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%
112.423967863971043971643964383965803968140.09
212.343972003971993972000.01
单位质量响应值RSD%判断
31949.6032188.010.53数据可信
长期3月-供试品溶液-2023120221批-10mg规格-pH1.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1323580-32358076.48283.655.3576.4883.655.35
2354036-35403683.68183.68
3341348-34134880.68280.68
4371993-37199387.92587.92
5372644-37264488.07988.08
6359905-35990585.06885.07
5min1412276-41227697.44698.772.3097.4598.772.30
2404225-40422595.54395.54
3416903-41690398.54098.54
4433042-433042102.355102.35
5420530-42053099.39799.40
6420251-42025199.33199.33
10min1413941-41394197.84099.072.1697.8499.072.16
2406052-40605295.97595.98
3419031-41903199.04399.04
4433223-433223102.397102.40
5422077-42207799.76399.76
6420542-42054299.40099.40
15min1413631-41363197.76799.142.1397.7799.142.13
2407533-40753396.32596.33
3419185-41918599.07999.08
4434032-434032102.589102.59
5422207-42220799.79499.79
6420065-42006599.28799.29
20min1413969-41396997.84699.182.1897.8599.182.18
2406783-40678396.14896.15
3419223-41922399.08899.09
4434166-434166102.620102.62
5422339-42233999.82599.82
6421139-42113999.54199.54
30min1414650-41465098.00799.392.2198.0199.392.21
2407953-40795396.42596.42
3419894-41989499.24799.25
4435603-435603102.960102.96
5423230-423230100.035100.04
6421638-42163899.65999.66
45min1415087-41508798.11199.452.1198.1199.452.11
2408826-40882696.63196.63
3420346-42034699.35499.35
4435224-435224102.870102.87
5423101-423101100.005100.00
6421991-42199199.74399.74
极限1414140-41414097.88799.452.1697.8999.452.16
2408911-40891196.65196.65
3420556-42055699.40399.40
4435522-435522102.941102.94
5423390-423390100.073100.07
6422039-42203999.75499.75
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%
112.423967863967783967273968503964513967180.04
212.344033103981064007080.92
单位质量响应值RSD%判断
31941.8732472.291.17数据可信
长期3月-供试品溶液-2023120521批-10mg规格
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1381702-38170289.83789.272.0889.8489.262.08
2393374-39337492.58492.58
3377542-37754288.85888.86
4374765-37476588.20588.20
5377852-37785288.93188.93
6370400-37040087.17787.18
5min1418849-41884998.58097.202.0598.5897.202.05
2420571-42057198.98698.99
3420087-42008798.87298.87
4399467-39946794.01894.02
5411320-41132096.80896.81
6407662-40766295.94795.95
10min1419409-41940998.71297.342.1598.7197.342.15
2421270-42127099.15099.15
3421892-42189299.29699.30
4399961-39996194.13594.13
5411755-41175596.91196.91
6407166-40716695.83195.83
15min1418854-41885498.58197.402.0298.5897.402.02
2421675-42167599.24599.25
3421188-42118899.13199.13
4400466-40046694.25494.25
5411771-41177196.91496.91
6409032-40903296.27096.27
20min1418717-41871798.54997.322.0798.5597.322.07
2421701-42170199.25199.25
3421394-42139499.17999.18
4400457-40045794.25194.25
5410893-41089396.70896.71
6407859-40785995.99495.99
30min1421065-42106599.10297.902.0099.1097.902.00
2423461-42346199.66699.67
3424478-42447899.90599.91
4403795-40379595.03795.04
5412245-41224597.02697.03
6410664-41066496.65496.65
45min1419823-41982398.80997.701.9298.8197.701.92
2422850-42285099.52299.52
3421993-42199399.32099.32
4402427-40242794.71594.72
5413235-41323597.25997.26
6410265-41026596.56096.56
极限1421664-42166499.24397.692.0699.2497.692.06
2421530-42153099.21199.21
3422677-42267799.48199.48
4401190-40119094.42494.42
5413326-41332697.28097.28
6409972-40997296.49196.49
