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%
110.138491585447851168488484961850650.28
210.108422484266842450.04
单位质量响应值RSD%判断
8397.338341.090.48数据可信
供试品溶液-2025120621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%
5min189358-8935895.90297.681.3395.9097.681.33
292901-9290199.70499.70
390559-9055997.19197.19
490391-9039197.01097.01
591456-9145698.15398.15
691448-9144898.14598.14
10min190047-9004796.64198.771.5396.8098.931.53
294070-94070100.959101.13
392262-9226299.01899.18
490928-9092897.58797.75
592757-9275799.55099.71
692117-9211798.86399.03
15min189585-8958596.14598.411.4796.4798.741.47
293649-93649100.507100.84
391878-9187898.60698.93
491074-9107497.74398.07
592317-9231799.07899.41
691660-9166098.37298.70
20min189481-8948196.03498.341.6296.5198.831.62
294081-94081100.971101.47
391874-9187498.60299.09
491161-9116197.83798.32
591481-9148198.18098.67
691707-9170798.42398.92
30min188418-8841894.89397.661.6395.5398.321.62
292732-9273299.523100.19
391447-9144798.14498.80
490335-9033596.95097.60
591527-9152798.23098.89
691532-9153298.23598.89
45min188585-8858595.07296.861.5095.8797.681.50
292366-9236699.13099.97
390299-9029996.91297.73
489002-8900295.52096.33
590725-9072597.36998.19
690531-9053197.16197.98
极限187538-8753893.94996.071.6794.9197.051.67
291887-9188798.61699.62
390377-9037796.99597.98
488747-8874795.24696.22
589545-8954596.10397.09
689001-8900195.51996.50
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%
110.138397483853842328437284581842020.35
210.108406383806839340.22
单位质量响应值RSD%判断
8312.148310.300.02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%
5min192039-9203999.467100.342.3599.47100.342.36
296618-96618104.416104.42
394267-94267101.875101.88
491416-9141698.79498.79
590866-9086698.20098.20
691882-9188299.29899.30
10min193684-93684101.245102.462.30101.41102.632.30
298605-98605106.563106.74
396262-96262104.031104.20
493342-93342100.875101.04
593081-93081100.593100.76
693900-93900101.478101.64
15min193529-93529101.078102.552.69101.41102.882.68
298168-98168106.091106.44
398156-98156106.078106.42
493282-93282100.811101.14
592891-92891100.388100.72
693308-93308100.839101.17
20min193336-93336100.869102.132.29101.37102.642.29
298252-98252106.182106.71
395953-95953103.697104.22
493208-93208100.731101.23
592705-92705100.187100.69
693563-93563101.114101.62
30min193413-93413100.952102.062.37101.62102.742.36
298127-98127106.047106.75
396284-96284104.055104.75
492918-92918100.417101.09
592817-92817100.308100.97
693082-93082100.594101.27
45min193632-93632101.189102.402.89102.03103.252.88
298396-98396106.337107.22
398090-98090106.007106.87
492417-9241799.876100.71
592798-92798100.288101.12
693208-93208100.731101.57
极限193658-93658101.217101.822.23102.22102.842.23
297894-97894105.795106.85
395477-95477103.183104.23
492670-92670100.149101.15
592638-92638100.115101.11
692958-92958100.460101.47
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%
110.138416684035839058405584174840670.14
210.108386583919838920.05
单位质量响应值RSD%判断
8298.828306.140.07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%
5min191988-9198899.517100.710.9699.52100.710.96
293160-93160100.785100.78
392215-9221599.76299.76
494392-94392102.118102.12
593194-93194100.822100.82
693577-93577101.236101.24
10min194514-94514102.250102.300.65102.42102.470.65
295095-95095102.878103.05
393426-93426101.073101.24
495017-95017102.794102.96
594812-94812102.572102.74
694491-94491102.225102.39
15min194175-94175101.883102.310.65102.22102.650.65
294947-94947102.718103.06
393609-93609101.271101.61
495323-95323103.125103.47
594816-94816102.576102.92
694526-94526102.263102.60
