Creatinine
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»Creatinine contains not less than 98.5percent and not more than 102.0percent of C4H7N3O,as Creatinine,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification,
Infrared Absorption á197Kñ.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 3.0%of its weight.
for 3hours:it loses not more than 3.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Heavy metals,Method Iá231ñ:
0.001%.
Assay—
Dissolve about 40mg of Creatinine,accurately weighed,in 10mLof glacial acetic acid,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically,using a glass indicator electrode and a silver-silver chloride reference electrode containing a saturated solution of lithium perchlorate and silver chloride in glacial acetic acid (see Titrimetry á541ñ).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 11.312mg of C4H7N3O.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2992
Phone Number:1-301-816-8262