Transfer about 400mg of Betaine Hydrochloride,accurately weighed,to a conical flask,add 50mLof glacial acetic acid,and heat gently with swirling until solution is complete.Add 25mLof mercuric acetate TS,cool,add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 15.36mg of C5H11NO2·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 241
Phone Number:1-301-816-8251