Fentanyl Citrate
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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 98.0percent and not more than 102.0percent of C22H28N2O·C6H8O7,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:Infrared Absorption á197Kñ.
B:Ultraviolet Absorption á197Uñ—
Solution:
500µg per mL.
Medium:
dilute hydrochloric acid in methanol (1in 10).
Loss on drying á731ñ—
Dry it in vacuum at 60for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.5%.
Heavy metals,Method IIá231ñ:
0.002%.
Ordinary impurities á466ñ—
Test solution:
a mixture of chloroform and methanol (4:1).
Standard solution:
a mixture of chloroform and methanol (4:1)except to eliminate the 0.01mg per mLsolution and add a 0.02mg per mLsolution.
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).
Visualization:
3.
Assay—
Dissolve about 500mg of Fentanyl Citrate,accurately weighed,in 30mLof glacial acetic acid.Add 3drops of p-naphtholbenzein TS,and titrate with 0.05Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.05Nperchloric acid is equivalent to 26.43mg of C22H28N2O·C6H8O7.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 814
Pharmacopeial Forum:Volume No.29(6)Page 1885
Phone Number:1-301-816-8139