坎地沙坦酯片项目信息
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100685-201903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)8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%
115.977397373332745217415473475738910.67
215.947368873951738200.26
单位质量响应值RSD%判断
4626.864631.120.07数据可信
供试品溶液-2025022821批-含0.35%吐温20的磷酸盐缓冲液(pH6.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121218-2121825.73224.6211.7025.7324.6111.71
216000-1600019.40419.40
321369-2136925.91525.91
420241-2024124.54724.55
519906-1990624.14124.14
623049-2304927.95227.95
10min150393-5039361.11360.378.4161.1660.428.41
241720-4172050.59550.63
351118-5111861.99362.04
451490-5149062.44462.48
550029-5002960.67260.71
653944-5394465.42065.47
15min169442-6944284.21583.602.9484.3683.742.96
264924-6492478.73678.85
369161-6916183.87484.02
469876-6987684.74184.89
569617-6961784.42784.57
670606-7060685.62785.78
20min176989-7698993.36792.380.7293.6592.660.72
275781-7578191.90292.15
375854-7585491.99192.28
476675-7667592.98793.27
576137-7613792.33492.62
675628-7562891.71792.02
30min179608-7960896.54496.530.8696.9896.960.84
280224-8022497.29197.69
380055-8005597.08697.53
479962-7996296.97397.41
579338-7933896.21696.65
678373-7837395.04695.50
45min180078-8007897.11497.011.0797.7297.611.05
281155-8115598.42098.98
379908-7990896.90797.51
480553-8055397.69098.29
579628-7962896.56897.16
678655-7865595.38896.00
60min180559-8055997.69797.201.1698.4697.961.14
281253-8125398.53999.27
379934-7993496.93997.70
480886-8088698.09498.86
579422-7942296.31897.08
678823-7882395.59296.36
极限180144-8014497.19497.241.1298.1298.161.10
281548-8154898.89699.79
380135-8013597.18398.11
480686-8068697.85198.78
579650-7965096.59597.51
678924-7892495.71496.64
坎地沙坦酯片项目信息
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100685-201903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)8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%
115.977452074187739467373273859740490.43
215.947415474005740800.15
单位质量响应值RSD%判断
4636.764647.430.17数据可信
供试品溶液-2025030121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115850-1585019.16818.9218.8519.1718.9218.84
212781-1278115.45615.46
316702-1670220.19820.20
420073-2007324.27524.27
516527-1652719.98619.99
611942-1194214.44214.44
10min136855-3685544.56947.8216.7244.6047.8616.73
232029-3202938.73338.76
342544-4254451.44951.48
450264-5026460.78560.83
541309-4130949.95649.99
634270-3427041.44341.47
15min155826-5582667.51171.2112.6167.6271.3212.62
247844-4784457.85957.95
362422-6242275.48875.61
468885-6888583.30483.45
563140-6314076.35676.47
655177-5517766.72666.82
20min169344-6934483.85985.528.2184.0885.758.22
260475-6047573.13373.32
373755-7375589.19389.44
476407-7640792.40092.68
574962-7496290.65390.90
669351-6935183.86784.07
30min176103-7610392.03393.483.7792.3993.853.80
272060-7206087.14387.45
379086-7908695.64096.03
479267-7926795.85996.29
579843-7984396.55596.95
677427-7742793.63493.98
45min177051-7705193.17994.883.1693.6995.413.19
274135-7413589.65390.11
380163-8016396.94297.50
480260-8026097.06097.65
580401-8040197.23097.79
678742-7874295.22495.72
60min177500-7750093.72295.122.7294.3995.812.75
274950-7495090.63891.24
380131-8013196.90497.62
479980-7998096.72197.48
580605-8060597.47798.19
678779-7877995.26995.93
极限178959-7895995.48696.351.4696.3197.201.50
277812-7781294.09994.85
380848-8084897.77198.65
480162-8016296.94197.86
580733-8073397.63298.51
679544-7954496.19497.01
坎地沙坦酯片项目信息
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100685-201903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)8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%
115.977404774341742707455974221742880.26
215.947500374669748360.32
单位质量响应值RSD%判断
4651.724694.860.66数据可信
供试品溶液-2025030221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115236-1523618.30317.6721.2118.3017.6721.22
211630-1163013.97113.97
320600-2060024.74624.75
414031-1403116.85516.85
513647-1364716.39416.39
613102-1310215.73915.74
10min139004-3900446.85446.0215.4746.8846.0515.47
234402-3440241.32641.35
349846-4984659.87859.92
435666-3566642.84442.87
536794-3679444.19944.23
634146-3414641.01841.04
15min160439-6043972.60370.649.0872.7170.749.09
255601-5560166.79266.88
368734-6873482.56882.71
455242-5524266.36066.46
558211-5821169.92770.03
654601-5460165.59065.68
20min172966-7296687.65286.393.4487.8886.613.46
271370-7137085.73485.94
375608-7560890.82591.10
469478-6947883.46283.67
573026-7302687.72487.94
669037-6903782.93283.14
30min178542-7854294.35094.371.0994.7394.741.09
278301-7830194.06094.41
378618-7861894.44194.87
477744-7774493.39193.74
580160-8016096.29496.66
678008-7800893.70894.05
45min179441-7944195.43095.631.1095.9696.161.09
279284-7928495.24195.74
379140-7914095.06895.66
478889-7888994.76795.27
581322-8132297.68998.21
679593-7959395.61296.11
60min179725-7972595.77195.660.9496.4696.350.93
279608-7960895.63096.29
379269-7926995.22395.97
478840-7884094.70895.37
581021-8102197.32898.01
679353-7935395.32495.98
极限180022-8002296.12896.481.4696.9897.321.44
282044-8204498.55799.38
379205-7920595.14696.05
479246-7924695.19696.02
581426-8142697.81498.66
679925-7992596.01196.83
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