Papaverine Hydrochloride
(pa pav' er een hye'' droe klor' ide).
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375.85Isoquinoline, 1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-, hydrochloride.
6,7-Dimethoxy-1-veratrylisoquinoline hydrochloride
[61-25-6].» Papaverine Hydrochloride contains not less than 98.5 percent and not more than 100.5 percent of C20H21NO4·HCl, calculated on the dried basis.
Packaging and storage—
Preserve in tight, light-resistant containers. Store at 25
, excursions permitted between 15 and 30.
, excursions permitted between 15 and 30.
USP Reference standards 
11
—
11—
USP Papaverine Hydrochloride RS 
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Completeness of solution—
A 1 in 15 solution in chloroform is clear and free from undissolved solid.
Identification—
B:
Ultraviolet Absorption 197U—
197U—
Solution:
2.5 µg per mL.
Medium:
0.1 N hydrochloric acid.
Absorptivities at 251 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
A solution (1 in 50) responds to the tests for Chloride 191.
191.
pH 791:
between 3.0 and 4.5, in a solution (1 in 50).
791:
between 3.0 and 4.5, in a solution (1 in 50).
Loss on drying 731—
Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
731—
Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281:
not more than 0.1%.
281:
not more than 0.1%.
Limit of cryptopine, thebaine, or other organic impurities—
Dissolve 50 mg in 2 mL of 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 271), and it is not more pink than a standard prepared, in equal volume, by diluting 3.0 mL of 0.1 N potassium permanganate with water to 1000 mL.
271), and it is not more pink than a standard prepared, in equal volume, by diluting 3.0 mL of 0.1 N potassium permanganate with water to 1000 mL.
Assay—
Dissolve about 700 mg of Papaverine Hydrochloride, accurately weighed, in 80 mL of glacial acetic acid; add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS; and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 37.59 mg of C20H21NO4·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4216
Pharmacopeial Forum: Volume No. 29(5) Page 1551