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%
110.323267473271293264343268193268993268060.08
210.243280803273273277040.17
单位质量响应值RSD%判断
31667.2532002.340.75数据可信
供试品溶液-2024122521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%
5min1232262-23226265.40271.575.7565.4071.575.76
2249717-24971770.31770.32
3268074-26807475.48675.49
4256917-25691772.34472.34
5271647-27164776.49276.49
6246331-24633169.36369.36
10min1326680-32668091.98992.590.5792.1092.710.58
2327235-32723592.14592.26
3328641-32864192.54192.67
4331921-33192193.46493.59
5329574-32957492.80492.93
6328762-32876292.57592.69
15min1340087-34008795.76495.370.7596.0395.640.75
2335677-33567794.52294.79
3337046-33704694.90895.19
4342355-34235596.40396.68
5336944-33694494.87995.16
6339992-33999295.73796.01
20min1345015-34501597.15296.390.9097.5796.820.90
2338853-33885395.41695.84
3339140-33914095.49795.94
4346339-34633997.52497.96
5341397-34139796.13396.57
6343184-34318496.63697.07
30min1348544-34854498.14597.280.7898.7397.870.77
2343713-34371396.78597.37
3341807-34180796.24896.85
4347591-34759197.87798.48
5343946-34394696.85197.45
6347142-34714297.75098.34
45min1351768-35176899.05398.010.6699.8098.770.65
2346192-34619297.48398.23
3345823-34582397.37998.14
4349383-34938398.38299.14
5346807-34680797.65698.42
6348472-34847298.12598.88
60min1354057-35405799.69898.170.92100.6199.080.91
2346957-34695797.69898.61
3346691-34669197.62498.54
4349817-34981798.50499.43
5345014-34501497.15198.08
6349190-34919098.32799.24
极限1354700-35470099.87998.370.91100.9699.450.90
2347832-34783297.94599.02
3348342-34834298.08899.17
4350495-35049598.69599.79
5345302-34530297.23298.32
6349384-34938498.38299.46
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%
110.323281513276973281673284033282993281430.09
210.243290933294223292580.08
单位质量响应值RSD%判断
31796.8032154.100.80数据可信
供试品溶液-2024122521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%
5min1258941-25894172.59470.813.9572.5970.803.95
2236348-23634866.26066.26
3258398-25839872.44272.44
4262770-26277073.66773.67
5253666-25366671.11571.11
6245244-24524468.75468.75
10min1345662-34566296.90692.872.5997.0392.992.59
2320013-32001389.71589.83
3326544-32654491.54691.67
4333571-33357193.51693.64
5332395-33239593.18793.31
6329357-32935792.33592.45
15min1356112-35611299.83695.662.74100.1295.932.74
2328628-32862892.13092.39
3335097-33509793.94494.22
4342804-34280496.10596.38
5344986-34498696.71696.99
6339677-33967795.22895.50
20min1358124-358124100.40096.622.58100.8597.052.58
2331903-33190393.04993.46
3339644-33964495.21995.65
4346048-34604897.01497.45
5349117-34911797.87598.31
6343019-34301996.16596.59
30min1359112-359112100.67797.252.47101.2997.842.47
2333362-33336293.45894.03
3343424-34342496.27996.87
4348655-34865597.74598.35
5350968-35096898.39398.99
6345721-34572196.92297.51
45min1363208-363208101.82597.812.66102.6198.572.66
2335239-33523993.98494.71
3345318-34531896.80997.56
4348995-34899597.84098.60
5353579-35357999.12599.89
6346990-34699097.27898.03
60min1363132-363132101.80497.822.63102.7698.732.63
2336149-33614994.23995.12
3344323-34432396.53197.44
4349946-34994698.10799.03
5353824-35382499.194100.12
6346052-34605297.01597.93
极限1365534-365534102.47798.402.51103.6099.482.51
2338922-33892295.01696.05
3346599-34659997.16998.24
4351280-35128098.48199.57
5353885-35388599.211100.30
6349765-34976598.05699.13
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%
