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%
112.113933133937693939933932293933353935280.09
212.053933803936413935100.05
单位质量响应值RSD%判断
32496.1232656.430.35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%
5min1406543-40654394.19695.291.2194.2095.291.21
2412954-41295495.68295.68
3405881-40588194.04394.04
4408759-40875994.71094.71
5418021-41802196.85696.86
6415363-41536396.24096.24
10min1409851-40985194.96395.761.1195.1295.921.11
2415989-41598996.38596.54
3410921-41092195.21195.37
4416904-41690496.59796.75
5407311-40731194.37494.54
6418898-41889897.05997.22
15min1417062-41706296.63496.671.4696.9596.981.46
2415294-41529496.22496.54
3419785-41978597.26597.58
4416708-41670896.55296.87
5407840-40784094.49794.82
6426507-42650798.82299.14
20min1409215-40921594.81695.501.0195.2995.981.01
2413993-41399395.92396.40
3409753-40975394.94095.42
4415267-41526796.21896.70
5406991-40699194.30094.78
6417836-41783696.81397.30
30min1407422-40742294.40095.281.0695.0395.921.06
2413213-41321395.74296.38
3408834-40883494.72795.36
4415180-41518096.19896.84
5406108-40610894.09694.73
6416484-41648496.50097.15
45min1406884-40688494.27595.320.8095.0796.120.80
2413305-41330595.76396.56
3408484-40848494.64695.44
4413152-41315295.72896.53
5411008-41100895.23196.02
6415617-41561796.29997.11
60min1406670-40667094.22694.950.9695.1795.910.96
2412142-41214295.49496.45
3407215-40721594.35295.30
4413328-41332895.76996.73
5405153-40515393.87494.82
6414309-41430995.99696.97
极限1406138-40613894.10395.520.8295.2196.640.82
2411972-41197295.45496.57
3415965-41596596.38097.49
4411995-41199595.46096.58
5412966-41296695.68596.79
6414549-41454996.05197.18
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%
112.113933793928513937993931283934973933310.10
212.053946443945293945860.03
单位质量响应值RSD%判断
32479.8532745.730.58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%
5min1414179-41417995.85992.085.3295.8692.085.32
2360392-36039283.41183.41
3421243-42124397.49497.49
4400477-40047792.68892.69
5395665-39566591.57491.57
6395165-39516591.45991.46
10min1416766-41676696.45894.092.9896.6294.252.98
2395657-39565791.57291.71
3425836-42583698.55798.72
4404071-40407193.52093.67
5398183-39818392.15792.31
6398806-39880692.30192.45
15min1423081-42308197.92094.653.1598.2494.963.15
2396334-39633491.72992.02
3426631-42663198.74199.07
4404017-40401793.50793.82
5405516-40551693.85494.16
6398094-39809492.13692.44
20min1415509-41550996.16794.142.9396.6594.612.94
2394823-39482391.37991.82
3424838-42483898.32698.82
4409442-40944294.76395.23
5397594-39759492.02192.48
6398324-39832492.19092.65
30min1414896-41489696.02594.193.9396.6794.813.92
2393937-39393791.17491.77
3435842-435842100.873101.53
4402360-40236093.12493.75
5397060-39706091.89792.51
6397581-39758192.01892.63
45min1413998-41399895.81794.273.1896.6295.063.18
2400091-40009192.59993.35
3430832-43083299.714100.54
4401508-40150892.92793.71
5396852-39685291.84992.62
6400646-40064692.72793.49
60min1425624-42562498.50893.893.6299.4794.833.61
2393316-39331691.03191.93
3422951-42295197.88998.88
4400664-40066492.73193.67
5395223-39522391.47292.39
6396242-39624291.70892.63
极限1413199-41319995.63293.683.0996.7694.773.08
2392459-39245990.83291.89
3422384-42238497.75898.91
4411115-41111595.15096.24
5394665-39466591.34392.42
6394670-39467091.34492.42
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%
