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250
标示量(mg)50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%
117.274754824755684752134756834754294754750.04
217.234768094752534760310.24
单位质量响应值RSD%判断
27531.8527628.030.25数据可信
供试品溶液-2024051712批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1535080-53508098.23797.280.9398.2497.280.93
2533748-53374897.99297.99
3529927-52992797.29197.29
4521579-52157995.75895.76
5531624-53162497.60297.60
6527323-52732396.81396.81
10min1538457-53845798.85798.230.7499.0298.390.74
2538207-53820798.81198.97
3536407-53640798.48098.64
4527897-52789796.91897.08
5535813-53581398.37198.53
6533551-53355197.95698.12
15min1538015-53801598.77698.200.7399.1098.520.73
2537898-53789898.75499.08
3536014-53601498.40898.73
4527651-52765196.87397.19
5535775-53577598.36498.69
6533847-53384798.01098.34
20min1537683-53768398.71598.090.8399.2198.580.83
2537195-53719598.62599.12
3536715-53671598.53799.03
4526374-52637496.63897.12
5535965-53596598.39998.89
6531884-53188497.65098.14
30min1535863-53586398.38197.840.8799.0498.500.87
2536410-53641098.48199.14
3532985-53298597.85298.51
4524574-52457496.30896.95
5536608-53660898.51799.17
6531136-53113697.51398.16
45min1534442-53444298.12097.690.8698.9498.510.86
2535324-53532498.28299.10
3535991-53599198.40499.22
4523918-52391896.18896.99
5532924-53292497.84198.66
6530145-53014597.33198.14
极限1534068-53406898.05197.530.7599.0498.510.76
2535099-53509998.24099.23
3533025-53302597.86098.84
4524250-52425096.24897.21
5531593-53159397.59798.58
6529278-52927897.17298.15
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250
标示量(mg)50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%
117.274756904759984766974752084758564758900.12
217.234751134750564750840.01
单位质量响应值RSD%判断
27555.8827573.070.05数据可信
供试品溶液-2024051712批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1529558-52955897.27796.451.1197.2896.451.10
2523860-52386096.23196.23
3531446-53144697.62497.62
4514849-51484994.57594.58
5525008-52500896.44196.44
6525521-52552196.53696.54
10min1533600-53360098.02098.090.6298.1898.250.62
2533018-53301897.91398.07
3538090-53809098.84599.01
4537638-53763898.76298.92
5529868-52986897.33497.49
6531781-53178197.68697.85
15min1533791-53379198.05598.320.7798.3898.640.77
2532136-53213697.75198.07
3537136-53713698.66999.00
4539618-53961899.12599.45
5529457-52945797.25997.58
6539119-53911999.03499.36
20min1531289-53128997.59597.960.7798.0898.440.77
2531668-53166897.66598.15
3537134-53713498.66999.16
4539248-53924899.05799.54
5528287-52828797.04497.53
6531920-53192097.71198.20
30min1530753-53075397.49797.710.7098.1598.360.69
2529948-52994897.34998.00
3534583-53458398.20098.86
4537733-53773398.77999.43
5527370-52737096.87597.52
6531011-53101197.54498.20
45min1530026-53002697.36397.530.7098.1898.350.70
2529784-52978497.31998.13
3533972-53397298.08898.91
4536430-53643098.54099.36
5525940-52594096.61397.42
6529539-52953997.27498.09
极限1529211-52921197.21497.440.8498.1998.420.84
2528567-52856797.09598.07
3535273-53527398.32799.31
4536495-53649598.55299.53
5525129-52512996.46497.43
6528118-52811897.01397.99
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250
标示量(mg)50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%
117.274765874765664759584766914758624763330.09
217.234764094767204765640.05
单位质量响应值RSD%判断
27581.5327658.970.20数据可信
供试品溶液-2024051713批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1537178-53717898.47896.761.4898.4896.761.49
2533655-53365597.83297.83
3515280-51528094.46394.46
4530576-53057697.26897.27
5523877-52387796.04096.04
6526155-52615596.45796.46
10min1545200-54520099.94998.071.47100.1198.231.47
2538367-53836798.69698.86
3523787-52378796.02396.18
4540206-54020699.03399.20
5529006-52900696.98097.14
6533045-53304597.72097.88
15min1544931-54493199.89998.041.34100.2398.361.34
2537973-53797398.62498.95
3525966-52596696.42296.74
4539281-53928198.86399.19
5528748-52874896.93397.25
6531881-53188197.50797.83
20min1543569-54356999.65097.951.20100.1598.441.20
2535614-53561498.19198.68
3525498-52549896.33796.81
4538755-53875598.76799.26
5531066-53106697.35797.84
6531332-53133297.40697.89
30min1542423-54242399.43997.671.21100.1098.321.21
2533609-53360997.82498.48
3526596-52659696.53897.18
4537745-53774598.58299.24
5526289-52628996.48297.13
6529898-52989897.14397.79
45min1542036-54203699.36997.601.23100.2098.411.23
2534769-53476998.03698.85
3525891-52589196.40997.21
4536586-53658698.36999.19
5525632-52563296.36197.17
6529347-52934797.04297.85
极限1540663-54066399.11797.331.19100.1198.311.19
2533264-53326497.76098.74
3524706-52470696.19297.15
4534098-53409897.91398.90
5524309-52430996.11997.09
6528461-52846196.88097.85
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250
标示量(mg)50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%
117.274759454759554759904761884757644759680.04
217.234751654754394753020.05
单位质量响应值RSD%判断
27560.3927585.720.07数据可信
供试品溶液-2024051713批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1520293-52029395.54695.770.6495.5595.770.64
2518888-51888895.28895.29
3519656-51965695.42995.43
4519291-51929195.36295.36
5527259-52725996.82596.82
6523779-52377996.18696.19
10min1526034-52603496.60097.310.8096.7697.470.80
2528846-52884697.11697.28
3535365-53536598.31398.47
4524418-52441896.30396.46
5532684-53268497.82197.98
6532114-53211497.71697.88
15min1525154-52515496.43896.960.8096.7697.280.80
2524614-52461496.33996.66
3530849-53084997.48497.81
4523277-52327796.09496.41
5530496-53049697.41997.74
6533642-53364297.99798.32
20min1523275-52327596.09396.870.7496.5797.350.74
2525972-52597296.58897.07
3529887-52988797.30797.79
4523159-52315996.07296.55
5530626-53062697.44397.93
6532098-53209897.71398.20
30min1522224-52222495.90096.630.8296.5497.280.82
2523340-52334096.10596.75
3528391-52839197.03397.68
4521773-52177395.81796.46
5529440-52944097.22597.87
6532038-53203897.70298.35
45min1521208-52120895.71496.360.8196.5197.170.81
2521773-52177395.81796.62
3526404-52640496.66897.48
4520441-52044195.57396.37
5527576-52757696.88397.69
6531012-53101297.51498.33
极限1520748-52074895.62996.210.8396.5997.170.83
2521307-52130795.73296.69
3525732-52573296.54497.51
4519321-51932195.36796.33
5525228-52522896.45297.42
6531059-53105997.52398.50
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