(fen' ta nil sit' rate).
Propanamide, N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1).
N-(1-Phenethyl-4-piperidyl)propionanilide citrate (1:1) [990-73-8].
» Fentanyl Citrate contains not less than 98.0 percent and not more than 102.0 percent of C22H28N2O·C6H8O7, calculated on the dried basis.
Packaging and storage Preserve in well-closed, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 500 µg per mL.
Medium: dilute hydrochloric acid in methanol (1 in 10).
Loss on drying 731 Dry it in vacuum at 60 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.5%.
Heavy metals, Method II 231: 0.002%.
Ordinary impurities 466
Test solution: a mixture of chloroform and methanol (4:1).
Standard solution: a mixture of chloroform and methanol (4:1) except to eliminate the 0.01 mg per mL solution and add a 0.02 mg per mL solution.
Procedure Use a thin-layer chromatographic plate coated with chromatographic silica gel with a calcium sulfate binder.
Eluant: a mixture of chloroform, methanol, and formic acid (85:10:5).
Assay Dissolve about 500 mg of Fentanyl Citrate, accurately weighed, in 30 mL of glacial acetic acid. Add 3 drops of p-naphtholbenzein TS, and titrate with 0.05 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.05 N perchloric acid is equivalent to 26.43 mg of C22H28N2O·C6H8O7.
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USP35NF30 Page 3169Pharmacopeial Forum: Volume No. 29(6) Page 1885