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%
19.878398283470837298371883981837760.26
29.868347683379834280.09
单位质量响应值RSD%判断
8487.948461.260.23数据可信
供试品溶液-25011502批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194532-94532100.19299.912.20100.1999.912.20
293702-9370299.31299.31
390873-9087396.31496.31
496854-96854102.653102.65
595888-95888101.629101.63
693765-9376599.37999.38
10min193868-9386899.488100.122.0499.66100.292.04
293587-9358799.19199.36
392390-9239097.92298.08
497802-97802103.658103.83
595531-95531101.251101.42
693626-9362699.23299.40
15min193626-9362699.23299.801.5399.56100.141.53
293889-9388999.51199.84
392504-9250498.04398.37
496457-96457102.232102.58
595234-95234100.936101.27
693275-9327598.86099.19
20min193338-9333898.92799.101.9199.4299.601.91
293271-9327198.85699.35
391989-9198997.49797.98
496195-96195101.955102.47
594846-94846100.525101.03
691389-9138996.86197.36
30min193001-9300198.56998.931.6599.2399.601.65
292613-9261398.15898.82
391657-9165797.14597.79
495785-95785101.520102.20
594578-94578100.241100.91
692424-9242497.95898.62
45min192082-9208297.59598.391.6398.4299.221.63
292184-9218497.70498.53
391364-9136496.83497.65
495180-95180100.879101.73
594215-9421599.856100.70
691955-9195597.46198.28
极限192047-9204797.55897.991.5598.5598.981.55
291708-9170897.19998.19
390884-9088496.32697.30
494596-94596100.260101.28
593801-9380199.417100.42
691691-9169197.18198.16
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%
19.878287383173831668295982984830310.17
29.868314483301832220.14
单位质量响应值RSD%判断
8412.468440.370.24数据可信
供试品溶液-25011502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%
5min190559-9055996.53096.653.7096.5396.653.70
291767-9176797.81897.82
384504-8450490.07690.08
494139-94139100.346100.35
590230-9023096.17996.18
692811-9281198.93198.93
10min191963-9196398.02799.222.2898.1999.382.28
295918-95918102.243102.41
391470-9147097.50197.65
494581-94581100.817100.98
590418-9041896.38096.54
694124-94124100.330100.50
15min191218-9121897.23398.632.3897.5698.952.38
294994-94994101.258101.59
390569-9056996.54196.85
494740-94740100.987101.32
590014-9001495.94996.27
693626-9362699.799100.13
20min191098-9109897.10598.632.5897.5999.122.58
295959-95959102.286102.79
390470-9047096.43596.91
494248-94248100.462100.97
589958-8995895.89096.37
693426-9342699.586100.08
30min190932-9093296.92898.142.1497.5898.802.14
294173-94173100.382101.06
390415-9041596.37797.01
494171-94171100.380101.05
589710-8971095.62596.27
693042-9304299.17799.84
45min190460-9046096.42597.852.1897.2398.662.18
293830-93830100.017100.86
390152-9015296.09696.89
494049-94049100.250101.09
589507-8950795.40996.21
692766-9276698.88399.71
极限190252-9025296.20397.712.3197.1798.692.31
293567-9356799.737100.74
389929-8992995.85996.81
493680-9368099.857100.86
589127-8912795.00495.96
693463-9346399.626100.62
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%
19.878296883004828998270883022829200.16
29.868336083461834100.09
单位质量响应值RSD%判断
8401.228459.430.49数据可信
供试品溶液-25011502批-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%
5min191434-9143497.41999.192.3897.4299.192.38
296580-96580102.901102.90
391488-9148897.47697.48
494178-94178100.342100.34
590875-9087596.82396.82
694015-94015100.168100.17
10min192570-9257098.629101.252.7398.79101.422.72
298840-98840105.309105.48
393495-9349599.61499.78
496962-96962103.308103.48
592538-9253898.59598.76
695774-95774102.043102.21
15min192735-9273598.805101.182.7299.13101.512.72
298817-98817105.285105.63
393225-9322599.32799.66
496900-96900103.242103.58
592468-9246898.52098.85
