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%
112.073811283814943810853808553812163811560.07
212.153802613806333804470.07
单位质量响应值RSD%判断
31578.7931312.510.60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%
2min1349505-34950584.24785.092.8684.2585.092.86
2362709-36270987.43087.43
3345346-34534683.24583.24
4347960-34796083.87583.87
5344076-34407682.93882.94
6368422-36842288.80788.81
5min1396114-39611495.48298.502.6395.4898.502.63
2417107-417107100.542100.54
3418156-418156100.795100.80
4408175-40817598.38998.39
5395155-39515595.25195.25
6417151-417151100.553100.55
10min1399424-39942496.28099.802.3896.2899.802.38
2419922-419922101.221101.22
3420699-420699101.408101.41
4422477-422477101.837101.84
5403719-40371997.31597.32
6417902-417902100.734100.73
15min1401173-40117396.701100.432.2996.70100.432.29
2421207-421207101.531101.53
3423107-423107101.989101.99
4426191-426191102.732102.73
5409225-40922598.64298.64
6418883-418883100.970100.97
20min1401887-40188796.874100.772.2996.87100.772.29
2422321-422321101.799101.80
3423313-423313102.038102.04
4428867-428867103.377103.38
5412497-41249799.43199.43
6419406-419406101.096101.10
30min1403719-40371997.315101.292.2697.32101.292.25
2423341-423341102.045102.04
3424808-424808102.399102.40
4431755-431755104.073104.07
5416829-416829100.475100.48
6420736-420736101.417101.42
45min1405248-40524897.684101.592.2797.68101.592.27
2423308-423308102.037102.04
3426439-426439102.792102.79
4434063-434063104.629104.63
5418842-418842100.961100.96
6420870-420870101.449101.45
极限1405991-40599197.863101.742.2697.86101.742.26
2423708-423708102.133102.13
3425426-425426102.548102.55
4435329-435329104.935104.93
5421607-421607101.627101.63
6420435-420435101.345101.34
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%
112.073816733818273815523816193822093817760.07
212.153809803811703810750.04
单位质量响应值RSD%判断
31630.1631364.200.60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%
2min1316671-31667176.20885.029.3676.2185.029.36
2391735-39173594.27294.27
3355888-35588885.64585.65
4314415-31441575.66575.66
5386752-38675293.07393.07
6354151-35415185.22785.23
5min1387988-38798893.37097.692.7093.3797.702.70
2417357-417357100.438100.44
3413195-41319599.43699.44
4400314-40031496.33796.34
5413306-41330699.46399.46
6403581-40358197.12397.12
10min1395756-39575695.24099.242.7495.2499.242.74
2428836-428836103.200103.20
3417870-417870100.561100.56
4406512-40651297.82897.83
5416075-416075100.129100.13
6409295-40929598.49898.50
15min1399914-39991496.24099.251.8796.2499.251.87
2420437-420437101.179101.18
3419673-419673100.995101.00
4408724-40872498.36098.36
5414810-41481099.82599.83
6411020-41102098.91398.91
20min1401564-40156496.63799.791.7896.6499.791.77
2419736-419736101.010101.01
3421042-421042101.325101.32
4411113-41111398.93598.94
5415638-415638100.024100.02
6418963-418963100.824100.82
30min1405170-40517097.50599.791.4597.5199.791.45
2419980-419980101.069101.07
3422156-422156101.593101.59
4413159-41315999.42899.43
5414585-41458599.77199.77
6412930-41293099.37399.37
45min1407227-40722798.000100.011.2898.00100.011.28
2419330-419330100.913100.91
3422673-422673101.717101.72
4414900-41490099.84799.85
5416003-416003100.112100.11
6413336-41333699.47099.47
极限1407547-40754798.07799.971.3098.0899.971.30
2420064-420064101.089101.09
3422523-422523101.681101.68
4415741-415741100.049100.05
5414260-41426099.69399.69
6412423-41242399.25199.25