20min194269-94269101.985102.130.73102.49102.640.72
294266-94266101.981102.49
393563-93563101.221101.72
495588-95588103.411103.92
594664-94664102.412102.92
694091-94091101.792102.30
30min193651-93651101.316101.820.76101.99102.500.76
294317-94317102.036102.72
393233-93233100.864101.54
495303-95303103.103103.79
594271-94271101.987102.67
693950-93950101.639102.32
45min193564-93564101.222101.870.86102.07102.720.86
294367-94367102.091102.94
393180-93180100.806101.65
494850-94850102.613103.47
595273-95273103.071103.92
693740-93740101.412102.26
极限193531-93531101.186101.650.60102.20102.670.60
294112-94112101.815102.84
393229-93229100.859101.87
494815-94815102.575103.60
594208-94208101.919102.94
693880-93880101.564102.58
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%
110.138454984531840338435884018842980.31
210.108414783968840580.16
单位质量响应值RSD%判断
8321.628322.570.01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%
5min192538-9253899.87699.572.0799.8899.572.07
293590-93590101.011101.01
390142-9014297.29097.29
495197-95197102.746102.75
590774-9077497.97297.97
691302-9130298.54298.54
10min193940-93940101.389101.132.81101.56101.292.81
297441-97441105.168105.34
390906-9090698.11498.28
496127-96127103.749103.92
591550-9155098.80998.97
692213-9221399.52599.69
15min193523-93523100.939101.242.31101.27101.582.31
294410-94410101.896102.24
390812-9081298.01398.34
496030-96030103.645103.99
596143-96143103.767104.09
691905-9190599.19399.52
20min195447-95447103.016100.872.37103.52101.372.37
294524-94524102.019102.53
390802-9080298.00298.49
496182-96182103.809104.33
591748-9174899.02399.52
692043-9204399.34299.84
30min193628-93628101.052100.541.89101.73101.211.89
294448-94448101.937102.62
391212-9121298.44599.10
495748-95748103.340104.03
591787-9178799.06599.73
692075-9207599.376100.04
45min193436-93436100.845100.222.03101.69101.052.03
294126-94126101.590102.44
390566-9056697.74798.56
495608-95608103.189104.05
591457-9145798.70999.54
691922-9192299.211100.04
极限193412-93412100.819100.052.08101.83101.052.08
293783-93783101.220102.24
390693-9069397.88598.86
495685-95685103.272104.31
591307-9130798.54799.54
691295-9129598.53499.53
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%
110.138451283898844078415584167842280.29
210.108422684427843260.17
单位质量响应值RSD%判断
8314.718349.110.30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%
5min149928-4992853.82450.7518.4953.8250.7518.48
235332-3533238.08938.09
356662-5666261.08361.08
456327-5632760.72260.72
543826-4382647.24647.25
640404-4040443.55743.56
10min169523-6952374.94874.079.6675.0474.159.67
260392-6039265.10465.17
375438-7543881.32481.43
476838-7683882.83482.93
567433-6743372.69572.77
662618-6261867.50467.58
15min186550-8655093.30387.767.9593.5287.967.96
274248-7424880.04180.21
385929-8592992.63492.87
488196-8819695.07895.32
580027-8002786.27186.47
673483-7348379.21779.40
20min188082-8808294.95593.995.3395.3394.345.35
282571-8257189.01489.32
390623-9062397.69498.09
493775-93775101.092101.49
586300-8630093.03493.38
681746-8174688.12588.44
30min193041-93041100.30199.622.36100.83100.132.39
290836-9083697.92498.38
392769-92769100.008100.56
495490-95490102.941103.51
593171-93171100.441100.94
689149-8914996.10596.57
45min193819-93819101.140100.991.96101.84101.671.97
293827-93827101.148101.77
393195-93195100.467101.19
495959-95959103.447104.18
594773-94773102.168102.83
690512-9051297.57598.20
极限193442-93442100.733100.782.04101.60101.632.05
294119-94119101.463102.25
392585-9258599.809100.70
495453-95453102.901103.81
595089-95089102.509103.35
690242-9024297.28398.07
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