C4H7N3O 113.12

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Creatinine RS.

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%.

Heavy metals, Method I 231: 0.001%.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3318

Phone Number : 1-301-816-8262