利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123211993213323204483203723203083207320.16
210.123218443211693215060.15
单位质量响应值RSD%判断
31692.8931769.370.18数据可信
加速6月-供试品溶液-2023073011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%
5min1113362-11336232.02532.225.2332.0232.225.23
2123961-12396135.01935.02
3118200-11820033.39133.39
4110533-11053331.22531.23
5108603-10860330.68030.68
6109601-10960130.96230.96
10min1155829-15582944.02243.992.2244.0944.062.22
2161634-16163445.66145.74
3157450-15745044.47944.55
4153972-15397243.49743.57
5152241-15224143.00843.08
6153203-15320343.28043.35
15min1175809-17580949.66649.612.0249.8349.782.02
2180833-18083351.08551.26
3178147-17814750.32650.50
4174596-17459649.32349.49
5170810-17081048.25448.42
6173477-17347749.00749.17
20min1188040-18804053.12153.321.0953.4053.601.10
2192352-19235254.33954.63
3189742-18974253.60253.89
4187939-18793953.09353.37
5186447-18644752.67152.94
6187962-18796253.09953.37
30min1206153-20615358.23858.311.0158.6458.711.02
2209568-20956859.20359.62
3206883-20688358.44458.85
4206422-20642258.31458.71
5203063-20306357.36557.75
6206283-20628358.27558.67
45min1218936-21893661.84961.891.7262.3862.421.72
2222302-22230262.80063.35
3220346-22034662.24862.78
4220452-22045262.27762.80
5211720-21172059.81160.33
6220757-22075762.36462.89
60min1226490-22649063.98364.171.4064.6564.841.40
2229773-22977364.91165.60
3227777-22777764.34765.02
4228958-22895864.68065.34
5221096-22109662.45963.11
6228822-22882264.64265.30
极限1234050-23405066.11966.201.2966.9367.011.29
2236801-23680166.89667.72
3235265-23526566.46267.28
4235535-23553566.53867.34
5228481-22848164.54665.33
6235869-23586966.63367.44
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123245803246323240283245783246253244890.08
210.123243393246913245150.08
单位质量响应值RSD%判断
32064.1332066.700.01数据可信
长期6月-供试品溶液-2023073011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%
5min1108511-10851130.33532.765.4230.3332.765.43
2119360-11936033.36833.37
3122208-12220834.16434.16
4110466-11046630.88130.88
5124252-12425234.73534.74
6118314-11831433.07533.08
10min1152114-15211442.52444.032.2342.5944.102.23
2156431-15643143.73143.80
3159972-15997244.72144.80
4155251-15525143.40143.47
5161054-16105445.02345.10
6160225-16022544.79144.86
15min1177512-17751249.62450.521.0749.7950.691.07
2179570-17957050.19950.37
3181336-18133650.69350.87
4180872-18087250.56350.73
5182225-18222550.94251.12
6182766-18276651.09351.27
20min1190280-19028053.19354.491.3053.4754.771.29
2194175-19417554.28254.57
3195473-19547354.64554.93
4195585-19558554.67654.95
5196488-19648854.92955.22
6197440-19744055.19555.48
30min1208172-20817258.19559.090.9458.5959.500.94
2210298-21029858.79059.19
3211584-21158459.14959.56
4212609-21260959.43659.83
5211704-21170459.18359.60
6213887-21388759.79360.20
45min1220977-22097761.77562.350.9762.2962.880.97
2222705-22270562.25862.79
3220823-22082361.73262.27
4225233-22523362.96563.50
5222435-22243562.18262.73
6225992-22599263.17763.72
60min1229270-22927064.09364.910.9064.7565.580.90
2231756-23175664.78865.46
3230618-23061864.47065.15
4234941-23494165.67966.35
5232640-23264065.03565.72
6233848-23384865.37366.06
极限1235522-23552265.84166.420.9166.6467.240.91
2236397-23639766.08666.90
3235692-23569265.88966.71
4240262-24026267.16667.98
5237474-23747466.38767.21
6240224-24022467.15567.98
