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)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%
110.298526585380852278538885572853660.16
210.298498684770848780.18
单位质量响应值RSD%判断
8296.028248.590.41数据可信
供试品溶液-2024021821批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187812-8781295.34693.234.8095.3593.234.80
286048-8604893.43193.43
391127-9112798.94698.95
486092-8609293.47993.48
585532-8553292.87192.87
678577-7857785.31985.32
10min192910-92910100.88299.112.03101.0499.272.03
288949-8894996.58196.74
392730-92730100.686100.85
492348-92348100.272100.43
591816-9181699.69499.85
688942-8894296.57396.72
15min192904-92904100.87599.641.96101.2099.961.96
289206-8920696.86097.18
393070-93070101.055101.39
493071-93071101.057101.38
592611-92611100.557100.88
689739-8973997.43997.74
20min192912-92912100.88499.641.96101.38100.131.96
288882-8888296.50896.99
392828-92828100.793101.29
493417-93417101.432101.92
592340-92340100.263100.75
690240-9024097.98398.45
30min193092-93092101.07999.581.75101.74100.241.75
289354-8935497.02197.66
392509-92509100.446101.12
493217-93217101.215101.88
591939-9193999.827100.48
690175-9017597.91298.54
45min192831-92831100.79699.551.85101.63100.371.85
289231-8923196.88797.69
392766-92766100.725101.56
493327-93327101.335102.16
591997-9199799.890100.71
689940-8994097.65798.45
极限192873-92873100.84299.391.97101.84100.381.97
288700-8870096.31197.27
392416-92416100.345101.35
493103-93103101.091102.09
592231-92231100.144101.13
689919-8991997.63498.59
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)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%
110.298526184976850728468784857849710.26
210.298454984827846880.24
单位质量响应值RSD%判断
8257.638230.130.24数据可信
供试品溶液-2024021821批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185579-8557993.24292.177.7493.2492.177.74
286582-8658294.33494.33
391047-9104799.19999.20
490054-9005498.11798.12
573463-7346380.04180.04
680870-8087088.11188.11
10min190626-9062698.74199.334.0498.9099.484.05
292369-92369100.640100.80
396319-96319104.943105.11
493552-93552101.929102.09
586823-8682394.59794.73
687314-8731495.13295.28
15min190446-9044698.544100.323.2698.86100.643.26
292893-92893101.211101.54
396626-96626105.278105.62
494073-94073102.496102.83
589516-8951697.53197.82
688881-8888196.83997.14
20min190746-9074698.871100.323.0699.36100.813.06
292818-92818101.129101.62
396724-96724105.385105.90
493315-93315101.670102.17
589178-8917897.16397.62
689697-8969797.72898.20
30min190243-9024398.323100.143.1698.97100.803.16
292658-92658100.954101.62
396533-96533105.176105.87
493572-93572101.950102.62
588972-8897296.93897.55
689499-8949997.51398.14
45min189809-8980997.85099.803.1198.66100.623.11
292181-92181100.435101.27
396191-96191104.804105.67
493286-93286101.639102.48
588913-8891396.87497.65
689221-8922197.21098.00
极限190156-9015698.22899.932.9099.20100.922.91
292364-92364100.634101.63
396047-96047104.647105.69
493131-93131101.470102.48
589538-8953897.55598.49
689075-8907597.05198.00
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)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%
110.298485684498847838500984653847600.23
210.298474684707847260.04
单位质量响应值RSD%判断
8237.128233.820.03数据可信
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%
5min175235-7523582.05580.996.6982.0580.996.69
279084-7908486.25386.25
364952-6495270.84070.84
474668-7466881.43781.44
573921-7392180.62280.62
677714-7771484.75984.76
10min187564-8756495.50293.253.0095.6493.383.00
286834-8683494.70594.85
381733-8173389.14289.26
484287-8428791.92792.06
584070-8407091.69191.83
688510-8851096.53396.67
15min190474-9047498.67596.642.3298.9796.932.32
288905-8890596.96497.27
387010-8701094.89795.16
487271-8727195.18295.47
586463-8646394.30194.59
691515-9151599.811100.11
20min191310-9131099.58797.732.07100.0598.182.07
289455-8945597.56498.03
388853-8885396.90797.33
488535-8853596.56197.01
587240-8724095.14895.59
692233-92233100.594101.06
30min192007-92007100.34798.281.97100.9798.891.97
290142-9014298.31398.94
389456-8945697.56598.15
488988-8898897.05597.66
587740-8774095.69396.30
692311-92311100.679101.31
45min191840-91840100.16598.441.95100.9699.221.95
289950-8995098.10498.89
390147-9014798.31999.07
489226-8922697.31498.08
587767-8776795.72396.49
692613-92613101.008101.81
极限191834-91834100.15998.201.95101.1299.141.95
289741-8974197.87698.83
389852-8985297.99798.91
488748-8874896.79397.73
587746-8774695.70096.62
692300-92300100.667101.64
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)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%
110.298485184807848498484784915848540.05
210.298461684737846760.11
单位质量响应值RSD%判断
8246.268228.960.15数据可信
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%
5min172107-7210778.62380.673.4878.6280.663.48
273739-7373980.40380.40
370286-7028676.63776.64
477230-7723084.20984.21
574241-7424180.95080.95
676277-7627783.17083.17
10min183525-8352591.07394.363.4891.2094.493.48
286417-8641794.22694.36
382651-8265190.12090.25
487197-8719795.07795.22
590188-9018898.33898.47
689254-8925497.32097.46
15min188446-8844696.43998.752.6796.7299.042.67
290562-9056298.74699.04
388063-8806396.02196.30
489820-8982097.93798.24
594548-94548103.092103.39
691935-91935100.243100.54
20min190570-9057098.754100.072.7199.20100.522.70
292022-92022100.338100.79
388731-8873196.74997.19
490511-9051198.69099.15
595907-95907104.574105.04
692912-92912101.308101.78
30min190108-9010898.251100.392.6898.86101.012.68
292007-92007100.321100.94
389899-8989998.02398.62
490606-9060698.79499.42
596254-96254104.952105.60
693535-93535101.987102.62
45min190911-9091199.126100.292.5499.90101.082.54
291742-91742100.032100.82
389326-8932697.39898.16
490780-9078098.98399.77
595999-95999104.674105.49
693124-93124101.539102.35
极限190009-9000998.143100.222.7599.08101.172.75
292370-92370100.717101.67
389371-8937197.44798.37
490361-9036198.52799.48
596055-96055104.735105.73
693292-93292101.722102.70
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