112.113927863925903929163924633927163926940.05
212.053933413934473933940.02
单位质量响应值RSD%判断
32427.2532646.800.48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%
5min1425460-42546098.69996.022.4498.7096.022.44
2400477-40047792.90392.90
3423081-42308198.14798.15
4417573-41757396.86996.87
5412627-41262795.72295.72
6404128-40412893.75093.75
10min1429079-42907999.53897.422.3099.7097.582.30
2410970-41097095.33895.49
3430688-43068899.912100.08
4423574-42357498.26198.42
5418499-41849997.08497.24
6406860-40686094.38494.54
15min1428231-42823199.34298.012.3299.6798.332.32
2413916-41391696.02196.33
3431989-431989100.214100.54
4424016-42401698.36498.69
5429466-42946699.62899.95
6407304-40730494.48794.80
20min1428581-42858199.42397.212.8699.9297.702.85
2402369-40236993.34293.82
3432735-432735100.387100.88
4422643-42264398.04598.53
5420841-42084197.62798.11
6407131-40713194.44794.92
30min1425965-42596598.81697.252.8699.4897.902.86
2401770-40177093.20393.83
3432247-432247100.273100.94
4428103-42810399.31299.96
5418969-41896997.19397.84
6408263-40826394.71095.34
45min1426313-42631398.89796.742.8099.7297.552.80
2400857-40085792.99293.78
3430784-43078499.934100.77
4420411-42041197.52898.35
5418065-41806596.98397.80
6405653-40565394.10494.89
60min1425209-42520998.64197.082.0499.6398.052.04
2415757-41575796.44897.39
3429232-42923299.574100.57
4418725-41872597.13798.12
5417250-41725096.79497.77
6404616-40461693.86494.81
极限1424307-42430798.43196.452.7199.5997.582.71
2399720-39972092.72893.83
3429370-42937099.606100.77
4418689-41868997.12898.27
5417032-41703296.74497.88
6405407-40540794.04795.15
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%
112.113943103941423938983934713927783937200.16
212.053924163924703924430.01
单位质量响应值RSD%判断
32511.9732567.880.13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%
5min1406300-40630094.24593.841.4894.2493.841.48
2398716-39871692.48692.49
3410987-41098795.33295.33
4396312-39631291.92891.93
5404708-40470893.87593.88
6410230-41023095.15695.16
10min1409753-40975395.04695.221.1095.2095.381.10
2405081-40508193.96294.12
3415309-41530996.33496.49
4407678-40767894.56494.72
5408578-40857894.77394.93
6416568-41656896.62796.79
15min1409155-40915594.90794.821.3995.2295.131.39
2404282-40428293.77794.09
3414547-41454796.15896.48
4401332-40133293.09293.40
5407512-40751294.52694.84
6415821-41582196.45396.77
20min1420568-42056897.55495.371.5498.0395.851.53
2403602-40360293.61994.09
3413385-41338595.88896.37
4406623-40662394.32094.79
5407690-40769094.56795.04
6415086-41508696.28396.76
30min1409162-40916294.90994.491.4195.5495.121.41
2402203-40220393.29493.92
3412224-41222495.61996.26
4399188-39918892.59593.22
5407380-40738094.49595.12
6413937-41393796.01696.66
45min1407464-40746494.51594.291.4395.3195.081.43
2401359-40135993.09993.88
3411815-41181595.52496.32
4398502-39850292.43693.21
5406303-40630394.24595.03
6413463-41346395.90696.71
60min1406860-40686094.37594.552.1195.3395.502.10
2401373-40137393.10294.04
3420986-42098697.65198.61
4397882-39788292.29293.22
5404292-40429293.77994.72
6414243-41424396.08797.05
极限1406554-40655494.30494.041.9995.4195.141.99
2399947-39994792.77193.86
3409278-40927894.93696.06
4394892-39489291.59992.68
5403613-40361393.62294.72
6418270-41827097.02198.14
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