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10071-202203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%
110.158379083958840598408583978839740.14
210.258415184182841660.03
单位质量响应值RSD%判断
8273.308211.320.54数据可信
供试品溶液-24090401批-比索洛尔-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193393-93393101.776104.274.55101.78104.274.54
298425-98425107.259107.26
389724-8972497.77897.78
496901-96901105.599105.60
5102030-102030111.188111.19
693604-93604102.006102.01
10min193936-93936102.368104.964.53102.54105.134.53
298827-98827107.698107.88
390460-9046098.58098.74
497424-97424106.169106.34
5102920-102920112.158112.34
694317-94317102.783102.95
15min193591-93591101.992104.754.57102.33105.094.57
298749-98749107.613107.97
390221-9022198.31998.65
497120-97120105.837106.19
5102749-102749111.972112.34
694278-94278102.740103.08
20min193661-93661102.068104.584.57102.58105.104.57
298722-98722107.583108.12
389905-8990597.97598.47
497141-97141105.860106.39
5102376-102376111.565112.12
693988-93988102.424102.94
30min193426-93426101.812104.354.59102.49105.044.59
298298-98298107.121107.84
389700-8970097.75198.41
496853-96853105.546106.25
5102325-102325111.510112.25
693913-93913102.343103.03
45min193260-93260101.631104.274.66102.48105.144.66
298310-98310107.134108.03
389629-8962997.67498.49
496844-96844105.537106.42
5102341-102341111.527112.46
693690-93690102.099102.95
极限193190-93190101.555104.134.56102.57105.184.56
298036-98036106.836107.91
389612-8961297.65598.64
496742-96742105.425106.48
5102077-102077111.239112.36
693670-93670102.078103.10
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931044451045751046111045701044711045340.07
213.991047021047071047040.01
单位质量响应值RSD%判断
7504.247484.200.19数据可信
供试品溶液-24090401批-氨氯地平-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103765-10376589.76990.401.6889.7790.401.68
2104055-10405590.02090.02
3107973-10797393.41093.41
4103651-10365189.67189.67
5103159-10315989.24589.25
6104347-10434790.27390.27
10min1108890-10889094.20393.791.8494.3593.941.84
2107455-10745592.96293.11
3112191-11219197.05997.21
4106884-10688492.46892.62
5107002-10700292.57092.72
6108057-10805793.48393.63
15min1108551-10855193.91093.571.9994.2293.881.99
2107565-10756593.05793.36
3111988-11198896.88397.20
4105937-10593791.64991.95
5106467-10646792.10792.41
6108457-10845793.82994.13
20min1107644-10764493.12593.192.2993.5993.652.28
2107608-10760893.09493.55
3111976-11197696.87397.35
4106462-10646292.10392.56
5104508-10450890.41290.87
6108085-10808593.50793.97
30min1108383-10838393.76593.391.8994.3894.011.89
2106844-10684492.43393.05
3111548-11154896.50397.14
4106401-10640192.05092.66
5106043-10604391.74092.35
6108488-10848893.85594.47
45min1108142-10814293.55693.182.0494.3393.962.04
2106188-10618891.86692.63
3111793-11179396.71597.52
4106048-10604891.74592.51
5106263-10626391.93192.69
6107813-10781393.27294.05
极限1108133-10813393.54893.111.9694.4894.041.96
2107182-10718292.72693.65
3111487-11148796.45097.41
4105550-10555091.31492.23
5106094-10609491.78492.70
6107305-10730592.83293.76
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10071-202203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%
110.158413184100841278400984072840880.06
210.258394884068840080.11
单位质量响应值RSD%判断
8284.538195.900.77数据可信
供试品溶液-24090402批-比索洛尔-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100755-100755109.828104.653.30109.83104.653.30
295853-95853104.485104.48
398841-98841107.742107.74
494284-94284102.774102.77
593024-93024101.401101.40
693265-93265101.664101.66
10min1101058-101058110.158105.193.19110.34105.373.19
296455-96455105.141105.32
399281-99281108.221108.40
494888-94888103.433103.60
593631-93631102.063102.23
693704-93704102.142102.31
15min1100835-100835109.915104.973.23110.28105.323.23
296246-96246104.913105.26
399200-99200108.133108.49
494595-94595103.113103.46
593202-93202101.595101.93
693701-93701102.139102.48
20min1100594-100594109.653104.803.16110.20105.333.16
296167-96167104.827105.35
398916-98916107.824108.36
494537-94537103.050103.57
593246-93246101.643102.15
693414-93414101.826102.34
30min1100425-100425109.468104.713.20110.20105.413.20
296145-96145104.803105.50
399056-99056107.976108.70
494229-94229102.714103.40
593056-93056101.436102.11
693462-93462101.878102.56
45min1100493-100493109.543104.533.25110.46105.403.25
295959-95959104.600105.47
398712-98712107.601108.50
494053-94053102.523103.38
593006-93006101.381102.23
693155-93155101.544102.39
极限1100546-100546109.600104.343.29110.70105.393.29
295598-95598104.207105.25
398412-98412107.274108.35
493930-93930102.389103.42
592814-92814101.172102.19
693022-93022101.399102.42