110.323272913272063272833274033272363272840.03
210.243269673272773271220.07
单位质量响应值RSD%判断
31713.5731945.510.52数据可信
供试品溶液-2024122721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%
5min1258215-25821572.72172.312.4972.7272.312.49
2262608-26260873.95873.96
3265149-26514974.67474.67
4248422-24842269.96369.96
5253060-25306071.26971.27
6253014-25301471.25671.26
10min1323666-32366691.15492.601.0691.2792.721.06
2332695-33269593.69793.82
3329898-32989892.90993.03
4329054-32905492.67192.79
5331643-33164393.40093.52
6325804-32580491.75691.87
15min1335185-33518594.39895.681.0694.6795.951.06
2340116-34011695.78796.07
3339871-33987195.71896.00
4342250-34225096.38896.66
5344708-34470897.08097.35
6336192-33619294.68194.95
20min1339367-33936795.57696.931.0196.0197.361.01
2344436-34443697.00397.44
3346036-34603697.45497.89
4346475-34647597.57798.01
5348098-34809898.03498.47
6340645-34064595.93596.36
30min1342100-34210096.34598.001.1596.9498.601.14
2346598-34659897.61298.21
3346994-34699497.72498.32
4351794-35179499.07599.67
5353150-35315099.457100.06
6347327-34732797.81798.41
45min1343596-34359696.76798.701.2197.5299.461.20
2349047-34904798.30299.07
3350826-35082698.80399.57
4354646-35464699.879100.64
5355088-355088100.003100.77
6349597-34959798.45799.21
60min1343822-34382296.83099.051.2997.7499.971.28
2349257-34925798.36199.29
3351870-35187099.097100.03
4355113-355113100.010100.94
5355461-355461100.108101.04
6354598-35459899.865100.78
极限1351738-35173899.06099.900.73100.13100.980.73
2356467-356467100.391101.48
3354828-35482899.930101.02
4357624-357624100.717101.81
5356194-356194100.315101.41
6351457-35145798.980100.06
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%
110.323252773254023259163260893259073257180.11
210.243266193266933266560.02
单位质量响应值RSD%判断
31561.8231900.000.76数据可信
供试品溶液-2024122721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%
5min1271444-27144476.68573.013.6176.6973.023.61
2260662-26066273.63973.64
3247898-24789870.03370.03
4266561-26656175.30675.31
5251207-25120770.96870.97
6252914-25291471.45071.45
10min1336474-33647495.05793.861.6795.1893.981.67
2336055-33605594.93895.06
3333920-33392094.33594.45
4328340-32834092.75992.88
5322765-32276591.18491.30
6335877-33587794.88895.01
15min1344408-34440897.29897.181.6097.5897.461.59
2352552-35255299.59999.88
3345012-34501297.46997.74
4337758-33775895.42095.70
5338294-33829495.57195.84
6345996-34599697.74798.02
20min1347099-34709998.05897.941.0898.5198.381.08
2349182-34918298.64799.09
3347631-34763198.20998.65
4340143-34014396.09396.53
5345172-34517297.51497.94
6350858-35085899.12099.56
30min1351262-35126299.23599.581.7499.85100.191.73
2353587-35358799.891100.50
3362762-362762102.483103.08
4344847-34484797.42298.02
5348401-34840198.42699.02
6354158-354158100.053100.66
45min1352981-35298199.72099.660.83100.50100.430.83
2354297-354297100.092100.87
3353737-35373799.934100.70
4347615-34761598.20498.97
5351753-35175399.373100.13
6356217-356217100.634101.41
60min1352367-35236799.54799.810.63100.49100.740.63
2355078-355078100.313101.26
3353519-35351999.872100.81
4349560-34956098.75499.68
5353356-35335699.826100.75
6355871-355871100.537101.48
极限1353357-35335799.826100.220.60100.94101.330.59
2357496-357496100.996102.11
3354898-354898100.262101.37
4351587-35158799.326100.42
5356384-356384100.682101.77
6354850-354850100.248101.36
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