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)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%
110.323283573274343282943284133283123281620.13
2 10.243273533281393277460.17
单位质量响应值RSD%判断
31798.6432006.450.47数据可信
供试品溶液-2024122621批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186231-18623152.32854.875.7652.3354.885.76
2192962-19296254.21954.22
3199295-19929555.99956.00
4185246-18524652.05152.05
5192275-19227554.02654.03
6215739-21573960.61960.62
10min1259116-25911672.80773.731.9472.8973.831.95
2262080-26208073.64073.73
3262767-26276773.83373.93
4257639-25763972.39272.48
5260856-26085673.29673.39
6272031-27203176.43676.54
15min1282334-28233479.33179.791.4679.5480.011.46
2284644-28464479.98080.19
3282458-28245879.36679.58
4280055-28005578.69178.90
5282488-28248879.37579.59
6291880-29188082.01482.24
20min1295455-29545583.01883.402.5283.3683.752.52
2295810-29581083.11883.46
3294413-29441382.72583.07
4290129-29012981.52281.86
5293643-29364382.50982.85
6311470-31147087.51887.88
30min1308970-30897086.81686.701.2487.2987.181.25
2308671-30867186.73287.22
3307433-30743386.38486.87
4303956-30395685.40785.88
5306864-30686486.22486.71
6315426-31542688.63089.14
45min1318211-31821189.41289.350.6990.0489.980.70
2317652-31765289.25589.88
3317791-31779189.29489.92
4315310-31531088.59789.21
5316997-31699789.07189.70
6321927-32192790.45691.11
60min1321133-32113390.23389.920.7691.0190.700.77
2320272-32027289.99190.77
3319581-31958189.79790.58
4317243-31724389.14089.90
5318008-31800889.35590.13
6323984-32398491.03491.84
极限1323447-32344790.88390.660.5291.8191.590.53
2323757-32375790.97091.90
3322902-32290290.73091.66
4320816-32081690.14491.06
5320480-32048090.05090.97
6324583-32458391.20392.16
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)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%
110.323268973274323276103276403272503273660.10
2 10.243275243275093275160.01
单位质量响应值RSD%判断
31721.5131983.980.59数据可信
供试品溶液-2024122621批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182560-18256051.37750.399.6651.3850.399.66
2151553-15155342.65142.65
3196223-19622355.22255.22
4196881-19688155.40755.41
5178822-17882250.32550.32
6168344-16834447.37647.38
10min1254489-25448971.62071.613.1571.7171.703.17
2242381-24238168.21268.28
3263245-26324574.08474.18
4261082-26108273.47573.57
5257706-25770672.52572.61
6247852-24785269.75269.83
15min1278262-27826278.31078.591.7378.5178.791.74
2275855-27585577.63277.82
3283897-28389779.89680.11
4282699-28269979.55979.77
5282996-28299679.64279.85
6271771-27177176.48376.68
20min1289652-28965281.51582.101.3081.8582.441.31
2289990-28999081.61081.92
3295511-29551183.16483.51
4293394-29339482.56882.92
5295731-29573183.22683.56
6286146-28614680.52980.85
30min1303157-30315785.31686.061.0785.7986.531.08
2304280-30428085.63286.08
3306838-30683886.35286.84
4309070-30907086.98087.46
5309766-30976687.17687.65
6301777-30177784.92885.38
45min1310679-31067987.43388.340.9288.0588.950.92
2311986-31198687.80188.39
3314398-31439888.47989.11
4315423-31542388.76889.40
5318600-31860089.66290.28
6312278-31227887.88388.48
60min1318345-31834589.59089.100.7490.3589.860.75
2314136-31413688.40689.14
3316037-31603788.94189.72
4316145-31614588.97189.75
5320327-32032790.14890.92
6314698-31469888.56489.31
极限1315070-31507088.66989.640.8789.5890.550.87
2317044-31704489.22490.11
3319624-31962489.95090.88
4319610-31961089.94690.87
5322855-32285590.85991.78
6316910-31691089.18690.08