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931047321046071046801044951044831045990.11
213.991043591042811043200.06
单位质量响应值RSD%判断
7508.907456.750.50数据可信
供试品溶液-24090402批-氨氯地平-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102038-10203888.41190.792.1688.4190.792.16
2106021-10602191.86291.86
3101822-10182288.22488.22
4106869-10686992.59792.60
5105449-10544991.36691.37
6106479-10647992.25992.26
10min1105452-10545291.36993.541.6091.5293.691.60
2109509-10950994.88495.04
3106314-10631492.11692.26
4109429-10942994.81594.97
5107980-10798093.55993.71
6109074-10907494.50794.66
15min1105333-10533391.26693.231.8191.5793.541.81
2109686-10968695.03795.35
3106609-10660992.37192.67
4108333-10833393.86594.18
5105864-10586491.72692.03
6109798-10979895.13495.45
20min1105318-10531891.25392.581.9391.7093.041.92
2109309-10930994.71195.18
3106126-10612691.95392.41
4104119-10411990.21490.68
5107207-10720792.88993.35
6109000-10900094.44394.91
30min1101652-10165288.07692.622.8488.6893.242.83
2109946-10994695.26395.89
3105382-10538291.30891.92
4108061-10806193.62994.25
5107075-10707592.77593.39
6109247-10924794.65795.28
45min1104189-10418990.27492.761.7791.0393.541.77
2108759-10875994.23495.02
3105693-10569391.57892.34
4108051-10805193.62194.40
5106701-10670192.45193.22
6108976-10897694.42295.21
极限1104707-10470790.72392.531.6191.6293.451.61
2108189-10818993.74094.68
3104612-10461290.64191.55
4107682-10768293.30194.23
5107100-10710092.79793.72
6108433-10843393.95294.89
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10071-202203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%
110.158406684212840668411184049841010.08
210.258396484050840070.08
单位质量响应值RSD%判断
8285.818195.800.78数据可信
供试品溶液-24090403批-比索洛尔-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196679-96679105.378105.602.36105.38105.602.36
293495-93495101.907101.91
397197-97197105.942105.94
497263-97263106.014106.01
5100566-100566109.614109.61
696072-96072104.716104.72
10min196895-96895105.613106.192.52105.79106.362.52
293857-93857102.302102.47
397727-97727106.520106.70
497901-97901106.710106.89
5101437-101437110.564110.75
696713-96713105.415105.59
15min196949-96949105.672106.032.39106.02106.382.39
293572-93572101.991102.33
397592-97592106.373106.73
498070-98070106.894107.25
5100746-100746109.811110.18
696740-96740105.444105.79
20min196642-96642105.337105.762.23105.87106.292.23
293591-93591102.012102.52
397481-97481106.252106.78
497561-97561106.339106.87
5100285-100285109.308109.86
696614-96614105.307105.83
30min196505-96505105.188105.702.28105.89106.412.28
293412-93412101.817102.50
397196-97196105.941106.65
497655-97655106.441107.15
5100265-100265109.286110.02
696818-96818105.529106.23
45min196279-96279104.942105.422.27105.82106.302.27
293210-93210101.596102.45
397145-97145105.886106.77
497365-97365106.125107.01
599998-99998108.995109.91
696321-96321104.987105.86
极限196120-96120104.768105.102.36105.82106.162.36
292933-92933101.295102.31
396438-96438105.115106.18
497063-97063105.796106.86
5100012-100012109.010110.11
695979-95979104.615105.67
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931043731045531043561043411042891043820.10
213.991041411042481041940.08
单位质量响应值RSD%判断
7493.327447.750.44数据可信
供试品溶液-24090403批-氨氯地平-pH4.5hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107323-10732393.14390.972.2393.1490.972.23
2107599-10759993.38293.38
3103744-10374490.03790.04
4104568-10456890.75290.75
5104313-10431390.53090.53
6101401-10140188.00388.00
10min1110302-11030295.72893.912.2795.8894.062.27
2110194-11019495.63495.79
3106380-10638092.32492.47
4110762-11076296.12796.28
5106251-10625192.21292.36
6105360-10536091.43991.59
15min1110820-11082096.17893.852.5796.4994.162.56
2110381-11038195.79796.11
3106693-10669392.59692.90
4110586-11058695.97596.29
5105650-10565091.69192.00
6104699-10469990.86591.16
20min1110140-11014095.58793.562.1196.0694.022.11
2110269-11026995.69996.17
3105942-10594291.94492.40
4109103-10910394.68795.16
5105916-10591691.92292.38
6105460-10546091.52691.98
30min1110203-11020395.64293.531.8296.2894.151.82
2109412-10941294.95695.59
3106493-10649392.42293.03
4108883-10888394.49795.13
5105739-10573991.76892.38
6105896-10589691.90492.51
45min1109478-10947895.01393.082.5195.8193.862.50
2109646-10964695.15995.95
3105587-10558791.63692.40
4109836-10983695.32496.11
5104995-10499591.12291.89
6103966-10396690.22990.99
极限1109941-10994195.41593.222.5196.3794.152.51
2109597-10959795.11696.07
3104743-10474390.90491.82
4110016-11001695.48096.43
5104680-10468090.84991.76
6105471-10547191.53592.44
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