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800
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%
112.044838914841804841064848894844334843000.08
212.064846534841484844000.08
单位质量响应值RSD%判断
40224.2540165.840.11数据可信
供试品溶液-2024010911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%
5min1132207-13220724.57025.903.5124.5725.903.52
2141543-14154326.30526.30
3136752-13675225.41525.41
4143557-14355726.67926.68
5145150-14515026.97526.98
6136998-13699825.46025.46
10min1191084-19108435.51237.063.6535.5737.123.64
2201897-20189737.52137.58
3189857-18985735.28435.34
4201134-20113437.38037.44
5206592-20659238.39438.45
6205947-20594738.27438.33
15min1222186-22218641.29242.352.1341.4342.502.13
2230162-23016242.77442.92
3221372-22137241.14141.28
4229594-22959442.66942.81
5232103-23210343.13543.28
6231965-23196543.10943.25
20min1241064-24106444.80045.491.2945.0345.721.29
2246720-24672045.85146.09
3240533-24053344.70244.93
4245774-24577445.67645.91
5247706-24770646.03546.28
6246855-24685545.87646.11
30min1263062-26306248.88849.370.9049.2149.700.89
2266052-26605249.44449.78
3269677-26967750.11850.44
4266021-26602149.43849.78
5265570-26557049.35549.70
6263461-26346148.96349.30
45min1277922-27792251.65051.890.6952.0852.340.68
2278266-27826651.71452.16
3282013-28201352.41052.85
4280723-28072352.17152.62
5279498-27949851.94352.40
6276882-27688251.45751.91
60min1283918-28391852.76453.090.5853.3153.660.57
2286073-28607353.16553.73
3288067-28806753.53554.09
4286588-28658853.26153.83
5285716-28571653.09953.67
6283807-28380752.74453.31
极限1292943-29294354.44254.280.4455.1154.960.43
2291056-29105654.09154.77
3293761-29376154.59455.27
4291685-29168554.20854.89
5292602-29260254.37855.06
6290310-29031053.95254.63
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800
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%
112.044827904828454828684829974830494829100.03
212.064832834836694834760.06
单位质量响应值RSD%判断
40108.8040089.220.04数据可信
供试品溶液-2024010911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%
5min1142307-14230726.51027.463.4926.5127.463.49
2155714-15571429.00829.01
3142231-14223126.49626.50
4146302-14630227.25427.25
5150388-15038828.01628.02
6147392-14739227.45727.46
10min1198495-19849536.97738.042.1037.0438.102.10
2211109-21110939.32739.39
3204764-20476438.14538.20
4201997-20199737.63037.69
5206095-20609538.39338.46
6202617-20261737.74537.81
15min1228074-22807442.48843.571.5542.6343.721.55
2238241-23824144.38244.53
3235892-23589243.94444.09
4233839-23383943.56243.71
5235603-23560343.89044.04
6231610-23161043.14643.29
20min1246222-24622245.86846.671.0146.1046.911.02
2253498-25349847.22447.47
3251596-25159646.87047.11
4250234-25023446.61646.86
5251976-25197646.94047.19
6249559-24955946.49046.73
30min1264690-26469049.30950.100.8249.6550.440.82
2270278-27027850.35050.71
3269681-26968150.23950.58
4269333-26933350.17450.52
5270830-27083050.45350.80
6268653-26865350.04750.39
45min1278171-27817151.82052.420.5952.2752.870.59
2282000-28200052.53353.00
3281592-28159252.45752.91
4282814-28281452.68553.14
5282253-28225352.58153.04
6281378-28137852.41852.87
60min1284119-28411952.92853.360.5053.4953.930.51
2287284-28728453.51854.10
3287213-28721353.50554.08
4287602-28760253.57754.15
5287154-28715453.49454.07
6285190-28519053.12853.70
极限1289747-28974753.97754.370.9054.6655.070.90
2292499-29249954.48955.19
3295050-29505054.96555.66
4293770-29377054.72655.42
5292255-29225554.44455.14
6287917-28791753.63654.33
