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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.903201653203563204253201923197663201810.09
2 9.983197543198893198220.03
单位质量响应值RSD%判断
32341.5232046.290.65数据可信
供试品溶液-JPS7149批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1286604-28660479.80377.272.2379.8077.282.23
2277458-27745877.25677.26
3276664-27666477.03577.04
4280855-28085578.20278.20
5275694-27569476.76576.77
6267859-26785974.58474.58
10min1336653-33665393.73990.532.3893.8790.662.37
2321056-32105689.39689.52
3323109-32310989.96890.10
4328866-32886691.57191.70
5327233-32723391.11691.24
6313929-31392987.41287.54
15min1350532-35053297.60394.412.3997.8994.692.39
2334392-33439293.10993.39
3336161-33616193.60293.88
4344535-34453595.93496.22
5341187-34118795.00195.28
6327620-32762091.22491.49
20min1355943-35594399.11096.002.3499.5696.442.34
2340126-34012694.70695.14
3341374-34137495.05395.49
4350241-35024197.52297.97
5347506-34750696.76197.20
6333463-33346392.85193.27
30min1360527-360527100.38697.342.35101.0097.942.35
2344020-34402095.79096.38
3345342-34534296.15896.75
4355572-35557299.00799.61
5353361-35336198.39198.99
6338714-33871494.31394.89
45min1362196-362196100.85197.592.49101.6498.352.49
2346411-34641196.45697.21
3346501-34650196.48197.23
4357170-35717099.452100.22
5352803-35280398.23699.00
6337834-33783494.06894.80
60min1361284-361284100.59797.262.58101.5598.182.58
2343671-34367195.69396.60
3344688-34468895.97696.89
4357254-35725499.475100.41
5351468-35146897.86498.79
6337456-33745693.96294.85
极限1360490-360490100.37697.192.56101.5098.272.56
2343247-34324795.57596.65
3344733-34473395.98997.06
4357848-35784899.641100.74
5350495-35049597.59398.68
6337387-33738793.94394.99
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.904854054851094840584849024850454849040.11
2 9.984876144882574879360.10
单位质量响应值RSD%判断
48980.2048891.380.13数据可信
供试品溶液-JPS8079批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min140385-403857.3987.465.587.407.465.55
240690-406907.4547.45
337048-370486.7866.79
443956-439568.0528.05
540376-403767.3967.40
641964-419647.6877.69
10min180804-8080414.80214.856.0014.8114.865.99
279491-7949114.56114.57
377244-7724414.14914.16
490734-9073416.62116.63
579098-7909814.48914.50
679174-7917414.50314.52
15min1104904-10490419.21619.214.7919.2519.254.78
2102983-10298318.86418.90
3101694-10169418.62818.66
4114436-11443620.96221.00
5105030-10503019.23919.28
6100331-10033118.37918.42
20min1123132-12313222.55522.523.7722.6222.593.77
2120531-12053122.07922.15
3121266-12126622.21322.28
4131993-13199324.17824.25
5121807-12180722.31222.38
6119036-11903621.80521.87
30min1148420-14842027.18727.263.1727.2927.363.17
2145662-14566226.68226.79
3147599-14759927.03727.14
4158005-15800528.94329.06
5148005-14800527.11127.22
6145071-14507126.57426.68
45min1176828-17682832.39132.502.4132.5432.652.41
2174493-17449331.96332.11
3177080-17708032.43732.59
4185661-18566134.00934.17
5176814-17681432.38932.54
6173701-17370131.81831.97
60min1197468-19746836.17236.312.0236.3836.512.02
2196074-19607435.91736.12
3198614-19861436.38236.58
4205383-20538337.62237.84
5198292-19829236.32336.53
6193421-19342135.43135.63
极限1235132-23513243.07143.151.3143.3443.421.33
2233752-23375242.81843.08
3235299-23529943.10243.36
4241427-24142744.22444.51
5235219-23521943.08743.35
6232526-23252642.59442.85
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