C
17H
23NO·C
4H
6O
6·2H
2O
443.49
Morphinan-3-ol, 17-methyl-, [
R-(
R*,
R*)]-2,3-dihydroxybutanedioate (1:1) (salt), dihydrate.
17-Methylmorphinan-3-ol, tartrate (1:1) (salt) dihydrate
[
5985-38-6].
Anhydrous
407.47
[
125-72-4].
Packaging and storage—
Preserve in well-closed containers. Store at 25
, excursions permitted between 15
and 30
.
Identification—
A: Infrared Absorption 
197K
—
Obtain the test specimen as follows. Dissolve 50 mg 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.
B: Ultraviolet Absorption 197U—
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.
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.
Assay—
Transfer about 250 mg of Levorphanol Tartrate, accurately weighed, to a 250-mL flask, add 25 mL of dehydrated alcohol, and warm slightly to dissolve. Add 100 mL of chloroform, then add 4 drops of methanolic methyl red TS, and titrate with 0.02 N perchloric acid in dioxane VS to a red endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.02 N perchloric acid is equivalent to 8.149 mg of C17H23NO·C4H6O6.
Auxiliary Information—
Staff Liaison :
Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1247
Pharmacopeial Forum : Volume No. 29(6) Page 1916
Phone Number : 1-301-816-8139
;)