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800
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%
112.044841564837354834914925484848434857550.79
212.064833604831994832800.03
单位质量响应值RSD%判断
40345.1040072.970.48数据可信
供试品溶液-JPS5451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%
5min1189368-18936835.18137.844.1235.1837.844.12
2208964-20896438.82238.82
3206293-20629338.32538.33
4199201-19920137.00837.01
5213175-21317539.60439.60
6205110-20511038.10638.11
10min1236397-23639743.91845.622.0944.0045.702.09
2247195-24719545.92446.01
3248270-24827046.12446.21
4243880-24388045.30845.39
5251403-25140346.70646.79
6246183-24618345.73645.82
15min1255851-25585147.53248.851.5947.7149.041.59
2263121-26312148.88349.07
3267481-26748149.69349.88
4261289-26128948.54348.73
5266506-26650649.51249.70
6263547-26354748.96249.15
20min1268035-26803549.79650.821.1450.0851.111.14
2272744-27274450.67150.97
3276211-27621151.31551.61
4273229-27322950.76151.05
5276570-27657051.38251.68
6274338-27433850.96751.26
30min1278565-27856551.75252.761.0952.1453.161.10
2282263-28226352.43952.85
3285911-28591153.11753.53
4284475-28447552.85053.25
5285710-28571053.08053.50
6286910-28691053.30353.71
45min1288994-28899453.69054.060.5854.2054.580.59
2288606-28860653.61854.14
3292165-29216554.27954.81
4291824-29182454.21554.74
5291886-29188654.22754.76
6292288-29228854.30254.83
60min1291805-29180554.21254.650.4954.8455.300.51
2292995-29299554.43355.08
3295269-29526954.85555.51
4294652-29465254.74155.38
5294763-29476354.76155.42
6295443-29544354.88855.54
极限1294160-29416054.64954.900.4955.4055.670.49
2293639-29363954.55355.32
3297537-29753755.27756.05
4296189-29618955.02655.79
5295589-29558954.91555.69
6296045-29604555.00055.77
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800
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%
112.044847494832104832194838434834444836930.14
212.064837574838774838170.02
单位质量响应值RSD%判断
40173.8440117.500.10数据可信
供试品溶液-JPS5451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%
5min1179427-17942733.38637.345.9033.3937.345.90
2204220-20422038.00038.00
3208188-20818838.73838.74
4209238-20923838.93338.93
5208729-20872938.83938.84
6194222-19422236.13936.14
10min1226167-22616742.08345.173.6342.1645.253.63
2243984-24398445.39945.48
3247496-24749646.05246.14
4250398-25039846.59246.68
5247722-24772246.09446.18
6240788-24078844.80444.88
15min1251985-25198546.88749.082.4247.0649.262.43
2263267-26326748.98749.17
3267036-26703649.68849.88
4267804-26780449.83150.02
5269770-26977050.19750.39
6262756-26275648.89249.07
20min1263720-26372049.07150.621.7049.3450.911.71
2269981-26998150.23650.53
3275895-27589551.33651.64
4275182-27518251.20451.50
5274765-27476551.12651.43
6272759-27275950.75351.04
30min1282050-28205052.48253.391.4852.8653.801.48
2283513-28351352.75453.16
3287561-28756153.50753.92
4286862-28686253.37753.79
5294233-29423354.74955.16
6287448-28744853.48653.89
45min1287076-28707653.41754.150.9253.9154.670.93
2288909-28890953.75854.28
3291079-29107954.16254.69
4294460-29446054.79155.32
5291870-29187054.30954.84
6292670-29267054.45854.98
60min1291911-29191154.31754.550.6654.9355.190.66
2291543-29154354.24854.89
3293718-29371854.65355.31
4291178-29117854.18054.84
5294536-29453654.80555.46
6296041-29604155.08555.73
极限1293866-29386654.68055.452.2155.4256.212.19
2293193-29319354.55555.32
3295962-29596255.07055.84
4310978-31097857.86458.64
5296074-29607455.09155.87
6297896-29789655.43056.19
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