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%
112.423966883967783965773965023965293966150.03
212.343973573972043972800.03
单位质量响应值RSD%判断
31933.5732194.490.58数据可信
长期3月-供试品溶液-2023120621批-10mg规格
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1349582-34958282.64081.495.2382.6481.495.23
2347022-34702282.03582.04
3355153-35515383.95783.96
4349687-34968782.66582.67
5308915-30891573.02773.03
6357945-35794584.61784.62
5min1414743-41474398.04497.171.6998.0497.171.69
2402155-40215595.06995.07
3413734-41373497.80697.81
4421449-42144999.63099.63
5407322-40732296.29096.29
6406767-40676796.15996.16
10min1416128-41612898.37297.681.6798.3797.681.66
2403005-40300595.26995.27
3417343-41734398.65998.66
4422232-42223299.81599.81
5412139-41213997.42997.43
6408371-40837196.53896.54
15min1417401-41740198.67397.971.7098.6797.971.70
2404323-40432395.58195.58
3418458-41845898.92298.92
4423987-423987100.230100.23
5413133-41313397.66497.66
6409234-40923496.74296.74
20min1417184-41718498.62197.911.7398.6297.901.73
2403840-40384095.46795.47
3418297-41829798.88498.88
4423867-423867100.201100.20
5412577-41257797.53297.53
6409174-40917496.72896.73
30min1417723-41772398.74997.931.6398.7597.931.63
2404064-40406495.52095.52
3418494-41849498.93198.93
4422741-42274199.93599.93
5412464-41246497.50697.51
6410013-41001396.92696.93
45min1416696-41669698.50697.961.5998.5197.961.59
2404706-40470695.67295.67
3418798-41879899.00399.00
4423140-423140100.029100.03
5412565-41256597.52997.53
6410336-41033697.00297.00
极限1417371-41737198.66697.911.6098.6797.911.60
2404487-40448795.62095.62
3417103-41710398.60298.60
4423267-423267100.059100.06
5413231-41323197.68797.69
6409624-40962496.83496.83
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%
112.424049134048684049124046044046454047880.04
212.343998723997943998330.02
单位质量响应值RSD%判断
32591.6332401.380.42数据可信
长期3月-供试品溶液-2205008609批-10mg规格
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1258714-25871460.34551.4625.0760.3451.4525.07
2189538-18953844.21044.21
3308227-30822771.89471.89
4157449-15744936.72536.72
5186065-18606543.40043.40
6223624-22362452.16052.16
5min1377585-37758588.07288.152.6588.0788.152.65
2367409-36740985.69885.70
3393010-39301091.66991.67
4366853-36685385.56885.57
5384264-38426489.62989.63
6378300-37830088.23888.24
10min1403288-40328894.06794.821.8694.0794.821.86
2403648-40364894.15194.15
3398289-39828992.90192.90
4410649-41064995.78495.78
5419622-41962297.87797.88
6403707-40370794.16594.16
15min1402522-40252293.88895.472.1393.8995.472.13
2408834-40883495.36095.36
3399316-39931693.14093.14
4416516-41651697.15297.15
5422420-42242098.52998.53
6406165-40616594.73894.74
20min1401284-40128493.59995.522.4693.6095.522.46
2409440-40944095.50295.50
3397974-39797492.82792.83
4417631-41763197.41297.41
5424580-42458099.03399.03
6406153-40615394.73594.74
30min1401478-40147893.64595.402.2993.6495.402.29
2407513-40751395.05295.05
3398272-39827292.89792.90
4417226-41722697.31897.32
5422813-42281398.62198.62
6406617-40661794.84394.84
45min1401174-40117493.57495.842.9493.5795.842.94
2408479-40847995.27895.28
3397675-39767592.75892.76
4427188-42718899.64299.64
5423976-42397698.89298.89
6406972-40697294.92694.93
极限1402626-40262693.91295.462.3593.9195.462.35
2407242-40724294.98994.99
3397503-39750392.71792.72
4417235-41723597.32097.32
5423644-42364498.81598.81
6407387-40738795.02395.02
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