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%
115.194796824799624801194801654800764800010.05
215.134801654803424802540.03
单位质量响应值RSD%判断
31599.8031741.840.32数据可信
供试品溶液-24073001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%
5min1253340-25334047.61150.043.0347.6150.043.03
2270525-27052550.84150.84
3268057-26805750.37750.38
4259689-25968948.80448.80
5273959-27395951.48651.49
6271956-27195651.11051.11
10min1365868-36586868.75970.431.9868.8470.521.98
2372873-37287370.07670.16
3385482-38548272.44572.53
4371182-37118269.75869.84
5381920-38192071.77671.86
6371284-37128469.77769.86
15min1413054-41305477.62777.651.1077.8277.851.10
2410803-41080377.20477.41
3419194-41919478.78178.99
4408683-40868376.80677.00
5418143-41814378.58378.79
6409249-40924976.91277.11
20min1431763-43176381.14381.021.0481.4781.351.04
2428716-42871680.57080.90
3436881-43688182.10582.44
4426824-42682480.21580.54
5435750-43575081.89282.23
6426642-42664280.18180.51
30min1450659-45065984.69484.560.8585.1585.020.85
2446965-44696584.00084.46
3454395-45439585.39685.87
4447120-44712084.02984.49
5454439-45443985.40585.88
6446066-44606683.83184.29
45min1464923-46492387.37587.180.9887.9787.780.98
2460797-46079786.60087.20
3469980-46998088.32588.94
4460528-46052886.54987.15
5468138-46813887.97988.59
6458920-45892086.24786.85
60min1471619-47161988.63388.601.1589.3889.351.15
2467710-46771087.89988.65
3479717-47971790.15590.92
4468286-46828688.00788.75
5475822-47582289.42390.19
6465502-46550287.48488.23
极限1479214-47921490.06190.210.7790.9591.110.77
2477710-47771089.77890.67
3485497-48549791.24192.15
4477718-47771889.78090.67
5483516-48351690.86991.78
6476362-47636289.52590.42
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%
115.194807864809234806224807334806044807340.03
215.134808414808214808310.01
单位质量响应值RSD%判断
31648.0631779.970.30数据可信
供试品溶液-24073002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%
5min1254749-25474947.81146.866.0947.8146.866.09
2240920-24092045.21545.22
3261899-26189949.15349.15
4233135-23313543.75443.75
5270953-27095350.85250.85
6236417-23641744.37044.37
10min1374022-37402270.19667.803.6670.2867.883.66
2355862-35586266.78766.86
3368796-36879669.21569.30
4340877-34087763.97564.05
5373870-37387070.16770.25
6354240-35424066.48366.56
15min1410976-41097677.13176.411.4777.3376.601.47
2413425-41342577.59177.78
3406455-40645576.28376.48
4396128-39612874.34574.52
5407517-40751776.48276.68
6408432-40843276.65476.84
20min1428604-42860480.44080.211.1980.7680.531.18
2433793-43379381.41381.73
3425320-42532079.82380.15
4420999-42099979.01279.32
5423384-42338479.46079.79
6432249-43224981.12481.44
30min1447289-44728983.94683.881.3184.4184.331.30
2454758-45475885.34885.80
3444031-44403183.33583.79
4440957-44095782.75883.19
5441612-44161282.88183.34
6452915-45291585.00285.45
45min1461279-46127986.57286.781.3787.1787.371.36
2470907-47090788.37988.97
3460382-46038286.40487.00
4456236-45623685.62586.20
5456248-45624885.62886.23
6469219-46921988.06288.65
60min1468159-46815987.86388.271.4488.6189.011.43
2479298-47929889.95490.69
3469061-46906188.03288.77
4464349-46434987.14887.86
5463347-46334786.96087.70
6477781-47778189.66990.41
极限1472567-47256788.69089.261.4489.5890.151.43
2483215-48321590.68991.58
3474032-47403288.96589.85
4468749-46874987.97488.83
5470220-47022088.25089.14
6484945-48494591.01491.90
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