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%
115.344922194923794922374917594919434921070.06
215.224917124917754917440.01
单位质量响应值RSD%判断
32079.9932309.070.51数据可信
供试品溶液-1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%
5min192252-9225217.12417.392.0217.1217.392.04
294848-9484817.60617.61
391174-9117416.92416.92
496540-9654017.92017.92
593673-9367317.38817.39
693518-9351817.35917.36
10min1159680-15968029.64029.401.6629.6729.431.66
2160100-16010029.71829.75
3161792-16179230.03230.06
4156353-15635329.02329.05
5157562-15756229.24729.28
6154730-15473028.72228.75
15min1192710-19271035.77235.551.5435.8535.631.53
2192814-19281435.79135.87
3195897-19589736.36336.44
4188582-18858235.00535.08
5191101-19110135.47335.55
6188060-18806034.90834.99
20min1215652-21565240.03039.811.2640.1739.951.26
2215666-21566640.03340.17
3218159-21815940.49640.63
4211062-21106239.17839.31
5214765-21476539.86640.00
6211606-21160639.27939.41
30min1244878-24487845.45545.211.0245.6645.421.02
2244371-24437145.36145.57
3246937-24693745.83746.04
4239880-23988044.52744.73
5243635-24363545.22445.43
6241792-24179244.88245.08
45min1270935-27093550.29250.080.7750.5750.360.77
2271327-27132750.36550.65
3272025-27202550.49450.78
4266459-26645949.46149.74
5269570-26957050.03950.32
6268550-26855049.84950.12
60min1285812-28581253.05452.830.4953.4253.190.49
2286085-28608553.10453.47
3285380-28538052.97353.34
4282503-28250352.43952.80
5283867-28386752.69353.05
6284001-28400152.71753.08
极限1299066-29906655.51455.270.6355.9755.720.64
2300327-30032755.74856.20
3298682-29868255.44355.90
4295745-29574554.89755.34
5295873-29587354.92155.37
6296920-29692055.11555.56
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%
115.344933584937354931554931894934564933790.05
215.224948474950914949690.04
单位质量响应值RSD%判断
32162.9132520.960.79数据可信
供试品溶液-1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%
5min1169307-16930731.28531.463.8931.2831.463.89
2169786-16978631.37331.37
3180003-18000333.26133.26
4159545-15954529.48129.48
5169804-16980431.37731.38
6173089-17308931.98431.98
10min1235722-23572243.55743.441.7743.6143.491.77
2234338-23433843.30143.35
3239651-23965144.28344.34
4227448-22744842.02842.08
5237308-23730843.85043.90
6235931-23593143.59643.65
15min1264066-26406648.79448.401.3748.9248.531.37
2261778-26177848.37248.50
3264452-26445248.86649.00
4255047-25504747.12847.25
5264363-26436348.84948.97
6261892-26189248.39348.52
20min1279634-27963451.67151.111.2051.8851.321.20
2276819-27681951.15151.36
3278838-27883851.52451.73
4270597-27059750.00150.20
5278346-27834651.43351.64
6275411-27541150.89151.10
30min1294378-29437854.39654.110.9054.6954.400.91
2293710-29371054.27254.56
3293898-29389854.30754.60
4287614-28761453.14653.43
5294607-29460754.43854.73
6292664-29266454.07954.37
45min1306384-30638456.61456.380.7557.0056.760.76
2306198-30619856.58056.96
3306681-30668156.66957.06
4300721-30072155.56855.94
5306142-30614256.56956.95
6304443-30444356.25556.64
60min1314381-31438158.09257.510.7958.5757.980.80
2311612-31161257.58058.06
3312351-31235157.71758.20
4306963-30696356.72157.18
5311258-31125857.51557.99
6310680-31068057.40857.88
极限1315852-31585258.36458.260.5258.9458.830.53
2316239-31623958.43559.01
3316781-31678158.53559.11
4312165-31216557.68258.24
5315637-31563758.32458.90
6314989-31498958.20458.78
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%
