利伐沙班颗粒片项目信息
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对照品来源原料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%
110.423391563386463385493387983382493386800.10
210.413387993391863389920.09
单位质量响应值RSD%判断
32502.8832564.070.14数据可信
供试品溶液-24030601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%
5min1153637-15363728.10823.9141.5028.1123.9241.50
2151906-15190627.79127.79
320162-201623.6893.69
4148107-14810727.09627.10
5152803-15280327.95527.96
6157612-15761228.83528.84
10min1212073-21207338.79933.0645.1038.8533.1045.09
2215086-21508639.35039.40
314486-144862.6502.66
4210526-21052638.51638.56
5212903-21290338.95139.00
6219270-21927040.11540.16
15min1238378-23837843.61143.811.3443.7243.901.40
2241546-24154644.19144.30
3235911-23591143.16043.17
4237025-23702543.36443.47
5239120-23912043.74743.86
6244665-24466544.76244.88
20min1253539-25353946.38546.651.2346.5746.821.26
2256436-25643646.91547.10
3252966-25296646.28046.36
4253130-25313046.31046.49
5253169-25316946.31746.50
6260806-26080647.71547.90
30min1271246-27124649.62549.860.8749.8950.110.88
2272629-27262949.87850.14
3272070-27207049.77549.93
4271257-27125749.62749.89
5270938-27093849.56849.83
6277202-27720250.71450.98
45min1284865-28486552.11652.380.5352.4652.710.50
2286513-28651352.41852.76
3287869-28786952.66652.91
4284800-28480052.10452.45
5285483-28548352.22952.57
6288279-28827952.74153.09
60min1291394-29139453.31153.560.5153.7453.980.48
2293233-29323353.64754.08
3294023-29402353.79254.12
4291748-29174853.37553.80
5291458-29145853.32253.75
6294844-29484453.94254.38
极限1298684-29868454.64454.950.5355.1655.450.46
2300845-30084555.04055.56
3303028-30302855.43955.86
4300436-30043654.96555.48
5298951-29895154.69355.21
6300090-30009054.90255.43
利伐沙班颗粒片项目信息
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对照品来源原料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%
110.423403123396003401343397123395453398610.11
210.413391273384733388000.14
单位质量响应值RSD%判断
32616.2232545.630.16数据可信
供试品溶液-24030601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%
5min1280497-28049751.24256.496.2451.2456.496.24
2323377-32337759.07659.08
3332509-33250960.74460.74
4309211-30921156.48856.49
5293650-29365053.64553.65
6316191-31619157.76357.76
10min1378774-37877469.19673.413.7569.2873.503.75
2412232-41223275.30875.41
3422055-42205577.10377.20
4398968-39896872.88572.98
5405190-40519074.02274.11
6393832-39383271.94772.04
15min1420387-42038776.79878.312.2977.0078.532.29
2434158-43415879.31479.54
3441405-44140580.63880.87
4424939-42493977.62977.85
5435137-43513779.49279.71
6415944-41594475.98676.20
20min1429620-42962078.48580.382.2478.8180.722.25
2444459-44445981.19581.55
3454545-45454583.03883.40
4438489-43848980.10580.45
5444019-44401981.11581.46
6428722-42872278.32178.66
30min1443503-44350381.02182.982.3381.4883.462.33
2461068-46106884.23084.72
3467745-46774585.44985.95
4452418-45241882.64983.13
5459672-45967283.97584.46
6440793-44079380.52681.00
45min1450607-45060782.31984.631.9582.9185.251.96
2467307-46730785.36986.00
3476052-47605286.96787.61
4461928-46192884.38785.00
5467285-46728585.36585.99
6456296-45629683.35883.97
60min1454353-45435383.00372.0745.5583.7372.8345.09
2469684-46968485.80486.58
3479039-47903987.51388.30
4464247-46424784.81085.57
5471713-47171386.17486.94
628089-280895.1315.88
极限1476342-47634287.02088.781.9587.8989.661.97
2478857-47885787.47988.40
3491854-49185489.85490.79
4498706-49870691.10692.00
5492334-49233489.94190.85
6477876-47787687.30088.06
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