盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303930223926323926433927973927733927730.05
212.273920553911053915800.18
单位质量响应值RSD%判断
31932.7631913.610.05数据可信
长期6月-供试品溶液-2023120221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%
2min1349105-34910582.89085.217.3082.8985.217.30
2395676-39567693.94893.95
3363206-36320686.23886.24
4362935-36293586.17486.17
5315518-31551874.91674.92
6366693-36669387.06687.07
5min1405257-40525796.22395.791.9096.2295.791.90
2403913-40391395.90495.90
3401670-40167095.37195.37
4394419-39441993.65093.65
5398461-39846194.60994.61
6416822-41682298.96998.97
10min1409715-40971597.28196.531.8797.2896.531.87
2404324-40432496.00196.00
3402092-40209295.47195.47
4396716-39671694.19594.19
5407428-40742896.73896.74
6418955-41895599.47599.48
15min1409112-40911297.13897.082.1397.1497.082.13
2405170-40517096.20296.20
3404086-40408695.94595.94
4399246-39924694.79694.80
5411005-41100597.58897.59
6424521-424521100.797100.80
20min1409076-40907697.13097.221.8797.1397.221.86
2405872-40587296.36996.37
3404945-40494596.14996.15
4402124-40212495.47995.48
5411116-41111697.61497.61
6423610-423610100.581100.58
30min1406692-40669296.56496.862.0696.5696.862.06
2402545-40254595.57995.58
3401966-40196695.44195.44
4400128-40012895.00595.01
5415428-41542898.63898.64
6420881-42088199.93399.93
45min1408291-40829196.94397.332.1196.9497.332.11
2405695-40569596.32796.33
3402999-40299995.68795.69
4401771-40177195.39595.40
5417144-41714499.04599.05
6423583-423583100.574100.57
60min1406433-40643396.50297.002.1496.5097.002.14
2400802-40080295.16595.17
3402730-40273095.62395.62
4402426-40242695.55195.55
5417706-41770699.17999.18
6421176-421176100.003100.00
极限1405571-40557196.29796.762.1596.3096.762.14
2402075-40207595.46795.47
3400679-40067995.13695.14
4399974-39997494.96994.97
5417001-41700199.01199.01
6419911-41991199.70299.70
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303923133933633924533918903952613930560.35
212.273933823929843931830.08
单位质量响应值RSD%判断
31955.7732044.250.20数据可信
长期6月-供试品溶液-2023120521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%
2min1355157-35515784.12583.354.6284.1383.364.62
2324005-32400576.74676.75
3341241-34124180.82980.83
4362816-36281685.93985.94
5364194-36419486.26686.27
6363986-36398686.21686.22
5min1393950-39395093.31493.320.3593.3193.320.35
2391764-39176492.79692.80
3393687-39368793.25293.25
4394200-39420093.37393.37
5394140-39414093.35993.36
6396005-39600593.80193.80
10min1400474-40047494.85993.713.1494.8693.713.14
2409257-40925796.94096.94
3372424-37242488.21588.22
4395034-39503493.57193.57
5396044-39604493.81093.81
6400409-40040994.84494.84
15min1400312-40031294.82194.681.5294.8294.681.52
2411225-41122597.40697.41
3396350-39635093.88293.88
4394221-39422193.37893.38
5396741-39674193.97593.97
6399464-39946494.62094.62
20min1399786-39978694.69694.391.9594.7094.391.95
2412758-41275897.76997.77
3392851-39285193.05393.05
4392649-39264993.00693.01
5393247-39324793.14793.15
6399626-39962694.65894.66
30min1400681-40068194.90894.352.1194.9194.362.11
2413016-41301697.83097.83
3392221-39222192.90492.90
4389679-38967992.30292.30
5394340-39434093.40693.41
6400122-40012294.77694.78
45min1400334-40033494.82694.342.3494.8394.342.34
2415582-41558298.43898.44
3391413-39141392.71392.71
4391095-39109592.63892.64
5392822-39282293.04793.05
6398405-39840594.36994.37
60min1398354-39835494.35794.212.4494.3694.222.45
2415621-41562198.44798.45
3388956-38895692.13192.13
4390531-39053192.50492.50
5393487-39348793.20493.20
6399575-39957594.64694.65
极限1399605-39960594.65394.212.5994.6594.212.59
2417103-41710398.79898.80
3390350-39035092.46192.46
4389968-38996892.37192.37
5391985-39198592.84892.85
6397343-39734394.11794.12
