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100638-202405对照品来源中检所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%
1 13.761173546117240211727981170238117008111718130.14
2 13.741166686116767811671820.07
单位质量响应值RSD%判断
85160.8384947.740.18数据可信
供试品溶液-NPA3080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%
5min11266050-126605097.68498.561.1797.6898.561.17
21277428-127742898.56298.56
31258714-125871497.11897.12
41302060-1302060100.463100.46
51281878-128187898.90698.91
61278393-127839398.63798.64
10min11273839-127383998.28599.000.8098.4599.170.80
21284704-128470499.12499.29
31271940-127194098.13998.30
41299745-1299745100.284100.45
51287584-128758499.34699.51
61281029-128102998.84099.00
15min11271761-127176198.12598.291.7098.4598.621.70
21278873-127887398.67499.00
31271078-127107898.07298.40
41298202-1298202100.165100.50
51288482-128848299.41599.75
61235199-123519995.30495.63
30min11269321-126932197.93797.981.1198.4398.471.10
21277509-127750998.56899.06
31265864-126586497.67098.16
41245695-124569596.11496.62
51287753-128775399.35999.85
61272803-127280398.20598.69
极限11265458-126545897.63998.280.8898.2998.930.88
21271862-127186298.13398.79
31258994-125899497.14097.79
41291216-129121699.626100.29
51278709-127870998.66199.32
61276159-127615998.46499.12
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100638-202405对照品来源中检所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%
1 13.761164861116417611630141167473116333311645710.16
2 13.741160958115916711600620.11
单位质量响应值RSD%判断
84634.5284429.550.18数据可信
供试品溶液-NPA3080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%
5min11271636-127163698.72199.501.0498.7299.501.04
21272599-127259998.79698.80
31281259-128125999.46899.47
41307098-1307098101.474101.47
51283060-128306099.60899.61
61274213-127421398.92198.92
10min11279420-127942099.326100.001.1099.49100.171.10
21276359-127635999.08899.25
31287213-128721399.931100.10
41314805-1314805102.073102.24
51290352-1290352100.174100.34
61280665-128066599.42299.59
15min11276544-127654499.10299.820.9699.43100.160.96
21274271-127427198.92699.26
31290424-1290424100.180100.51
41306140-1306140101.400101.74
51290333-1290333100.173100.51
61277097-127709799.14599.48
30min11271949-127194998.74699.441.2899.2499.941.27
21265378-126537898.23698.73
31280549-128054999.41399.91
41311875-1311875101.845102.35
51281665-128166599.500100.00
61274128-127412898.91599.41
极限11267313-126731398.38699.150.9699.0599.820.95
21265171-126517198.22098.88
31278890-127889099.28599.95
41299106-1299106100.854101.53
51278441-127844199.25099.92
61274074-127407498.91199.57
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100638-202405对照品来源中检所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%
1 13.761164221116393511644771165216116332611642350.06
2 13.741158257116199411601260.23
单位质量响应值RSD%判断
84610.1084434.210.15数据可信
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%
5min11327539-1327539103.07399.472.69103.0799.472.69
21275998-127599899.07299.07
31231529-123152995.61995.62
41258722-125872297.73097.73
51284268-128426899.71499.71
61308814-1308814101.620101.62
10min11324442-1324442102.833101.581.74103.00101.741.74
21301148-1301148101.024101.19
31271706-127170698.73898.90
41337359-1337359103.836104.00
51301572-1301572101.057101.22
61313424-1313424101.977102.15
15min11328693-1328693103.163101.541.71103.51101.881.71
21287852-128785299.992100.33
31283332-128333299.64199.96
41339398-1339398103.994104.33
51299580-1299580100.903101.24
61307972-1307972101.554101.89
30min11324337-1324337102.825101.762.67103.34102.272.66
21285919-128591999.842100.34
31270474-127047498.64399.13
41368413-1368413106.247106.76
51294762-1294762100.528101.03
61320170-1320170102.501103.01
极限11338909-1338909103.956101.121.95104.64101.791.94
21281053-128105399.464100.13
31272413-127241398.79399.45
41323089-1323089102.728103.41
51293586-1293586100.437101.11
61305194-1305194101.338102.02
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100638-202405对照品来源中检所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%
1 13.761162254115885011624151163187116205911617530.15
2 13.741160640115611311583760.28
单位质量响应值RSD%判断
84429.7284306.840.11数据可信
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%
5min11254480-125448097.57897.634.3397.5897.634.33
21280500-128050099.60299.60
31262739-126273998.22198.22
41264775-126477598.37998.38
51315058-1315058102.290102.29
61153453-115345389.72089.72
10min11263409-126340998.273100.012.1898.44100.172.18
21289188-1289188100.278100.44
31281767-128176799.70199.86
41283914-128391499.868100.03
51337098-1337098104.005104.18
61258794-125879497.91498.06
15min11263156-126315698.25399.852.2798.58100.182.27
21292363-1292363100.525100.86
31268045-126804598.63498.96
41277529-127752999.37199.70
51338499-1338499104.114104.46
61262499-126249998.20298.51
30min11257827-125782797.83999.822.1698.33100.312.16
21292813-1292813100.560101.06
31275716-127571699.23099.72
41278884-127888499.47799.97
51333279-1333279103.708104.23
61261118-126111898.09598.57
极限11256548-125654897.73999.522.2098.39100.182.20
21285588-128558899.998100.67
31267606-126760698.59999.26
41273462-127346299.05599.72
51332632-1332632103.657104.35
61260475-126047598.04598.68
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100638-202405对照品来源中检所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%
1 13.761159111115980211599531160716115817011595500.09
2 13.741157650115915911584040.10
单位质量响应值RSD%判断
84269.6284308.880.04数据可信
供试品溶液-2025020821批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11311522-1311522102.111101.291.24102.11101.281.24
21275333-127533399.29399.29
31294569-1294569100.791100.79
41301893-1301893101.361101.36
51299353-1299353101.164101.16
61322917-1322917102.998103.00
10min11319756-1319756102.752102.251.14102.92102.411.14
21290546-1290546100.478100.64
31313006-1313006102.227102.39
41310080-1310080101.999102.17
51309814-1309814101.978102.15
61336272-1336272104.038104.21
15min11321057-1321057102.853102.161.03103.19102.501.03
21290274-1290274100.457100.79
31316906-1316906102.530102.87
41308824-1308824101.901102.24
51306751-1306751101.740102.08
61328921-1328921103.466103.81
30min11318059-1318059102.620101.981.03103.13102.481.03
21287127-1287127100.212100.71
31309470-1309470101.951102.46
41309631-1309631101.964102.47
51306793-1306793101.743102.25
61327600-1327600103.363103.88
极限11310766-1310766102.052101.781.03102.74102.461.02
21286304-1286304100.148100.82
31309057-1309057101.919102.60
41306554-1306554101.724102.40
51303119-1303119101.457102.13
61327718-1327718103.372104.06
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