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%
110.091676071681351682111680451673981678790.22
210.111657201665161661180.34
单位质量响应值RSD%判断
16638.1616431.060.89数据可信
供试品溶液-25011501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%
5min1183128-18312899.483100.281.4199.48100.281.41
2185063-185063100.535100.53
3188019-188019102.140102.14
4183865-18386599.88499.88
5186738-186738101.445101.44
6180785-18078598.21198.21
10min1188811-188811102.571101.811.32102.74101.981.32
2185055-185055100.530100.70
3189251-189251102.810102.98
4187816-187816102.030102.20
5189798-189798103.107103.28
6183696-18369699.79299.96
15min1187700-187700101.967101.361.26102.30101.701.26
2184735-184735100.356100.69
3188744-188744102.534102.88
4186048-186048101.070101.41
5189098-189098102.727103.07
6183225-18322599.53699.87
20min1186616-186616101.378101.061.14101.89101.561.14
2183975-18397599.944100.45
3188362-188362102.327102.84
4186249-186249101.179101.68
5187861-187861102.055102.57
6183079-18307999.45799.95
30min1186385-186385101.253100.821.20101.93101.501.20
2183508-18350899.690100.36
3187625-187625101.926102.61
4185218-185218100.619101.29
5188160-188160102.217102.90
6182661-18266199.23099.89
45min1185092-185092100.550100.541.04101.39101.381.04
2183497-18349799.684100.52
3187605-187605101.916102.77
4184545-184545100.253101.09
5186944-186944101.557102.41
6182729-18272999.267100.09
极限1185038-185038100.521100.141.09101.53101.151.09
2183117-18311799.477100.48
3186879-186879101.521102.54
4184272-184272100.105101.11
5185548-185548100.798101.82
6181178-18117898.42499.42
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%
110.091670681671761676451675851674301673810.16
210.111668601673771671180.22
单位质量响应值RSD%判断
16588.8016529.970.26数据可信
供试品溶液-25012001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%
5min1178453-17845396.79599.471.7796.8099.471.77
2182266-18226698.86398.86
3187435-187435101.667101.67
4183270-18327099.40899.41
5186475-186475101.146101.15
6182393-18239398.93298.93
10min1180540-18054097.927100.481.4798.09100.651.47
2184395-184395100.018100.18
3187761-187761101.844102.01
4185397-185397100.562100.73
5188012-188012101.980102.15
6185429-185429100.579100.74
15min1180520-18052097.916100.371.4998.24100.701.49
2183879-18387999.738100.07
3188528-188528102.260102.60
4185062-185062100.380100.71
5186970-186970101.415101.75
6185339-185339100.530100.86
20min1180320-18032097.808100.682.6898.30101.182.67
2182917-18291799.21799.71
3187036-187036101.451101.96
4184587-184587100.122100.62
5194703-194703105.609106.12
6184132-18413299.876100.38
30min1179056-17905697.12299.461.3997.77100.121.39
2182041-18204198.74199.40
3185952-185952100.863101.54
4183555-18355599.563100.23
5185525-185525100.631101.31
6184040-18404099.826100.49
45min1178462-17846296.80099.141.4797.6199.971.47
2181533-18153398.46699.29
3186045-186045100.913101.76
4182762-18276299.13399.97
5184967-184967100.329101.18
6182879-18287999.196100.03
极限1177434-17743496.24398.941.5997.2299.941.59
2180969-18096998.16099.15
3185787-185787100.773101.79
4183177-18317799.358100.36
5184077-18407799.846100.86
6183017-18301799.271100.27
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%
110.091660841664501660401664241662801662560.12
210.111666141662901664520.14
单位质量响应值RSD%判断
16477.3016464.090.06数据可信
供试品溶液-25012002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%
5min1186133-186133101.504100.020.93101.50100.020.93
2181897-18189799.19499.19
3182747-18274799.65899.66
4181697-18169799.08599.09
5184600-184600100.668100.67
6183347-18334799.98599.99
10min1189218-189218103.187101.690.85103.36101.860.85
2185171-185171100.980101.15
3185454-185454101.134101.30
4185340-185340101.072101.24
5187399-187399102.195102.36
6186285-186285101.587101.75
15min1188840-188840102.981101.500.92103.32101.840.92
2184532-184532100.631100.96
3185338-185338101.071101.41
4184694-184694100.720101.05
5187489-187489102.244102.58
6185890-185890101.372101.71
20min1188183-188183102.622101.350.84103.14101.850.84
2184415-184415100.567101.07
3185216-185216101.004101.51
4184267-184267100.487100.99
5187138-187138102.052102.56
6185847-185847101.348101.85
30min1188424-188424102.754101.180.92103.44101.850.92
2184037-184037100.361101.03
3184844-184844100.801101.47
4184064-184064100.376101.04
5186561-186561101.738102.42
6185295-185295101.047101.72
45min1188675-188675102.891101.250.98103.75102.100.98
2184033-184033100.359101.20
3184465-184465100.595101.43
4184251-184251100.478101.31
5186727-186727101.828102.68
6185897-185897101.376102.22
极限1187858-187858102.445100.950.88103.47101.960.88
2184054-184054100.371101.37
3184528-184528100.629101.64
4183167-18316799.887100.89
5185693-185693101.264102.28
6185368-185368101.087102.10
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%
110.098349483748839368361683740837070.20
210.118298583238831120.22
单位质量响应值RSD%判断
8296.048220.770.65数据可信
供试品溶液-25011502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%
5min190549-9054998.485100.561.7198.48100.561.71
290371-9037198.29198.29
393092-93092101.251101.25
493442-93442101.631101.63
593961-93961102.196102.20
693310-93310101.488101.49
10min192063-92063100.132102.281.56100.30102.451.56
292307-92307100.397100.56
394876-94876103.191103.36
494494-94494102.776102.95
595307-95307103.660103.83
695196-95196103.539103.71
15min191918-9191899.974102.101.63100.30102.441.63
292028-92028100.094100.42
394861-94861103.175103.52
494521-94521102.805103.15
594397-94397102.670103.01
695520-95520103.892104.23
20min191816-9181699.863102.041.83100.36102.551.82
291465-9146599.48199.98
394702-94702103.002103.51
494657-94657102.953103.46
595022-95022103.350103.86
695270-95270103.620104.13
30min191290-9129099.291101.661.8899.95102.341.87
291201-9120199.19499.86
394388-94388102.660103.34
494129-94129102.379103.06
594895-94895103.212103.90
694913-94913103.231103.92
45min191576-9157699.602101.601.57100.43102.451.57
291705-9170599.742100.57
393840-93840102.064102.92
493789-93789102.009102.86
594434-94434102.710103.57
695157-95157103.497104.36
极限191443-9144399.457101.591.66100.45102.611.66
291466-9146699.482100.48
393927-93927102.159103.18
494095-94095102.342103.37
594689-94689102.988104.02
694822-94822103.132104.16
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