A xanthine derivative, acebrophylline is used as a bronchodilator for the treatment of bronchial asthma and chronic obstructive pulmonary disease in adults. Specifications:
1. Description:- White crystalline powder.
2. Appearance of the solution:- Should be clear
3. Colour of the solution:-Not more intensely coloured than reference solution Y6.
4. Melting point:- About 2I5 C.
5. Loss on drying :- Not more than 0.50% w/w.
6. pH:- Between 4.5 and 6.0.
7. Sulphated ash:- Not more than 0.10% w/w.
8. Heavy metals :- Not more than 20 ppm
9. Ethyl acetate:- Not more than 5000 ppm
10.Methanol:- Not more than 1000 ppm
11. Dimethyl formamide:- Not more than 800 ppm
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Europe: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, etc.
OCEANIA: Australia, New Zealand, Fiji, etc.
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