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%
110.033224053221153218183221163219493220810.07
210.133237733236853237290.02
单位质量响应值RSD%判断
32111.7631957.450.35数据可信
加速3月-供试品溶液-2024010511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%
5min1207671-20767158.11162.459.9758.1162.459.97
2244808-24480868.50368.50
3229871-22987164.32364.32
4230167-23016764.40664.41
5240420-24042067.27567.28
6186120-18612052.08152.08
10min1273512-27351276.53579.464.8776.6679.604.88
2295946-29594682.81382.97
3291098-29109881.45681.60
4285244-28524479.81879.96
5296247-29624782.89783.05
6261649-26164973.21673.33
15min1303580-30358084.94986.692.5885.2587.012.60
2312725-31272587.50887.84
3314291-31429187.94688.27
4308876-30887686.43186.75
5320894-32089489.79490.13
6298501-29850183.52883.81
20min1320782-32078289.76290.651.1490.2591.161.16
2324621-32462190.83791.37
3324482-32448290.79891.32
4322343-32234390.19990.71
5330666-33066692.52893.06
6320850-32085089.78290.25
30min1336478-33647894.15593.821.1694.8494.531.14
2329841-32984192.29793.03
3333541-33354193.33394.05
4333484-33348493.31794.03
5341050-34105095.43496.17
6337328-33732894.39295.06
45min1342603-34260395.86995.321.3196.7796.241.29
2333812-33381293.40994.35
3338729-33872994.78495.71
4338712-33871294.78095.70
5346089-34608996.84497.79
6344007-34400796.26197.13
60min1344203-34420396.31695.831.3597.4396.961.33
2335639-33563993.92095.07
3339695-33969595.05596.19
4340739-34073995.34796.48
5347629-34762997.27598.44
6346844-34684497.05598.14
极限1346361-34636196.92096.371.3798.2497.721.35
2337180-33718094.35195.71
3342489-34248995.83797.19
4342408-34240895.81497.16
5350557-35055798.09499.48
6347468-34746897.23098.53
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%
110.033233373235003228233228993226943230510.11
210.133198203199093198640.02
单位质量响应值RSD%判断
32208.4731575.911.41数据可信
加速3月-供试品溶液-2024010611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%
5min1237568-23756866.78067.533.4566.7867.533.44
2230885-23088564.90264.90
3231527-23152765.08265.08
4243513-24351368.45168.45
5251024-25102470.56370.56
6246865-24686569.39469.39
10min1294003-29400382.64483.231.9082.7983.381.90
2288981-28898181.23281.38
3291938-29193882.06482.21
4296583-29658383.36983.52
5303148-30314885.21585.37
6301964-30196484.88285.04
15min1314502-31450288.40689.260.9088.7489.600.90
2315090-31509088.57288.90
3316785-31678589.04889.38
4317123-31712389.14389.48
5320135-32013589.99090.34
6321704-32170490.43190.77
20min1324190-32419091.13092.040.7491.6692.570.75
2326475-32647591.77292.29
3326900-32690091.89192.42
4326561-32656191.79692.33
5329424-32942492.60193.15
6331004-33100493.04593.59
30min1334448-33444894.01394.790.6394.7495.530.63
2336149-33614994.49195.22
3336865-33686594.69395.42
4336828-33682894.68295.42
5338368-33836895.11595.87
6340631-34063195.75196.50
45min1339991-33999195.57196.030.4996.5196.980.49
2340413-34041395.69096.63
3341306-34130695.94196.88
4341492-34149295.99396.94
5341860-34186096.09797.06
6344682-34468296.89097.85
60min1341902-34190296.10996.480.5397.2697.640.54
2341609-34160996.02697.17
3343086-34308696.44197.59
4342632-34263296.31497.48
5343429-34342996.53897.71
6346606-34660697.43198.61
极限1344540-34454096.85097.040.5098.2298.420.51
2343769-34376996.63397.99
3344108-34410896.72998.10
4345319-34531997.06998.45
5345101-34510197.00898.40
6348520-34852097.96999.36
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%
110.033242473246823242043246813249053245440.10
210.133228553231293229920.06
单位质量响应值RSD%判断
32357.3331884.701.05数据可信
加速3月-供试品溶液-2024010612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%
5min1223679-22367962.42563.839.8662.4363.839.86
2198493-19849355.39655.40
3210109-21010958.63858.64
4234278-23427865.38365.38
5247598-24759869.10169.10
6258153-25815372.04772.05
10min1290207-29020780.99281.223.9881.1381.363.99
2271912-27191275.88676.01
3286639-28663979.99780.13
4291546-29154681.36681.51
5302860-30286084.52484.68
6303040-30304084.57484.73
15min1312863-31286387.31587.522.0487.6387.842.06
2303965-30396584.83285.12
3310978-31097886.78987.10
4312508-31250887.21687.54
5321843-32184389.82190.16
6319461-31946189.15789.50
20min1325223-32522390.76590.701.2091.2891.221.22
2319947-31994789.29289.77
3323098-32309890.17290.67
4323096-32309690.17190.69
5330941-33094192.36192.90
6327722-32772291.46292.01
30min1332878-33287892.90193.200.9393.6293.920.95
2330941-33094192.36193.04
3332673-33267392.84493.55
4332170-33217092.70493.42
5339418-33941894.72695.47
6335626-33562693.66894.42
45min1336911-33691194.02794.210.8994.9595.130.91
2334616-33461693.38694.27
3335966-33596693.76394.67
4335911-33591193.74894.67
5342795-34279595.66996.63
6339138-33913894.64895.61
60min1335070-33507093.51394.481.0694.6495.621.07
2336107-33610793.80294.89
3337392-33739294.16195.28
4337279-33727994.12995.26
5344749-34474996.21497.38
6340659-34065995.07396.24
极限1337837-33783794.28594.490.9895.6295.830.99
2335984-33598493.76895.07
3336146-33614693.81395.14
4336578-33657893.93495.28
5344333-34433396.09897.48
6340515-34051595.03396.41
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