Packaging and storage
Preserve in well-closed containers.
Identification
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.
Specific rotation 781S:
between +42
and +48
.
Test solution:
20 mg per mL, in 0.1 N hydrochloric acid.
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 C
22H
23NO
7.