比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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%
19.998241482484825718258982680825480.13
29.958223582269822520.03
单位质量响应值RSD%判断
8263.068266.530.03数据可信
加速6月-供试品溶液-2024021621批-比索洛尔-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%
5min188881-8888196.59497.452.2596.5997.452.25
292063-92063100.052100.05
391978-9197899.96099.96
489228-8922896.97196.97
589003-8900396.72796.73
686851-8685194.38894.39
10min191444-9144499.379100.082.7099.54100.242.70
294651-94651102.865103.03
395262-95262103.529103.70
491355-9135599.28399.44
591267-9126799.18799.35
688544-8854496.22896.38
15min191787-9178799.752100.302.69100.08100.632.69
294978-94978103.220103.56
395400-95400103.679104.02
491386-9138699.31699.64
591329-9132999.25499.58
688856-8885696.56796.88
20min191593-9159399.541100.152.78100.03100.652.78
294870-94870103.103103.61
395495-95495103.782104.29
491120-9112099.02799.52
591134-9113499.04299.53
688727-8872796.42796.91
30min191513-9151399.454100.032.74100.11100.692.74
294673-94673102.889103.57
395282-95282103.550104.24
490972-9097298.86699.52
591235-9123599.15299.81
688560-8856096.24596.88
45min191173-9117399.08599.742.7499.91100.572.73
294370-94370102.559103.41
394937-94937103.175104.03
490875-9087598.76199.58
591135-9113599.04499.87
688157-8815795.80796.61
极限191219-9121999.13599.702.86100.12100.692.86
294510-94510102.711103.74
395088-95088103.340104.37
490654-9065498.52199.51
590835-9083598.71799.70
688115-8811595.76196.72
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.54100280996021002181005161000961001420.34
213.519928099584994320.22
单位质量响应值RSD%判断
7396.017359.880.35数据可信
加速6月-供试品溶液-2024021621批-氨氯地平-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%
5min147722-4772241.93042.192.2041.9342.202.21
249243-4924343.26743.27
348513-4851342.62542.63
447791-4779141.99141.99
546207-4620740.59940.60
648651-4865142.74742.75
10min177012-7701267.66670.142.0067.7470.222.00
280248-8024870.50970.58
379964-7996470.25970.33
481617-8161771.71271.78
579301-7930169.67769.74
680860-8086071.04771.12
15min188988-8898878.18880.572.3378.3780.762.33
291150-9115080.08880.28
390368-9036879.40179.59
493336-9333682.00982.20
591405-9140580.31280.50
694945-9494583.42283.61
20min192220-9222081.02882.413.0281.3482.743.01
294126-9412682.70383.03
395440-9544083.85784.18
489595-8959578.72279.05
593502-9350282.15482.47
697899-9789986.01886.35
30min196360-9636084.66686.771.7285.1187.231.72
298764-9876486.77887.24
398488-9848886.53587.00
498951-9895186.94287.40
598337-9833786.40386.86
6101648-10164889.31289.78
45min1100516-10051688.31788.811.5388.9189.411.53
2100667-10066788.45089.06
399544-9954487.46388.07
4101440-10144089.12989.73
5100305-10030588.13288.73
6103975-10397591.35691.98
极限1106453-10645393.53495.852.0794.2796.602.06
2109355-10935596.08496.84
3109320-10932096.05396.80
4109890-10989096.55497.30
5106877-10687793.90694.65
6112648-11264898.97799.75
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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%
19.998233282354822888225782281823020.05
29.958235582535824450.16
单位质量响应值RSD%判断
8238.448285.930.41数据可信
加速6月-供试品溶液-2024021821批-比索洛尔-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%
5min188882-8888296.62696.912.4296.6396.912.42
285644-8564493.10693.11
387752-8775295.39895.40
490993-9099398.92198.92
591028-9102898.95998.96
690573-9057398.46598.46
10min190716-9071698.62099.012.0898.7899.172.08
288418-8841896.12296.28
389318-8931897.10097.26
492597-92597100.665100.83
592651-92651100.724100.89
692749-92749100.830100.99
15min190582-9058298.47499.012.1898.8099.342.18
288119-8811995.79796.11
389576-8957697.38197.70
492636-92636100.707101.04
592458-92458100.514100.85
693082-93082101.192101.52
20min190589-9058998.48299.031.7498.9799.521.74
289000-8900096.75597.23
389631-8963197.44197.92
492448-92448100.503101.00
592100-92100100.125100.63
692792-92792100.877101.38
30min190506-9050698.39298.831.7699.0599.481.76
288730-8873096.46197.10
389470-8947097.26697.91
492017-92017100.035100.70
591936-9193699.946100.61
692770-92770100.853101.52
45min190142-9014297.99698.741.7998.8199.561.80
288719-8871996.44997.25
389398-8939897.18797.99
492239-92239100.276101.11
591888-9188899.894100.73
692592-92592100.660101.50
极限190204-9020498.06498.671.7399.0499.661.74
288806-8880696.54497.50
389209-8920996.98297.95
492043-92043100.063101.06
591817-9181799.817100.82
692495-92495100.554101.56
