Specifications are set to ± 5.0 per cent around target for both drug substances at release and minus 7.5 to plus 5.0 per cent around target at end of shelf-life for drug substances to take into account a slight degradation over storage.
考虑到贮存期间含量会有轻微下降，为保证有效期内主药含量在92.5-105%，两主药含量内控放行标准均为标示量的95-105%。
考虑到贮存期间含量会有轻微下降，两物质的放行标准应为95-105%,而近有效期时标准应为92.5-105%.