洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481127049113012711293781127983112687411282820.13
213.521127787112909311284400.09
单位质量响应值RSD%判断
83700.4583464.500.20数据可信
加速6月-供试品溶液-2025020621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11245129-124512997.76299.380.9897.7699.380.99
21263515-126351599.20599.21
31278034-1278034100.345100.35
41271140-127114099.80499.80
51276916-1276916100.258100.26
61259940-125994098.92598.92
10min11253992-125399298.458100.521.1998.62100.681.19
21272678-127267899.925100.09
31292063-1292063101.447101.61
41293288-1293288101.543101.71
51290138-1290138101.296101.46
61279031-1279031100.424100.59
15min11276399-1276399100.217100.680.80100.54101.010.81
21271100-127110099.801100.13
31294882-1294882101.668102.00
41293133-1293133101.531101.87
51284842-1284842100.880101.22
61273158-127315899.963100.29
30min11247499-124749997.948100.071.2898.44100.571.27
21269028-126902899.638100.14
31292422-1292422101.475101.98
41287896-1287896101.120101.62
51270075-127007599.720100.22
61280462-1280462100.536101.03
极限11246098-124609897.83899.991.4098.50100.661.39
21266088-126608899.407100.07
31291754-1291754101.423102.10
41291996-1291996101.442102.11
51279110-1279110100.430101.10
61265828-126582899.387100.05
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481126144112682211282881127225112920811275370.11
213.521125421112681111261160.09
单位质量响应值RSD%判断
83645.1883292.600.30数据可信
加速6月-供试品溶液-2025020721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11275103-1275103100.252101.321.61100.25101.321.62
21324248-1324248104.116104.12
31300296-1300296102.232102.23
41288809-1288809101.329101.33
51273098-1273098100.094100.09
61270694-127069499.90599.91
10min11284547-1284547100.994101.891.57101.16102.061.57
21333045-1333045104.807104.98
31302293-1302293102.389102.56
41296043-1296043101.898102.07
51279934-1279934100.632100.80
61280092-1280092100.644100.81
15min11282518-1282518100.835101.511.58101.17101.851.58
21326549-1326549104.297104.64
31299491-1299491102.169102.51
41292431-1292431101.614101.95
51273349-1273349100.114100.45
61272529-1272529100.049100.38
30min11279752-1279752100.617101.281.67101.12101.791.67
21326062-1326062104.258104.78
31295526-1295526101.857102.37
41289821-1289821101.409101.92
51268158-126815899.706100.21
61269869-126986999.840100.34
极限11277772-1277772100.462101.091.55101.13101.771.55
21321729-1321729103.918104.61
31291035-1291035101.504102.19
41286839-1286839101.174101.85
51268330-126833099.719100.39
61268920-126892099.766100.43
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481127026112667411258971126848112639811265690.04
213.521127652112736911275100.02
单位质量响应值RSD%判断
83573.3783395.710.16数据可信
加速6月-供试品溶液-2025020821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11283549-1283549100.897102.381.32100.90102.381.32
21310844-1310844103.042103.04
31319246-1319246103.703103.70
41312630-1312630103.183103.18
51310291-1310291102.999103.00
61278078-1278078100.466100.47
10min11288616-1288616101.295102.231.45101.46102.401.45
21318015-1318015103.606103.78
31277732-1277732100.439100.61
41314748-1314748103.349103.52
51319364-1319364103.712103.88
61284733-1284733100.990101.16
15min11288282-1288282101.269102.321.44101.61102.661.44
21314165-1314165103.303103.65
31282641-1282641100.825101.17
41325039-1325039104.158104.50
51315751-1315751103.428103.77
61283960-1283960100.929101.26
30min11287695-1287695101.222101.961.43101.73102.471.43
21313037-1313037103.215103.73
31274159-1274159100.158100.67
41313741-1313741103.270103.79
51313502-1313502103.251103.77
61280136-1280136100.628101.13
极限11308025-1308025102.821101.971.33103.49102.651.33
21309474-1309474102.934103.62
31273075-1273075100.073100.75
41306107-1306107102.670103.36
51309463-1309463102.934103.62
61277179-1277179100.396101.07
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481125729112569111254501126080112598611257870.03
213.521142577114154411420600.07
单位质量响应值RSD%判断
83515.3684471.890.81数据可信
加速6月-供试品溶液-NPA3053批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11233296-123329696.36296.231.2296.3696.231.22
21241529-124152997.00597.00
31206740-120674094.28794.29
41235739-123573996.55396.55
51223093-122309395.56495.56
61249252-124925297.60897.61
10min11237347-123734796.67896.161.0096.8496.321.00
21246151-124615197.36697.53
31210534-121053494.58394.74
41235826-123582696.55996.72
51226203-122620395.80795.97
61228204-122820495.96496.13
15min11236609-123660996.62196.391.3096.9496.711.30
21258918-125891898.36498.69
31212479-121247994.73595.05
41241258-124125896.98497.31
51224128-122412895.64595.96
61228421-122842195.98196.30
30min11234382-123438296.44795.921.1196.9396.401.11
21240018-124001896.88797.37
31202382-120238293.94694.42
41236554-123655496.61697.10
51227851-122785195.93696.41
61224528-122452895.67796.16
极限11229443-122944396.06195.650.9196.7096.290.91
21236930-123693096.64697.29
31206136-120613694.24094.87
41231882-123188296.25196.90
51218325-121832595.19295.83
61222157-122215795.49196.13
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