富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
1 9.871683621694751692251691451691141690640.25
2 9.861687651686941687300.03
单位质量响应值RSD%判断
17129.0817112.580.07数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193336-193336101.42998.641.89101.4398.641.89
2188841-18884199.07199.07
3189407-18940799.36899.37
4187441-18744198.33698.34
5182641-18264195.81895.82
6186436-18643697.80997.81
10min1194529-194529102.05599.351.64102.2299.521.64
2190128-19012899.74699.91
3190052-19005299.70699.87
4188911-18891199.10799.27
5185528-18552897.33297.49
6187120-18712098.16898.33
15min1193866-193866101.70799.251.54102.0599.581.54
2189385-18938599.35699.69
3189873-18987399.61299.94
4189453-18945399.39299.72
5185221-18522197.17197.49
6187259-18725998.24198.57
20min1192809-192809101.15298.891.45101.6699.381.46
2188719-18871999.00799.50
3189163-18916399.24099.74
4189109-18910999.21199.71
5184894-18489497.00097.48
6186285-18628597.73098.22
30min1192589-192589101.03798.571.54101.7199.241.54
2188256-18825698.76499.43
3188166-18816698.71699.38
4188550-18855098.91899.58
5184142-18414296.60597.25
6185671-18567197.40898.06
45min1191901-191901100.67698.301.60101.5299.121.60
2187746-18774698.49699.32
3187649-18764998.44599.27
4188446-18844698.86399.69
5183014-18301496.01496.82
6185481-18548197.30898.12
极限1190677-190677100.03497.731.59101.0598.721.59
2186512-18651297.84998.84
3186643-18664397.91798.91
4187724-18772498.48599.47
5182164-18216495.56896.53
6184015-18401596.53997.52
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
1 9.871688831688381690441693081691061690360.12
2 9.861690131689541689840.03
单位质量响应值RSD%判断
17126.2417138.340.05数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183284-18328496.09197.271.4496.0997.271.44
2187534-18753498.31998.32
3187496-18749698.29998.30
4185188-18518897.08997.09
5188128-18812898.63098.63
6181594-18159495.20595.20
10min1185264-18526497.12998.261.3397.2998.421.33
2188399-18839998.77398.94
3188818-18881898.99299.16
4186561-18656197.80997.97
5191064-191064100.170100.33
6184404-18440496.67896.84
15min1185130-18513097.05998.071.4297.3898.391.42
2187997-18799798.56298.89
3188359-18835998.75299.08
4186321-18632197.68398.01
5191002-191002100.137100.47
6183492-18349296.20096.52
20min1184444-18444496.69997.741.3297.1898.231.32
2187674-18767498.39298.89
3187460-18746098.28098.77
4185679-18567997.34797.83
5190048-19004899.637100.14
6183274-18327496.08696.57
30min1183703-18370396.31197.401.2696.9698.051.26
2186796-18679697.93298.59
3187082-18708298.08298.74
4184962-18496296.97197.62
5189174-18917499.17999.84
6182952-18295295.91796.56
45min1182787-18278795.83096.871.2596.6497.681.25
2185762-18576297.39098.21
3185988-18598897.50998.33
4184141-18414196.54097.35
5188099-18809998.61599.44
6181827-18182795.32796.13
极限1180794-18079494.78596.301.4595.7597.271.45
2184941-18494196.96097.94
3185190-18519097.09098.07
4183378-18337896.14097.11
5187261-18726198.17699.17
6180517-18051794.64095.60
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
1 9.871673891672851677691679191675501675820.16
2 9.861678861674811676840.18
单位质量响应值RSD%判断
16978.9317006.490.12数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189499-189499100.16599.211.83100.1799.211.83
2185448-18544898.02498.02
3183477-18347796.98296.98
4185605-18560598.10798.11
5189420-189420100.124100.12
6192708-192708101.862101.86
10min1190904-190904100.90899.991.71101.07100.151.71
2187655-18765599.19199.35
3184307-18430797.42197.58
4188147-18814799.45199.61
5190241-190241100.558100.72
6193760-193760102.418102.59
15min1190629-190629100.76399.911.74101.10100.241.74
2187089-18708998.89299.22
3184058-18405897.28997.61
4188009-18800999.37899.71
5191002-191002100.960101.29
6193279-193279102.163102.50
20min1189842-189842100.34799.491.70100.8599.991.70
2186563-18656398.61399.11
3183410-18341096.94797.43
4187842-18784299.29099.78
5188803-18880399.797100.30
6192913-192913101.970102.48
30min1190711-190711100.80699.401.72101.48100.061.72
2186000-18600098.31698.97
3183449-18344996.96797.62
4187455-18745599.08599.75
5188288-18828899.525100.19
6192394-192394101.696102.38
45min1188283-18828399.52398.691.72100.3699.521.72
2184668-18466897.61298.43
3181926-18192696.16296.97
4186822-18682298.75099.58
5187236-18723698.96999.80
6191308-191308101.122101.97
极限1187261-18726198.98298.191.6799.9999.181.67
2183719-18371997.11098.09
3181121-18112195.73796.71
4186035-18603598.33499.32
5186190-18619098.41699.42
6190194-190194100.533101.55
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
1 9.871681311677921676301680051679251678970.12
2 9.861680411679421679920.05
单位质量响应值RSD%判断
17010.8417037.730.12数据可信
供试品溶液-3批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186301-18630198.29294.667.4798.2994.667.47
2185072-18507297.64497.64
3187071-18707198.69998.70
4185962-18596298.11398.11
5179426-17942694.66594.67
6152671-15267180.54980.55
10min1187928-18792899.15199.181.6699.3199.331.66
2187357-18735798.84999.01
3189559-189559100.011100.18
4191408-191408100.987101.15
5182299-18229996.18196.34
6189303-18930399.876100.01
15min1186410-18641098.35098.921.6698.6899.241.65
2187018-18701898.67199.00
3189276-18927699.862100.19
4190796-190796100.664101.00
5182096-18209696.07496.39
6189335-18933599.893100.19
20min1187021-18702198.67298.691.6699.1799.181.66
2186585-18658598.44298.93
3188769-18876999.594100.09
4190280-190280100.392100.89
5181311-18131195.66096.14
6188326-18832699.36199.83
30min1185963-18596398.11498.301.7398.7798.951.72
2185859-18585998.05998.72
3187784-18778499.07599.74
4189566-189566100.015100.68
5180431-18043195.19595.83
6188237-18823799.31499.95
45min1185416-18541697.82597.821.7098.6598.641.70
2184530-18453097.35898.18
3186891-18689198.60499.43
4188776-18877699.598100.43
5179718-17971894.81995.62
6187111-18711198.72099.52
极限1184251-18425197.21197.201.4798.1998.181.47
2183985-18398597.07098.05
3185949-18594998.10799.10
4186724-18672498.51699.52
5179145-17914594.51795.47
6185372-18537297.80298.77
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