阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531068411067751067871068021069761068360.08
210.551064391066111065250.12
单位质量响应值RSD%判断
10145.8710097.160.35数据可信
中间条件6月-供试品溶液-2023111721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%
5min161846-6184654.82954.4719.2954.8354.4719.29
260339-6033953.49253.49
384229-8422974.67274.67
456487-5648750.07850.08
555021-5502148.77848.78
650703-5070344.95044.95
10min190416-9041680.15779.357.9380.4679.667.97
287529-8752977.59777.89
3102708-10270891.05491.47
488756-8875678.68578.96
581881-8188172.59072.86
685776-8577676.04376.29
15min198093-9809386.96386.995.0887.7187.735.12
297414-9741486.36187.09
3104745-10474592.86093.78
4102531-10253190.89791.61
591059-9105980.72781.40
694900-9490084.13284.80
20min1100698-10069889.27290.354.1290.5191.584.16
2100910-10091089.46090.67
3106631-10663194.53295.97
4107385-10738595.20096.42
598908-9890887.68588.81
696974-9697485.97187.11
30min1106863-10686394.73893.053.8296.4794.783.85
2104507-10450792.64994.35
3108636-10863696.30998.27
4107925-10792595.67997.43
5104136-10413692.32093.93
697660-9766086.57988.20
45min1105484-10548493.51591.853.8195.7794.093.80
2102253-10225390.65192.87
3105834-10583493.82596.32
4105587-10558793.60695.89
5106333-10633394.26896.39
696119-9611985.21387.31
60min1105919-10591993.90192.373.0796.6895.123.04
2102822-10282291.15593.88
3104254-10425492.42595.44
4106017-10601793.98896.79
5107546-10754695.34397.99
698568-9856887.38489.96
极限1104688-10468892.80994.941.7796.1198.211.79
2105570-10557093.59196.82
3109576-10957697.143100.67
4108150-10815095.87999.20
5108370-10837096.07499.25
6106221-10622194.16897.23
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531069561069271069161069491069651069430.02
210.551076611075721076160.06
单位质量响应值RSD%判断
10156.0310200.570.31数据可信
中间条件6月-供试品溶液-2023111821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%
5min150318-5031844.36048.2025.3144.3648.2025.31
250310-5031044.35344.35
366223-6622358.38158.38
433051-3305129.13729.14
572480-7248063.89763.90
655632-5563249.04449.04
10min181134-8113471.52774.0017.4971.7774.2717.51
275309-7530966.39166.64
391158-9115880.36480.69
460357-6035753.21053.37
597223-9722385.71086.07
698445-9844586.78887.06
15min190322-9032279.62781.2712.7880.2781.9412.82
282990-8299073.16373.78
396900-9690085.42686.20
474987-7498766.10766.56
5101672-10167289.63390.46
6106217-10621793.63994.39
20min192240-9224081.31784.738.5382.4085.868.63
290696-9069679.95680.98
3100492-10049288.59289.84
484671-8467174.64575.47
5102364-10236490.24391.57
6106205-10620593.62994.90
30min195593-9559384.27388.373.9385.8189.974.04
298480-9848086.81988.28
399695-9969587.89089.63
498170-9817086.54587.78
5102774-10277490.60492.43
6106708-10670894.07295.87
45min196437-9643785.01789.943.6587.0292.033.61
2102842-10284290.66492.61
399081-9908187.34889.57
4104058-10405891.73693.46
5102768-10276890.59992.93
6106915-10691594.25596.57
60min197441-9744185.90390.953.7188.3893.543.54
2106503-10650393.89296.34
3100340-10034088.45891.17
4107243-10724394.54496.77
5102341-10234190.22293.06
6105144-10514492.69395.53
极限1105593-10559393.08993.680.9396.0496.780.84
2106078-10607893.51796.49
3105060-10506092.61995.82
4107944-10794495.16297.92
5106350-10635093.75797.10
6106574-10657493.95497.31
