Papaverine Hydrochloride
;)
Isoquinoline,1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-,hydrochloride.
6,7-Dimethoxy-1-veratrylisoquinoline hydrochloride [61-25-6].
»Papaverine Hydrochloride contains not less than 98.5percent and not more than 100.5percent of C20H21NO4·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Completeness of solution—
A1in 15solution in chloroform is clear and free from undissolved solid.
Identification—
B:Ultraviolet Absorption á197Uñ—
Solution:
2.5µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 251nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Asolution (1in 50)responds to the tests for Chloride á191ñ.
pHá791ñ:
between 3.0and 4.5,in a solution (1in 50).
Loss on drying á731ñ—
Dry it at 105for 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 0.1%.
Limit of cryptopine,thebaine,or other organic impurities—
Dissolve 50mg in 2mLof sulfuric acid in a small test tube:the resulting solution is not more yellow-brown in color than Matching Fluid S(see Readily Carbonizable Substances Test á271ñ),and it is not more pink than a standard prepared,in equal volume,by diluting 3.0mLof 0.1Npotassium permanganate with water to 1000mL.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay—
Dissolve about 700mg of Papaverine Hydrochloride,accurately weighed,in 80mLof glacial acetic acid;add 10mLof mercuric acetate TSand 1drop of crystal violet TS;and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 37.59mg of C20H21NO4·HCl.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1466
Pharmacopeial Forum:Volume No.29(5)Page 1551
Phone Number:1-301-816-8305