Levorphanol Tartrate
If you find any inaccurate information, please let us know by providing your feedback here
Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
DOWNLOAD PDF HERE
Levorphanol Tartrate contains not less than 99.0 percent and not more than 101.0 percent of C17H23NO · C4H6O6, calculated on the anhydrous basis.
1 Packaging and storage
Preserve in well-closed containers. Store at 25°, excursions permitted between 15° and 30°.
USP Reference standards 〈11〉—
USP Levorphanol Tartrate RS
2 Identification
Change to read:
A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020) —Obtain the test specimen as follows. Dissolve 50mg in 25 mL of water in a 125-mL separator. Add 2 mL of 6 N ammonium hydroxide, extract with 25 mL of chloroform, and filter the chloroform extract through a layer of 4 g of granular anhydrous sodium sulfate supported on glass wool into a 125-mL conical flask.
Evaporate the chloroform extract on a steam bath with the aid of a stream of nitrogen to dryness. Dissolve the residue in 1 mL of acetone, and evaporate to dryness. Dry in vacuum at 90° for 1 hour. Proceed as directed with the dried levorphanol so obtained and a similar preparation of USP Levorphanol Tartrate RS.
Change to read:
B: Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)
Solution: 130 μg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 279 nm, calculated on the anhydrous basis, do not differ by more than 3.0%.
Specific rotation 〈781S〉: between −14.7° and −16.3°.
Test solution: 30 mg per mL, in water. Heat on a water bath or sonicate to dissolve 750 mg in 20 mL of water in a 25-mL volumetric flask, dilute with water to volume, and mix.
Water Determination, Method I 〈921〉 : between 7.0% and 9.0%.
Residue on ignition 〈281〉: not more than 0.1%.
Ordinary impurities 〈466〉—
Test solution: water.
Standard solution: water.
Eluant: a mixture of hexanes, dehydrated alcohol, and ammonium hydroxide (80:25:1).
Visualization: 17; then view immediately under short-wavelength UV light.
3 Assay
Dissolve about 900 mg of sample, accurately weighed, in 85 mL of glacial acetic acid, warming slightly if necessary. Titrate with 0.1 N perchloric acid VS and determine the endpoint potentiometrically. Perform a blank determination and make any nececssary corrections. Each mL of 0.1 N perchloric acid consumed by the sample is equivalent to 40.75 mg of C17H23NO · C4H6O6.
