Hydromorphone Hydrochloride
;)
Morphinan-6-one,4,5-epoxy-3-hydroxy-17-methyl-,hydrochloride,(5a)-.
4,5a-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride [71-68-1].
»Hydromorphone Hydrochloride,dried at 105
for 2hours,contains not less than 98.0percent and not more than 101.0percent of C17H19NO3·HCl.
for 2hours,contains not less than 98.0percent and not more than 101.0percent of C17H19NO3·HCl.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at 25,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
B:Ultraviolet Absorption á197Uñ—
Solution:
100µg per mL.
Medium:
water.
Absorptivities at 280nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Asolution (1in 20)responds to the tests for Chloride á191ñ.
Specific rotation á781Sñ:
between -136and -139.
and -139.
Test solution:
50mg per mL,in water.
Acidity—
Dissolve 300mg in 10mLof water,add 1drop of methyl red TS,and titrate with 0.020Nsodium hydroxide VS:not more than 0.30mLis required to produce a yellow color.
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 1.5%of its weight.
for 2hours:it loses not more than 1.5%of its weight.
Residue on ignition á281ñ:
not more than 0.3%.
Sulfate—
To a solution of 100mg in 5mLof water add 0.5mLof 3Nhydrochloric acid and 1mLof barium chloride TS:no turbidity is produced.
Ordinary impurities á466ñ—
Test solution:
water.
Standard solution:
water.
Eluant:
a mixture of methylene chloride,methanol,and ammonium hydroxide (80:20:1).
Visualization:
3,followed by overspraying with hydrogen peroxide TSand exposure of the plate to iodine vapors for about 30minutes.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 225mg of Hydromorphone Hydrochloride,previously dried and accurately weighed,to a 250-mLconical flask,and dissolve in 80mLof glacial acetic acid,warming,if necessary.Cool,and add 5mLof acetic anhydride and 10mLof mercuric acetate TS.Add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 32.18mg of C17H19NO3·HCl.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 972
Pharmacopeial Forum:Volume No.30(4)Page 1254
Phone Number:1-301-816-8139