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C4H7N3O 113.12
» Creatinine contains not less than 98.5 percent and not more than 102.0 percent of C4H7N3O, as Creatinine, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification, Infrared Absorption 197K.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 3.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Assay— Dissolve about 40 mg of Creatinine, accurately weighed, in 10 mL of glacial acetic acid, and titrate with 0.1 N perchloric 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 541). Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 11.312 mg of C4H7N3O.
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Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, B.A.
(EM105) Excipient Monographs 1
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1218