枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.189368819365109365519363519361639364910.03
217.069364969360889362920.04
单位质量响应值RSD%判断
54510.5454882.300.49数据可信
每杯投2片--供试品溶液-2024051711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%
5min1560008-56000851.84349.795.0051.8449.795.00
2535000-53500049.52849.53
3559041-55904151.75351.75
4492295-49229545.57445.57
5523636-52363648.47648.48
6557276-55727651.59051.59
10min1562686-56268652.09150.374.3452.1850.464.34
2541574-54157450.13650.22
3556287-55628751.49851.58
4499537-49953746.24546.32
5543299-54329950.29650.38
6561470-56147051.97852.06
15min1555348-55534851.41149.674.1151.5849.844.11
2532919-53291949.33549.50
3547505-54750550.68550.86
4495635-49563545.88346.04
5535132-53513249.54049.70
6552852-55285251.18051.35
20min1548092-54809250.74049.253.8951.0049.503.90
2529019-52901948.97449.22
3541219-54121950.10350.36
4493055-49305545.64545.87
5532465-53246549.29349.54
6548462-54846250.77451.03
30min1539193-53919349.91648.393.7250.2648.733.72
2519423-51942348.08648.42
3530392-53039249.10149.44
4487427-48742745.12445.43
5520309-52030948.16848.50
6539710-53971049.96450.31
45min1528939-52893948.96747.463.6049.3947.873.60
2507801-50780147.01047.42
3518015-51801547.95548.38
4478989-47898944.34244.72
5513639-51363947.55047.96
6528296-52829648.90749.33
极限1499438-49943846.23544.943.3046.7445.433.30
2482762-48276244.69245.18
3492482-49248245.59246.09
4455756-45575642.19242.65
5484666-48466644.86845.36
6497422-49742246.04946.56
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.189364359346299370469363679362419361440.10
217.069367479362369364920.04
单位质量响应值RSD%判断
54490.3454894.020.53数据可信
每杯投2片--供试品溶液-2024051712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%
5min1530479-53047949.11352.486.1549.1152.486.16
2588998-58899854.53154.53
3550033-55003350.92350.92
4528549-52854948.93448.93
5594133-59413355.00655.01
6608858-60885856.36956.37
10min1581092-58109253.79953.354.3153.8853.444.31
2583641-58364154.03554.13
3550360-55036050.95451.04
4542074-54207450.18650.27
5596369-59636955.21355.30
6603850-60385055.90656.00
15min1573873-57387353.13052.683.7853.3052.863.78
2571650-57165052.92553.11
3552576-55257651.15951.33
4535751-53575149.60149.77
5588707-58870754.50454.69
6591587-59158754.77154.96
20min1569829-56982952.75652.243.5353.0252.503.54
2573456-57345653.09253.36
3547931-54793150.72950.98
4532116-53211649.26549.51
5578868-57886853.59353.87
6583016-58301653.97754.26
30min1558760-55876051.73151.143.7352.0851.493.72
2558315-55831551.69052.05
3534079-53407949.44649.79
4520803-52080348.21748.55
5571932-57193252.95153.31
6570327-57032752.80253.17
45min1544251-54425150.38848.804.8550.8249.234.81
2530585-53058549.12349.57
3527894-52789448.87449.30
4510128-51012847.22947.64
5488349-48834945.21245.66
6561188-56118851.95652.41
极限1512214-51221447.42247.223.1347.9447.743.13
2512303-51230347.43047.96
3498729-49872946.17346.68
4485049-48504944.90745.40
5524352-52435248.54649.07
6527393-52739348.82749.37
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.189363909360759363409367729358839362920.04
217.069388359370259379300.14
单位质量响应值RSD%判断
54498.9554978.310.62数据可信
每杯投2片--供试品溶液-2024051713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%
5min1523333-52333348.41150.583.4648.4150.583.47
2527476-52747648.79448.79
3573021-57302153.00753.01
4544640-54464050.38250.38
5556851-55685151.51151.51
6555208-55520851.35951.36
10min1540527-54052750.00151.013.0650.0851.103.05
2526086-52608648.66548.75
3570853-57085352.80652.89
4551543-55154351.02051.10
5568062-56806252.54852.63
6551786-55178651.04351.13
15min1541020-54102050.04750.521.8550.2150.691.85
2530081-53008149.03549.20
3554423-55442351.28651.46
4543424-54342450.26950.44
5557444-55744451.56651.74
6550519-55051950.92551.10
20min1538189-53818949.78550.181.9050.0350.431.90
2525182-52518248.58248.83
3552828-55282851.13951.40
4540195-54019549.97050.22
5551482-55148251.01451.27
6546642-54664250.56750.82
30min1529028-52902848.93749.081.6649.2749.421.66
2515961-51596147.72948.05
3540807-54080750.02750.37
4527166-52716648.76549.10
5537243-53724349.69750.04
6533343-53334349.33749.68
45min1518774-51877447.98948.181.6348.4048.601.64
2507418-50741846.93847.34
3531863-53186349.20049.63
4518650-51865047.97748.39
5527814-52781448.82549.25
6520378-52037848.13748.56
极限1485557-48555744.91644.722.5845.4145.222.55
2478248-47824844.24044.72
3461178-46117842.66143.17
4488546-48854645.19345.69
5496182-49618245.89946.41
6491170-49117045.43545.94
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