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.549954799838996129982399135995910.29
213.519948899899996940.30
单位质量响应值RSD%判断
7355.327379.270.23数据可信
加速6月-供试品溶液-2024021821批-氨氯地平-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%
5min161151-6115153.80752.952.4853.8152.952.48
258187-5818751.19951.20
362122-6212254.66254.66
459618-5961852.45852.46
560972-6097253.65053.65
658979-5897951.89651.90
10min184438-8443874.29874.202.7574.3974.292.75
281195-8119571.44471.53
386780-8678076.35876.45
483687-8368773.63773.72
587159-8715976.69276.78
682731-8273172.79672.88
15min193197-9319782.00582.923.0882.2283.133.08
290079-9007979.26179.47
398157-9815786.36986.59
494009-9400982.71982.93
596865-9686585.23285.45
693112-9311281.93082.14
20min197890-9789086.13486.962.8086.4887.312.80
294447-9444783.10483.44
3102179-10217989.90890.27
498761-9876186.90087.25
5101404-10140489.22689.59
698310-9831086.50486.85
30min199688-9968887.71689.792.7088.2190.292.69
298171-9817186.38186.86
3103887-10388791.41191.92
4103699-10369991.24591.74
5105323-10532392.67493.18
6101530-10153089.33789.83
45min1103931-10393191.45093.962.4192.0994.602.41
2103231-10323190.83491.45
3108133-10813395.14795.81
4107476-10747694.56995.21
5109476-10947696.32996.99
6108444-10844495.42196.06
极限1112115-11211598.65198.711.5799.4499.511.57
2110419-11041997.15897.93
3115048-115048101.231102.05
4110440-11044097.17797.98
5113146-11314699.558100.38
6111912-11191298.47299.27
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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%
19.998249482461824338243282338824320.08
29.958255582535825450.02
单位质量响应值RSD%判断
8251.458295.980.39数据可信
加速6月-供试品溶液-2024022021批-比索洛尔-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%
5min189724-8972497.40696.321.3197.4196.321.31
290172-9017297.89297.89
387455-8745594.94294.94
489200-8920096.83796.84
588330-8833095.89295.89
687471-8747194.96094.96
10min192704-92704100.64198.821.30100.8098.981.29
292023-9202399.901100.06
389627-8962797.30097.46
490997-9099798.78898.95
589980-8998097.68497.84
690811-9081198.58698.74
15min193153-93153101.12899.081.44101.4699.411.44
292239-92239100.136100.47
389732-8973297.41497.73
490894-9089498.67699.00
590051-9005197.76198.08
691537-9153799.37499.70
20min193081-93081101.05099.071.39101.5599.561.39
291985-9198599.860100.36
389710-8971097.39097.87
490998-9099898.78999.28
590056-9005697.76698.25
691693-9169399.543100.03
30min193092-93092101.06298.971.48101.7399.631.48
291915-9191599.784100.45
389593-8959397.26397.91
491040-9104098.83499.49
589716-8971697.39798.05
691641-9164199.487100.14
45min193175-93175101.15298.831.59101.9999.661.59
291902-9190299.770100.60
389355-8935597.00597.81
490710-9071098.47699.30
589643-8964397.31898.13
691446-9144699.275100.10
极限192899-92899100.85298.571.57101.8699.561.57
291563-9156399.402100.40
389155-8915596.78897.76
490568-9056898.32299.31
589352-8935297.00297.97
691253-9125399.066100.05
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.549947799917999909945699845997370.26
213.519963299405995180.17
单位质量响应值RSD%判断
7366.107366.250.01数据可信
加速6月-供试品溶液-2024022021批-氨氯地平-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%
5min155829-5582949.13250.083.4649.1350.073.46
256080-5608049.35349.35
357109-5710950.25850.26
458991-5899151.91451.91
559247-5924752.14052.14
654150-5415047.65447.65
10min179003-7900369.52671.173.0969.6171.263.09
282335-8233572.45872.54
379740-7974070.17470.26
483284-8328473.29373.38
583438-8343873.42973.52
677432-7743268.14368.22
15min186198-8619875.85778.104.1676.0678.304.16
290718-9071879.83580.04
388852-8885278.19378.39
493138-9313881.96582.17
590713-9071379.83180.04
682866-8286672.92573.12
20min190352-9035279.51382.333.5879.8482.663.58
293494-9349482.27882.61
393516-9351682.29882.63
497387-9738785.70486.05
597201-9720185.54185.88
689336-8933678.61978.93
30min193952-9395282.68185.992.7783.1486.462.77
298399-9839986.59587.07
398170-9817086.39386.86
4100847-10084788.74989.24
599857-9985787.87888.36
695023-9502383.62484.07
45min197024-9702485.38588.662.9485.9889.282.93
2100087-10008788.08088.70
3102133-10213389.88190.49
4102937-10293790.58891.22
5104498-10449891.96292.59
697826-9782686.09186.68
极限1106866-10686694.04693.032.5594.7893.792.51
2109419-10941996.29397.06
3103443-10344391.03491.80
4102674-10267490.35791.14
5104119-10411991.62992.41
6107733-10773394.80995.54
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