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%
117.429463789464339440739432249419459444110.21
217.479429179420989425080.07
单位质量响应值RSD%判断
54214.1853950.090.35数据可信
供试品溶液-2022072301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%
5min1526932-52693249.33544.638.2449.3344.638.23
2469749-46974943.98143.98
3426788-42678839.95839.96
4442434-44243441.42341.42
5514820-51482048.20148.20
6479675-47967544.91044.91
10min1524568-52456849.11344.277.6849.2044.347.69
2473638-47363844.34544.42
3428064-42806440.07840.14
4440228-44022841.21741.29
5501639-50163946.96647.05
6468831-46883143.89543.97
15min1511142-51114247.85643.647.1348.0243.797.14
2467181-46718143.74043.89
3424493-42449339.74439.88
4435507-43550740.77540.91
5494760-49476046.32246.48
6463851-46385143.42843.58
20min1510414-51041447.78843.277.7348.0343.497.72
2460832-46083243.14643.37
3418114-41811439.14639.35
4430733-43073340.32840.53
5495180-49518046.36246.60
6457801-45780142.86243.08
30min1499348-49934846.75242.527.4947.0842.817.49
2452728-45272842.38742.68
3411610-41161038.53738.80
4424771-42477139.77040.04
5486349-48634945.53545.85
6449807-44980742.11442.41
45min1488093-48809345.69841.068.2446.1041.438.23
2412960-41296038.66439.03
3401071-40107137.55137.88
4413751-41375138.73839.08
5475894-47589444.55644.95
6439734-43973441.17141.53
极限1452127-45212742.33139.366.0942.8139.806.11
2419288-41928839.25639.68
3387659-38765936.29536.69
4398457-39845737.30637.71
5447043-44704341.85542.32
6418058-41805839.14139.57
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%
117.429436589451669444269439679451659444760.08
217.479431089426009428540.04
单位质量响应值RSD%判断
54217.9153969.890.33数据可信
供试品溶液-2022272501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%
5min1528751-52875149.49447.266.3449.4947.266.34
2512555-51255547.97847.98
3510596-51059647.79547.79
4510956-51095647.82847.83
5524787-52478749.12349.12
6441432-44143241.32041.32
10min1528914-52891449.50947.245.7149.5947.325.71
2506135-50613547.37747.46
3515060-51506048.21248.29
4509465-50946547.68947.77
5520349-52034948.70848.79
6448323-44832341.96642.03
15min1521358-52135848.80246.166.4648.9746.326.46
2459221-45922142.98643.14
3507736-50773647.52747.69
4507353-50735347.49147.65
5516367-51636748.33548.50
6446551-44655141.80041.94
20min1516203-51620348.31946.275.3048.5746.515.31
2493610-49361046.20546.44
3503167-50316747.09947.34
4501016-50101646.89847.14
5508798-50879847.62647.87
6443168-44316841.48341.69
30min1505230-50523047.29245.575.2647.6245.895.27
2485327-48532745.42945.74
3497917-49791746.60846.93
4494536-49453646.29146.61
5501754-50175446.96747.29
6436521-43652140.86141.14
45min1492748-49274846.12444.575.3546.5344.965.36
2471064-47106444.09444.48
3484843-48484345.38445.78
4486667-48666745.55545.95
5494458-49445846.28446.69
6426977-42697739.96740.31
极限1467306-46730643.74242.134.8344.2242.594.83
2441489-44148941.32641.78
3457150-45715042.79243.26
4457501-45750142.82543.29
5466761-46676143.69144.17
6410076-41007638.38538.80
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%
117.429427259439099424879430889428739430160.06
217.479415839421149418480.04
单位质量响应值RSD%判断
54134.1053912.310.30数据可信
供试品溶液-2022272501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%
5min1529085-52908549.59044.087.8649.5944.087.87
2476109-47610944.62544.62
3438652-43865241.11441.11
4458580-45858042.98242.98
5428263-42826340.14040.14
6491168-49116846.03646.04
10min1535188-53518850.16245.857.3350.2445.927.32
2481948-48194845.17245.25
3441875-44187541.41641.48
4459262-45926243.04643.12
5522198-52219848.94549.01
6494620-49462046.36046.44
15min1527308-52730849.42345.187.6049.5945.337.60
2477298-47729844.73644.89
3430257-43025740.32740.46
4455116-45511642.65742.80
5516839-51683948.44248.59
6485417-48541745.49745.65
20min1521334-52133448.86444.697.6849.1144.927.67
2473294-47329444.36144.59
3434483-43448340.72340.93
4438609-43860941.11041.32
5514823-51482348.25348.48
6478445-47844544.84445.07
30min1513152-51315248.09744.217.1348.4344.517.13
2464239-46423943.51243.81
3427794-42779440.09640.37
4444487-44448741.66141.94
5506280-50628047.45347.76
6474246-47424644.45044.75
45min1481198-48119845.10242.946.2345.5143.326.23
2452869-45286942.44642.82
3419931-41993139.35939.70
4434536-43453640.72841.08
5496231-49623146.51146.90
6464117-46411743.50143.88
极限1439462-43946241.19040.504.8841.6840.954.88
2431730-43173040.46540.91
3403425-40342537.81238.22
4415618-41561838.95539.38
5464189-46418943.50743.97
6438190-43819041.07141.52
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