Packaging and storage—
Preserve in well-closed, light-resistant containers. Store at 25
, excursions permitted between 15
and 30
.
Loss on drying 
731
—
Dry it in vacuum at 60
for 2 hours: it loses not more than 0.5% of its weight.
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).
Visualization:
3.
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.
Auxiliary Information—
Staff Liaison :
Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 894
Pharmacopeial Forum : Volume No. 29(6) Page 1885
Phone Number : 1-301-816-8139
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