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)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%
19.853128703158763156353157883156023151540.41
29.913136873165163151020.64
单位质量响应值RSD%判断
31995.3331796.370.45数据可信
供试品溶液-24091801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%
5min1140134-14013439.22539.306.4139.2339.306.41
2138684-13868438.82038.82
3133678-13367837.41837.42
4149757-14975741.91941.92
5151656-15165642.45142.45
6128515-12851535.97335.97
10min1190077-19007753.20554.833.3253.2754.903.32
2194768-19476854.51854.58
3192234-19223453.80953.87
4203468-20346856.95357.02
5204490-20449057.24057.31
6190300-19030053.26853.33
15min1212853-21285359.58061.042.3759.7361.202.38
2217335-21733560.83560.99
3215532-21553260.33060.48
4223739-22373962.62862.79
5225104-22510463.01063.18
6213941-21394159.88560.03
20min1225618-22561863.15464.762.1263.4165.022.13
2230169-23016964.42764.68
3229910-22991064.35564.61
4236422-23642266.17866.45
5238115-23811566.65266.92
6227831-22783163.77364.02
30min1241517-24151767.60469.332.0667.9669.702.06
2246488-24648868.99569.36
3246235-24623568.92569.28
4251762-25176270.47270.85
5255512-25551271.52171.90
6244607-24460768.46968.82
45min1255674-25567471.56773.171.7172.0473.651.72
2260158-26015872.82273.30
3260429-26042972.89873.37
4265035-26503574.18774.68
5268114-26811475.04975.55
6258909-25890972.47272.94
60min1263161-26316173.66275.281.4974.2575.891.50
2268626-26862675.19275.79
3268807-26880775.24375.84
4272280-27228076.21576.84
5274334-27433476.79077.42
6266486-26648674.59375.18
极限1270078-27007875.59977.021.3176.3177.751.32
2274897-27489776.94777.67
3274784-27478476.91677.64
4277331-27733177.62978.38
5280621-28062178.55079.30
6273246-27324676.48577.20
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)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%
19.853133183161273163223164103164883157330.43
29.913140803160173150480.44
单位质量响应值RSD%判断
32054.1131790.920.59数据可信
供试品溶液-24091801批-pH4.5jz(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%
5min1255668-25566871.50670.973.6971.5170.973.69
2252274-25227470.55670.56
3265450-26545074.24274.24
4259528-25952872.58572.59
5251778-25177870.41870.42
6237724-23772466.48766.49
10min1321214-32121489.83889.271.5789.9689.391.58
2325118-32511890.93091.05
3323663-32366390.52390.65
4318160-31816088.98489.10
5314157-31415787.86487.98
6312872-31287287.50587.62
15min1334307-33430793.50092.991.1393.7793.261.12
2337010-33701094.25694.52
3335785-33578593.91394.19
4330126-33012692.33092.60
5327770-32777091.67191.94
6329850-32985092.25392.51
20min1338086-33808694.55794.170.9994.9894.590.99
2342051-34205195.66596.09
3338139-33813994.57195.00
4334168-33416893.46193.88
5333584-33358493.29793.71
6334259-33425993.48693.90
30min1341879-34187995.61795.160.8496.2095.740.85
2344799-34479996.43497.02
3340961-34096195.36195.95
4338389-33838994.64195.22
5338033-33803394.54295.11
6337330-33733094.34594.91
45min1343771-34377196.14795.750.7596.8996.490.75
2346968-34696897.04197.79
3340886-34088695.34096.09
4340985-34098595.36796.10
5340707-34070795.29096.02
6340857-34085795.33296.06
60min1344075-34407596.23295.980.8097.1396.880.79
2348267-34826797.40498.31
3341959-34195995.64096.55
4342298-34229895.73596.63
5341053-34105395.38696.27
6341364-34136495.47396.36
极限1345428-34542896.61096.610.6897.6797.660.67
2348470-34847097.46198.53
3341587-34158795.53696.60
4344321-34432196.30097.36
5346001-34600196.77097.82
6346718-34671896.97198.01
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