Pentazocine Hydrochloride
C19H27NO·HCl
321.88
2,6-Methano-3-benzazocin-8-ol,1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-,hydrochloride,(2a,6a,11R*)-.
(2R*,6R*,11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride [64024-15-3].
»Pentazocine Hydrochloride contains not less than 98.0percent and not more than 102.0percent of C19H27NO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
Solution:
80µg per mLof pentazocine.
Medium:
0.01Nhydrochloric acid.
Absorptivities at 278nm,calculated on the dried basis,do not differ by more than 3.0%.[NOTE—The molecular weight of pentazocine (C19H27NO)is 285.43.]
B:
Dissolve 50mg of USP Pentazocine RSin 25mLof 0.01Nhydrochloric acid in a separator,and use this in place of the Standard solution specified under Identification—Organic Nitrogenous Bases á181ñ:Pentazocine Hydrochloride meets the requirements of the test.
C:
Asolution (1in 100)responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at a pressure not exceeding 5mm of mercury at 100
to constant weight:it loses not more than 1.0%of its weight.
to constant weight:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol,USP Pentazocine RSbeing used.
Eluant:
a mixture of chloroform,methanol,and isopropylamine (94:3:3).
Visualization—
Heat the plate in an oven at 105for 15minutes,cool,follow with visualization technique 17,and view under short-wavelength UVlight.
for 15minutes,cool,follow with visualization technique 17,and view under short-wavelength UVlight.
Limits—
The total of any ordinary impurities observed does not exceed 1.0%.
Assay—
Dissolve about 650mg of Pentazocine Hydrochloride,accurately weighed,in 50mLof glacial acetic acid,and add 10mLof mercuric acetate TS.Add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 32.19mg of C19H27NO·HCl.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1501
Phone Number:1-301-816-8143