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%
115.534932044937514936824942394932674936290.09
215.424979774987784983780.12
单位质量响应值RSD%判断
31785.5132320.231.18数据可信
供试品溶液-1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%
5min1255238-25523847.39944.855.5047.4044.855.50
2232528-23252843.18243.18
3248498-24849846.14846.15
4256218-25621847.58147.58
5228653-22865342.46242.46
6228051-22805142.35042.35
10min1355902-35590266.09366.110.9966.1766.180.99
2352747-35274765.50765.58
3359980-35998066.85066.93
4358518-35851866.57966.66
5350938-35093865.17165.24
6357768-35776866.44066.51
15min1393875-39387573.14573.370.8273.3373.550.82
2391697-39169772.74172.92
3394618-39461873.28373.47
4392924-39292472.96873.16
5396538-39653873.64073.82
6400777-40077774.42774.61
20min1411547-41154776.42776.951.0176.7477.261.00
2410473-41047376.22776.53
3414765-41476577.02477.33
4411534-41153476.42476.74
5416413-41641377.33077.63
6421534-42153478.28178.59
30min1430958-43095880.03280.680.9880.4781.120.98
2432431-43243180.30580.73
3434053-43405380.60681.05
4431182-43118280.07380.51
5435754-43575480.92281.35
6442313-44231382.14082.58
45min1448405-44840583.27283.710.9283.8484.280.91
2448985-44898583.37983.94
3449456-44945683.46784.04
4447273-44727383.06183.63
5451880-45188083.91784.48
6458584-45858485.16285.73
60min1454601-45460184.42285.081.2085.1385.791.19
2451602-45160283.86584.57
3459002-45900285.23985.95
4455310-45531084.55485.26
5461577-46157785.71886.42
6466739-46673986.67687.39
极限1466533-46653386.63886.830.6687.4987.680.66
2465081-46508186.36887.21
3466488-46648886.63087.48
4466085-46608586.55587.41
5467796-46779686.87387.72
6473571-47357187.94588.80
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%
115.534967664968474971614971974969914969920.04
215.424978024982234980120.06
单位质量响应值RSD%判断
32002.0632296.500.65数据可信
供试品溶液-24072201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%
5min1265230-26523049.10547.125.9449.1047.125.93
2231351-23135142.83242.83
3249057-24905746.11046.11
4272953-27295350.53550.53
5246547-24654745.64645.65
6261911-26191148.49048.49
10min1371475-37147568.77567.032.4168.8667.112.42
2355921-35592165.89565.97
3358123-35812366.30366.38
4367902-36790268.11368.20
5349681-34968164.74064.82
6369234-36923468.36068.44
15min1405347-40534775.04673.691.8275.2473.881.82
2392697-39269772.70472.89
3401276-40127674.29274.48
4400333-40033374.11874.32
5386055-38605571.47471.66
6402425-40242574.50574.70
20min1420062-42006277.77076.861.5378.0977.181.53
2411673-41167376.21776.52
3419371-41937177.64277.95
4414992-41499276.83277.15
5404331-40433174.85875.16
6420579-42057977.86678.19
30min1439602-43960281.38880.321.6681.8480.761.66
2429192-42919279.46179.89
3439558-43955881.38081.82
4433560-43356080.26980.72
5422007-42200778.13078.56
6439184-43918481.31181.76
45min1453795-45379584.01682.831.7484.6083.411.74
2442002-44200281.83282.39
3452868-45286883.84484.42
4448457-44845783.02783.61
5434393-43439380.42480.98
6452983-45298383.86584.45
60min1463823-46382385.87284.341.7886.6085.051.77
2452286-45228683.73684.43
3460444-46044485.24785.96
4454672-45467284.17884.90
5441521-44152181.74382.44
6460496-46049685.25685.98
极限1468609-46860986.75885.721.4587.6386.571.46
2458811-45881184.94485.78
3467285-46728586.51387.37
4463160-46316085.75086.61
5451639-45163983.61784.44
6468336-46833686.70887.57
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