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4000
标示量(mg)2.5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%
110.428726187299874488718287674873730.23
210.358661086785866980.15
单位质量响应值RSD%判断
8385.128376.620.08数据可信
供试品溶液-2025070921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%
5min188183-8818394.50894.691.8094.5194.701.81
288922-8892295.30095.30
389580-8958096.00596.01
490340-9034096.82096.82
586991-8699193.23193.23
686126-8612692.30492.30
10min192642-9264299.28798.891.3699.4499.051.36
292428-9242899.05899.22
392792-9279299.44899.61
494005-94005100.748100.91
591399-9139997.95598.11
690371-9037196.85397.01
15min193471-93471100.17599.421.24100.5099.741.24
292554-9255499.19399.52
393450-93450100.153100.48
494048-94048100.794101.12
592197-9219798.81099.13
690875-9087597.39397.71
20min193212-9321299.89899.391.42100.3999.881.42
293226-9322699.913100.40
392612-9261299.25599.75
494684-94684101.475101.97
591869-9186998.45898.94
690830-9083097.34597.82
30min193182-9318299.86699.111.31100.5299.761.31
292198-9219898.81199.47
392973-9297399.642100.30
494155-94155100.908101.57
591562-9156298.12998.78
690788-9078897.30097.94
45min193357-93357100.05399.561.28100.88100.381.29
293074-9307499.750100.57
393685-93685100.405101.23
494286-94286101.049101.88
591854-9185498.44299.25
691116-9111697.65198.45
极限193711-93711100.43399.981.54101.42100.971.54
293475-93475100.180101.17
394192-94192100.948101.94
495056-95056101.874102.88
592276-9227698.89599.87
691045-9104597.57598.54
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4000
标示量(mg)2.5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%
110.428651486797866538654486791866600.16
210.358683186499866650.28
单位质量响应值RSD%判断
8316.708373.430.49数据可信
供试品溶液-G01TD1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177062-7706282.94575.937.2582.9475.927.25
273343-7334378.94278.94
361741-6174166.45466.45
469340-6934074.63374.63
570154-7015475.50975.51
671616-7161677.08377.08
10min189150-8915095.95593.173.1596.0993.293.16
288855-8885595.63895.77
381834-8183488.08188.19
485195-8519591.69991.82
587442-8744294.11794.24
686885-8688593.51893.65
15min190148-9014897.03096.121.2997.3396.411.30
290492-9049297.40097.69
387306-8730693.97194.23
489283-8928396.09996.38
589799-8979996.65496.94
688805-8880595.58495.87
20min189866-8986696.72696.550.7797.1997.000.77
290540-9054097.45297.90
388631-8863195.39795.81
490234-9023497.12297.56
589681-8968196.52796.97
689288-8928896.10496.55
30min189344-8934496.16496.400.6396.7997.010.64
290076-9007696.95297.57
388897-8889795.68396.26
489784-8978496.63897.24
590271-9027197.16297.77
689031-8903195.82796.43
45min189194-8919496.00396.631.0296.7897.391.02
290811-9081197.74398.52
388988-8898895.78196.51
490784-9078497.71498.47
590119-9011996.99897.77
688765-8876595.54196.30
极限189077-8907795.87796.680.7596.8297.600.75
290567-9056797.48198.42
389398-8939896.22297.11
490125-9012597.00597.93
590542-9054297.45498.38
689238-8923896.05096.97
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4000
标示量(mg)2.5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%
110.428672486637865858637986890866430.22
210.358696287075870180.10
单位质量响应值RSD%判断
8315.078407.540.79数据可信
供试品溶液-G01TD1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174524-7452480.05975.039.4980.0675.039.49
273624-7362479.09279.09
361120-6112065.65965.66
461992-6199266.59666.60
571418-7141876.72276.72
676393-7639382.06782.07
10min186928-8692893.38491.754.2993.5291.884.30
289434-8943496.07696.21
379462-7946285.36385.47
482681-8268188.82288.93
587557-8755794.06094.19
686389-8638992.80592.94
15min188490-8849095.06295.062.7695.3595.342.77
292412-9241299.27599.57
385143-8514391.46691.72
487376-8737693.86594.12
589707-8970796.36996.65
687814-8781494.33694.63
20min189000-8900095.61096.241.8296.0696.681.83
292746-9274699.634100.09
388085-8808594.62795.03
489068-8906895.68396.10
589650-8965096.30896.75
688969-8896995.57796.03
30min188620-8862095.20296.711.6495.8197.301.63
292721-9272199.607100.23
390120-9012096.81397.37
489957-8995796.63897.21
589937-8993796.61697.22
688782-8878295.37695.98
45min189337-8933795.97296.861.4496.7497.621.44
292761-9276199.650100.44
389884-8988496.55997.28
489786-8978696.45497.19
589873-8987396.54897.31
689357-8935795.99396.76
极限189183-8918395.80696.751.4596.7397.671.45
292353-9235399.212100.17
390688-9068897.42398.31
489360-8936095.99796.89
590014-9001496.69997.63
688793-8879395.38796.31
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4000
标示量(mg)2.5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%
110.421733521732391730981729791731081731550.09
210.351720991724131722560.13
单位质量响应值RSD%判断
16617.5616643.090.11数据可信
供试品溶液-2025070922批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179124-17912496.74596.461.3096.7496.461.30
2174711-17471194.36194.36
3180673-18067397.58197.58
4181120-18112097.82397.82
5177876-17787696.07096.07
6178130-17813096.20896.21
10min1184743-18474399.77999.511.1699.9499.671.16
2181533-18153398.04698.20
3186395-186395100.672100.83
4186813-186813100.897101.06
5183496-18349699.10699.27
6182441-18244198.53698.70
15min1186862-186862100.92499.881.25101.25100.201.24
2182083-18208398.34398.66
3187713-187713101.383101.71
4186208-186208100.571100.90
5183452-18345299.08299.41
6183210-18321098.95199.28
20min1185812-185812100.35799.990.96100.85100.480.96
2183446-18344699.07999.56
3187798-187798101.429101.93
4186105-186105100.515101.01
5183228-18322898.96199.45
6184383-18438399.585100.07
30min1186602-186602100.783100.050.95101.45100.720.95
2183338-18333899.02099.67
3187250-187250101.133101.80
4186641-186641100.804101.47
5183991-18399199.373100.03
6183693-18369399.21299.87
45min1186062-186062100.49299.830.96101.32100.660.96
2182568-18256898.60599.42
3187330-187330101.177102.01
4185552-185552100.216101.05
5183585-18358599.15499.97
6183974-18397499.364100.18
极限1185000-18500099.91899.970.70100.92100.970.69
2184162-18416299.466100.44
3187186-187186101.099102.10
4185385-185385100.126101.13
5183446-18344699.079100.07
6185436-185436100.154101.14
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