Choline Theophyllinate Tablets
Action and use
Non-selective phosphodiesterase inhibitor (xanthine); treatment of reversible airways obstruction.
Definition
Choline Theophyllinate Tablets contain Choline Theophyllinate. They are coated.
Content of choline theophyllinate, C12H21N5O3
95.0 to 105.0% of the stated amount.
Identification
Tests
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
5 volumes of ethanol (96%) and 95 volumes of chloroform.
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. To a quantity of the powder containing 0.1 g of Choline Theophyllinate add 500 mL of water shake vigorously for 2 minutes, dilute to 1000 mL with water, mix and filter. To 10 mL of the filtrate add 10 mL of 0.1m sodium hydroxide and dilute to 100 mL with water. Measure the absorbance of the resulting solution at the maximum at 275 nm, Appendix II B. Calculate the content of C12H21N5O3 taking 415 as the value of A(1%, 1 cm) at the maximum at 275 nm.
Storage
Choline Theophyllinate Tablets should be protected from light.