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%
110.138280682906828778284182876828610.05
210.108217381959820660.19
单位质量响应值RSD%判断
8179.768125.350.48数据可信
供试品溶液-2025120521批-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%
5min188913-8891397.96099.061.7797.9699.061.77
292345-92345101.741101.74
389970-8997099.12599.12
490078-9007899.24499.24
587618-8761896.53396.53
690533-9053399.74599.74
10min190994-90994100.253102.702.47100.42102.872.47
294373-94373103.976104.15
397190-97190107.079107.24
492422-92422101.826101.99
591278-91278100.566100.73
693047-93047102.515102.68
15min190903-90903100.153102.622.73100.48102.952.72
294360-94360103.961104.30
392091-92091101.462101.81
492432-92432101.837102.17
591340-91340100.634100.96
697705-97705107.647107.98
20min190739-9073999.972101.601.40100.47102.111.40
294181-94181103.764104.28
391586-91586100.905101.42
492668-92668102.097102.60
591186-91186100.464100.96
692962-92962102.421102.94
30min190522-9052299.733102.823.72100.40103.503.70
294256-94256103.847104.54
391672-91672101.000101.68
499863-99863110.024110.70
590991-90991100.250100.91
692638-92638102.064102.75
45min189999-8999999.157101.191.5299.99102.041.52
293995-93995103.559104.42
391482-91482100.791101.64
492000-92000101.361102.22
590948-90948100.202101.03
692658-92658102.086102.94
极限190323-9032399.514101.141.32100.51102.161.32
293656-93656103.186104.22
391373-91373100.670101.69
492077-92077101.446102.47
590858-90858100.103101.10
692516-92516101.930102.96
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%
110.138253182512829348306682863827810.30
210.108082281017809200.18
单位质量响应值RSD%判断
8171.878011.881.40数据可信
供试品溶液-2025120522批-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%
5min189410-8941099.255100.861.5299.26100.861.52
289306-8930699.14099.14
392283-92283102.444102.44
490564-90564100.536100.54
592555-92555102.746102.75
690994-90994101.013101.01
10min190734-90734100.725102.551.33100.89102.721.34
291139-91139101.174101.34
393689-93689104.005104.18
492452-92452102.632102.80
593603-93603103.910104.08
692656-92656102.858103.03
15min191009-91009101.030102.521.26101.36102.861.26
290984-90984101.002101.34
393649-93649103.961104.30
492606-92606102.803103.14
593494-93494103.789104.13
692347-92347102.515102.86
20min192544-92544102.734102.761.04103.24103.271.04
290909-90909100.919101.42
393640-93640103.951104.47
492533-92533102.722103.23
593371-93371103.652104.17
692389-92389102.562103.07
30min190522-90522100.489102.742.05101.16103.422.04
291140-91140101.176101.85
395881-95881106.439107.13
492248-92248102.406103.09
593237-93237103.503104.19
692271-92271102.431103.11
45min190856-90856100.860102.151.13101.70103.001.14
290975-90975100.992101.83
393542-93542103.842104.71
491835-91835101.947102.80
592777-92777102.993103.86
692127-92127102.271103.12
极限190332-90332100.279101.891.25101.29102.911.25
290588-90588100.563101.57
393223-93223103.488104.53
491827-91827101.938102.96
592719-92719102.928103.96
692008-92008102.139103.16
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%
110.138382383581835058367183598836360.15
210.108293382579827560.31
单位质量响应值RSD%判断
8256.278193.660.54数据可信
供试品溶液-2025120621批-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%
5min189130-8913097.33599.471.5997.3499.471.59
291318-9131899.72499.72
392240-92240100.731100.73
490482-9048298.81198.81
593111-93111101.683101.68
690212-9021298.51798.52
10min190807-9080799.166100.751.2699.33100.911.26
292516-92516101.033101.20
393389-93389101.986102.15
491764-91764100.212100.38
593726-93726102.354102.52
691322-9132299.72999.89
15min197031-97031105.963101.822.25106.29102.162.24
292746-92746101.284101.62
393131-93131101.704102.04
491457-9145799.876100.21
593771-93771102.403102.74
691305-9130599.710100.04
20min190704-9070499.054101.001.3699.56101.501.35
292967-92967101.525102.03
393615-93615102.233102.74
492145-92145100.628101.13
593944-93944102.592103.10
691536-9153699.963100.46
30min190374-9037498.694100.601.3299.36101.281.32
292372-92372100.875101.55
393130-93130101.703102.38
491878-91878100.336101.00
593699-93699102.325103.01
691279-9127999.682100.35
45min190294-9029498.606100.371.3699.44101.211.35
292124-92124100.605101.45
392955-92955101.512102.36
491526-9152699.952100.78
593621-93621102.239103.09
690956-9095699.329100.16
极限190169-9016998.470101.033.0499.47102.043.02
291874-91874100.332101.34
392848-92848101.395102.41
491241-9124199.640100.64
597951-97951106.968107.99
690997-9099799.374100.37
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%
110.138364083714837538362983252835980.24
210.108348683756836210.23
单位质量响应值RSD%判断
8252.528279.310.23数据可信
供试品溶液-G02PSP批-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%
5min148722-4872252.94362.3215.3452.9462.3215.34
265253-6525370.90670.91
349950-4995054.27754.28
452605-5260557.16257.16
557123-5712362.07262.07
670481-7048176.58776.59
10min176123-7612382.71883.607.4682.8183.707.47
279838-7983886.75586.87
374330-7433080.77080.86
469119-6911975.10775.20
575931-7593182.50982.61
686240-8624093.71193.84
15min186390-8639093.87491.834.8094.1092.084.80
285307-8530792.69892.96
384055-8405591.33791.56
477409-7740984.11584.34
584177-8417791.47091.71
689719-8971997.49297.78
20min190330-9033098.15695.682.7898.5496.072.78
288660-8866096.34196.76
388386-8838696.04396.42
483485-8348590.71891.08
587636-8763695.22895.62
689799-8979997.57998.02
30min191977-9197799.94598.411.47100.4998.971.45
291195-9119599.09699.67
392024-9202499.996100.53
489117-8911796.83897.35
589737-8973797.51198.06
689359-8935997.10197.71
45min192341-92341100.34198.921.62101.0599.641.59
291514-9151499.442100.19
392676-92676100.705101.41
491096-9109698.98899.66
589471-8947197.22297.94
689116-8911696.83797.61
极限191870-9187099.82998.721.70100.7199.601.67
291107-9110799.00099.91
392913-92913100.962101.83
491091-9109198.98399.82
589018-8901896.73097.61
689099-8909996.81897.75
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