富马酸比索洛尔左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)1.5
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%
110.248574986355865868692686157863550.52
210.238601986766863920.62
单位质量响应值RSD%判断
8433.118444.970.10数据可信
供试品溶液-2023101323批-富马酸比索洛尔-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%
5min193874-9387499.91498.353.2899.9198.343.28
286479-8647992.04392.04
393389-9338999.39899.40
493043-9304399.02999.03
595087-95087101.205101.20
692536-9253698.49098.49
10min195502-95502101.647100.432.13101.81100.592.14
290799-9079996.64196.79
394083-94083100.136100.30
495468-95468101.610101.78
596492-96492102.700102.87
693788-9378899.82299.99
15min195089-95089101.207100.381.18101.54100.711.18
292473-9247398.42398.74
394191-94191100.251100.58
494476-94476100.555100.89
595714-95714101.872102.21
693911-9391199.953100.28
20min195403-95403101.541100.411.09102.05100.911.10
292716-9271698.68199.16
394468-94468100.546101.05
494293-94293100.360100.86
595408-95408101.547102.06
693773-9377399.806100.30
30min195109-95109101.228100.390.98101.90101.060.98
293040-9304099.02699.67
393981-93981100.028100.69
494737-94737100.832101.50
595419-95419101.558102.24
693665-9366599.691100.35
45min195461-95461101.603100.271.17102.45101.101.17
292640-9264098.60099.41
393851-9385199.889100.72
494665-94665100.756101.59
595219-95219101.345102.19
693405-9340599.415100.24
极限195765-95765101.927100.251.28102.94101.251.28
292921-9292198.90099.87
393728-9372899.758100.76
493820-9382099.856100.86
595612-95612101.764102.78
693313-9331399.317100.31
富马酸比索洛尔左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)1.5
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%
110.248627886189861198550286786861750.54
210.238682386906868640.07
单位质量响应值RSD%判断
8415.538491.100.64数据可信
供试品溶液-2023101323批-富马酸比索洛尔-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%
5min192937-9293798.75198.441.7298.7598.441.72
294449-94449100.358100.36
391213-9121396.92096.92
490369-9036996.02396.02
594043-9404399.92799.93
692827-9282798.63598.63
10min194365-94365100.26999.461.70100.4399.621.70
295140-95140101.092101.26
391614-9161497.34697.51
491705-9170597.44297.60
595033-95033100.979101.15
693768-9376899.63499.80
15min194366-94366100.27099.721.83100.60100.041.83
295473-95473101.446101.78
391652-9165297.38697.71
492181-9218197.94898.27
595861-95861101.858102.19
693540-9354099.39299.72
20min193855-9385599.72799.371.38100.2399.871.38
295180-95180101.135101.64
391860-9186097.60798.09
492174-9217497.94198.43
594411-94411100.318100.82
693637-9363799.49599.99
30min193774-9377499.64199.301.69100.3199.961.69
295601-95601101.582102.26
391660-9166097.39598.04
491609-9160997.34097.99
594439-94439100.347101.02
693638-9363899.496100.16
45min194090-9409099.97799.191.81100.81100.021.80
295306-95306101.269102.11
390807-9080796.48897.30
492048-9204897.80798.62
594607-94607100.526101.36
693234-9323499.06799.89
极限193753-9375399.61898.641.94100.6299.631.94
295430-95430101.400102.41
390868-9086896.55397.52
491978-9197897.73298.71
593838-9383899.709100.72
691115-9111596.81597.81
富马酸比索洛尔左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)1.5
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%
110.244428643986440844441644148441840.39
210.234451244557445340.08
单位质量响应值RSD%判断
4314.844353.270.63数据可信
供试品溶液-2024010421批-富马酸比索洛尔-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%
5min194287-94287195.406192.163.32195.41192.163.32
289566-89566185.622185.62
397622-97622202.318202.32
492667-92667192.049192.05
592744-92744192.208192.21
689427-89427185.334185.33
10min195054-95054196.996194.603.08197.32194.923.08
290012-90012186.547186.86
398635-98635204.417204.75
493615-93615194.014194.33
593860-93860194.521194.84
692211-92211191.104191.41
15min194501-94501195.850194.702.65196.50195.352.65
290519-90519187.597188.22
398192-98192203.499204.18
493503-93503193.781194.42
593748-93748194.289194.93
693228-93228193.212193.84
20min194695-94695196.252194.692.73197.23195.662.73
289990-89990186.501187.43
397985-97985203.070204.09
493679-93679194.146195.11
593571-93571193.922194.89
693740-93740194.273195.22
30min194574-94574196.001195.002.72197.31196.292.72
290293-90293187.129188.37
398287-98287203.696205.05
493807-93807194.412195.70
593745-93745194.283195.57
693843-93843194.486195.76
45min194723-94723196.310194.772.61197.94196.392.62
290118-90118186.766188.32
397759-97759202.602204.30
494071-94071194.959196.57
593552-93552193.883195.50
693662-93662194.111195.71
极限194517-94517195.883193.912.59197.84195.852.60
289708-89708185.916187.78
397182-97182201.406203.44
493152-93152193.054194.99
593053-93053192.849194.79
693782-93782194.360196.28
富马酸比索洛尔左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)1.5
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%
110.244489844630442294437144456445170.58
210.234419744304442500.18
单位质量响应值RSD%判断
4347.364325.510.36数据可信
供试品溶液-2024010421批-富马酸比索洛尔-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%
5min189784-89784185.969189.681.35185.97189.681.35
293480-93480193.625193.62
391219-91219188.942188.94
492292-92292191.164191.16
591326-91326189.163189.16
691354-91354189.221189.22
10min190923-90923188.329192.831.82188.64193.151.82
295016-95016196.806197.13
391797-91797190.139190.45
492764-92764192.142192.46
592971-92971192.571192.89
695107-95107196.995197.31
15min191499-91499189.522192.421.57190.15193.061.57
293847-93847194.385195.04
392127-92127190.822191.45
492589-92589191.779192.42
591948-91948190.452191.09
695368-95368197.536198.18
20min191200-91200188.902192.201.57189.84193.161.57
293996-93996194.694195.67
391575-91575189.679190.63
492482-92482191.558192.52
592482-92482191.558192.51
695009-95009196.792197.76
30min191507-91507189.538192.851.56190.79194.131.56
294293-94293195.309196.61
392103-92103190.773192.04
492961-92961192.550193.83
592410-92410191.409192.68
695356-95356197.511198.81
45min190401-90401187.247191.551.80188.82193.151.80
294109-94109194.928196.55
391458-91458189.437191.02
492416-92416191.421193.02
591734-91734190.008191.60
694755-94755196.266197.90
极限190972-90972188.430191.551.72190.31193.471.72
293981-93981194.663196.61
391085-91085188.664190.56
492458-92458191.508193.43
591584-91584189.698191.61
694798-94798196.355198.31
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