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%
113.811163406116511111616801162525116369811632840.12
213.761161092116176011614260.05
单位质量响应值RSD%判断
84234.9084405.960.15数据可信
长期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%
5min11144110-114411089.04496.684.1689.0496.684.16
21265417-126541798.48598.49
31289056-1289056100.325100.32
41234552-123455296.08396.08
51248285-124828597.15297.15
61271832-127183298.98498.98
10min11235708-123570896.173100.052.3096.32100.212.30
21300147-1300147101.188101.35
31317858-1317858102.567102.73
41270556-127055698.88599.05
51283921-128392199.925100.09
61304900-1304900101.558101.72
15min11254760-125476097.656100.571.9797.96100.901.97
21303976-1303976101.486101.82
31322204-1322204102.905103.24
41271886-127188698.98999.31
51289517-1289517100.361100.69
61311204-1311204102.049102.38
30min11288250-1288250100.262100.821.36100.73101.311.36
21298990-1298990101.098101.60
31319982-1319982102.732103.24
41269992-126999298.84199.33
51287115-1287115100.174100.67
61308000-1308000101.799102.30
极限11289464-1289464100.357100.671.31101.00101.341.31
21296676-1296676100.918101.59
31317535-1317535102.541103.22
41268967-126896798.76199.42
51283946-128394699.927100.59
61304487-1304487101.526102.20
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%
113.811161237116131611607241159749116071411607480.06
213.761160233115988011600560.03
单位质量响应值RSD%判断
84051.2784306.400.22数据可信
长期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%
5min11239366-123936696.62099.371.6696.6299.371.66
21278609-127860999.67999.68
31290434-1290434100.601100.60
41286489-1286489100.294100.29
51259668-125966898.20398.20
61293352-1293352100.829100.83
10min11254828-125482897.825101.121.9697.99101.291.96
21318575-1318575102.795102.96
31311510-1311510102.244102.41
41310476-1310476102.164102.33
51277155-127715599.56699.73
61310303-1310303102.150102.32
15min11250395-125039597.480100.872.0097.80101.202.00
21317732-1317732102.729103.07
31307846-1307846101.959102.30
41306910-1306910101.886102.22
51274646-127464699.37099.70
61305453-1305453101.772102.11
30min11249094-124909497.378100.922.1097.86101.422.11
21315395-1315395102.547103.06
31303417-1303417101.613102.12
41304840-1304840101.724102.23
51275016-127501699.39999.89
61319561-1319561102.872103.38
极限11247355-124735597.243100.431.9097.89101.101.90
21312807-1312807102.345103.02
31300428-1300428101.380102.06
41299327-1299327101.295101.97
51270481-127048199.04699.71
61299201-1299201101.285101.96
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%
113.811161625116134611608751161425116099511612530.03
213.761162036116125611616460.05
单位质量响应值RSD%判断
84087.8384421.950.29数据可信
长期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%
5min11316359-1316359102.530101.012.21102.53101.012.21
21319500-1319500102.774102.77
31288822-1288822100.385100.39
41244385-124438596.92496.92
51316047-1316047102.506102.51
61295860-1295860100.933100.93
10min11335639-1335639104.032102.312.28104.20102.482.27
21333332-1333332103.852104.02
31298966-1298966101.175101.34
41259166-125916698.07598.24
51331290-1331290103.693103.86
61322686-1322686103.023103.19
15min11334704-1334704103.959102.362.15104.30102.702.15
21331368-1331368103.699104.04
31304565-1304565101.611101.95
41261255-126125598.23898.56
51331670-1331670103.722104.07
61321356-1321356102.919103.26
30min11334512-1334512103.944102.232.16104.46102.742.16
21329571-1329571103.559104.08
31303711-1303711101.545102.05
41259282-125928298.08498.57
51327752-1327752103.417103.93
61320509-1320509102.853103.36
极限11331382-1331382103.700102.072.15104.39102.752.15
21331805-1331805103.733104.42
31299994-1299994101.255101.93
41258474-125847498.02198.67
51323762-1323762103.106103.80
61317565-1317565102.624103.31
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