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%
112.303938873939933939403938093936883938630.04
212.273926773934423930600.14
单位质量响应值RSD%判断
32021.3832034.230.03数据可信
加速6月-供试品溶液-2023120221批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1314944-31494474.53572.617.9474.5472.627.94
2277945-27794565.77965.78
3291299-29129968.93968.94
4311368-31136873.68973.69
5297212-29721270.33970.34
6348177-34817782.40082.40
5min1386174-38617491.39292.562.2991.3992.562.29
2396704-39670493.88493.88
3390187-39018792.34292.34
4381064-38106490.18390.18
5386505-38650591.47191.47
6405939-40593996.07096.07
10min1392981-39298193.00394.272.2793.0094.272.27
2404463-40446395.72195.72
3401726-40172695.07395.07
4388868-38886892.03092.03
5390353-39035392.38192.38
6411568-41156897.40297.40
15min1392986-39298693.00594.602.9293.0094.602.92
2411093-41109397.29097.29
3401272-40127294.96594.97
4388996-38899692.06092.06
5388249-38824991.88391.88
6415670-41567098.37398.37
20min1394802-39480293.43494.653.0993.4394.653.09
2406908-40690896.29996.30
3409723-40972396.96696.97
4386145-38614591.38691.39
5386874-38687491.55891.56
6415112-41511298.24198.24
30min1396883-39688393.92795.761.7993.9395.761.79
2407864-40786496.52696.53
3409022-40902296.80096.80
4397900-39790094.16794.17
5400946-40094694.88894.89
6415230-41523098.26998.27
45min1396849-39684993.91996.332.1393.9296.332.13
2407838-40783896.51996.52
3411217-41121797.31997.32
4397623-39762394.10294.10
5409005-40900596.79696.80
6419698-41969899.32699.33
60min1404611-40461195.75696.462.6095.7696.462.60
2405731-40573196.02196.02
3414886-41488698.18798.19
4388873-38887392.03192.03
5413138-41313897.77497.77
6418215-41821598.97598.98
极限1406269-40626996.14897.461.4596.1597.461.45
2409614-40961496.94096.94
3413641-41364197.89397.89
4406892-40689296.29696.30
5412004-41200497.50597.51
6422503-42250399.99099.99
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%
112.303933363932583930623932363934423932670.04
212.273939193939793939490.02
单位质量响应值RSD%判断
31972.9332106.680.30数据可信
加速6月-供试品溶液-2023120521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1356267-35626784.28375.587.5284.2875.587.52
2283300-28330067.02167.02
3316772-31677274.94074.94
4325169-32516976.92676.93
5327107-32710777.38577.38
6308284-30828472.93272.93
5min1371941-37194187.99191.362.3287.9991.362.32
2394684-39468493.37293.37
3392709-39270992.90592.90
4378620-37862089.57189.57
5390472-39047292.37592.38
6388648-38864891.94491.94
10min1406897-40689796.26192.842.7396.2692.842.73
2388816-38881691.98491.98
3392917-39291792.95492.95
4396439-39643993.78793.79
5374368-37436888.56688.57
6395155-39515593.48393.48
15min1406353-40635396.13294.222.3396.1394.222.33
2403129-40312995.37095.37
3396229-39622993.73793.74
4391584-39158492.63892.64
5384304-38430490.91690.92
6408044-40804496.53296.53
20min1407309-40730996.35994.951.0196.3694.951.01
2403819-40381995.53395.53
3398644-39864494.30994.31
4395735-39573593.62093.62
5400761-40076194.80994.81
6401832-40183295.06395.06
30min1403351-40335195.42295.171.5195.4295.161.51
2404935-40493595.79795.80
3391686-39168692.66392.66
4402165-40216595.14295.14
5401370-40137094.95494.95
6410080-41008097.01497.01
45min1409272-40927296.82393.683.2696.8293.683.25
2404899-40489995.78895.79
3402933-40293395.32395.32
4373991-37399188.47688.48
5395263-39526393.50993.51
6389667-38966792.18592.18
60min1397731-39773194.09395.742.3494.0995.742.34
2406445-40644596.15496.15
3404728-40472895.74895.75
4392359-39235992.82292.82
5406842-40684296.24896.25
6420067-42006799.37799.38
极限1402819-40281995.29695.212.9295.3095.222.92
2381199-38119990.18290.18
3405905-40590596.02696.03
4404950-40495095.80095.80
5402703-40270395.26995.27
6417269-41726998.71598.71
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%
112.303939313938703935683935683935243936920.05
212.273939493954423946960.27
单位质量响应值RSD%判断
32007.4832167.560.36数据可信
加速6月-供试品溶液-2023120621批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1308056-30805672.77077.425.7772.7777.425.77
2340789-34078980.50280.50
3312190-31219073.74673.75
4339307-33930780.15280.15
5353016-35301683.39083.39
6313128-31312873.96873.97
5min1368815-36881587.12293.153.9287.1293.153.92
2406134-40613495.93895.94
3396670-39667093.70293.70
4407691-40769196.30696.31
5403708-40370895.36595.36
6382910-38291090.45290.45
10min1402707-40270795.12896.161.1395.1396.161.13
2412737-41273797.49897.50
3402521-40252195.08495.08
4412361-41236197.40997.41
5407210-40721096.19296.19
6404824-40482495.62895.63
15min1421657-42165799.60597.182.2999.6097.182.29
2414273-41427397.86097.86
3412864-41286497.52897.53
4414770-41477097.97897.98
5411149-41114997.12397.12
6393637-39363792.98692.99
20min1418676-41867698.90196.932.1998.9096.932.19
2401377-40137794.81494.81
3413183-41318397.60397.60
4420894-42089499.42499.42
5408954-40895496.60496.60
6398919-39891994.23494.23
30min1416574-41657498.40496.991.3398.4096.991.33
2406112-40611295.93395.93
3412141-41214197.35797.36
4416793-41679398.45698.46
5408106-40810696.40496.40
6403829-40382995.39395.39
45min1421751-42175199.62797.652.2299.6397.652.22
2416579-41657998.40598.41
3417143-41714398.53898.54
4420252-42025299.27399.27
5406064-40606495.92195.92
6398389-39838994.10894.11
60min1413673-41367397.71996.123.4097.7296.123.40
2385865-38586591.15091.15
3410899-41089997.06397.06
4426848-426848100.831100.83
5403566-40356695.33195.33
6400491-40049194.60594.60
极限1416102-41610298.29397.402.2098.2997.402.20
2405985-40598595.90395.90
3414961-41496198.02398.02
4426249-426249100.689100.69
5410548-41054896.98196.98
6400058-40005894.50394.50
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