利伐沙班颗粒项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.339977419963859954389917369911849944970.30
212.319989189989989989580.01
单位质量响应值RSD%判断
80656.6981150.120.44数据可信
供试品溶液-2024010511批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1218812-21881220.20420.081.0120.2020.081.01
2217137-21713720.04920.05
3220828-22082820.39020.39
4214591-21459119.81419.81
5217474-21747420.08020.08
6215992-21599219.94319.94
10min1266685-26668524.62424.290.9824.6624.320.98
2262053-26205324.19624.23
3264517-26451724.42424.46
4262261-26226124.21524.25
5263707-26370724.34924.38
6259129-25912923.92623.96
15min1283497-28349726.17625.810.9726.2525.890.97
2279818-27981825.83625.91
3279573-27957325.81425.89
4278867-27886725.74925.82
5280445-28044525.89425.97
6275119-27511925.40325.48
20min1290406-29040626.81426.600.6926.9326.720.68
2288633-28863326.65026.77
3287985-28798526.59126.71
4289068-28906826.69126.81
5288054-28805426.59726.71
6284518-28451826.27026.39
30min1298070-29807027.52227.320.6327.6827.480.63
2296425-29642527.37027.53
3294963-29496327.23527.40
4297148-29714827.43727.60
5296095-29609527.33927.50
6292764-29276427.03227.19
45min1304126-30412628.08127.830.6428.2928.040.63
2301580-30158027.84628.05
3299437-29943727.64827.86
4302577-30257727.93828.14
5301724-30172427.85928.07
6299067-29906727.61427.82
60min1305947-30594728.24928.060.4928.5028.310.49
2303652-30365228.03728.29
3302705-30270527.95028.20
4305398-30539828.19828.45
5303584-30358428.03128.28
6302192-30219227.90228.15
极限1307286-30728628.37328.240.4228.6828.540.43
2306493-30649328.29928.60
3305315-30531528.19128.49
4306596-30659628.30928.61
5305419-30541928.20028.50
6303754-30375428.04728.34
利伐沙班颗粒项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.339978459991309990029983159994359987450.07
212.319962349940969951650.16
单位质量响应值RSD%判断
81001.2280842.000.14数据可信
供试品溶液-2024010511批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1219485-21948520.26120.572.7120.2620.562.72
2226550-22655020.91320.91
3232587-23258721.47021.47
4218085-21808520.13220.13
5216577-21657719.99319.99
6223417-22341720.62420.62
10min1265795-26579524.53624.541.9924.5724.581.99
2272604-27260425.16525.20
3269911-26991124.91624.95
4266501-26650124.60124.63
5257570-25757023.77723.81
6262965-26296524.27524.31
15min1284378-28437826.25126.171.5126.3326.241.50
2289208-28920826.69726.77
3285053-28505326.31426.39
4284696-28469626.28126.36
5276740-27674025.54625.62
6280723-28072325.91425.99
20min1294814-29481427.21527.041.1027.3327.161.11
2297302-29730227.44427.57
3293428-29342827.08727.21
4293609-29360927.10427.22
5288313-28831326.61526.73
6290264-29026426.79526.91
30min1304481-30448128.10727.970.7628.2728.140.76
2304995-30499528.15528.32
3304387-30438728.09828.26
4304117-30411728.07428.24
5300057-30005727.69927.86
6300150-30015027.70727.87
45min1309988-30998828.61628.560.5728.8328.760.57
2310207-31020728.63628.85
3311136-31113628.72128.93
4310385-31038528.65228.86
5307358-30735828.37328.58
6306944-30694428.33528.54
60min1314008-31400828.98728.860.5429.2429.120.55
2312929-31292928.88729.15
3314234-31423429.00729.27
4313655-31365528.95429.21
5310565-31056528.66928.92
6310544-31054428.66728.92
极限1315137-31513729.09128.960.6529.4029.270.65
2313575-31357528.94729.26
3316745-31674529.23929.55
4313838-31383828.97129.28
5311596-31159628.76429.07
6311584-31158428.76329.07
