Mepyramine Tablets
Action and use
Histamine H1 receptor antagonist; antihistamine.
Definition
Mepyramine Tablets contain Mepyramine Maleate.
Content of mepyramine maleate, C17H23N3O,C4H4O4
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 in chloroform. Prepare the solutions immediately before use.
2 volumes of diethylamine and 100 volumes of ethyl acetate.
The test is not valid unless the Rf values of the principal spots in the chromatograms obtained with solutions (1) and (3) are at least 0.2 and unless the spot in the chromatogram obtained with solution (6) is clearly visible.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (5) (0.2%). Disregard the spot due to maleic acid on the line of application.
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 0.1 g of Mepyramine Maleate add 75 mL of water and 5 mL of 2m hydrochloric acid, shake vigorously for 15 minutes and dilute to 100 mL with water. Centrifuge and dilute 10 mL of the clear, supernatant liquid to 100 mL with water. To 10 mL of the resulting solution add 10 mL of 0.1m hydrochloric acid and dilute to 100 mL with water. Measure the absorbance of the resulting solution at the maximum at 316 nm, Appendix II B. Calculate the content of C17H23N3O,C4H4O4 in the tablets taking 206 as the value of A(1%, 1 cm) at the maximum at 316 nm.