非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.321945161945771946501943951946821945640.06
211.321961931960611961270.05
单位质量响应值RSD%判断
17187.6317325.710.57数据可信
供试品溶液-BXK34K1批-pH4.5(内含0.1%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191731-9173147.84245.187.4447.8445.187.43
287619-8761945.69745.70
375117-7511739.17739.18
483382-8338243.48843.49
590847-9084747.38147.38
691035-9103547.47947.48
10min1175371-17537191.46489.416.1291.5489.486.12
2178089-17808992.88292.96
3153362-15336279.98580.05
4166089-16608986.62386.70
5182976-18297695.43095.51
6172667-17266790.05490.13
15min1186238-18623897.13295.222.1097.3695.452.11
2182493-18249395.17895.41
3175501-17550191.53291.73
4183204-18320495.54995.77
5185636-18563696.81897.06
6182378-18237895.11895.35
20min1187418-18741897.74796.001.2598.1496.391.25
2183055-18305595.47295.86
3181110-18111094.45794.81
4185264-18526496.62497.00
5185141-18514196.56096.96
6182473-18247395.16895.56
30min1187377-18737797.72696.081.0898.2896.621.08
2182672-18267295.27295.82
3183344-18334495.62296.13
4185174-18517496.57797.11
5184835-18483596.40096.96
6181935-18193594.88795.43
45min1186942-18694297.49995.831.0698.2296.531.06
2182050-18205094.94795.65
3183291-18329195.59596.26
4184583-18458396.26896.97
5183986-18398695.95796.68
6181602-18160294.71495.42
60min1186188-18618897.10695.391.1997.9996.251.19
2181446-18144694.63295.50
3183143-18314395.51796.34
4184004-18400495.96796.83
5182742-18274295.30896.19
6179829-17982993.78994.65
极限1185681-18568196.84195.371.1297.8996.391.12
2181075-18107594.43995.46
3183351-18335195.62696.61
4183906-18390695.91596.93
5183172-18317295.53396.57
6179995-17999593.87694.89
非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.321948981955031954251953901952811952990.13
211.321951931953151952540.05
单位质量响应值RSD%判断
17252.5617248.590.02数据可信
供试品溶液-BXK3152批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180486-8048641.99143.0814.7541.9943.0814.74
273221-7322138.20138.20
387740-8774045.77645.78
474955-7495539.10639.11
574235-7423538.73038.73
6104815-10481554.68454.68
10min1178790-17879093.27992.452.4693.3592.522.47
2172345-17234589.91689.98
3180733-18073394.29294.37
4178099-17809992.91892.98
5171368-17136889.40689.47
6181834-18183494.86794.96
15min1184699-18469996.36195.891.0796.5996.121.08
2180865-18086594.36194.57
3184010-18401096.00296.24
4185295-18529596.67296.89
5182014-18201494.96195.17
6185899-18589996.98897.24
20min1185322-18532296.68796.150.9497.0796.530.94
2181064-18106494.46594.84
3183973-18397395.98396.38
4185827-18582796.95097.33
5184328-18432896.16896.54
6185193-18519396.61997.03
30min1185284-18528496.66796.290.8997.2196.830.89
2181356-18135694.61795.15
3184430-18443096.22196.77
4185717-18571796.89397.44
5184923-18492396.47897.01
6185617-18561796.84097.41
45min1184181-18418196.09195.971.0396.8096.681.03
2180567-18056794.20694.89
3183668-18366895.82496.54
4185457-18545796.75797.46
5183929-18392995.96096.65
6185907-18590796.99297.73
60min1184441-18444196.22795.810.9197.1096.680.92
2180347-18034794.09194.93
3183903-18390395.94696.82
4184407-18440796.20997.07
5183819-18381995.90296.76
6184935-18493596.48597.38
极限1183596-18359695.78695.520.8396.8196.550.84
2180322-18032294.07895.08
3182667-18266795.30196.33
4183617-18361795.79796.82
5183564-18356495.76996.78
6184796-18479696.41297.47
