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%
113.761161432115980611581621162055116412511611160.20
213.741135141113513711351390.01
单位质量响应值RSD%判断
84383.4382615.651.50数据可信
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%
5min11294240-1294240101.730100.590.89101.73100.590.89
21277988-1277988100.452100.45
31259934-125993499.03399.03
41279360-1279360100.560100.56
51284539-1284539100.967100.97
61282276-1282276100.790100.79
10min11317757-1317757103.578102.271.77103.75102.441.77
21299124-1299124102.114102.28
31303250-1303250102.438102.60
41321149-1321149103.845104.01
51257501-125750198.84299.01
61307825-1307825102.798102.97
15min11315610-1315610103.410103.250.66103.75103.590.66
21302766-1302766102.400102.74
31309321-1309321102.915103.25
41325768-1325768104.208104.55
51320403-1320403103.786104.12
61307594-1307594102.780103.12
30min11316068-1316068103.446103.040.71103.96103.560.70
21296254-1296254101.888102.40
31306649-1306649102.705103.21
41320715-1320715103.811104.33
51318370-1318370103.627104.13
61307754-1307754102.792103.30
极限11310496-1310496103.008102.800.67103.69103.480.66
21296996-1296996101.947102.62
31302390-1302390102.371103.05
41317455-1317455103.555104.24
51317639-1317639103.569104.25
61302339-1302339102.367103.05
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%
113.761159869116220311600611161392116086411608780.09
213.741161833115969511607640.14
单位质量响应值RSD%判断
84366.1384480.640.10数据可信
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%
5min11274360-127436099.060100.021.4299.06100.021.42
21304200-1304200101.380101.38
31290513-1290513100.316100.32
41281724-128172499.63399.63
51308734-1308734101.732101.73
61260539-126053997.98697.99
10min11298151-1298151100.909101.561.67101.07101.731.67
21322397-1322397102.794102.96
31291808-1291808100.416100.58
41301306-1301306101.155101.32
51342205-1342205104.334104.50
61283418-128341899.76499.93
15min11300086-1300086101.060101.421.44101.39101.761.44
21322188-1322188102.778103.12
31295827-1295827100.729101.06
41303077-1303077101.292101.63
51329507-1329507103.347103.69
61277657-127765799.31699.65
30min11294252-1294252100.606101.191.48101.11101.701.48
21323011-1323011102.842103.35
31291137-1291137100.364100.87
41301186-1301186101.145101.65
51325367-1325367103.025103.54
61275821-127582199.17499.67
极限11293754-1293754100.568100.981.51101.24101.651.51
21321391-1321391102.716103.40
31287759-1287759100.102100.77
41296341-1296341100.769101.44
51322536-1322536102.805103.49
61272603-127260398.92499.58
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%
113.761173044117249911733851171272117566911731740.14
213.741159980116016211600710.02
单位质量响应值RSD%判断
85259.7484430.200.70数据可信
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%
5min11302370-1302370100.73799.551.25100.7499.551.25
21291633-129163399.90699.91
31290091-129009199.78799.79
41282840-128284099.22699.23
51257183-125718397.24297.24
61297769-1297769100.381100.38
10min11312705-1312705101.536100.600.98101.70100.760.98
21297814-1297814100.384100.55
31311097-1311097101.412101.58
41294834-1294834100.154100.32
51279088-127908898.93699.10
61307751-1307751101.153101.32
15min11308783-1308783101.233100.360.97101.57100.690.97
21294875-1294875100.157100.49
31306742-1306742101.075101.41
41293826-1293826100.076100.41
51275431-127543198.65398.98
61305032-1305032100.943101.28
30min11305173-1305173100.954100.520.73101.46101.020.73
21301684-1301684100.684101.18
31310349-1310349101.354101.86
41297265-1297265100.342100.84
51282770-128277099.22199.71
61300392-1300392100.584101.09
极限11314979-1314979101.712100.301.38102.39100.971.37
21287826-128782699.612100.28
31309532-1309532101.291101.96
41304660-1304660100.914101.58
51265951-126595197.92098.58
61297581-1297581100.366101.04
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%
113.761159560116007311615951159989115909311600620.09
213.741162006116303911625220.07
单位质量响应值RSD%判断
84306.8384608.590.26数据可信
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%
5min11334992-1334992103.731102.422.23103.73102.422.24
21339946-1339946104.116104.12
31293576-1293576100.513100.51
41291276-1291276100.335100.33
51291676-1291676100.366100.37
61357307-1357307105.465105.47
10min11350031-1350031104.900103.442.25105.07103.612.25
21357730-1357730105.498105.67
31309793-1309793101.773101.94
41304517-1304517101.363101.53
51299066-1299066100.940101.11
61366082-1366082106.147106.32
15min11348585-1348585104.788103.212.21105.14103.552.21
21347974-1347974104.740105.09
31309577-1309577101.757102.09
41298282-1298282100.879101.22
51299488-1299488100.973101.31
61365666-1365666106.115106.47
30min11342691-1342691104.330103.032.13104.85103.542.13
21346173-1346173104.600105.12
31307995-1307995101.634102.14
41298771-1298771100.917101.42
51296959-1296959100.776101.28
61362947-1362947105.904106.43
极限11343564-1343564104.397102.712.05105.09103.402.05
21339825-1339825104.107104.81
31300018-1300018101.014101.69
41295772-1295772100.684101.36
51296928-1296928100.774101.45
61354986-1354986105.285105.99
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%
113.761161520116197411615021161983116249111618940.04
213.741159252115862111589360.04
单位质量响应值RSD%判断
84439.9784347.600.08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%
5min11302160-1302160101.257101.081.77101.26101.081.77
21278374-127837499.40799.41
31311528-1311528101.985101.99
41308642-1308642101.761101.76
51330466-1330466103.458103.46
61268226-126822698.61898.62
10min11311667-1311667101.996102.171.97102.16102.341.97
21291389-1291389100.419100.58
31321854-1321854102.788102.96
41326955-1326955103.185103.35
51351845-1351845105.120105.29
61279793-127979399.51799.68
15min11310379-1310379101.896101.942.05102.23102.282.05
21288371-1288371100.184100.52
31319520-1319520102.607102.95
41325300-1325300103.056103.40
51348782-1348782104.882105.23
61273721-127372199.04599.38
30min11303822-1303822101.386101.691.93101.89102.201.93
21286626-1286626100.049100.55
31315890-1315890102.324102.84
41322637-1322637102.849103.36
51343557-1343557104.476105.00
61273834-127383499.05499.55
极限11301924-1301924101.238101.471.98101.92102.151.98
21283191-128319199.782100.45
31312654-1312654102.073102.76
41317264-1317264102.431103.12
51343411-1343411104.464105.16
61271159-127115998.84699.51
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