培哚普利叔丁胺项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.244454664451754456794449624449314452430.08
210.184438474462304450380.38
单位质量响应值RSD%判断
43480.7643716.900.39数据可信
供试品溶液-2023091111批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min188861-8886145.76742.647.3645.7742.647.36
278276-7827640.31540.32
381407-8140741.92841.93
491692-9169247.22547.23
579864-7986441.13341.13
676606-7660639.45539.46
10min1190802-19080298.27194.873.1298.3594.943.12
2185768-18576895.67895.75
3189113-18911397.40197.47
4184235-18423594.88894.97
5175575-17557590.42890.50
6179729-17972992.56892.63
15min1194856-194856100.35997.951.91100.6098.181.91
2189702-18970297.70497.93
3193572-19357299.69799.93
4190047-19004797.88298.12
5184998-18499895.28195.50
6187929-18792996.79197.01
20min1194812-194812100.33697.931.67100.7498.321.67
2190555-19055598.14498.53
3192206-19220698.99499.39
4188640-18864097.15797.56
5185671-18567195.62896.01
6188964-18896497.32497.71
30min1197605-197605101.77598.461.82102.3599.011.82
2189362-18936297.52998.08
3191887-19188798.83099.39
4190225-19022597.97498.54
5187544-18754496.59397.13
6190373-19037398.05098.59
培哚普利叔丁胺项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.244456194464024462124459724460744460560.07
210.184433684436714435200.05
单位质量响应值RSD%判断
43560.1643567.780.02数据可信
供试品溶液-2023091111批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194985-9498548.96049.9313.4748.9649.9313.47
2118843-11884361.25761.26
387137-8713744.91544.91
482942-8294242.75242.75
592746-9274647.80647.81
6104510-10451053.87053.87
10min1186522-18652296.14396.361.0796.2296.441.07
2187456-18745696.62496.73
3186528-18652896.14696.22
4186554-18655496.15996.23
5184252-18425294.97295.05
6190357-19035798.11998.21
15min1191140-19114098.52398.451.2698.7698.691.26
2189896-18989697.88298.14
3190159-19015998.01798.25
4192843-19284399.40199.63
5187532-18753296.66396.90
6194400-194400100.203100.46
20min1191273-19127398.59198.461.4399.0098.871.43
2190712-19071298.30298.73
3189579-18957997.71898.12
4192239-19223999.08999.49
5187042-18704296.41196.81
6195221-195221100.626101.05
30min1190706-19070698.29998.741.2298.8799.311.22
2191545-19154598.73299.32
3190185-19018598.03198.59
4193095-19309599.531100.09
5188576-18857697.20197.76
6195217-195217100.624101.21
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