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%
110.218770187638876208756287656876350.06
210.208743987604875220.14
单位质量响应值RSD%判断
8583.258580.590.03数据可信
供试品溶液-25053001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%
5min192401-9240196.70996.721.2496.7196.721.24
292253-9225396.55496.55
393157-9315797.50097.50
492816-9281697.14397.14
593553-9355397.91497.91
690297-9029794.50794.51
10min194651-9465199.06498.881.4999.2299.041.48
293163-9316397.50697.67
395509-9550999.962100.12
495439-9543999.888100.05
595737-95737100.200100.36
692362-9236296.66896.83
15min194897-9489799.32198.961.4599.6599.291.45
293283-9328397.63297.96
396206-96206100.691101.02
495142-9514299.57799.91
595255-9525599.696100.03
692539-9253996.85397.17
20min194420-9442098.82298.891.5699.3199.381.55
293204-9320497.54998.04
396250-96250100.737101.23
495251-9525199.692100.19
595412-9541299.860100.36
692351-9235196.65697.14
30min194266-9426698.66199.212.2199.3299.872.21
293508-9350897.86798.52
398331-98331102.915103.58
495702-95702100.164100.82
594736-9473699.15299.82
692212-9221296.51197.15
45min194380-9438098.78099.291.9299.60100.111.91
293380-9338097.73398.55
396334-96334100.825101.66
496211-96211100.696101.52
596658-96658101.164101.99
692246-9224696.54697.35
极限195896-95896100.36799.111.68101.35100.101.68
293767-9376798.13899.11
396062-96062100.540101.54
496035-96035100.512101.51
594270-9427098.66599.66
692161-9216196.45797.42
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%
110.218753487505875068731687476874670.10
210.208718087153871660.03
单位质量响应值RSD%判断
8566.808545.690.18数据可信
供试品溶液-25053002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%
5min191758-9175896.32494.491.3496.3294.491.34
290813-9081395.33295.33
389288-8928893.73193.73
488555-8855592.96292.96
590469-9046994.97194.97
689174-8917493.61193.61
10min194107-9410798.79096.801.3698.9596.961.36
292938-9293897.56397.72
392012-9201296.59196.75
490667-9066795.17995.33
592435-9243597.03597.19
691117-9111795.65195.81
15min194095-9409598.77797.221.1099.1097.541.10
292789-9278997.40697.73
392584-9258497.19197.51
491391-9139195.93996.25
593216-9321697.85598.17
691605-9160596.16396.48
20min194157-9415798.84297.111.2299.3397.591.22
292876-9287697.49897.98
392309-9230996.90297.38
491272-9127295.81496.29
593139-9313997.77498.26
691274-9127495.81696.29
30min194600-9460099.30797.541.2099.9698.181.20
293065-9306597.69698.34
392817-9281797.43698.08
491492-9149296.04596.68
593523-9352398.17798.82
691978-9197896.55597.19
45min194013-9401398.69197.291.1699.5198.091.16
292567-9256797.17397.98
392792-9279297.40998.21
491501-9150196.05496.85
593712-9371298.37599.18
691476-9147696.02896.82
极限195082-9508299.81397.851.39100.8098.821.39
294295-9429598.98799.96
392864-9286497.48598.45
491671-9167196.23397.19
593259-9325997.90098.87
692115-9211596.69997.66
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%
110.218738187574876118723087365874320.19
210.208751587276873960.20
单位质量响应值RSD%判断
8563.378568.240.05数据可信
供试品溶液-25053003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%
5min192269-9226996.75294.271.6396.7594.271.62
288995-8899593.31993.32
388070-8807092.34992.35
489966-8996694.33794.34
589424-8942493.76993.77
690673-9067395.07995.08
10min194625-9462599.22396.461.7999.3896.621.79
290999-9099995.42095.58
390180-9018094.56294.72
492916-9291697.43197.59
590864-9086495.27995.44
692361-9236196.84997.01
15min195103-9510399.72496.572.05100.0596.892.05
290880-9088095.29695.61
389970-8997094.34194.65
493204-9320497.73398.05
590953-9095395.37295.69
692486-9248696.98097.30