非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.323878033877433871233876053870623874670.10
211.323902293906643904460.08
单位质量响应值RSD%判断
34228.5334491.700.55数据可信
供试品溶液-BXK0LE1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123574-12357432.36831.537.8532.3731.537.85
2125135-12513532.77732.78
3126272-12627233.07533.08
4125115-12511532.77232.77
5101523-10152326.59226.59
6120641-12064131.60031.60
10min1294183-29418377.05775.112.3477.1175.162.34
2282957-28295774.11674.17
3294037-29403777.01977.07
4276744-27674472.48972.54
5286686-28668675.09375.14
6285814-28581474.86574.92
15min1341107-34110789.34892.364.0889.5392.544.07
2334846-33484687.70887.89
3349785-34978591.62191.80
4351865-35186592.16692.34
5373367-37336797.79897.97
6364715-36471595.53295.71
20min1363801-36380195.29297.051.3295.6297.381.32
2367292-36729296.20796.53
3369999-36999996.91697.25
4372797-37279797.64997.98
5378089-37808999.03599.37
6371175-37117597.22497.56
30min1372029-37202997.44898.050.9197.9498.540.90
2373770-37377097.90498.39
3373525-37352597.83998.34
4375134-37513498.26198.75
5380532-38053299.675100.17
6370898-37089897.15197.65
45min1373068-37306897.72098.100.6798.3798.760.67
2373707-37370797.88798.53
3374316-37431698.04798.71
4374762-37476298.16398.82
5379224-37922499.332100.00
6372148-37214897.47998.14
60min1372623-37262397.60397.980.8398.4298.800.83
2372112-37211297.46998.28
3373802-37380297.91298.74
4374918-37491898.20499.02
5379776-37977699.477100.31
6371111-37111197.20798.03
极限1371320-37132097.26297.670.8198.2498.660.81
2371823-37182397.39498.37
3371610-37161097.33898.33
4373527-37352797.84098.82
5378673-37867399.188100.18
6370390-37039097.01898.00
非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.323858293855983854303851783851663854400.08
211.323900843901843901340.02
单位质量响应值RSD%判断
34049.4734464.130.86数据可信
供试品溶液-BXK0LE1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156009-15600940.98834.9412.3240.9934.9412.33
2136204-13620435.78535.79
3144541-14454137.97537.98
4131574-13157434.56934.57
5115497-11549730.34530.34
6114009-11400929.95429.95
10min1334650-33465087.92380.609.7187.9980.669.71
2315362-31536282.85582.92
3326503-32650385.78385.85
4298382-29838278.39478.45
5251422-25142266.05666.11
6314414-31441482.60682.66
15min1371381-37138197.57393.646.0997.7993.846.10
2367149-36714996.46196.66
3371769-37176997.67597.88
4348015-34801591.43491.62
5315865-31586582.98883.15
6364342-36434295.72495.91
20min1374545-37454598.40596.991.8098.7897.341.82
2368909-36890996.92497.28
3377894-37789499.28599.65
4365816-36581696.11196.45
5358961-35896194.31094.61
6368794-36879496.89497.24
30min1373969-37396998.25397.771.0298.7998.281.04
2370604-37060497.36997.89
3379018-37901899.580100.11
4369136-36913696.98497.48
5369542-36954297.09097.55
6370455-37045597.33097.84
45min1374777-37477798.46697.711.0799.1798.381.08
2369516-36951697.08397.77
3378555-37855599.458100.16
4369811-36981197.16197.82
5370431-37043197.32497.94
6368278-36827896.75897.43
60min1373795-37379598.20897.660.8799.0898.500.88
2369588-36958897.10297.95
3377181-37718199.09799.96
4369838-36983897.16897.99
5371096-37109697.49898.28
6368771-36877196.88897.72
极限1374238-37423898.32497.400.9699.3698.400.97
2367894-36789496.65797.66
3376176-37617698.83399.86
4368323-36832396.77097.76
5369106-36910696.97697.92
6368598-36859896.84297.84
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