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430060-202303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%
111.724705824705414699564692654699794700650.12
211.674690994697144694060.10
单位质量响应值RSD%判断
40107.9440223.310.21数据可信
供试品溶液-2026030522批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202227-20222737.61035.955.6637.6135.955.66
2187524-18752434.87634.88
3192576-19257635.81535.82
4207190-20719038.53338.53
5176253-17625332.78032.78
6194109-19410936.10036.10
10min1234903-23490343.68743.082.0543.7743.162.06
2227834-22783442.37342.45
3233882-23388243.49743.58
4237927-23792744.25044.34
5225390-22539041.91841.99
6229861-22986142.75042.83
15min1251118-25111846.70346.281.2846.8846.451.28
2246005-24600545.75245.92
3250743-25074346.63346.81
4252970-25297047.04747.23
5245645-24564545.68545.85
6246426-24642645.83046.01
20min1261233-26123348.58448.131.1348.8748.411.14
2256261-25626147.66047.93
3260409-26040948.43148.71
4262476-26247648.81549.10
5256532-25653247.71047.98
6255791-25579147.57247.85
30min1270507-27050750.30950.130.8250.7050.520.83
2267710-26771049.78950.17
3270053-27005350.22550.61
4273210-27321050.81251.21
5268708-26870849.97450.35
6267181-26718149.69050.07
45min1279744-27974452.02751.730.7352.5352.230.74
2276563-27656351.43551.93
3278716-27871651.83652.33
4280932-28093252.24852.76
5277577-27757751.62452.11
6275479-27547951.23451.73
60min1285054-28505453.01452.840.6453.6353.450.65
2282810-28281052.59753.20
3283485-28348552.72353.34
4287350-28735053.44154.07
5283330-28333052.69453.29
6282700-28270052.57753.18
极限1287459-28745953.46253.370.3854.2054.100.39
2286190-28619053.22653.95
3286427-28642753.27054.00
4288810-28881053.71354.46
5286939-28693953.36554.08
6285848-28584853.16253.89
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430060-202303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%
111.724686334691504691224690084693704690570.06
211.674696384691904694140.07
单位质量响应值RSD%判断
40021.9340223.990.36数据可信
供试品溶液-2026030522批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181515-18151533.79435.642.9833.7935.642.98
2194949-19494936.29536.30
3191072-19107235.57435.57
4194592-19459236.22936.23
5197382-19738236.74836.75
6189087-18908735.20435.20
10min1224215-22421541.74442.831.4541.8242.911.45
2231982-23198243.19043.27
3230903-23090342.98943.07
4230942-23094242.99743.08
5233689-23368943.50843.59
6228530-22853042.54742.63
15min1244163-24416345.45846.170.8845.6346.340.88
2250199-25019946.58246.76
3248418-24841846.25046.42
4248397-24839746.24646.42
5249622-24962246.47446.65
6246981-24698145.98346.16
20min1257210-25721047.88748.020.5948.1648.300.58
2255361-25536147.54347.82
3259663-25966348.34448.62
4258506-25850648.12848.41
5258800-25880048.18348.46
6258031-25803148.04048.31
30min1269141-26914150.10850.360.6850.4850.740.68
2267478-26747849.79950.18
3270903-27090350.43650.82
4271678-27167850.58150.97
5272253-27225350.68851.08
6271447-27144750.53850.92
45min1280034-28003452.13652.210.3152.6252.700.31
2278899-27889951.92552.42
3281017-28101752.31952.82
4281094-28109452.33452.83
5280409-28040952.20652.71
6281042-28104252.32452.82
60min1282422-28242252.58153.020.4253.1853.630.43
2285678-28567853.18753.80
3284867-28486753.03653.65
4285390-28539053.13453.75
5285380-28538053.13253.75
6284853-28485353.03453.64
极限1284960-28496053.05453.810.7153.7754.540.71
2289312-28931253.86454.59
3289155-28915553.83554.57
4289868-28986853.96754.70
5290456-29045654.07754.81
6290265-29026554.04154.77