20min194418-9441899.00696.571.7399.5097.051.73
290901-9090195.31895.79
390288-9028894.67595.14
493305-9330597.83998.32
591144-9114495.57396.05
692536-9253697.03297.51
30min194809-9480999.41696.621.97100.0797.261.97
290805-9080595.21795.85
389923-8992394.29294.92
493469-9346998.01198.66
591291-9129195.72796.36
692531-9253197.02797.67
45min194609-9460999.20696.621.92100.0397.421.92
290300-9030094.68895.48
390095-9009594.47395.26
493502-9350298.04598.85
592299-9229996.78497.58
692069-9206996.54297.35
极限194528-9452899.12196.791.74100.1197.761.74
291990-9199096.46097.41
390509-9050994.90795.85
493932-9393298.49699.47
590970-9097095.39096.34
691917-9191796.38397.35
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%
110.218706687137871408698887329871320.15
210.208692287032869770.09
单位质量响应值RSD%判断
8533.998527.160.06数据可信
供试品溶液-25053001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%
5min195633-95633100.69498.932.68100.6998.932.68
292799-9279997.71097.71
392632-9263297.53497.53
494188-9418899.17299.17
597814-97814102.990102.99
690693-9069395.49295.49
10min196325-96325101.42299.682.59101.5999.842.59
294035-9403599.01199.17
393923-9392398.89399.06
494337-9433799.32999.49
598303-98303103.505103.68
691087-9108795.90796.07
15min196147-96147101.23599.582.72101.5799.912.72
293794-9379498.75799.09
393630-9363098.58598.91
494060-9406099.03899.37
598685-98685103.907104.25
691132-9113295.95596.27
20min195732-95732100.79899.272.76101.3099.772.76
293285-9328598.22298.71
393604-9360498.55799.05
494114-9411499.09499.59
598355-98355103.560104.08
690615-9061595.41095.89
30min195992-95992101.07299.442.58101.75100.102.58
293702-9370298.66199.32
393969-9396998.94299.60
494066-9406699.04499.70
598084-98084103.275103.96
690838-9083895.64596.28
45min195847-95847100.91999.182.48101.76100.012.48
293502-9350298.45099.27
393557-9355798.50899.33
493674-9367498.63199.46
597709-97709102.880103.74
690878-9087895.68796.48
极限195473-95473100.52598.782.65101.5499.782.65
293346-9334698.28699.27
392885-9288597.80098.79
493367-9336798.30899.30
597571-97571102.734103.77
690269-9026995.04696.00
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%
110.218731287485877408756487536875270.18
210.208802487962879930.05
单位质量响应值RSD%判断
8572.678626.760.45数据可信
供试品溶液-25053002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%
5min193769-9376997.93897.800.9697.9497.800.96
293050-9305097.18797.19
395244-9524499.47999.48
493740-9374097.90897.91
592649-9264996.76896.77
693358-9335897.50997.51
10min194481-9448198.68298.600.8398.8598.760.83
293699-9369997.86598.03
395830-95830100.091100.26
493733-9373397.90198.06
594257-9425798.44898.61
694388-9438898.58598.75
15min194605-9460598.81198.470.8499.1498.800.84
293669-9366997.83498.16
395688-9568899.943100.28
493550-9355097.71098.04
594120-9412098.30598.63
694052-9405298.23498.56
20min194650-9465098.85898.970.8999.3599.460.89
294470-9447098.67099.16
395982-95982100.250100.75
493682-9368297.84798.34
594269-9426998.46098.95
695481-9548199.726100.22
30min194475-9447598.67698.480.8199.3399.140.81
293811-9381197.98298.63
395690-9569099.945100.61
493535-9353597.69498.35
594161-9416198.34899.00
694078-9407898.26198.92
45min193889-9388998.06498.290.9198.8999.110.91
293645-9364597.80998.62
395725-9572599.981100.81
493234-9323497.37998.19
594021-9402198.20199.02
694146-9414698.33299.15
极限194029-9402998.21098.020.9399.1999.000.93
293330-9333097.48098.46
395491-9549199.737100.74
493044-9304497.18198.16
593701-9370197.86798.85
693491-9349197.64898.63
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