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%
111.963842703849143846913844353843743845370.07
2 12.003841413837783839600.07
单位质量响应值RSD%判断
32151.9231996.670.35数据可信
供试品溶液-6021201批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1416104-41610497.92197.971.1297.9297.971.12
2414577-41457797.56197.56
3408838-40883896.21196.21
4422975-42297599.53899.54
5417162-41716298.17098.17
6418144-41814498.40198.40
10min1420595-42059598.97799.141.1699.1499.301.16
2418414-41841498.46498.63
3413590-41359097.32997.49
4427296-427296100.554100.72
5423519-42351999.66699.83
6424289-42428999.847100.01
15min1419642-41964298.75398.981.2999.0899.301.28
2415924-41592497.87898.20
3413104-41310497.21597.54
4427238-427238100.541100.87
5422921-42292199.52599.85
6424697-42469799.943100.27
20min1418931-41893198.58698.741.1199.0899.241.11
2417052-41705298.14498.63
3412421-41242197.05497.54
4425900-425900100.226100.73
5421207-42120799.12199.62
6422011-42201199.31199.81
30min1418291-41829198.43598.801.2099.0999.461.20
2416801-41680198.08598.74
3412516-41251697.07697.72
4426252-426252100.309100.98
5421183-42118399.11699.78
6424042-42404299.789100.45
45min1417257-41725798.19298.661.2799.0199.481.27
2415571-41557197.79598.61
3411637-41163796.86997.68
4425387-425387100.105100.94
5422177-42217799.350100.18
6423516-42351699.665100.49
60min1416521-41652198.01998.421.1799.0099.401.17
2415258-41525897.72298.70
3410963-41096396.71197.68
4424120-42412099.807100.81
5420280-42028098.90399.89
6422167-42216799.347100.34
极限1414143-41414397.45998.171.3398.6199.321.32
2414744-41474497.60198.74
3409072-40907296.26697.40
4424043-42404399.789100.96
5419331-41933198.68099.84
6421551-42155199.202100.36
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%
111.963857503861193859243853953846343855640.16
2 12.003840803841953841380.03
单位质量响应值RSD%判断
32237.7932011.500.50数据可信
供试品溶液-6021201批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1403869-40386994.89393.204.4394.8993.204.43
2414569-41456997.40797.41
3377868-37786888.78488.78
4408876-40887696.06996.07
5403085-40308594.70994.71
6371686-37168687.33187.33
10min1414485-41448597.38796.532.1897.5596.682.18
2420491-42049198.79998.96
3394989-39498992.80792.95
4414598-41459897.41497.57
5406636-40663695.54395.70
6413830-41383097.23397.38
15min1415777-41577797.69196.742.0498.0197.062.04
2420064-42006498.69899.03
3397156-39715693.31693.62
4415200-41520097.55597.88
5406659-40665995.54995.87
6415459-41545997.61697.92
20min1413790-41379097.22496.572.0097.7197.052.00
2418830-41883098.40898.90
3396864-39686493.24793.71
4415018-41501897.51398.00
5405692-40569295.32195.80
6415937-41593797.72998.20
30min1417275-41727598.04396.751.9398.6997.391.93
2418723-41872398.38399.04
3398725-39872593.68494.30
4414697-41469797.43798.08
5405409-40540995.25595.89
6415891-41589197.71898.35
45min1418221-41822198.26596.702.0099.0797.502.00
2417520-41752098.10098.92
3398600-39860093.65594.42
4414051-41405197.28598.10
5404084-40408494.94495.74
6416810-41681097.93498.73
60min1417226-41722698.03196.602.0199.0097.562.00
2416673-41667397.90198.88
3397749-39774993.45594.38
4414457-41445797.38198.35
5404018-40401894.92895.88
6416595-41659597.88398.84
极限1416372-41637297.83196.461.9498.9797.591.94
2416282-41628297.81098.96
3398316-39831693.58894.67
4414296-41429697.34398.48
5402740-40274094.62895.74
6415293-41529397.57798.70
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%
