Background: The use of substandard and degraded medicines is a major public health problem in developing\r\ncountries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillinââ?¬â??clavulanic\r\nacid preparations under tropical conditions in a developing country.\r\nMethods: Amoxicillin-clavulanic acid tablets were obtained from outlets in Cambodia. Packaging condition, printed\r\ninformation, and other sources of information were examined. The samples were tested for quantity, content\r\nuniformity, and dissolution. Authenticity was verified with manufacturers and regulatory authorities.\r\nResults: A total of 59 samples were collected from 48 medicine outlets. Most (93.2%) of the samples were of\r\nforeign origin. Using predetermined acceptance criteria, 12 samples (20.3%) were non-compliant. Eight (13.6%),\r\n10 (16.9%), and 20 (33.9%) samples failed quantity, content uniformity, and dissolution tests, respectively.\r\nSamples that violated our observational acceptance criteria were significantly more likely to fail the quality tests\r\n(Fisherââ?¬â?¢s exact test, p < 0.05).\r\nConclusions: Improper packaging and storage conditions may reduce the quality of amoxicillinââ?¬â??clavulanic acid\r\npreparations at community pharmacies. Strict quality control measures are urgently needed to maintain the\r\nquality of amoxicillinââ?¬â??clavulanic acid in tropical countries.
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