A xanthine derivative, acebrophylline is used as a bronchodilator for the treatment of bronchial asthma and chronic obstructive pulmonary disease in adults. Specifications:
Description:- White crystalline powder.
Appearance of the solution:- Should be clear
Colour of the solution:-Not more intensely coloured than reference solution Y6.
Melting point:- About 2I5 C.
Loss on drying :- Not more than 0.50% w/w.
pH:- Between 4.5 and 6.0.
Sulphated ash:- Not more than 0.10% w/w.
Heavy metals :- Not more than 20 ppm
Ethyl acetate:- Not more than 5000 ppm
Methanol:- Not more than 1000 ppm
Dimethyl formamide:- Not more than 800 ppm