Noscapine

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₂₂H₂₃NO₇           413.42

1(3H)-Isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetra hydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl), [S-(R*,S*)]-;

Narcotine CAS RN: 128-62-1; UNII: 8V32U4AOQU.

1 DEFINITION

Noscapine contains NLT 99.0% and NMT 100.5% of noscapine (C₂₂H₂₃NO₇), calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K. _{(CN 1-May-2020)} Do not dry specimens.

Change to read:

B. SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 1974 _{(CN 1-MAY-2020)}

Solution: 60 µg/mL

Medium: Methanol

Acceptance criteria: Meets the requirements

C.

Analysis: Place about 100 mg in a small porcelain dish, add a few drops of sulfuric acid, and stir.

Acceptance criteria: A greenish yellow solution is produced, and on warming it becomes red and then turns violet.

3 ASSAY

PROCEDURE

Sample solution: Dissolve about 1.5 g of Noscapine in 25 mL of glacial acetic acid.

Analysis: Add 25 mL of dioxane and 5 drops of crystal violet TS to the Sample solution, 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 noscapine (C₂₂H₂₃NO₇).

Acceptance criteria: 99.0%-100.5% on the anhydrous basis

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.1%

CHLORIDE AND SULFATE, Chloride (221): A 700-mg portion shows no more chloride than corresponds to 0.20 mL of 0.020 N hydrochloric acid (0.02%).

4.1 LIMIT OF MORPHINE

Sample solution: Dissolve 100 mg in 10 mL of 0.1 N hydrochloric acid.

Analysis: To 1.0 mL of the Sample 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).

Acceptance criteria: No blue or dark green color develops within 1 min.

4.2 ORDINARY IMPURITIES (466).

Standard solution: Chloroform

Test solution: Chloroform

Eluant: Ethyl acetate and ether (80:20)

Visualization: 17; then examine the plate immediately.

Acceptance criteria: The sum of the intensities of all secondary spots of the Test solution corresponds to NMT 1.0%.

5 SPECIFIC TESTS

Melting Range or Temperature 〈741〉: 174°–176°

Optical Rotation, Specific Rotation〈781S〉

Sample solution: 20 mg/mL in 0.1 N hydrochloric acid

Acceptance criteria: +42° to +48°

Water Determination, Method I〈921〉: NMT 1.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Noscapine RS