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%
110.989090690798907809075690872908220.08
210.889079790799907980.01
单位质量响应值RSD%判断
8271.588345.400.63数据可信
供试品溶液-G01T7A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%
5min184505-8450591.35779.0210.6791.3679.0210.67
276458-7645882.65782.66
370806-7080676.54776.55
466190-6619071.55771.56
577143-7714383.39883.40
663454-6345468.59968.60
10min191820-9182099.26592.905.3499.4293.035.35
287962-8796295.09495.23
385520-8552092.45492.58
482450-8245089.13589.25
588709-8870995.90296.04
679115-7911585.53085.64
15min192429-9242999.92396.632.62100.2496.922.63
290145-9014597.45497.75
389783-8978397.06397.34
488529-8852995.70795.98
590062-9006297.36597.66
685374-8537492.29692.55
20min192390-9239099.88197.831.86100.3798.281.87
290285-9028597.60698.06
390841-9084198.20798.65
491840-9184099.28799.71
589968-8996897.26397.72
687633-8763394.73995.15
30min191982-9198299.44098.202.13100.0998.812.13
290194-9019497.50798.13
391059-9105998.44299.05
493710-93710101.308101.90
590055-9005597.35797.98
688009-8800995.14595.71
45min192253-9225399.73398.472.19100.5599.242.19
290374-9037497.70298.49
391308-9130898.71299.48
494146-94146101.780102.54
590050-9005097.35298.14
688351-8835195.51596.24
极限191908-9190899.36098.272.25100.3499.212.25
290140-9014097.44998.40
391051-9105198.43499.37
494171-94171101.807102.74
589991-8999197.28898.24
688115-8811595.26096.15
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%
110.989065090756908009066390710907160.07
210.889094490987909660.04
单位质量响应值RSD%判断
8261.938360.850.85数据可信
供试品溶液-24112102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%
5min188984-8898496.16796.151.6996.1796.141.69
290601-9060197.91597.91
387425-8742594.48294.48
488999-8899996.18396.18
590646-9064697.96397.96
687130-8713094.16394.16
10min188913-8891396.09096.461.7996.2596.621.79
290912-9091298.25198.41
387313-8731394.36194.52
489405-8940596.62296.78
591220-9122098.58498.75
687788-8778894.87595.03
15min188873-8887396.04796.241.7696.3796.561.76
290710-9071098.03298.36
387142-8714294.17694.49
488924-8892496.10296.42
591015-9101598.36298.69
687659-8765994.73595.05
20min188580-8858095.73195.871.7496.2196.351.74
290318-9031897.60998.10
386798-8679893.80594.28
488770-8877095.93696.42
590554-9055497.86498.36
687224-8722494.26594.74
30min188118-8811895.23195.601.7095.8796.241.70
290169-9016997.44898.10
386636-8663693.63094.26
488497-8849795.64196.28
590223-9022397.50698.16
687138-8713894.17294.80
45min188460-8846095.60195.861.7596.4096.661.75
290240-9024097.52598.34
386629-8662993.62294.41
488766-8876695.93296.73
590641-9064197.95898.78
687473-8747394.53495.32
极限188309-8830995.43895.661.6996.4096.621.69
290114-9011497.38898.37
386734-8673493.73694.68
488471-8847195.61396.57
590356-9035697.65098.63
687101-8710194.13295.08
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%
110.989074790757907989075690720907560.04
210.889076290701907320.05
单位质量响应值RSD%判断
8265.578339.340.63数据可信
供试品溶液-24121201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%
5min190134-9013497.51398.071.7297.5198.071.72
290185-9018597.56897.57
392538-92538100.114100.11
488443-8844395.68495.68
590227-9022797.61497.61
692371-9237199.93399.93
10min191125-9112598.58599.061.5998.7599.221.59
290998-9099898.44898.61
393258-93258100.893101.06
489601-8960196.93797.10
591073-9107398.52998.69
693303-93303100.942101.11
15min191151-9115198.61499.011.5298.9499.341.52
290964-9096498.41198.74
392960-92960100.571100.91
489492-8949296.81997.14
591275-9127598.74899.07
693243-93243100.877101.21
20min191396-9139698.87998.901.4799.3799.401.47
290705-9070598.13198.62
392685-92685100.273100.78
489597-8959796.93297.41
590923-9092398.36798.86
693216-93216100.848101.35
30min190786-9078698.21998.641.4398.8799.301.43
290439-9043997.84398.50
392550-92550100.127100.80
489602-8960296.93897.58
590713-9071398.14098.80
692946-92946100.555101.23
45min190673-9067398.09698.671.6998.9299.501.69
290334-9033497.73098.55
393608-93608101.272102.11
489602-8960296.93897.74
590453-9045397.85898.68
692572-92572100.151100.99
极限190333-9033397.72998.281.3398.7199.271.33
290053-9005397.42698.41
392181-9218199.728100.73
489643-8964396.98297.95
590323-9032397.71898.70
692550-92550100.127101.13
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%
110.989071090861907829070890620907360.10
210.889059690587905920.01
单位质量响应值RSD%判断
8263.758326.470.54数据可信
供试品溶液-24121202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%
5min192288-9228899.931100.360.6099.93100.360.60
293252-93252100.975100.98
393175-93175100.892100.89
492217-9221799.85599.85
592052-9205299.67699.68
693109-93109100.820100.82
10min192616-92616100.287100.950.65100.45101.120.65
293339-93339101.070101.24
394073-94073101.864102.03
492967-92967100.667100.83
592634-92634100.306100.47
693760-93760101.525101.69
15min192622-92622100.293100.800.68100.63101.140.68
293025-93025100.730101.07
394020-94020101.807102.14
492731-92731100.411100.75
592451-92451100.108100.44
693703-93703101.464101.80
20min192316-9231699.962100.530.67100.46101.030.66
292797-92797100.483100.99
393757-93757101.522102.03
492458-92458100.116100.62
592293-9229399.937100.44
693402-93402101.138101.64
30min192202-9220299.838100.300.65100.51100.970.64
292506-92506100.168100.84
393456-93456101.196101.87
492378-92378100.029100.70
591969-9196999.586100.25
693247-93247100.970101.64
45min191933-9193399.547100.140.66100.38100.980.66
292499-92499100.160101.00
393419-93419101.156102.00
492241-9224199.881100.72
591854-9185499.462100.29
692961-92961100.660101.50
极限191542-9154299.12499.790.68100.12100.800.68
292191-9219199.826100.83
393101-93101100.812101.83
491942-9194299.557100.56
591549-9154999.131100.13
692638-92638100.310101.32
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