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531068851068201067361067391067241067810.07
210.551068681067121067900.11
单位质量响应值RSD%判断
10140.6510122.270.13数据可信
中间条件6月-供试品溶液-2023111921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%
5min154119-5411947.93144.2012.3447.9344.2012.34
243657-4365738.66538.67
356944-5694450.43350.43
446311-4631141.01641.02
543316-4331638.36338.36
655096-5509648.79648.80
10min195291-9529184.39576.727.9284.6676.977.92
287825-8782577.78378.00
392055-9205581.52981.81
485432-8543275.66475.89
575805-7580567.13767.35
683363-8336373.83174.10
15min1101471-10147189.86984.305.2690.6084.985.27
296683-9668385.62886.27
399345-9934587.98688.72
494001-9400183.25383.90
587960-8796077.90278.49
691673-9167381.19181.87
20min1104173-10417392.26289.413.8193.5090.553.82
2103658-10365891.80692.93
3105290-10529093.25194.47
498010-9801086.80387.91
598141-9814186.91987.94
696420-9642085.39586.53
30min1108518-10851896.11093.881.7797.8695.521.79
2105185-10518593.15894.79
3107276-10727695.01096.75
4104412-10441292.47394.07
5106955-10695594.72696.23
6103676-10367691.82193.43
45min1107646-10764695.33895.310.6597.6297.460.66
2107183-10718394.92797.08
3108275-10827595.89598.16
4108275-10827595.89598.00
5107814-10781495.48697.51
6106476-10647694.30196.42
60min1106627-10662794.43595.330.9397.2598.020.93
2109003-10900396.53999.22
3108739-10873996.30699.11
4107393-10739395.11397.75
5107204-10720494.94697.50
6106885-10688594.66497.30
极限1108491-10849196.08695.500.9999.4298.710.95
2108481-10848196.07799.29
3107012-10701294.77698.11
4108150-10815095.78498.95
5108770-10877096.33399.42
6106054-10605493.92897.09
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531061021059381059301060421060311060090.07
210.551073641072961073300.05
单位质量响应值RSD%判断
10067.3310173.460.75数据可信
中间条件6月-供试品溶液批-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%
5min121345-2134518.92622.5018.7918.9322.5018.78
226439-2643923.44223.44
327391-2739124.28624.29
426620-2662023.60323.60
531957-3195728.33528.33
618498-1849816.40116.40
10min157555-5755551.03153.896.7751.1454.026.79
260090-6009053.27953.41
364185-6418556.91057.04
461761-6176154.76054.89
566071-6607158.58258.74
655034-5503448.79648.89
15min178660-7866069.74471.614.3770.1372.044.39
277516-7751668.73069.16
386244-8624476.46876.92
480467-8046771.34671.78
583782-8378274.28574.77
677942-7794269.10769.47
20min199434-9943488.16388.343.4388.9489.163.39
299736-9973688.43189.24
3103814-10381492.04792.92
493639-9363983.02583.86
599392-9939288.12689.02
6101778-10177890.24190.99
30min1103687-10368791.93495.332.7393.2096.642.71
2107420-10742095.24496.54
3111019-11101998.43599.82
4105065-10506593.15694.45
5107223-10722395.06996.45
6110664-11066498.12099.37
45min1106820-10682094.71296.251.7896.4998.101.78
2107880-10788095.65297.48
3111177-11117798.575100.51
4106890-10689094.77496.58
5107798-10779895.57997.49
6110786-11078698.228100.02
60min1106516-10651694.44296.681.3296.7599.061.30
2110243-11024397.747100.11
3109659-10965997.22999.71
4109870-10987097.41699.75
5108159-10815995.89998.34
6109816-10981697.36899.71
极限1105890-10589093.88795.541.7796.7198.461.70
2106597-10659794.51497.42
3106563-10656394.48497.51
4110699-11069998.151101.03
5107302-10730295.13998.12
6109470-10947097.06299.94
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