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%
113.661110134111109111109321112800111226311114440.10
213.581117649111413211158900.23
单位质量响应值RSD%判断
81364.8682171.580.70数据可信
中间条件12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%
5min11245234-124523499.94298.530.7899.9498.530.78
21222009-122200998.07898.08
31222688-122268898.13298.13
41220204-122020497.93397.93
51223693-122369398.21398.21
61232023-123202398.88198.88
10min11260379-1260379101.157100.850.58101.32101.020.57
21244678-124467899.897100.06
31259888-1259888101.118101.28
41251174-1251174100.418100.58
51263780-1263780101.430101.59
61259557-1259557101.091101.26
15min11261015-1261015101.208100.870.46101.54101.200.46
21248419-1248419100.197100.53
31262937-1262937101.362101.69
41251420-1251420100.438100.77
51257658-1257658100.939101.27
61259675-1259675101.101101.43
30min11257250-1257250100.906100.690.60101.41101.190.60
21241698-124169899.658100.15
31262450-1262450101.323101.82
41249953-1249953100.320100.82
51259059-1259059101.051101.55
61257195-1257195100.902101.40
极限11257002-1257002100.886100.620.62101.56101.290.62
21238406-123840699.394100.06
31259668-1259668101.100101.77
41258074-1258074100.972101.64
51253794-1253794100.629101.30
61255224-1255224100.743101.41
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%
113.661114458111251111117291112396111392511130040.11
213.581089647109594310927950.41
单位质量响应值RSD%判断
81479.0680470.910.89数据可信
中间条件12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%
5min11232942-123294299.926100.831.4399.93100.841.43
21263957-1263957102.440102.44
31219187-121918798.81198.81
41263247-1263247102.382102.38
51248257-1248257101.167101.17
61237309-1237309100.280100.28
10min11262522-1262522102.323102.620.42102.49102.790.42
21269777-1269777102.911103.08
31262603-1262603102.330102.49
41270194-1270194102.945103.12
51272459-1272459103.129103.30
61259532-1259532102.081102.25
15min11267398-1267398102.718102.720.66103.06103.060.66
21268720-1268720102.826103.17
31276088-1276088103.423103.76
41271001-1271001103.010103.35
51269248-1269248102.868103.21
61251695-1251695101.446101.78
30min11260043-1260043102.122102.540.88102.63103.050.87
21265652-1265652102.577103.09
31270035-1270035102.932103.44
41267122-1267122102.696103.21
51280738-1280738103.800104.31
61247474-1247474101.104101.61
极限11255991-1255991101.794102.010.56102.47102.690.56
21259832-1259832102.105102.79
31261593-1261593102.248102.93
41265403-1265403102.557103.24
51262964-1262964102.359103.04
61245949-1245949100.980101.65
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%
113.661118242111724611147601110792111152711145130.30
213.581112316111250911124120.02
单位质量响应值RSD%判断
81589.5381915.460.29数据可信
中间条件12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%
5min11262895-1262895101.376101.480.47101.38101.480.47
21264559-1264559101.510101.51
31272286-1272286102.130102.13
41260870-1260870101.214101.21
51255708-1255708100.800100.80
61268833-1268833101.853101.85
10min11279125-1279125102.679102.550.69102.85102.720.68
21276803-1276803102.493102.66
31292092-1292092103.720103.89
41271051-1271051102.031102.20
51266705-1266705101.682101.85
61279446-1279446102.705102.87
15min11281057-1281057102.834102.490.69103.17102.830.69
21276042-1276042102.432102.77
31289519-1289519103.514103.86
41272815-1272815102.173102.51
51263039-1263039101.388101.73
61277845-1277845102.577102.92
30min11272796-1272796102.171102.521.55102.68103.031.55
21267352-1267352101.734102.24
31316830-1316830105.706106.22
41268912-1268912101.859102.37
51263794-1263794101.449101.96
61273190-1273190102.203102.71
极限11272777-1272777102.170102.160.72102.85102.840.72
21279976-1279976102.748103.43
31284217-1284217103.088103.78
41266385-1266385101.657102.34
51258862-1258862101.053101.73
61273561-1273561102.233102.91
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