Quality of Aminophylline Injections
  • 1.04.2019
  • 1,105
Quality of Aminophylline Injections
Owner / Producer Owner / Producer
Natcha Chaysinsorn, Wipapan Saiyasombat, Sumana Sirisoonthorn, Nonthawat Phosua, Wathunya Hawhan
Year Year

Aminophylline is listed in class A of the National List of Essential Medicines 2018. Aminophylline is a Xanthine derivative which is utilized as bronchodilator. In the fiscal year 2018, aminophylline injections were chosen to study for the quality. A total of 11 samples were collected from public hospitals and manufacturer (2 registration numbers). The samples were evaluated according to the United States Pharmacopoeia specification (USP 40) for assay, pH, content of Ethylenediamine, organic impurities, particulate matter, sterility and bacterial endotoxins.The result showed that 5 samples were complied with the pharmacopoeial specifications. Meanwhile, 6 fail to meet the requirement in content of Ethylenediamine and pH (4 samples for content of Ethylenediamine and pH and 2 samples for content of Ethylenediamine). The information obtained will be useful for supporting the drug procurement in hospitals.
Key words : Aminophylline, Ethylenediamine