影子
第3楼2019/09/05
下面是药典举的例子,大概的意思是原始数据保留位数比标准多一位,报告的数据与标准位数一致,此外,标准<1%时要求保留两位小数
Illustration of Rounding Numerical Values for Comparison with Requirements | |||
Compendial Requirement | Unrounded Value | Rounded Result | Conforms |
Assay limit NLT 98.0% | 97.96% | 98.0% | Yes |
97.92% | 97.9% | No | |
97.95% | 98.0% | Yes | |
Assay limit NMT 101.5% | 101.55% | 101.6% | No |
101.46% | 101.5% | Yes | |
101.45% | 101.5% | Yes | |
Limit test NMT 0.02% | 0.025% | 0.03% | No |
0.015% | 0.02% | Yes | |
0.027% | 0.03% | No | |
Limit test NMT 3 ppm | 3.5 ppm | 4 ppm | No |
3.4 ppm | 3 ppm | Yes | |
2.5 ppm | 3 ppm | Yes |