盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.493830933834613832353833263835963833420.06
212.473833643835883834760.05
单位质量响应值RSD%判断
30691.9130751.880.14数据可信
长期9月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121137313937317837315891.6896.125.8290.25%～101.99%
2414468414337414402101.81
340389140358240373699.19
437100137056637078491.10
5416440416748416594102.35
636879136852536865890.57
2024030221139233039235439234296.3999.112.3996.63%～101.59%
239832439857539845097.89
340163640152040157898.66
4413277413556413416101.57
539787639768139777897.73
6416775416890416832102.41
2024030321140328440379240353899.1491.837.7684.36%～99.31%
238684538675938680295.03
334820134845434832885.58
437178537212837195691.38
540026840072040049498.40
633185433128733157081.46
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.493834523836943832323832343832033833630.06
212.473841923841813841860.01
单位质量响应值RSD%判断
30693.5930808.820.27数据可信
中间条件9月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211413852414040413946101.6096.945.3191.55%～102.33%
238877538326838602294.75
3407614407676407645100.06
439352939324739338896.56
535838635811235824987.93
6410212410614410413100.74
2024030221139938339883239910897.9699.063.1995.75%～102.36%
240083140065240074298.36
3413289413476413382101.47
4417433417021417227102.41
5409435409161409298100.46
638157338177138167293.68
2024030321139334139354239344296.5795.725.8689.84%～101.60%
239003439016039009795.75
340131440087040109298.45
434827134848534837885.51
5417093417215417154102.39
638968638952638960695.63
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.497475837473157468767464597473387471140.06
212.477469237466827468020.03
单位质量响应值RSD%判断
59816.9759887.890.09数据可信
长期9月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211798088798506798297100.67101.841.58100.15%～103.52%
2807478807721807600101.85
378611078789678700399.25
4815499815922815710102.87
5819463821223820343103.45
6816312816064816188102.93
2024030221173778373780373779393.0496.657.4989.06%～104.24%
277036377073977055197.17
3821307822450821878103.65
4810559809804810182102.17
579144779161979153399.82
666664366639466651884.05
2024030321177454677524377489497.7294.334.4889.89%～98.76%
278211978233178222598.65
375382975419575401295.09
476140976088776114895.99
571928371910571919490.70
669673169583969628587.81
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.497481227485597479597483987487247483520.05
212.477471607477627474610.06
单位质量响应值RSD%判断
59916.0959940.740.03数据可信
中间条件9月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121176755376681976718696.6398.784.6293.99%～103.57%
2810475809717810096102.03
3796977796474796726100.35
476634776689376662096.55
573248073135573191892.18
6833111833052833082104.93
20240302211832561832480832520104.8596.177.6388.47%～103.87%
276416276437476426896.26
366726266883766805084.14
472894672854772874691.78
5797123796369796746100.35
679085879133579109699.64
20240303211821734822173821954103.5297.553.3594.13%～100.97%
277284077255877269997.32
377270277308977289697.35
474335674354174344893.64
576284176329276306696.11
677303877322077312997.37
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