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)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%
110.323285453284443280953276353281763281790.11
2 10.243282493278583280540.09
单位质量响应值RSD%判断
31800.2932036.520.53数据可信
供试品溶液-2024122621批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1249866-24986670.17469.785.2570.1769.785.25
2244884-24488468.77468.77
3255276-25527671.69371.69
4235632-23563266.17666.18
5269754-26975475.75975.76
6235451-23545166.12566.13
10min1318786-31878689.52990.621.5389.6590.741.54
2319622-31962289.76489.88
3323333-32333390.80690.93
4322309-32230990.51990.63
5332068-33206893.26093.39
6319844-31984489.82789.94
15min1329574-32957492.55994.001.7092.8394.271.70
2329810-32981092.62592.89
3333721-33372193.72493.99
4337659-33765994.83095.09
5344566-34456696.77097.05
6332988-33298893.51893.78
20min1334114-33411493.83495.511.5294.2595.931.52
2336742-33674294.57294.99
3338250-33825094.99695.42
4342627-34262796.22596.64
5348779-34877997.95398.40
6339990-33999095.48495.90
30min1338311-33831195.01396.681.6295.5997.271.62
2339976-33997695.48196.06
3341302-34130295.85396.44
4347134-34713497.49198.07
5353333-35333399.23299.84
6345511-34551197.03597.61
45min1338910-33891095.18197.141.7495.9297.881.74
2341191-34119195.82296.56
3342285-34228596.12996.87
4349895-34989598.26699.01
5354454-35445499.547100.32
6348523-34852397.88198.62
60min1338732-33873295.13197.361.7996.0298.271.78
2341596-34159695.93696.83
3345093-34509396.91897.82
4350178-35017898.34699.25
5355764-35576499.915100.85
6348726-34872697.93898.84
极限1347480-34748097.58899.492.5398.64100.562.51
2350001-35000198.29699.35
3350111-35011198.32799.39
4351129-35112998.61399.68
5354970-35497099.692100.80
6371862-371862104.436105.50
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)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%
110.323273173271833275973273133274263273670.05
2 10.243277413276223276820.03
单位质量响应值RSD%判断
31721.6132000.200.62数据可信
供试品溶液-2024122621批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1266049-26604974.85473.361.3474.8573.361.34
2258329-25832972.68272.68
3263766-26376674.21174.21
4259410-25941072.98672.99
5259982-25998273.14773.15
6256806-25680672.25372.25
10min1333765-33376593.90694.410.4594.0394.540.45
2334627-33462794.14894.27
3334643-33464394.15394.28
4337808-33780895.04395.17
5336285-33628594.61594.74
6336314-33631494.62394.74
15min1343681-34368196.69697.130.3696.9897.410.36
2345470-34547097.19997.48
3344867-34486797.02997.31
4347390-34739097.73998.02
5345263-34526397.14197.42
6344635-34463596.96497.24
20min1347299-34729997.71498.030.3498.1698.470.34
2348923-34892398.17198.61
3347172-34717297.67898.12
4349747-34974798.40298.85
5349664-34966498.37998.82
6347732-34773297.83698.28
30min1350950-35095098.74198.980.3399.3599.580.33
2352811-35281199.26599.87
3350164-35016498.52099.12
4353319-35331999.407100.01
5351760-35176098.96999.57
6351827-35182798.98899.59
45min1350896-35089698.72699.510.7699.50100.280.75
2353596-35359699.485100.25
3350329-35032998.56699.34
4356398-356398100.274101.05
5356647-356647100.344101.11
6354339-35433999.694100.46
60min1349835-34983598.42799.610.8899.36100.540.88
2355107-35510799.911100.85
3350927-35092798.73499.67
4356767-356767100.378101.32
5357579-357579100.606101.54
6353977-35397799.593100.53
极限1357161-357161100.488100.320.45101.59101.430.45
2356861-356861100.404101.51
3354634-35463499.777100.88
4357136-357136100.481101.59
5358836-358836100.960102.07
6354856-35485699.840100.94
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