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430060-202303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%
111.724689034688994682414688414681804686130.08
211.674694554694674694610.01
单位质量响应值RSD%判断
39984.0440228.020.44数据可信
供试品溶液-2026031021批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192644-19264435.88136.263.8735.8836.263.87
2199307-19930737.12337.12
3189422-18942235.28135.28
4194988-19498836.31836.32
5185173-18517334.49034.49
6206463-20646338.45538.46
10min1229779-22977942.79843.822.5542.8843.902.54
2239169-23916944.54744.63
3225767-22576742.05142.13
4237752-23775244.28344.36
5238932-23893244.50344.58
6240121-24012144.72444.81
15min1248287-24828746.24546.861.8146.4247.031.81
2253926-25392647.29647.48
3243748-24374845.40045.57
4254194-25419447.34647.52
5254233-25423347.35347.53
6254987-25498747.49347.68
20min1258606-25860648.16748.621.3648.4548.911.36
2262626-26262648.91649.20
3255089-25508947.51247.79
4264401-26440149.24749.53
5262037-26203748.80649.09
6263558-26355849.09049.38
30min1270298-27029850.34550.630.9650.7351.020.96
2273427-27342750.92851.32
3267264-26726449.78050.16
4274291-27429151.08951.48
5272704-27270450.79351.18
6272882-27288250.82651.23
45min1281593-28159352.44952.610.7452.9553.120.75
2282420-28242052.60353.11
3279358-27935852.03352.52
4285197-28519753.12053.63
5281934-28193452.51253.01
6284302-28430252.95453.47
60min1285558-28555853.18753.340.5153.8053.960.52
2286793-28679353.41754.04
3284568-28456853.00353.61
4288722-28872253.77754.40
5285584-28558453.19253.81
6286894-28689453.43654.07
极限1289305-28930553.88553.910.3354.6254.650.34
2289615-28961553.94354.69
3287940-28794053.63154.35
4290123-29012354.03854.78
5289125-28912553.85254.59
6290640-29064054.13454.88
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430060-202303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%
111.724719724717774718124720054720684719270.03
211.674687194685194686190.04
单位质量响应值RSD%判断
40266.8140155.870.20数据可信
供试品溶液-2026031021批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194042-19404236.04736.592.6336.0536.592.63
2188028-18802834.93034.93
3198035-19803536.78936.79
4202129-20212937.54937.55
5198862-19886236.94236.94
6200695-20069537.28337.28
10min1229853-22985342.70043.501.9642.7843.591.96
2227438-22743842.25142.33
3234335-23433543.53243.61
4237468-23746844.11444.20
5237625-23762544.14344.23
6238389-23838944.28544.37
15min1249553-24955346.35946.531.0146.5346.701.01
2246298-24629845.75445.93
3249965-24996546.43646.61
4253599-25359947.11147.29
5251138-25113846.65446.83
6252140-25214046.84047.02
20min1261640-26164048.60548.531.5148.8848.811.51
2254952-25495247.36247.64
3267320-26732049.66049.94
4261975-26197548.66748.95
5260763-26076348.44248.73
6260683-26068348.42748.71
30min1271193-27119350.37950.510.6250.7750.900.62
2268927-26892749.95850.34
3272152-27215250.55750.95
4272325-27232550.59050.98
5273075-27307550.72951.12
6273598-27359850.82651.22
45min1282456-28245652.47252.300.8152.9752.800.81
2277484-27748451.54852.04
3284364-28436452.82653.33
4282006-28200652.38852.89
5280970-28097052.19552.70
6281810-28181052.35252.86
60min1284962-28496252.93753.050.4953.5553.660.50
2283408-28340852.64853.25
3286203-28620353.16853.79
4287612-28761253.42954.05
5285349-28534953.00953.63
6285763-28576353.08653.71
极限1288748-28874853.64053.670.6854.3754.400.69
2285204-28520452.98253.70
3289854-28985453.84654.59
4290742-29074254.01154.75
5288873-28887353.66454.40
6290018-29001853.87654.62