695633-95633101.892102.23
20min192410-9241098.458100.842.6698.95101.342.66
298257-98257104.688105.21
392945-9294599.02899.52
496559-96559102.879103.39
592148-9214898.17998.67
695539-95539101.792102.30
30min192297-9229798.338100.672.6698.99101.342.66
298195-98195104.622105.32
392642-9264298.70699.36
496413-96413102.723103.41
592191-9219198.22598.88
695171-95171101.400102.08
45min191898-9189897.913100.412.7198.73101.252.71
298075-98075104.494105.37
392706-9270698.77499.60
496115-96115102.406103.26
591798-9179897.80698.62
694850-94850101.058101.90
极限191751-9175197.756100.122.7198.74101.122.71
297690-97690104.084105.13
392117-9211798.14699.13
495872-95872102.147103.17
591572-9157297.56698.55
694814-94814101.020102.03
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%
19.878367483408834578345983657835310.15
29.868298382912829480.07
单位质量响应值RSD%判断
8463.128412.580.43数据可信
供试品溶液-25011502批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136272-3627238.61257.0521.5038.6157.0521.50
245344-4534448.26948.27
363296-6329667.37967.38
452385-5238555.76455.76
567323-6732371.66571.67
656939-5693960.61260.61
10min154029-5402957.51475.3616.5357.5875.4616.54
259938-5993863.80463.88
384234-8423489.66789.78
477665-7766582.67482.77
578387-7838783.44383.56
670530-7053075.07975.18
15min168918-6891873.36385.6610.7973.5285.8810.81
272006-7200676.65076.84
391331-9133197.22297.48
487031-8703192.64492.88
583651-8365189.04689.30
679855-7985585.00685.23
20min179307-7930784.42291.625.6384.7091.985.66
282311-8231187.62087.93
391760-9176097.67898.10
490792-9079296.64897.03
587239-8723992.86693.27
684984-8498490.46590.83
30min191008-9100896.87896.920.7297.3097.440.73
290783-9078396.63897.10
391633-9163397.54398.13
492003-9200397.93798.48
590577-9057796.41996.98
690305-9030596.13096.65
45min194838-94838100.95597.951.76101.5498.621.70
292674-9267498.65199.27
390979-9097996.84797.60
491805-9180597.72698.44
591574-9157497.48098.20
690198-9019896.01696.69
极限194310-94310100.39397.571.72101.1598.411.66
292362-9236298.31999.11
390521-9052196.36097.27
491603-9160397.51198.38
591348-9134897.24098.12
689820-8982095.61396.45
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%
19.878245882486825178243982574824950.07
29.868332183466833940.13
单位质量响应值RSD%判断
8358.168457.810.84数据可信
供试品溶液-25011502批-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%
5min171452-7145276.33368.0718.0176.3368.0618.01
276270-7627081.48081.48
356632-5663260.50060.50
471117-7111775.97575.97
545569-4556948.68248.68
661244-6124465.42765.43
10min178285-7828583.63279.2813.0083.7679.3913.01
283546-8354689.25389.39
373689-7368978.72378.82
481523-8152387.09287.22
556914-5691460.80260.88
671288-7128876.15876.27
15min182424-8242488.05486.7210.0588.3286.9710.07
288986-8898695.06495.35
384848-8484890.64490.88
486804-8680492.73393.01
566684-6668471.23971.42
677310-7731082.59182.83
20min186199-8619992.08791.556.7292.5091.946.74
291618-9161897.87698.32
388696-8869694.75595.14
489639-8963995.76296.19
576179-7617981.38381.68
681820-8182087.40987.78
30min190322-9032296.49295.803.2097.0696.353.24
293867-93867100.279100.88
389192-8919295.28595.83
491467-9146797.71598.30
585967-8596791.83992.28
687249-8724993.20993.73
45min192504-9250498.82397.672.3199.5598.382.35
294783-94783101.257102.03
389539-8953995.65596.36
492240-9224098.54199.29
589765-8976595.89796.49
689743-8974395.87396.55
极限193764-93764100.16999.012.17101.0699.872.17
295421-95421101.939102.88
389591-8959195.71196.57
492565-9256598.88899.80
593264-9326499.635100.38
691449-9144997.69698.53
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