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123233623241763240343240603235263238320.12
210.123248493242063245280.15
单位质量响应值RSD%判断
31999.2132067.980.16数据可信
中间条件6月-供试品溶液-2023073011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%
5min1120894-12089433.83035.4111.5233.8335.4111.52
2131917-13191736.91536.91
3117616-11761632.91332.91
4152912-15291242.79042.79
5111729-11172931.26531.27
6124112-12411234.73034.73
10min1160046-16004644.78645.746.8744.8645.826.88
2165584-16558446.33646.42
3155964-15596443.64443.72
4184767-18476751.70451.80
5153677-15367743.00443.07
6160598-16059844.94045.02
15min1180631-18063150.54651.604.6850.7251.784.69
2185630-18563051.94552.13
3178806-17880650.03650.21
4201172-20117256.29456.50
5178592-17859249.97650.14
6181442-18144250.77350.95
20min1194131-19413154.32455.313.7854.6155.603.80
2198236-19823655.47355.77
3192814-19281453.95554.24
4212394-21239459.43559.77
5193362-19336254.10954.38
6194987-19498754.56454.85
30min1212193-21219359.37859.782.4959.7960.202.51
2212114-21211459.35659.78
3210439-21043958.88759.29
4224377-22437762.78863.25
5211903-21190359.29759.69
6210839-21083958.99959.41
45min1222283-22228362.20263.181.7162.7463.731.74
2225726-22572663.16563.72
3224246-22424662.75163.28
4233136-23313665.23965.85
5225821-22582163.19263.72
6223485-22348562.53863.08
60min1232799-23279965.14465.531.3065.8266.221.34
2233104-23310465.23065.93
3232357-23235765.02165.69
4240236-24023667.22667.98
5234246-23424665.54966.22
6232392-23239265.03165.71
极限1238469-23846966.73167.121.1567.5567.961.17
2238844-23884466.83667.68
3238133-23813366.63767.45
4245125-24512568.59469.49
5240568-24056867.31968.13
6238062-23806266.61767.44
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123244993245123238123240023244983242650.11
210.123272393267953270170.10
单位质量响应值RSD%判断
32042.0032313.930.60数据可信
加速6月-供试品溶液-JPS5249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%
5min1137565-13756538.32336.496.4838.3236.496.47
2116037-11603732.32632.33
3127533-12753335.52835.53
4137447-13744738.29038.29
5137170-13717038.21338.21
6130195-13019536.27036.27
10min1176371-17637149.13447.054.7749.2247.134.77
2156204-15620443.51543.59
3165879-16587946.21146.29
4175626-17562648.92649.01
5174646-17464648.65348.74
6164572-16457245.84745.93
15min1194762-19476254.25752.783.5154.4552.973.52
2178688-17868849.77949.95
3186609-18660951.98652.17
4196809-19680954.82755.02
5192622-19262253.66153.85
6187350-18735052.19252.37
20min1207544-20754457.81856.692.6258.1356.992.63
2194376-19437654.14954.43
3200136-20013655.75456.05
4208423-20842358.06358.38
5205477-20547757.24257.55
6204974-20497457.10257.40
30min1219813-21981361.23660.821.4661.6861.241.48
2213047-21304759.35159.75
3216557-21655760.32960.75
4222193-22219361.89962.34
5219846-21984661.24561.68
6218362-21836260.83161.26
45min1232985-23298564.90564.351.0565.4864.921.08
2226760-22676063.17163.70
3230146-23014664.11464.67
4233238-23323864.97665.56
5232268-23226864.70565.28
6230660-23066064.25764.82
60min1238339-23833966.39765.711.5867.1266.421.57
2234355-23435565.28765.96
3235506-23550665.60766.31
4240037-24003766.87067.60
5229509-22950963.93764.66
6237566-23756666.18166.88
极限1243084-24308467.71967.191.1568.5968.041.15
2240727-24072767.06267.88
3241461-24146167.26668.11
4243854-24385467.93368.81
5236013-23601365.74966.61
6241939-24193967.40068.25