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303937023933913947423931033922733934420.23
212.273933993934953934470.02
单位质量响应值RSD%判断
31987.1532065.770.18数据可信
长期6月-供试品溶液-2023120621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%
2min1346765-34676582.06982.105.7082.0782.105.70
2371152-37115287.84187.84
3333897-33389779.02479.02
4370550-37055087.69987.70
5325334-32533476.99777.00
6333758-33375878.99178.99
5min1399257-39925794.49394.073.5094.4994.063.50
2413109-41310997.77197.77
3389615-38961592.21192.21
4405813-40581396.04496.04
5373883-37388388.48788.49
6403056-40305695.39295.39
10min1400225-40022594.72294.893.2394.7294.893.23
2416031-41603198.46398.46
3393541-39354193.14093.14
4409793-40979396.98696.99
5379762-37976289.87989.88
6406220-40622096.14196.14
15min1400340-40034094.74995.113.1094.7595.113.09
2416956-41695698.68298.68
3395593-39559393.62693.63
4410169-41016997.07597.08
5381569-38156990.30690.31
6406462-40646296.19896.20
20min1399136-39913694.46495.202.7694.4695.202.76
2415137-41513798.25198.25
3398715-39871594.36494.36
4411380-41138097.36297.36
5383990-38399090.87990.88
6405070-40507095.86895.87
30min1399245-39924594.49095.242.5694.4995.242.56
2414191-41419198.02798.03
3399292-39929294.50194.50
4410969-41096997.26597.26
5385409-38540991.21591.22
6405367-40536795.93995.94
45min1399476-39947694.54595.162.4594.5495.162.46
2413180-41318097.78897.79
3401589-40158995.04595.04
4409801-40980196.98896.99
5384971-38497191.11291.11
6403558-40355895.51195.51
60min1397894-39789494.17095.082.1194.1795.082.11
2413055-41305597.75897.76
3401378-40137894.99594.99
4409237-40923796.85596.85
5389321-38932192.14192.14
6399492-39949294.54894.55
极限1396759-39675993.90294.702.2993.9094.702.29
2411608-41160897.41697.42
3401291-40129194.97494.97
4406245-40624596.14796.15
5384794-38479491.07091.07
6400176-40017694.71094.71
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303927993916283916383918893918023919510.13
212.273924383923473923920.02
单位质量响应值RSD%判断
31865.9331979.790.26数据可信
长期6月-供试品溶液-2205008609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%
2min1242142-24214257.49448.8811.3957.4948.8811.39
2223420-22342053.04953.05
3183037-18303743.46043.46
4183847-18384743.65343.65
5195153-19515346.33746.34
6207575-20757549.28749.29
5min1390588-39058892.74188.973.6592.7488.973.65
2375609-37560989.18589.18
3359248-35924885.30085.30
4390315-39031592.67692.68
5371496-37149688.20888.21
6361005-36100585.71785.72
10min1409496-40949697.23195.171.8397.2395.171.83
2404482-40448296.04096.04
3392879-39287993.28593.29
4407595-40759596.77996.78
5397227-39722794.31894.32
6393261-39326193.37693.38
15min1409792-40979297.30195.461.7597.3095.461.75
2404935-40493596.14896.15
3395307-39530793.86293.86
4409332-40933297.19297.19
5399114-39911494.76694.77
6393635-39363593.46593.46
20min1408439-40843996.98095.301.6696.9895.301.67
2403402-40340295.78495.78
3395893-39589394.00194.00
4409380-40938097.20397.20
5397331-39733194.34294.34
6393795-39379593.50393.50
30min1412062-41206297.84095.052.0797.8495.062.07
2403165-40316595.72795.73
3393859-39385993.51893.52
4406714-40671496.57096.57
5395262-39526293.85193.85
6390899-39089992.81592.82
45min1408273-40827396.94095.101.8496.9495.101.84
2402960-40296095.67995.68
3392493-39249393.19393.19
4408678-40867897.03697.04
5398462-39846294.61194.61
6392253-39225393.13793.14
60min1407190-40719096.68394.642.0396.6894.642.02
2402178-40217895.49395.49
3391246-39124692.89792.90
4405998-40599896.40096.40
5397555-39755594.39594.40
6387296-38729691.96091.96
极限1404722-40472296.09794.491.8796.1094.491.87
2401580-40158095.35195.35
3389039-38903992.37392.37
4406135-40613596.43396.43
5396728-39672894.19994.20
6389613-38961392.51092.51
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