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%
113.811172612117288711717181172467117223411723840.04
213.761171339117104411711920.02
单位质量响应值RSD%判断
84893.8585115.700.19数据可信
中间条件3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%
5min11288996-128899699.51390.8210.6599.5190.8210.65
21293385-129338599.85199.85
31282373-128237399.00199.00
41018347-101834778.61878.62
51083343-108334383.63683.64
61091736-109173684.28484.28
10min11300697-1300697100.41697.254.78100.5897.404.79
21321921-1321921102.055102.22
31313325-1313325101.391101.56
41176253-117625390.80990.94
51219386-121938694.13994.28
61226727-122672794.70594.85
15min11300833-1300833100.42699.961.89100.76100.281.90
21321464-1321464102.019102.36
31316667-1316667101.649101.98
41254591-125459196.85797.14
51291166-129116699.68099.98
61284355-128435599.15499.45
30min11297010-1297010100.131100.830.94100.63101.310.95
21318465-1318465101.788102.29
31315040-1315040101.523102.03
41286852-128685299.34799.79
51313752-1313752101.424101.89
61305065-1305065100.753101.22
极限11296632-1296632100.102100.690.90100.77101.340.91
21316775-1316775101.657102.33
31308039-1308039100.983101.66
41285092-128509299.21199.82
51313324-1313324101.391102.02
61305979-1305979100.824101.46
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%
113.811171674117006611725441171024117071311712040.09
213.761176090117594211760160.01
单位质量响应值RSD%判断
84808.4085466.280.55数据可信
中间条件3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%
5min11331091-1331091102.604100.461.70102.60100.461.70
21309499-1309499100.939100.94
31290832-129083299.50199.50
41266551-126655197.62997.63
51308720-1308720100.879100.88
61313173-1313173101.223101.22
10min11343608-1343608103.569101.601.69103.74101.771.69
21324571-1324571102.101102.27
31301406-1301406100.316100.48
41282284-128228498.84299.00
51328651-1328651102.416102.58
61328200-1328200102.381102.55
15min11343801-1343801103.584101.551.62103.93101.891.62
21321782-1321782101.886102.22
31301825-1301825100.348100.68
41283672-128367298.94999.28
51325569-1325569102.178102.52
61327780-1327780102.349102.69
30min11341974-1341974103.443101.331.68103.96101.841.68
21319603-1319603101.718102.23
31300580-1300580100.252100.75
41278791-127879198.57299.06
51320803-1320803101.811102.32
61325643-1325643102.184102.69
极限11349773-1349773104.044101.271.97104.73101.951.96
21319576-1319576101.716102.39
31292531-129253199.632100.30
41276414-127641498.38999.05
51321149-1321149101.837102.52
61323580-1323580102.025102.71
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%
113.811172761117247411725881173309117175311725770.05
213.761169350116581111675800.22
单位质量响应值RSD%判断
84907.8284853.200.05数据可信
中间条件3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%
5min11320571-1320571102.09997.1513.69102.1097.1513.70
21321368-1321368102.161102.16
31297191-1297191100.292100.29
4907911-90791170.19570.19
51359988-1359988105.147105.15
61332303-1332303103.006103.01
10min11327287-1327287102.619101.355.95102.79101.515.96
21338760-1338760103.506103.68
31318626-1318626101.949102.12
41156900-115690089.44589.56
51375361-1375361106.335106.51
61348084-1348084104.227104.40
15min11324623-1324623102.413102.473.02102.75102.803.03
21337958-1337958103.444103.79
31318866-1318866101.968102.30
41254236-125423696.97197.24
51374595-1374595106.276106.63
61342018-1342018103.758104.10
30min11320921-1320921102.126102.891.81102.64103.391.82
21334525-1334525103.178103.69
31315848-1315848101.734102.24
41303025-1303025100.743101.17
51372069-1372069106.081106.61
61338637-1338637103.496104.01
极限11322911-1322911102.280102.961.53102.96103.631.55
21332054-1332054102.987103.67
31316127-1316127101.756102.43
41311327-1311327101.385101.98
51367012-1367012105.690106.40
61340607-1340607103.648104.34
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