115.344930964928504925574926834922224926820.07
215.224953034953264953140.01
单位质量响应值RSD%判断
32117.4732543.630.94数据可信
供试品溶液-1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%
5min1131808-13180824.36524.145.6524.3624.145.65
2136222-13622225.18025.18
3136608-13660825.25225.25
4135777-13577725.09825.10
5118973-11897321.99221.99
6124259-12425922.96922.97
10min1174107-17410732.18332.552.4132.2232.582.41
2180892-18089233.43833.48
3179924-17992433.25933.30
4178373-17837332.97233.01
5170651-17065131.54531.58
6172478-17247831.88231.92
15min1198321-19832136.65937.201.6536.7537.291.66
2205176-20517637.92738.02
3204273-20427337.76037.86
4202544-20254437.44037.54
5196885-19688536.39436.48
6200270-20027037.02037.11
20min1215761-21576139.88340.351.3740.0440.511.37
2222034-22203441.04341.20
3220761-22076140.80740.97
4218402-21840240.37140.53
5214069-21406939.57039.72
6218733-21873340.43340.59
30min1238613-23861344.10744.521.2044.3344.741.20
2244410-24441045.17945.41
3242771-24277144.87645.10
4240587-24058744.47244.70
5236535-23653543.72343.94
6242096-24209644.75144.97
45min1258289-25828947.74448.020.8748.0448.320.87
2262056-26205648.44148.75
3261308-26130848.30248.61
4259521-25952147.97248.27
5256201-25620147.35847.65
6261315-26131548.30448.60
60min1269249-26924949.77050.010.7650.1550.390.76
2272235-27223550.32250.71
3272483-27248350.36850.75
4270307-27030749.96650.35
5267272-26727249.40549.77
6271834-27183450.24850.62
极限1279287-27928751.62651.730.5652.0852.190.57
2281137-28113751.96852.44
3281512-28151252.03752.50
4279235-27923551.61652.08
5277313-27731351.26151.71
6280679-28067951.88352.34
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%
115.344943994945034943724947114942744944520.04
215.224923714926884925300.05
单位质量响应值RSD%判断
32232.8632360.710.28数据可信
供试品溶液-1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%
5min1339412-33941262.80366.493.8262.8066.503.82
2369273-36927368.32868.33
3373491-37349169.10969.11
4345726-34572663.97163.97
5366557-36655767.82667.83
6361710-36171066.92966.93
10min1444935-44493582.32882.482.3782.4382.582.37
2450106-45010683.28583.40
3464554-46455485.95986.07
4435855-43585580.64880.75
5437969-43796981.03981.15
6441006-44100681.60181.71
15min1474169-47416987.73887.562.1187.9887.812.11
2475595-47559588.00288.25
3490696-49069690.79691.05
4470381-47038187.03787.28
5461512-46151285.39685.64
6467002-46700286.41286.66
20min1486242-48624289.97289.662.0590.3690.062.05
2486258-48625889.97590.37
3501895-50189592.86893.28
4481683-48168389.12889.51
5472559-47255987.44087.83
6478778-47877888.59188.98
30min1498102-49810292.16691.932.1092.7092.482.10
2499922-49992292.50393.05
3514077-51407795.12295.69
4495123-49512391.61592.15
5482707-48270789.31889.85
6491125-49112590.87591.41
45min1506288-50628893.68193.372.1894.3794.072.18
2508854-50885494.15694.86
3522551-52255196.69097.41
4502265-50226592.93693.62
5490292-49029290.72191.41
6497516-49751692.05892.75
60min1513004-51300494.92494.322.1995.7795.172.19
2514656-51465695.22996.09
3526931-52693197.50098.38
4506761-50676193.76894.61
5494470-49447091.49492.33
6502687-50268793.01593.86
极限1511401-51140194.62795.011.7195.6396.021.71
2516229-51622995.52096.54
3528905-52890597.86698.91
4513613-51361395.03696.03
5505356-50535693.50894.50
6505375-50537593.51294.51
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