Pentazocine Hydrochloride
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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, (2α,6α,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 CAS RN®: 64024-15- 3; UNII: A36BXO4PPX.
1 DEFINITION
Pentazocine Hydrochloride contains NLT 98.0% and NMT 102.0% of pentazocine hydrochloride (C19H27NO · HCl), calculated on the dried basis.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)
Sample solution: 80 µg/mL of pentazocine
Medium: 0.01 N hydrochloric acid
Analytical wavelength: 278 nm
Acceptance criteria: Absorptivities do not differ by more than 3.0%, calculated on the dried basis. [Note—The molecular weight of pentazocine (C19H27NO) is 285.43.]
B. Identification—Organic Nitrogenous Bases 〈181〉
Standard solution: 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.
Acceptance criteria: Meets the requirements
C. Identification Tests—General, Chloride〈191〉: A solution (1 in 100) meets the requirements.
3 ASSAY
Procedure
Sample solution: Dissolve 650 mg of Pentazocine Hydrochloride in 50 mL of glacial acetic acid.
Analysis: To the Sample solution add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid 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 pentazocine hydrochloride (C19H27NO · HCl).
Acceptance criteria: 98.0%–102.0% on the dried basis
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.2%
Ordinary Impurities 〈466〉
Standard solution: Methanol, USP Pentazocine RS being used
Test solution: Methanol
Eluant: Chloroform, methanol, and isopropylamine (94:3:3)
Visualization: Heat the plate in an oven at 105° for 15 min. Cool, follow with visualization technique 17, and view under short-wavelength UV light.
Acceptance criteria: The total of any ordinary impurities observed does not exceed 1.0%.
5 SPECIFIC TESTS
Loss on Drying 〈731〉
Analysis: Dry at a pressure not exceeding 5 mm of mercury at 100° to constant weight.
Acceptance criteria: NMT 1.0%
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant containers.
USP Reference Standards 〈11〉
USP Pentazocine RS