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123243123246513240143243383243603243350.07
210.123262983257523260250.12
单位质量响应值RSD%判断
32048.9132215.910.37数据可信
长期6月-供试品溶液-JPS5249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%
5min1141672-14167239.52338.212.9439.5238.202.94
2130189-13018936.31936.32
3137180-13718038.26938.27
4138419-13841938.61538.62
5139417-13941738.89438.89
6134833-13483337.61537.61
10min1180815-18081550.44248.942.4150.5349.032.41
2168785-16878547.08647.17
3175529-17552948.96849.05
4176719-17671949.30049.39
5178082-17808249.68049.77
6172701-17270148.17948.26
15min1199293-19929355.59754.042.6055.8054.242.60
2185358-18535851.71051.90
3192039-19203953.57453.77
4196934-19693454.93955.13
5196760-19676054.89155.09
6191869-19186953.52653.72
20min1210615-21061558.75657.551.6059.0857.871.60
2201176-20117656.12356.42
3206458-20645857.59657.91
4207486-20748657.88358.20
5207985-20798558.02258.34
6204092-20409256.93657.25
30min1224305-22430562.57561.701.2363.0362.141.23
2217100-21710060.56560.99
3221023-22102361.65962.10
4222474-22247462.06462.51
5223121-22312162.24562.69
6219039-21903961.10661.54
45min1234552-23455265.43464.511.3466.0365.091.34
2229914-22991464.14064.70
3226386-22638663.15563.73
4233329-23332965.09265.68
5233450-23345065.12665.71
6229786-22978664.10464.68
60min1242797-24279767.73463.524.7168.4764.244.66
2236311-23631165.92466.63
3228013-22801363.60964.33
4212619-21261959.31560.04
5224357-22435762.58963.32
6222009-22200961.93462.65
极限1245675-24567568.53767.781.2169.4368.641.21
2242102-24210267.54068.39
3237733-23773366.32167.18
4245496-24549668.48769.35
5243989-24398968.06668.94
6242721-24272167.71268.56
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123271383270853273823273263266613271180.09
210.123278193271633274910.15
单位质量响应值RSD%判断
32323.9132360.770.09数据可信
中间条件6月-供试品溶液-JPS5249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%
5min1144885-14488540.15638.745.7640.1638.745.75
2144410-14441040.02540.02
3145338-14533840.28240.28
4126011-12601134.92534.93
5144265-14426539.98439.98
6133832-13383237.09337.09
10min1177578-17757849.21848.464.5849.3148.544.58
2180630-18063050.06350.15
3179267-17926749.68649.78
4165630-16563045.90645.98
5182071-18207150.46350.55
6163810-16381045.40245.48
15min1196329-19632954.41554.172.5254.6154.362.53
2199302-19930255.23955.44
3196493-19649354.46054.66
4187257-18725751.90052.08
5200756-20075655.64255.84
6192456-19245653.34153.52
20min1195584-19558454.20855.903.8854.5356.223.87
2210715-21071558.40258.72
3201607-20160755.87756.20
4201057-20105755.72556.02
5210227-21022758.26758.59
6191049-19104952.95153.25
30min1219314-21931460.78561.101.0761.2361.531.08
2222764-22276461.74162.19
3219318-21931860.78661.23
4217294-21729460.22560.64
5223580-22358061.96762.42
6220338-22033861.06961.49
45min1230136-23013663.78464.010.8764.3664.580.88
2232781-23278164.51865.11
3228966-22896663.46064.04
4228937-22893763.45264.00
5233753-23375364.78765.38
6231060-23106064.04164.60
60min1235909-23590965.38565.441.5566.1066.161.56
2239089-23908966.26667.00
3235272-23527265.20865.93
4236230-23623065.47466.17
5240313-24031366.60567.34
6229813-22981363.69564.39
极限1240671-24067166.70467.210.6767.5768.070.67
2243641-24364167.52868.41
3240391-24039166.62767.49
4242982-24298267.34568.18
5244306-24430667.71268.60
6242986-24298667.34668.19
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