Pentazocine Hydrochloride
C19H27NO·HCl
321.88
321.882,6-Methano-3-benzazocin-8-ol, 1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-, hydrochloride, (2
,6,11R*)-.
(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 98.0 percent and not more than 102.0 percent of C19H27NO·HCl, calculated on the dried basis.
Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
Solution:
80 µg per mL of pentazocine.
Medium:
0.01 N hydrochloric acid.
Absorptivities at 278 nm, 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 50 mg of USP Pentazocine RS in 25 mL of 0.01 N hydrochloric acid in a separator, and use this in place of the Standard solution specified under Identification—Organic Nitrogenous Bases 
181
: Pentazocine Hydrochloride meets the requirements of the test.
181: Pentazocine Hydrochloride meets the requirements of the test.
C:
A solution (1 in 100) responds to the tests for Chloride 191.
191.
Loss on drying 731—
Dry it at a pressure not exceeding 5 mm of mercury at 100
to constant weight: it loses not more than 1.0% of its weight.
731—
Dry it at a pressure not exceeding 5 mm of mercury at 100 to constant weight: it loses not more than 1.0% of its weight.
Residue on ignition 281:
not more than 0.2%.
281:
not more than 0.2%.
Ordinary impurities 466—
466—
Test solution:
methanol.
Standard solution:
methanol, USP Pentazocine RS being used.
Eluant:
a mixture of chloroform, methanol, and isopropylamine (94:3:3).
Visualization—
Heat the plate in an oven at 105 for 15 minutes, cool, follow with visualization technique 17, and view under short-wavelength UV light.
for 15 minutes, cool, follow with visualization technique 17, and view under short-wavelength UV light.
Limits—
The total of any ordinary impurities observed does not exceed 1.0%.
Assay—
Dissolve about 650 mg of Pentazocine Hydrochloride, accurately weighed, in 50 mL of glacial acetic acid, and add 10 mL of mercuric acetate TS. Add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 32.19 mg of C19H27NO·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Clydewyn M. Anthony, Ph.D.
Scientist 1-301-816-8139 |
(MDCCA05) Monograph Development-Cough Cold and Analgesics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 3243