Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

Table 3 Test Results by API in Medicine

Active Pharmaceutical Ingredientq	Failures
Amodiaquine	1/49 (2.0%)
Artemether¹	2/10 (20.0%)
Artemether and Lumefantrine¹	10/209 (4.8%)
Artesunate¹	10/89 (11.2%)
Chloroquine	66/447 (14.8%)
Dihydroartemisinin³	0/1 (0%)
Dihydroartemisinin-Piperaquine- Trimethoprim²	0/11 (0%)
Doxycycline^{1, 2}	2/60 (3.3%)
Mefloquine	16/99 (16.2%)
Primaquine	55/455 (12.1%)
Quinine	22/130 (16.9%)
Sulfadoxine-Pyrimethamine	14/67 (20.9%)
Tetracycline	0/6 (0%)

¹ Artemisinin derivatives containing medicines and doxycycline samples failed only V&P Inspection.
² For medicines containing doxycycline, in Brazil, and dihydroartemisinin or piperaquine, in Suriname, there was no validated TLC method available at the time; therefore, only disintegration was assessed. Subsets of doxycycline samples sent to the reference laboratory in Brazil passed validated tests for identification and content.

ISSN: 1475-2875