Dextromoramide Tablets
Action and use
Opioid receptor agonist; analgesic.
Definition
Dextromoramide Tablets contain Dextromoramide Tartrate.
Content of dextromoramide, C25H32N2O2
90.0 to 110.0% of the stated amount.
Identification
TEST
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing the equivalent of 0.1 g of dextromoramide with 25 mL of 1m hydrochloric acid for 5 minutes. Add 25 mL of water, make alkaline with 5m sodium hydroxide and extract with four 25 mL quantities of chloroform. Wash the combined chloroform extracts with two 10-mL quantities of water and extract the combined washings with 10 mL of chloroform. Filter the combined chloroform extracts through absorbent cotton moistened with chloroform and wash the filter with a small quantity of chloroform. Heat on a water bath until the volume is reduced to about 25 mL, cool, add 50 mL of anhydrous acetic acid, previously neutralised to crystal violet solution, and titrate with 0.02m perchloric acid VS using crystal violet solution as indicator. Each mL of 0.02m perchloric acid VS is equivalent to 7.851 mg of C25H32N2O2.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of dextromoramide.