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%
113.811153220115675211541171154897115699211551960.15
213.761157425116313811602820.35
单位质量响应值RSD%判断
83649.2484322.820.57数据可信
影响因素30天-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%
5min11143242-114324289.33295.663.3089.3395.663.30
21231119-123111996.19996.20
31233812-123381296.40996.41
41245264-124526497.30497.30
51241238-124123896.98996.99
61250696-125069697.72897.73
10min11261984-126198498.61099.250.6498.7699.410.64
21260811-126081198.51998.68
31273666-127366699.52399.68
41268219-126821999.09899.26
51281160-1281160100.109100.27
61275545-127554599.67099.83
15min11297917-1297917101.418100.060.99101.73100.380.99
21261027-126102798.53698.86
31281157-1281157100.109100.44
41285846-1285846100.475100.80
51285022-1285022100.411100.74
61272266-127226699.41499.74
30min11293653-1293653101.08599.831.16101.57100.321.16
21254084-125408497.99398.48
31271866-127186699.38399.88
41292198-1292198100.971101.47
51272515-127251599.43399.93
61280935-1280935100.091100.59
极限11287280-1287280100.58799.271.08101.2499.931.07
21252236-125223697.84998.50
31267312-126731299.02799.69
41280614-1280614100.066100.73
51258036-125803698.30298.96
61277104-127710499.792100.45
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%
113.811160543116873911684311169586116279011660180.35
213.761161029116228311616560.08
单位质量响应值RSD%判断
84432.8784422.670.01数据可信
影响因素30天-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%
5min11144120-114412088.93194.473.3788.9394.473.37
21205240-120524093.68293.68
31207264-120726493.84093.84
41257810-125781097.76997.77
51249146-124914697.09597.10
61228856-122885695.51895.52
10min11233482-123348295.87898.711.8196.0398.871.81
21284135-128413599.81599.97
31256497-125649797.66697.82
41286390-128639099.990100.15
51294693-1294693100.635100.80
61264625-126462598.29898.46
15min11258584-125858497.82999.271.5498.1499.601.54
21294546-1294546100.624100.95
31259369-125936997.89098.21
41283079-128307999.733100.06
51304094-1304094101.366101.70
61263189-126318998.18798.51
30min11263308-126330898.19699.331.5698.6799.821.56
21296823-1296823100.801101.29
31257075-125707597.71198.19
41286586-1286586100.005100.50
51302613-1302613101.251101.75
61261207-126120798.03398.52
极限11264952-126495298.32499.001.4098.9699.661.40
21294934-1294934100.654101.31
31251138-125113897.25097.90
41270451-127045198.75199.41
51295160-1295160100.672101.34
61265502-126550298.36699.02
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100638-202104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%
113.811163031116347911645171165690116551611644470.11
213.761155325115555911554420.02
单位质量响应值RSD%判断
84319.1283971.080.30数据可信
影响因素30天-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%
5min11239696-123969696.68597.561.0596.6897.561.05
21250714-125071497.54497.54
31234514-123451496.28196.28
41258423-125842398.14598.15
51250875-125087597.55797.56
61271104-127110499.13499.13
10min11305427-1305427101.811101.600.53101.97101.770.53
21304622-1304622101.748101.91
31288850-1288850100.518100.68
41305282-1305282101.800101.96
51305067-1305067101.783101.95
61307352-1307352101.961102.13
15min11289699-1289699100.584102.050.90100.92102.380.90
21319150-1319150102.881103.21
31303515-1303515101.662101.99
41322570-1322570103.148103.48
51307190-1307190101.949102.28
61308936-1308936102.085102.42
30min11284680-1284680100.193101.440.77100.69101.940.77
21306057-1306057101.860102.36
31301559-1301559101.509102.01
41314594-1314594102.526103.03
51296828-1296828101.140101.64
61300512-1300512101.428101.93
极限11264126-126412698.590101.031.2599.26101.701.25
21304090-1304090101.707102.38
31295377-1295377101.027101.69
41310515-1310515102.208102.88
51299870-1299870101.378102.05
61298130-1298130101.242101.92
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