111.963857233858703851743850063851163853780.11
2 12.003838803837993838400.02
单位质量响应值RSD%判断
32222.2431986.670.52数据可信
供试品溶液-6021301批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1409827-40982796.35493.742.2696.3593.742.26
2408827-40882796.11896.12
3388121-38812191.25091.25
4397744-39774493.51393.51
5396776-39677693.28593.29
6390855-39085591.89391.89
10min1415618-41561897.71597.292.8597.8897.442.85
2417416-41741698.13898.30
3427377-427377100.480100.63
4423110-42311099.47799.63
5401479-40147994.39194.55
6397810-39781093.52893.68
15min1416285-41628597.87297.643.2698.2097.963.25
2418131-41813198.30698.63
3431734-431734101.504101.82
4426691-426691100.318100.64
5401027-40102794.28594.60
6397976-39797693.56793.88
20min1415139-41513997.60297.703.5498.0998.183.54
2418843-41884398.47398.96
3433027-433027101.808102.30
4429157-429157100.898101.39
5400108-40010894.06994.54
6397094-39709493.36093.82
30min1414820-41482097.52797.823.7998.1898.463.78
2417874-41787498.24598.90
3435566-435566102.405103.06
4431163-431163101.370102.03
5400144-40014494.07794.70
6396739-39673993.27693.90
45min1414693-41469397.49897.943.9498.3198.753.93
2417336-41733698.11998.93
3437885-437885102.950103.78
4432153-432153101.603102.43
5400061-40006194.05894.84
6397308-39730893.41094.19
60min1415305-41530597.64297.864.2098.6298.834.19
2417432-41743298.14299.12
3438912-438912103.192104.19
4432074-432074101.584102.58
5398042-39804293.58394.52
6395582-39558293.00493.94
极限1413668-41366897.25797.734.2298.3998.864.21
2416379-41637997.89499.04
3436921-436921102.724103.90
4434116-434116102.064103.23
5397781-39778193.52194.62
6395240-39524092.92494.01
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%
111.963860343863783855143866123859163860910.11
2 12.003849753854043851900.08
单位质量响应值RSD%判断
32281.8632099.170.41数据可信
供试品溶液-6021301批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369253-36925386.58293.315.2486.5893.305.24
2426605-426605100.030100.03
3413648-41364896.99196.99
4398794-39879493.50893.51
5381194-38119489.38289.38
6398093-39809393.34493.34
10min1407521-40752195.55597.402.6195.7097.562.61
2431233-431233101.115101.28
3424867-42486799.62299.78
4403719-40371994.66394.82
5416389-41638997.63497.78
6408649-40864995.81995.97
15min1410489-41048996.25197.622.6496.5597.942.64
2431330-431330101.137101.47
3424933-42493399.63799.97
4402352-40235294.34394.66
5420109-42010998.50698.82
6408693-40869395.83096.14
20min1412886-41288696.81397.672.6097.2898.152.59
2431430-431430101.161101.66
3424461-42446199.527100.02
4402514-40251494.38194.85
5420070-42007098.49798.97
6407862-40786295.63596.11
30min1410919-41091996.35297.632.5696.9898.272.56
2430017-430017100.830101.50
3424477-42447799.531100.19
4402482-40248294.37395.00
5421762-42176298.89499.53
6408601-40860195.80896.44
45min1412416-41241696.70397.702.5497.4998.512.53
2429652-429652100.744101.58
3423694-42369499.347100.17
4401803-40180394.21495.00
5423296-42329699.254100.06
6409213-40921395.95296.75
60min1410076-41007696.15497.383.0297.1098.343.02
2429640-429640100.741101.75
3424144-42414499.452100.44
4401794-40179494.21295.15
5424875-42487599.624100.59
6401179-40117994.06895.02
极限1410896-41089696.34697.412.5997.4598.542.59
2427215-427215100.173101.35
3424586-42458699.556100.71
4400252-40025293.85094.95
5422024-42202498.955100.09
6407596-40759695.57296.68
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