1(3H)-Isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl), [S-(R*,S*)]-.
» Noscapine contains not less than 99.0 percent and not more than 100.5 percent of C22H23NO7, calculated on the anhydrous basis.
Packaging and storage Preserve in well-closed containers.
A: Infrared Absorption 197KDo not dry specimens.
B: Ultraviolet Absorption 197U
Solution: 60 µg per mL.
C: Place about 100 mg in a small porcelain dish, add a few drops of sulfuric acid, and stir: a greenish yellow solution is produced, and on warming it becomes red and then turns violet.
Melting range 741: between 174 and 176.
Specific rotation 781S: between +42 and +48.
Test solution: 20 mg per mL, in 0.1 N hydrochloric acid.
Water, Method I 921: not more than 1.0%.
Residue on ignition 281: not more than 0.1%.
Chloride 221 A 700-mg portion shows no more chloride than corresponds to 0.20 mL of 0.020 N hydrochloric acid (0.02%).
Limit of morphine Dissolve 100 mg in 10 mL of 0.1 N hydrochloric acid. To 1.0 mL of this solution add 5.0 mL of diluted ferricyanide reagent (prepared by dissolving 0.50 g of potassium ferricyanide in 50 mL of water, adding 0.50 mL of ferric chloride TS, and diluting 5.0 mL of the resulting solution to 25.0 mL): no blue or dark green color develops within 1 minute.
Ordinary impurities 466
Test solution: chloroform.
Standard solution: chloroform.
Eluant: a mixture of ethyl acetate and ether (80:20).
Visualization: 17; then examine the plate immediately.
Limits The sum of the intensities of all secondary spots obtained from the Test solution corresponds to not more than 1.0%.
Assay Dissolve about 1.5 g of Noscapine, accurately weighed, in 25 mL of glacial acetic acid. Add 25 mL of dioxane and 5 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 41.34 mg of C22H23NO7.
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USP32NF27 Page 3120