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430060-202303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%
111.724690634694954693814694734698184694460.06
211.674699454695774697610.06
单位质量响应值RSD%判断
40055.1240253.730.35数据可信
供试品溶液-2026040221批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201597-20159737.50437.325.6437.5037.325.64
2206724-20672438.45738.46
3191423-19142335.61135.61
4205505-20550538.23138.23
5183519-18351934.14134.14
6214734-21473439.94839.95
10min1237025-23702544.09444.471.7644.1844.561.77
2241799-24179944.98345.07
3232644-23264443.27943.36
4239537-23953744.56244.65
5238343-23834344.34044.42
6244959-24495945.57045.66
15min1251372-25137246.76347.001.4346.9447.181.44
2253650-25365047.18747.37
3247524-24752446.04846.22
4255416-25541647.51647.70
5250384-25038446.58046.75
6257483-25748347.90048.09
20min1259931-25993148.35648.581.1348.6448.861.14
2262696-26269648.87049.16
3256271-25627147.67547.95
4263404-26340449.00249.29
5260151-26015148.39748.67
6264278-26427849.16449.46
30min1272314-27231450.65950.570.9351.0550.960.94
2271696-27169650.54450.94
3267743-26774349.80950.19
4274704-27470451.10451.50
5270523-27052350.32650.71
6273977-27397750.96951.37
45min1278451-27845151.80151.830.6452.3152.330.65
2278168-27816851.74852.26
3275958-27595851.33751.83
4280716-28071652.22252.73
5277777-27777751.67652.17
6280430-28043052.16952.69
60min1281597-28159752.38652.560.5553.0153.180.56
2282101-28210152.48053.11
3280447-28044752.17252.78
4284582-28458252.94253.57
5282322-28232252.52153.13
6284054-28405452.84353.48
极限1285503-28550353.11353.180.6853.8553.920.69
2285804-28580453.16953.91
3283044-28304452.65653.38
4288630-28863053.69554.44
5284941-28494153.00853.74
6287262-28726253.44054.19
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430060-202303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%
111.724699554691044690664695564690704693500.09
211.674695284696904696090.03
单位质量响应值RSD%判断
40046.9340240.700.35数据可信
供试品溶液-2026040221批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1200824-20082437.37037.651.5937.3737.641.59
2198477-19847736.93336.93
3200981-20098137.39937.40
4207061-20706138.53038.53
5205294-20529438.20238.20
6201209-20120937.44137.44
10min1233341-23334143.42143.811.1243.5043.891.12
2233367-23336743.42543.51
3233193-23319343.39343.48
4239540-23954044.57444.66
5237442-23744244.18444.27
6235666-23566643.85343.94
15min1249250-24925046.38146.620.8846.5646.810.87
2248695-24869546.27846.46
3249567-24956746.44046.62
4254229-25422947.30747.49
5249376-24937646.40446.59
6252252-25225246.94047.12
20min1259275-25927548.24648.370.6048.5348.660.60
2258432-25843248.09048.37
3258998-25899848.19548.48
4262802-26280248.90349.19
5260443-26044348.46448.75
6259811-25981148.34648.63
30min1269622-26962250.17250.330.6950.5650.720.69
2269251-26925150.10350.49
3269536-26953650.15650.55
4274124-27412451.01051.41
5270577-27057750.35050.74
6269636-26963650.17450.57
45min1277966-27796651.72451.870.3652.2352.380.36
2277715-27771551.67852.18
3278541-27854151.83152.33
4280447-28044752.18652.70
5279188-27918851.95252.46
6278614-27861451.84552.35
60min1283812-28381252.81252.730.4053.4353.350.41
2281791-28179152.43653.05
3283080-28308052.67653.29
4285195-28519553.07053.70
5283532-28353252.76053.38
6282961-28296152.65453.27
极限1286546-28654653.32153.280.3254.0554.010.33
2285164-28516453.06453.79
3286309-28630953.27754.01
4287774-28777453.55054.30
5286438-28643853.30154.04
6285580-28558053.14153.88
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