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%
112.073805603804143804443804593804123804580.02
212.153804053804843804440.02
单位质量响应值RSD%判断
31520.9631312.260.47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%
2min1351503-35150384.80683.155.5184.8183.155.52
2362753-36275387.52187.52
3340144-34014482.06682.07
4324015-32401578.17478.17
5366802-36680288.49888.50
6322502-32250277.80977.81
5min1424615-424615102.44697.473.14102.4597.473.15
2404198-40419897.52097.52
3395596-39559695.44595.44
4412738-41273899.58099.58
5395112-39511295.32895.33
6391630-39163094.48894.49
10min1427060-427060103.03697.792.88103.0497.792.89
2407674-40767498.35998.36
3398686-39868696.19096.19
4405561-40556197.84997.85
5397688-39768895.94995.95
6395306-39530695.37595.37
15min1424825-424825102.49797.842.65102.5097.842.65
2407750-40775098.37798.38
3399669-39966996.42796.43
4407556-40755698.33098.33
5398245-39824596.08496.08
6395215-39521595.35395.35
20min1425128-425128102.57098.062.52102.5798.072.52
2408167-40816798.47898.48
3401127-40112796.77996.78
4408122-40812298.46798.47
5398259-39825996.08796.09
6397919-39791996.00596.01
30min1425431-425431102.64398.122.51102.6498.112.51
2407684-40768498.36198.36
3401343-40134396.83196.83
4408461-40846198.54998.55
5398083-39808396.04596.04
6398981-39898196.26196.26
45min1424741-424741102.47698.162.41102.4898.162.41
2407317-40731798.27398.27
3401919-40191996.97096.97
4409340-40934098.76198.76
5398467-39846796.13796.14
6399294-39929496.33796.34
极限1424519-424519102.42398.102.40102.4298.102.40
2407802-40780298.39098.39
3401830-40183096.94996.95
4407944-40794498.42498.42
5397527-39752795.91195.91
6399903-39990396.48496.48
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%
112.073805063806363807243806923808513806820.04
212.153810113809703809900.01
单位质量响应值RSD%判断
31539.5231357.200.41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%
2min1183078-18307844.12652.1935.1044.1352.1935.10
2265348-26534863.95563.96
3249873-24987360.22560.23
4100089-10008924.12424.12
5185520-18552044.71544.71
6315200-31520075.97175.97
5min1385579-38557992.93487.5115.9492.9387.5015.94
2395035-39503595.21395.21
3380208-38020891.63991.64
4245689-24568959.21759.22
5379192-37919291.39491.39
6392646-39264694.63794.64
10min1423166-423166101.99396.148.27101.9996.148.27
2417206-417206100.557100.56
3394932-39493295.18895.19
4334364-33436480.59080.59
5413233-41323399.59999.60
6410300-41030098.89298.89
15min1428394-428394103.25398.565.35103.2598.565.35
2426549-426549102.808102.81
3397203-39720395.73595.74
4370561-37056189.31489.31
5416752-416752100.447100.45
6414142-41414299.81899.82
20min1428705-428705103.32899.784.70103.3399.784.70
2419943-419943101.216101.22
3396671-39667195.60795.61
4386978-38697893.27193.27
5438601-438601105.713105.71
6412997-41299799.54299.54
30min1428555-428555103.29299.463.04103.2999.463.04
2419703-419703101.158101.16
3396470-39647095.55995.56
4398986-39898696.16596.17
5418214-418214100.799100.80
6414098-41409899.80799.81
45min1427154-427154102.95499.922.53102.9599.922.53
2421264-421264101.535101.53
3400486-40048696.52796.53
4403293-40329397.20397.20
5417647-417647100.663100.66
6417517-417517100.631100.63
极限1428287-428287103.22799.542.86103.2399.542.86
2420458-420458101.340101.34
3395851-39585195.40995.41
4403221-40322197.18697.19
5417064-417064100.522100.52
6412954-41295499.53299.53
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