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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214845474843604841394835064840614841230.09
215.184831074831764831420.02
单位质量响应值RSD%判断
31829.2631827.540.01数据可信
供试品溶液-JPS7664批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136980-369806.9436.895.216.946.895.23
238391-383917.2087.21
336539-365396.8606.86
438591-385917.2467.25
533287-332876.2506.25
636412-364126.8376.84
10min169322-6932213.01612.844.2613.0312.864.26
270792-7079213.29213.30
368953-6895312.94612.96
469746-6974613.09513.11
562630-6263011.75911.77
668944-6894412.94512.96
15min189748-8974816.85116.533.7616.8816.563.77
290130-9013016.92316.96
389733-8973316.84816.88
489367-8936716.77916.81
581510-8151015.30415.33
687651-8765116.45716.49
20min1105776-10577619.86019.564.0319.9219.624.03
2108603-10860320.39120.45
3105695-10569519.84519.91
4104995-10499519.71419.78
596277-9627718.07718.13
6103727-10372719.47519.54
30min1131243-13124324.64224.133.0524.7424.223.06
2130769-13076924.55324.65
3130043-13004324.41624.51
4130046-13004624.41724.51
5120805-12080522.68222.77
6128121-12812124.05624.15
45min1159707-15970729.98629.532.6930.1229.672.70
2159710-15971029.98730.12
3159421-15942129.93230.07
4158999-15899929.85329.99
5148918-14891827.96028.08
6157034-15703429.48429.62
60min1182228-18222834.21533.772.4134.4033.952.42
2182014-18201434.17434.36
3183324-18332434.42034.61
4180541-18054133.89834.08
5171452-17145232.19132.36
6179604-17960433.72233.90
极限1228886-22888642.97542.761.7743.2243.001.78
2230330-23033043.24643.49
3230750-23075043.32543.57
4227919-22791942.79343.04
5219790-21979041.26741.49
6228631-22863142.92743.17
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214832934834624836154833554831354833720.04
215.184845374842694844030.04
单位质量响应值RSD%判断
31779.8831910.610.30数据可信
供试品溶液-JPS7664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%
5min1146167-14616727.42928.864.1827.4328.864.18
2148060-14806027.78527.78
3163826-16382630.74330.74
4155511-15551129.18329.18
5152353-15235328.59028.59
6156815-15681529.42829.43
10min1208757-20875739.17539.591.4039.2239.641.41
2208505-20850539.12839.17
3215259-21525940.39540.45
4210733-21073339.54639.59
5208622-20862239.15039.20
6213894-21389440.13940.19
15min1233475-23347543.81444.080.9343.9244.190.93
2233647-23364743.84643.96
3238437-23843744.74544.86
4234384-23438443.98444.10
5232813-23281343.68943.80
6236574-23657444.39544.51
20min1247948-24794846.53046.730.8646.7146.920.87
2247620-24762046.46846.65
3252445-25244547.37347.57
4248684-24868446.66846.86
5246789-24678946.31246.50
6250679-25067947.04247.23
30min1268251-26825150.34050.200.6650.6050.460.66
2265998-26599849.91750.18
3270080-27008050.68350.95
4267516-26751650.20250.47
5265152-26515249.75850.02
6267922-26792250.27850.55
45min1282326-28232652.98152.900.6053.3353.250.60
2280737-28073752.68353.03
3284492-28449253.38753.74
4281510-28151052.82853.18
5279695-27969552.48752.83
6282758-28275853.06253.41
60min1290365-29036554.48954.340.5954.9254.780.59
2289300-28930054.29054.72
3291258-29125854.65755.10
4290528-29052854.52054.96
5286426-28642653.75054.18
6289681-28968154.36154.80
极限1296699-29669955.67855.550.2056.2056.080.20
2295746-29574655.49956.02
3296749-29674955.68756.22
4296047-29604755.55656.08
5295398-29539855.43455.96
6295491-29549155.45155.98
