利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.464824964826394836264836504827914830400.12
215.264829334833804831560.07
单位质量响应值RSD%判断
31244.5031661.600.94数据可信
供试品溶液-24081201批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1298038-29803856.40253.565.0356.4053.565.03
2277732-27773252.55952.56
3258650-25865048.94848.95
4280130-28013053.01353.01
5291510-29151055.16655.17
6292121-29212155.28255.28
10min1398202-39820275.35773.412.5475.4573.502.54
2383685-38368572.61072.70
3383455-38345572.56672.65
4372784-37278470.54770.64
5391769-39176974.13974.23
6397717-39771775.26575.36
15min1432218-43221881.79480.521.7282.0180.731.73
2423186-42318680.08580.29
3425204-42520480.46780.67
4412837-41283778.12678.33
5426525-42652580.71780.93
6432934-43293481.93082.15
20min1447550-44755084.69684.041.4785.0584.391.48
2441330-44133083.51983.86
3444158-44415884.05484.39
4432987-43298781.94082.28
5446462-44646284.49084.84
6452123-45212385.56185.92
30min1466885-46688588.35587.921.8288.8588.401.82
2459700-45970086.99587.48
3466485-46648588.27988.76
4451477-45147785.43985.91
5465966-46596688.18188.67
6476857-47685790.24290.74
45min1483798-48379891.55590.431.6392.2091.071.63
2472121-47212189.34589.97
3480007-48000790.83891.46
4464800-46480087.96088.58
5482600-48260091.32991.97
6483913-48391391.57792.22
60min1491475-49147593.00892.061.6593.8192.841.65
2481063-48106391.03891.81
3488446-48844692.43593.21
4472887-47288789.49090.25
5490598-49059892.84293.63
6494250-49425093.53394.33
极限1496906-49690694.03693.111.3794.9994.051.38
2487079-48707992.17693.10
3492010-49201093.10994.04
4481436-48143691.10892.02
5495397-49539793.75094.70
6499383-49938394.50595.46
利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.464860604857164862874852714847454856160.13
215.264879884882224881050.04
单位质量响应值RSD%判断
31411.1331985.911.29数据可信
供试品溶液-24081202批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276364-27636451.89759.036.3351.9059.036.33
2313287-31328758.83058.83
3313692-31369258.90658.91
4327748-32774861.54661.55
5326014-32601461.22061.22
6329074-32907461.79561.79
10min1419334-41933478.74480.311.2378.8380.411.23
2425455-42545579.89479.99
3428166-42816680.40380.50
4433080-43308081.32681.43
5433263-43326381.36081.46
6426705-42670580.12980.23
15min1458475-45847586.09486.400.7086.3186.630.70
2456928-45692885.80486.04
3458370-45837086.07586.31
4464079-46407987.14787.38
5464263-46426387.18187.42
6458524-45852486.10486.34
20min1473889-47388988.98989.050.7289.3589.430.72
2470677-47067788.38688.76
3472241-47224188.68089.06
4477644-47764489.69490.08
5479070-47907089.96290.34
6471845-47184588.60588.99
30min1490681-49068192.14291.760.7992.6592.290.79
2483751-48375190.84191.36
3486978-48697891.44791.97
4492102-49210292.40992.94
5493156-49315692.60793.14
6485302-48530291.13291.66
45min1499985-49998593.88993.720.8294.5594.400.82
2494401-49440192.84193.51
3496211-49621193.18193.86
4503147-50314794.48395.17
5504351-50435194.70995.40
6496469-49646993.22993.91
60min1505206-50520694.87094.440.7995.6995.280.79
2497862-49786293.49194.32
3500861-50086194.05494.89
4505268-50526894.88195.73
5508294-50829495.45096.29
6500022-50002293.89694.73
极限1509531-50953195.68294.970.8496.6695.960.84
2500223-50022393.93494.92
3500864-50086494.05495.04
4509171-50917195.61496.62
5508862-50886295.55696.56
6505833-50583394.98895.98
利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.464871274869874874074865924869834870190.07
215.264879164877464878310.03
单位质量响应值RSD%判断
31501.8831967.961.04数据可信
供试品溶液-24081203批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1344465-34446564.60965.823.5364.6165.823.53
2358964-35896467.32967.33
3368792-36879269.17269.17
4350582-35058265.75665.76
5332551-33255162.37562.37
6350272-35027265.69865.70
10min1445869-44586983.62983.591.1783.7483.701.17
2438060-43806082.16482.28
3452163-45216384.80984.92
4445909-44590983.63683.75
5441882-44188282.88182.99
6450185-45018584.43884.55
15min1468627-46862787.89787.671.2788.1487.921.27
2456548-45654885.63285.88
3471706-47170688.47588.73
4466965-46696587.58687.83
5467370-46737087.66287.90
6473422-47342288.79789.05
20min1477262-47726289.51789.401.2989.9189.801.28
2465467-46546787.30587.70
3481442-48144290.30190.71
4475950-47595089.27189.67
5476969-47696989.46289.85
6482787-48278790.55390.95
30min1488882-48888291.69791.311.5092.2491.861.49
2473505-47350588.81289.35
3491147-49114792.12192.68
4484651-48465190.90391.45
5488599-48859991.64392.18
6494230-49423092.70093.25
45min1496793-49679393.18092.551.5093.8893.241.50
2479173-47917389.87690.56
3495800-49580092.99493.70
4492469-49246992.36993.06
5496440-49644093.11493.80
6499930-49993093.76994.47
60min1503724-50372494.48093.261.6495.3394.111.63
2482147-48214790.43391.27
3497426-49742693.29994.16
4495294-49529492.89993.75
5500956-50095693.96194.81
6503647-50364794.46695.33
极限1505454-50545494.80594.041.1095.8195.051.10
2491178-49117892.12793.11
3499620-49962093.71194.73
4503388-50338894.41795.42
5502735-50273594.29595.30
6505922-50592294.89395.91
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