诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.18 3942634394048039429523941754394234639420330.03
210.133942373393981239410920.05
单位质量响应值RSD%判断
387233.10389051.530.34数据可信
供试品溶液-24022901批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13636338-363633883.98088.334.3883.9888.334.38
23765451-376545186.96286.96
34113865-411386595.00995.01
43705730-370573085.58385.58
53870041-387004189.37889.38
63857671-385767189.09289.09
10min14153506-415350695.92498.852.1496.0699.002.14
24319557-431955799.75999.90
34413266-4413266101.923102.08
44221368-422136897.49197.63
54250117-425011798.15598.30
64324531-432453199.874100.02
15min14260644-426064498.39999.651.2998.7099.961.29
24328870-432887099.974100.29
34407930-4407930101.800102.13
44302220-430222099.35999.66
54258835-425883598.35798.67
64330503-4330503100.012100.33
20min14268454-426845498.57999.641.2499.04100.121.24
24333623-4333623100.084100.56
34401650-4401650101.655102.15
44308903-430890399.51399.98
54251002-425100298.17698.65
64322399-432239999.825100.31
30min14261879-426187998.42799.621.2099.06100.271.20
24340969-4340969100.254100.90
34393787-4393787101.473102.14
44307129-430712999.472100.11
54256622-425662298.30698.95
64322095-432209599.818100.47
45min1-0.0000.00-0.790.812.14
2-0.0000.81
3-0.0000.84
4-0.0000.80
5-0.0000.80
6-0.0000.81
60min1-0.0000.00-0.790.812.14
2-0.0000.81
3-0.0000.84
4-0.0000.80
5-0.0000.80
6-0.0000.81
极限1-0.0000.00-0.790.812.14
2-0.0000.81
3-0.0000.84
4-0.0000.80
5-0.0000.80
6-0.0000.81
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.18 3934922393322939344613933847393104039335000.04
210.133922227392657339244000.08
单位质量响应值RSD%判断
386394.89387403.750.19数据可信
供试品溶液-24022901批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13685189-368518985.38280.985.4085.3880.985.40
23729074-372907486.39886.40
33344045-334404577.47877.48
43390612-339061278.55778.56
53270791-327079175.78075.78
63550408-355040882.25982.26
10min14141322-414132295.95092.145.2196.0992.275.21
24129584-412958495.67895.82
33892685-389268590.18990.32
43866333-386633389.57989.71
53653113-365311384.63884.76
64177055-417705596.77896.91
15min14182472-418247296.90396.411.4197.2196.701.41
24215171-421517197.66197.96
34086403-408640394.67794.96
44130899-413089995.70895.99
54118623-411862395.42495.69
64234342-423434298.10598.40
20min14206686-420668697.46497.061.1297.9397.511.13
24225573-422557397.90298.37
34140397-414039795.92896.37
44207783-420778397.49097.93
54120768-412076895.47395.90
64233166-423316698.07898.54
30min14194808-419480897.18997.401.2097.8298.011.21
24255311-425531198.59199.22
34165863-416586396.51897.12
44214252-421425297.63998.24
54132099-413209995.73696.32
64260191-426019198.70499.33
45min1-0.0000.00-0.790.772.41
2-0.0000.79
3-0.0000.76
4-0.0000.76
5-0.0000.75
6-0.0000.79
60min1-0.0000.00-0.790.772.41
2-0.0000.79
3-0.0000.76
4-0.0000.76
5-0.0000.75
6-0.0000.79
极限1-0.0000.00-0.790.772.41
2-0.0000.79
3-0.0000.76
4-0.0000.76
5-0.0000.75
6-0.0000.79
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.18 3933433393396039319263931892393319039328800.03
210.133922011392679739244040.09
单位质量响应值RSD%判断
386333.99387404.150.20数据可信
供试品溶液-24022901批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11105544-110554425.61624.893.8225.6224.893.82
21044396-104439624.19924.20
31027995-102799523.81923.82
41043598-104359824.18124.18
51129783-112978326.17826.18
61093210-109321025.33025.33
10min12271232-227123252.62651.201.8752.6751.241.86
22158249-215824950.00850.05
32223286-222328651.51551.55
42192853-219285350.81050.85
52233536-223353651.75351.80
62178410-217841050.47550.52
15min13092791-309279171.66269.971.8971.7970.101.88
23037823-303782370.38870.51
33063141-306314170.97571.10
42987332-298733269.21869.34
53004465-300446569.61569.75
62934299-293429967.99068.12
20min13616545-361654583.79882.301.6784.0582.551.67
23581756-358175682.99283.23
33591753-359175383.22383.47
43515394-351539481.45481.69
53552411-355241182.31282.56
63454787-345478780.05080.29
30min14066667-406666794.22793.681.0694.6294.061.05
24093748-409374894.85595.23
34064456-406445694.17694.56
44016848-401684893.07393.45
54041194-404119493.63794.02
63974136-397413692.08392.46
45min14183814-418381496.94297.321.0397.4997.851.03
24267918-426791898.89199.43
34234062-423406298.10698.65
44173200-417320096.69697.23
54190361-419036197.09397.63
64150182-415018296.16396.69
60min14188362-418836297.04797.371.2897.7698.071.28
24267100-426710098.87299.57
34255694-425569498.60799.31
44173486-417348696.70297.39
54207328-420732897.48798.19
64122649-412264995.52596.21
极限14138563-413856395.89397.321.3996.7698.181.39
24262859-426285998.77399.64
34272430-427243098.99599.86
44208579-420857997.51698.37
54175987-417598796.76097.62
64141582-414158295.96396.81
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