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214859034856094861214853514855034856970.07
215.184845444841344843390.06
单位质量响应值RSD%判断
31932.7431906.390.06数据可信
供试品溶液-JPS7664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%
5min1355149-35514966.49165.632.2066.4965.632.19
2344179-34417964.43764.44
3361715-36171567.72167.72
4354569-35456966.38366.38
5343063-34306364.22864.23
6344496-34449664.49764.50
10min1417046-41704678.08078.221.6378.1978.331.63
2420526-42052678.73178.84
3425810-42581079.72079.83
4419496-41949678.53878.65
5418706-41870678.39078.50
6405324-40532475.88575.99
15min1441864-44186482.72683.261.9782.9783.501.97
2449732-44973284.19984.44
3454317-45431785.05885.30
4448610-44861083.98984.23
5444749-44474983.26683.50
6429184-42918480.35280.59
20min1455944-45594485.36285.521.9385.7485.901.92
2464004-46400486.87187.25
3465149-46514987.08587.47
4459857-45985786.09586.48
5454678-45467885.12585.50
6441024-44102482.56982.94
30min1471347-47134788.24689.311.0088.7789.840.99
2480836-48083690.02290.55
3483661-48366190.55191.08
4477154-47715489.33389.86
5472449-47244988.45288.97
6476825-47682589.27189.78
45min1482629-48262990.35891.022.0591.0391.702.05
2494132-49413292.51293.19
3497610-49761093.16393.85
4488992-48899291.54992.22
5484222-48422290.65691.32
6469530-46953087.90688.56
60min1492577-49257792.22192.392.0193.0493.212.01
2500502-50050293.70494.53
3503442-50344294.25595.09
4497715-49771593.18394.01
5491076-49107691.94092.76
6475638-47563889.04989.85
极限1497058-49705893.06093.022.1694.0394.002.16
2506100-50610094.75295.74
3507191-50719194.95795.95
4500898-50089893.77894.76
5491410-49141092.00292.97
6478524-47852489.59090.54
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214879924880534877454880894865344876830.14
215.184836944841654839300.07
单位质量响应值RSD%判断
32063.3131879.450.41数据可信
供试品溶液-JPS7664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%
5min1421796-42179678.84278.401.9078.8478.401.90
2420299-42029978.56278.56
3426741-42674179.76679.77
4404219-40421975.55675.56
5419193-41919378.35578.36
6424488-42448879.34579.34
10min1494530-49453092.43791.182.5892.5791.312.57
2494512-49451292.43492.56
3502198-50219893.87094.00
4467652-46765287.41387.54
5478780-47878089.49389.62
6489126-48912691.42791.56
15min1520735-52073597.33595.983.4497.6296.263.44
2518627-51862796.94197.23
3540531-540531101.035101.32
4489801-48980191.55391.82
5499913-49991393.44393.72
6511408-51140895.59295.88
20min1531443-53144399.33797.492.8199.7897.932.80
2528333-52833398.75599.20
3537807-537807100.526100.98
4499236-49923693.31793.74
5509027-50902795.14795.58
6523633-52363397.87798.32
30min1541401-541401101.19899.042.89101.8199.642.89
2538003-538003100.563101.17
3546179-546179102.091102.72
4507338-50733894.83195.41
5516001-51600196.45097.04
6530239-53023999.11299.72
45min1543043-543043101.50599.902.65102.29100.672.65
2542431-542431101.391102.17
3551380-551380103.063103.86
4514309-51430996.13496.87
5521537-52153797.48598.24
6534060-53406099.826100.60
60min1547490-547490102.33699.993.05103.29100.923.05
2543166-543166101.528102.48
3551558-551558103.097104.06
4507982-50798294.95195.85
5525001-52500198.13399.05
6534299-53429999.870100.81
极限1545531-545531101.97099.673.08103.09100.773.08
2542467-542467101.397102.51
3548406-548406102.507103.65
4507268-50726894.81895.87
5519275-51927597.06298.14
6536359-536359100.256101.36
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