Medicine quality assessment in Nepal using semi randomised sampling and evaluation of a small scale dissolution test and portable Raman spectrometers.

ABSTRACT: Substandard and falsified medicines threaten global health and require reliable data and screening technologies to combat their spread. This study examined the quality of 241 samples containing azithromycin, cefixime, esomeprazole and losartan collected from licenced private vendors in the Saptari (121 samples; convenience sampling) and Kathmandu (120 samples; randomised sampling) districts of Nepal. Nearly 10% (24 samples; 95% CI 6.5-14.5) of samples failed pharmacopoeial quality analysis and were classified as 'substandard' or 'probably substandard'. No falsified medicines were identified. Small-scale dissolution acceptance criteria were applied to all 20 three-unit combinations of 213 samples tested in the first stage of the United States Pharmacopoeia dissolution test. Approximately 1%

SUBMITTER: Schreiber R 

PROVIDER: S-EPMC12370887 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature