利伐沙班颗粒片项目信息
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%
112.344883024880714891804891984887654887030.11
212.294882074883704882880.03
单位质量响应值RSD%判断
39603.1639730.510.23数据可信
供试品溶液-20210820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%
5min1155765-15576529.33427.553.8829.3327.553.88
2143269-14326926.98026.98
3146995-14699527.68227.68
4139285-13928526.23026.23
5148680-14868027.99928.00
6143701-14370127.06227.06
10min1204465-20446538.50537.771.7538.5737.831.75
2196678-19667837.03837.10
3204509-20450938.51338.57
4197288-19728837.15337.21
5201741-20174137.99238.05
6198734-19873437.42537.49
15min1228793-22879343.08642.731.0743.2442.871.07
2223210-22321042.03542.18
3230116-23011643.33543.48
4226218-22621842.60142.74
5227067-22706742.76142.91
6225882-22588242.53842.68
20min1243050-24305045.77145.690.7946.0245.930.79
2239389-23938945.08145.32
3244992-24499246.13746.38
4242264-24226445.62345.86
5243836-24383645.91946.16
6242224-24222445.61545.85
30min1259917-25991748.94748.970.5649.3049.310.56
2257857-25785748.55948.90
3262114-26211449.36149.71
4260302-26030249.02049.36
5260736-26073649.10249.45
6259262-25926248.82449.16
45min1273436-27343651.49351.520.4151.9551.970.41
2271749-27174951.17651.62
3274989-27498951.78652.24
4273992-27399251.59852.04
5274278-27427851.65252.10
6273127-27312751.43551.88
60min1280263-28026352.77952.830.3253.3553.400.32
2279143-27914352.56853.13
3281763-28176353.06153.63
4280540-28054052.83153.39
5281070-28107052.93153.50
6280434-28043452.81153.37
极限1286632-28663253.97854.020.3254.6754.700.32
2285597-28559753.78354.46
3288000-28800054.23654.92
4286329-28632953.92154.60
5287804-28780454.19954.88
6286832-28683254.01654.70
利伐沙班颗粒片项目信息
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%
112.344876374878054875794877244871624875810.06
212.294860464858144859300.04
单位质量响应值RSD%判断
39512.2439538.650.05数据可信
供试品溶液-JPS4394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%
5min1187607-18760735.45635.284.0235.4635.284.01
2193828-19382836.63236.63
3190403-19040335.98535.98
4186665-18666535.27835.28
5172261-17226132.55632.56
6189311-18931135.77835.78
10min1236167-23616744.63444.262.6544.7144.342.66
2238460-23846045.06745.15
3237314-23731444.85044.93
4237744-23774444.93245.01
5222062-22206241.96842.04
6233331-23333144.09844.18
15min1257023-25702348.57547.921.9648.7548.101.96
2255607-25560748.30848.49
3256434-25643448.46448.64
4256629-25662948.50148.68
5244374-24437446.18546.35
6251326-25132647.49947.68
20min1265248-26524850.13049.891.5850.4250.171.58
2265742-26574250.22350.51
3266586-26658650.38350.67
4267888-26788850.62950.91
5256557-25655748.48748.76
6261820-26182049.48249.76
30min1276303-27630352.21952.080.9252.6252.470.94
2276881-27688152.32852.73
3277134-27713452.37652.78
4277949-27794952.53052.93
5271271-27127151.26851.64
6273760-27376051.73952.13
45min1284789-28478953.82353.721.1454.3454.231.15
2285480-28548053.95354.47
3286120-28612054.07454.59
4287647-28764754.36354.88
5278440-27844052.62353.11
6282903-28290353.46653.97
60min1289759-28975954.76254.531.0555.4055.161.06
2289636-28963654.73955.38
3289818-28981854.77355.41
4290859-29085954.97055.61
5282578-28257853.40554.01
6288633-28863354.54955.18
极限1291962-29196255.17955.011.1855.9355.761.19
2292901-29290155.35656.11
3292565-29256555.29356.05
4293542-29354255.47756.24
5284273-28427353.72554.45
6291195-29119555.03455.78
利伐沙班颗粒片项目信息
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%
112.344867054871104873134873284872484871410.06
212.294870914869684870300.02
单位质量响应值RSD%判断
39476.5839628.150.28数据可信
供试品溶液-JPS4394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%
5min1195234-19523436.87335.386.9836.8735.386.97
2168481-16848131.82031.82
3176247-17624733.28733.29
4188946-18894635.68535.69
5190452-19045235.97035.97
6204669-20466938.65538.65
10min1235751-23575144.52543.864.7344.6143.944.73
2213593-21359340.34040.41
3226732-22673242.82242.90
4239564-23956445.24545.32
5232923-23292343.99144.07
6244760-24476046.22646.31
15min1254164-25416448.00247.583.2948.1847.753.30
2238116-23811644.97245.13
3247188-24718846.68546.85
4258182-25818248.76148.94
5252718-25271847.72947.91
6261120-26112049.31649.50
20min1264401-26440149.93649.762.2450.2250.042.25
2253348-25334847.84848.11
3261249-26124949.34149.61
4267693-26769350.55850.85
5263910-26391049.84350.13
6270289-27028951.04851.35
30min1275712-27571252.07252.011.4652.4752.401.48
2269916-26991650.97751.34
3274024-27402451.75352.14
4278717-27871752.64053.04
5272878-27287851.53751.93
6280945-28094553.06053.47
45min1283394-28339453.52352.983.8554.0453.483.82
2282008-28200853.26153.74
3284841-28484153.79654.29
4285751-28575153.96854.49
5258894-25889448.89649.40
6288130-28813054.41754.95
60min1288422-28842254.47354.391.5855.1155.011.58
2288105-28810554.41355.01
3289278-28927854.63455.25
4290459-29045954.85755.49
5279242-27924252.73953.36
6292309-29230955.20755.86
极限1291012-29101254.96254.911.0555.7255.651.06
2290274-29027454.82255.54
3291452-29145255.04555.78
4292594-29259455.26156.02
5285116-28511653.84854.58
6293882-29388255.50456.28
利伐沙班颗粒片项目信息
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%
112.344874194876174878364875254873584875510.04
212.294913484913724913600.01
单位质量响应值RSD%判断
39509.8139980.470.84数据可信
供试品溶液-JPS2875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%
5min1182148-18214834.23532.156.3334.2432.156.34
2174733-17473332.84232.84
3178799-17879933.60633.61
4171475-17147532.22932.23
5151712-15171228.51528.51
6167327-16732731.45031.45
10min1226068-22606842.49041.723.1042.5741.793.11
2222224-22222441.76841.84
3223919-22391942.08642.16
4227116-22711642.68742.76
5208389-20838939.16839.23
6224024-22402442.10642.18
15min1245875-24587546.21345.901.5146.3846.071.52
2244403-24440345.93746.10
3245518-24551846.14646.31
4246720-24672046.37246.54
5236876-23687644.52244.67
6245974-24597446.23246.40
20min1256904-25690448.28648.181.4448.5648.451.44
2254925-25492547.91448.18
3256585-25658548.22648.50
4260147-26014748.89649.17
5249992-24999246.98747.24
6259543-25954348.78249.05
30min1270696-27069650.87850.651.6551.2651.031.66
2268173-26817350.40450.78
3271011-27101150.93851.32
4272474-27247451.21351.59
5261219-26121949.09749.45
6273449-27344951.39651.77
45min1278130-27813052.27652.172.2852.7752.652.27
2278130-27813052.27652.76
3279470-27947052.52853.02
4281644-28164452.93653.43
5265239-26523949.85350.32
6282701-28270153.13553.62
60min1284506-28450653.47453.002.8554.0853.612.84
2283806-28380653.34353.95
3284107-28410753.39954.01
4286556-28655653.85954.47
5265873-26587349.97250.55
6287139-28713953.96954.58
极限1286975-28697553.93853.781.3554.6754.501.36
2284983-28498353.56454.28
3286303-28630353.81254.54
4289552-28955254.42255.15
5279247-27924752.48653.17
6289784-28978454.46655.19
利伐沙班颗粒片项目信息
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%
112.344858254861214856694857094858264858300.04
212.294874534874944874740.01
单位质量响应值RSD%判断
39370.3439664.280.53数据可信
供试品溶液-JPS2875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%
5min1164594-16459431.11433.695.7531.1133.695.75
2166043-16604331.38831.39
3180476-18047634.11634.12
4185446-18544635.05635.06
5187062-18706235.36135.36
6185602-18560235.08535.09
10min1219070-21907041.41242.772.4341.4842.852.44
2219559-21955941.50441.57
3227758-22775843.05443.13
4230395-23039543.55243.63
5230484-23048443.56943.65
6230325-23032543.53943.62
15min1242620-24262045.86346.611.5046.0246.781.51
2241134-24113445.58245.74
3248203-24820346.91947.09
4248640-24864047.00147.18
5249433-24943347.15147.33
6249284-24928447.12347.30
20min1254719-25471948.15048.710.9948.4148.991.01
2254351-25435148.08148.34
3258825-25882548.92749.20
4260477-26047749.23949.52
5259296-25929649.01649.30
6258548-25854848.87449.15
30min1268292-26829250.71650.950.5551.0951.340.56
2267605-26760550.58650.96
3270639-27063951.16051.54
4271513-27151351.32551.71
5269088-26908850.86751.26
6270130-27013051.06451.45
45min1277516-27751652.46052.750.5252.9453.240.53
2277132-27713252.38752.87
3279932-27993252.91753.41
4280799-28079953.08053.58
5279111-27911152.76153.26
6279811-27981152.89453.40
60min1283030-28303053.50253.570.4054.1054.180.41
2282353-28235353.37453.97
3283828-28382853.65354.27
4285433-28543353.95654.58
5282695-28269553.43954.06
6283022-28302253.50154.12
极限1284197-28419753.72353.990.4354.4454.720.45
2284155-28415553.71554.43
3286388-28638854.13754.87
4286856-28685654.22554.97
5286724-28672454.20054.94
6285417-28541753.95354.69
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