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500
标示量(mg)25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%
117.819335229336109331819389779316879341950.30
217.849235139308249271680.56
单位质量响应值RSD%判断
52453.4051971.300.66数据可信
影响因素30天-供试品溶液-2024051911批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1804871-80487178.05794.348.5178.0694.348.51
21007811-100781197.73897.74
31001529-100152997.12997.13
4998186-99818696.80496.80
51022123-102212399.12699.13
61002341-100234197.20797.21
10min11050629-1050629101.890100.641.10102.02100.801.09
21034297-1034297100.306100.47
31027842-102784299.68099.84
41025949-102594999.49799.66
51052658-1052658102.087102.25
61035044-1035044100.379100.54
15min11076017-1076017104.352101.711.63104.65102.041.61
21035309-1035309100.405100.73
31029781-102978199.868100.20
41041247-1041247100.980101.31
51058688-1058688102.672103.01
61051534-1051534101.978102.31
20min11088141-1088141105.528102.561.63106.00103.051.61
21050349-1050349101.863102.36
31057929-1057929102.598103.09
41040320-1040320100.891101.39
51063272-1063272103.116103.62
61045103-1045103101.354101.85
30min11068984-1068984103.670102.350.87104.32103.010.86
21040935-1040935100.950101.62
31058527-1058527102.656103.32
41051666-1051666101.991102.65
51056127-1056127102.423103.10
61055727-1055727102.385103.05
45min11082303-1082303104.962102.801.10105.78103.641.08
21052607-1052607102.082102.92
31061782-1061782102.972103.81
41050244-1050244101.853102.69
51056508-1056508102.460103.31
61056851-1056851102.494103.33
极限11081643-1081643104.898102.681.15105.90103.691.13
21053421-1053421102.161103.17
31062166-1062166103.009104.02
41047732-1047732101.609102.61
51053528-1053528102.171103.19
61054431-1054431102.259103.27
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500
标示量(mg)25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%
117.819210999339359309649302149324909297400.55
217.849215029234589224800.15
单位质量响应值RSD%判断
52203.2651708.520.68数据可信
影响因素30天-供试品溶液-2024051911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%
5min1435305-43530542.42444.839.5342.4244.839.53
2473472-47347246.14446.14
3490036-49003647.75847.76
4409925-40992539.95139.95
5525137-52513751.17951.18
6426035-42603541.52141.52
10min1452092-45209244.06045.966.9644.1346.036.97
2479351-47935146.71746.79
3487729-48772947.53447.61
4437155-43715542.60542.67
5525635-52563551.22851.31
6447584-44758443.62143.69
15min1455391-45539144.38246.057.9044.5346.207.89
2476275-47627546.41746.57
3477055-47705546.49346.65
4438456-43845642.73242.87
5541682-54168252.79252.96
6446407-44640743.50643.65
20min1457353-45735344.57345.596.1644.7945.826.16
2481336-48133646.91147.14
3472770-47277046.07646.31
4435035-43503542.39842.61
5515140-51514050.20550.46
6445246-44524643.39343.61
30min1451433-45143343.99644.946.2244.2945.246.23
2469056-46905645.71446.02
3461772-46177245.00445.32
4430113-43011341.91842.20
5512325-51232549.93150.27
6441858-44185843.06343.35
45min1442909-44290943.16643.975.2643.5344.345.27
2457095-45709544.54844.93
3451434-45143443.99644.38
4424966-42496641.41741.77
5493686-49368648.11448.54
6436644-43664442.55542.91
极限1419219-41921940.85741.984.0941.2942.444.12
2439227-43922742.80743.27
3430071-43007141.91442.38
4419688-41968840.90241.32
5461836-46183645.01045.52
6414740-41474040.42040.85
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500
标示量(mg)25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%
117.819387629389979389279396449389759390610.04
217.849214839280879247850.51
单位质量响应值RSD%判断
52726.6151837.721.21数据可信
影响因素30天-供试品溶液-2024051911批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11007234-100723497.55697.791.2397.5697.791.23
21015368-101536898.34498.34
31025750-102575099.35099.35
41002374-100237497.08697.09
5990506-99050695.93695.94
61016775-101677598.48098.48
10min11039455-1039455100.677100.991.17100.84101.151.17
21047980-1047980101.503101.67
31057821-1057821102.456102.62
41034713-1034713100.218100.38
51024538-102453899.23299.39
61051333-1051333101.828101.99
15min11047867-1047867101.492101.931.18101.82102.261.18
21051505-1051505101.844102.18
31064534-1064534103.106103.44
41038611-1038611100.595100.92
51042084-1042084100.932101.26
61069702-1069702103.607103.94
20min11039837-1039837100.714102.271.43101.21102.771.43
21065577-1065577103.207103.71
31076520-1076520104.267104.78
41045701-1045701101.282101.78
51042888-1042888101.010101.50
61064735-1064735103.126103.63
30min11055593-1055593102.240102.631.21102.91103.301.21
21060370-1060370102.703103.38
31079737-1079737104.579105.26
41047647-1047647101.471102.14
51046394-1046394101.349102.01
61068148-1068148103.456104.13
45min11034960-1034960100.242103.362.03101.08104.202.02
21064343-1064343103.088103.93
31076221-1076221104.238105.09
41100169-1100169106.558107.39
51056688-1056688102.346103.18
61070721-1070721103.705104.56
极限11045998-1045998101.311102.161.21102.32103.181.21
21064415-1064415103.095104.11
31069503-1069503103.587104.62
41042550-1042550100.977101.99
51041511-1041511100.876101.88
61064721-1064721103.124104.15
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500
标示量(mg)25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%
117.819242619348959346949345809346729326200.51
217.849254829277979266400.18
单位质量响应值RSD%判断
52364.9651941.700.58数据可信
影响因素30天-供试品溶液-2024051911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%
5min1479661-47966146.57043.0912.5246.5743.0912.52
2405577-40557739.37739.38
3487923-48792347.37247.37
4372471-37247136.16336.16
5509747-50974749.49149.49
6407696-40769639.58339.58
10min1482131-48213146.81044.248.7246.8944.328.72
2431256-43125641.87041.94
3486811-48681147.26447.34
4407131-40713139.52839.59
5502984-50298448.83448.92
6423731-42373141.14041.21
15min1488198-48819847.39944.388.1847.5544.538.19
2438100-43810042.53542.67
3483411-48341146.93447.09
4414133-41413340.20840.33
5498943-49894348.44248.61
6420081-42008140.78540.92
20min1481144-48114446.71444.137.3046.9544.357.31
2442493-44249342.96143.17
3472516-47251645.87646.11
4418352-41835240.61840.81
5495009-49500948.06048.30
6417539-41753940.53940.74
30min1473237-47323745.94643.477.2146.2643.777.22
2439613-43961342.68242.96
3465064-46506445.15345.47
4412114-41211440.01240.27
5486433-48643347.22847.55
6410097-41009739.81640.09
45min1462296-46229644.88442.476.5245.2742.846.54
2427723-42772341.52741.88
3449377-44937743.63044.02
4408423-40842339.65439.98
5472890-47289045.91346.32
6404110-40411039.23539.57
极限1432652-43265242.00640.275.8042.4740.705.83
2409120-40912039.72140.14
3424336-42433641.19941.66
4389321-38932137.79938.19
5446509-44650943.35143.83
6386682-38668237.54337.94
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