USP Monographs: Pentazocine

Pentazocine

C19H27NO

285.43

2,6-Methano-3-benzazocin-8-ol, 1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-, (2

,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

[359-83-1].

» Pentazocine contains not less than 98.0 percent and not more than 101.5 percent of C19H27NO, calculated on the dried basis.

Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards

— USP Pentazocine RS.

Identification—

A: Infrared Absorption

197K

B: Ultraviolet Absorption

197U

—

Solution: 80 µg per mL.

Medium: 0.01 N hydrochloric acid.

Absorptivities at 278 nm, calculated on the dried basis, do not differ by more than 3.0%.

Melting range

741

: between 147

and 158

, with slight darkening.

Loss on drying

731

— Dry it at a pressure not exceeding 5 mm of mercury at 60

to constant weight: it loses not more than 1.0% of its weight.

Residue on ignition

281

: not more than 0.2%.

Ordinary impurities

466

—

Test solution: methanol.

Standard solution: methanol.

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.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Dissolve about 500 mg of Pentazocine, accurately weighed, in 50 mL of glacial acetic acid, 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 28.54 mg of C19H27NO.

Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist

Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 1672

Phone Number : 1-301-816-8139


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