利伐沙班颗粒项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.331009546101212910095811009367101000110101250.12
212.311014777101426010145180.04
单位质量响应值RSD%判断
81924.1782414.130.43数据可信
供试品溶液-2024010611批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1220156-22015620.01520.091.8920.0120.081.90
2219656-21965619.96919.97
3214879-21487919.53519.53
4227806-22780620.71020.71
5221383-22138320.12620.13
6221793-22179320.16320.16
10min1256138-25613823.28623.191.2023.3223.221.19
2258378-25837823.48923.52
3250979-25097922.81722.85
4258351-25835123.48723.52
5253362-25336223.03323.07
6253122-25312223.01223.05
15min1270643-27064324.60424.591.1424.6824.661.14
2275705-27570525.06525.14
3267964-26796424.36124.43
4272033-27203324.73124.80
5269256-26925624.47824.55
6267419-26741924.31124.38
20min1279217-27921725.38425.371.1125.5025.481.11
2284013-28401325.82025.93
3276523-27652325.13925.25
4281082-28108225.55325.67
5278096-27809625.28225.39
6275656-27565625.06025.17
30min1286370-28637026.03426.070.9126.1926.230.93
2290599-29059926.41926.58
3285355-28535525.94226.09
4288841-28884126.25926.42
5286285-28628526.02626.18
6283222-28322225.74825.90
45min1292781-29278126.61726.590.8426.8226.790.83
2296121-29612126.92127.12
3290910-29091026.44726.64
4294061-29406126.73326.93
5291917-29191726.53826.74
6289168-28916826.28926.49
60min1295584-29558426.87226.850.8827.1227.100.88
2299033-29903327.18527.43
3292958-29295826.63326.87
4297385-29738527.03627.28
5294990-29499026.81827.06
6292250-29225026.56926.81
极限1296327-29632726.93926.980.7327.2327.270.73
2300074-30007427.28027.57
3295072-29507226.82527.11
4298157-29815727.10627.40
5296951-29695126.99627.28
6294042-29404226.73227.02
利伐沙班颗粒项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.331002824100194810022091004328100400110030620.11
212.311000940100031510006280.05
单位质量响应值RSD%判断
81351.3481285.780.06数据可信
供试品溶液-2024010611批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1220248-22024820.23220.302.0120.2320.302.02
2221828-22182820.37720.38
3214901-21490119.74119.74
4228449-22844920.98620.99
5221478-22147820.34520.35
6219016-21901620.11920.12
10min1258815-25881523.77523.411.2123.8123.441.22
2253258-25325823.26523.30
3252677-25267723.21123.24
4258073-25807323.70723.74
5254990-25499023.42423.46
6251149-25114923.07123.10
15min1269181-26918124.72724.841.1524.8024.921.15
2275785-27578525.33425.41
3270377-27037724.83724.91
4272059-27205924.99225.07
5267965-26796524.61624.69
6267398-26739824.56324.64
20min1276022-27602225.35625.581.2025.4725.691.19
2284122-28412226.10026.21
3275063-27506325.26825.38
4280196-28019625.73925.86
5276900-27690025.43625.55
6278156-27815625.55225.66
30min1287113-28711326.37426.340.8426.5326.500.84
2283431-28343126.03626.19
3285110-28511026.19026.35
4290122-29012226.65126.81
5286319-28631926.30226.46
6288647-28864726.51526.67
45min1292319-29231926.85326.880.9627.0527.080.95
2296529-29652927.23927.44
3292742-29274226.89227.09
4294656-29465627.06727.27
5290493-29049326.68526.89
6288771-28877126.52726.73
60min1291642-29164226.79127.090.8927.0427.340.88
2298718-29871827.44127.69
3295364-29536427.13227.38
4296799-29679927.26427.51
5294340-29434027.03827.28
6292785-29278526.89627.14
极限1295960-29596027.18727.230.8327.4827.520.83
2293418-29341826.95427.25
3294432-29443227.04727.34
4299823-29982327.54227.84
5295917-29591727.18327.47
6298708-29870827.44027.73
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