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4000
标示量(mg)4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%
116.113838038213381613844438288382970.31
216.153873938985388620.45
单位质量响应值RSD%判断
2377.222406.320.87数据可信
长期3月-供试品溶液-KC031批-含量0.35%吐温20的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%
5min18186-818619.21415.0323.7219.2115.0223.71
24919-491911.54611.55
35429-542912.74312.74
48380-838019.67019.67
55286-528612.40712.41
66209-620914.57414.57
10min121603-2160350.70743.1215.6250.7443.1415.62
216347-1634738.37038.39
317316-1731640.64440.67
422320-2232052.39052.42
515478-1547836.33036.35
617149-1714940.25240.28
15min133246-3324678.03569.1111.4078.1569.2111.41
227499-2749964.54664.63
329180-2918068.49168.58
433816-3381679.37379.49
525717-2571760.36360.44
627215-2721563.87963.97
20min139030-3903091.61186.396.0891.8686.606.10
236645-3664586.01386.20
336894-3689486.59886.80
439495-3949592.70392.96
533655-3365578.99579.18
635120-3512082.43482.63
30min141537-4153797.49694.551.9697.8994.901.98
239931-3993193.72694.06
340490-4049095.03895.39
440670-4067095.46195.87
539715-3971593.21993.53
639348-3934892.35892.69
45min141989-4198998.55795.451.7999.1295.961.81
240379-4037994.77895.27
340959-4095996.13996.64
440513-4051395.09295.66
540070-4007094.05294.52
640083-4008394.08394.57
60min141547-4154797.51995.231.6098.2595.911.63
240491-4049195.04095.69
340642-4064295.39596.06
440824-4082495.82296.55
539553-3955392.83993.46
640382-4038294.78595.43
极限141074-4107496.40994.901.2297.3095.741.22
240983-4098396.19597.00
339829-3982993.48794.31
440274-4027494.53195.42
540191-4019194.33695.12
640240-4024094.45195.26
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4000
标示量(mg)4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%
116.117733277784777637776077851776980.27
216.157857178551785610.02
单位质量响应值RSD%判断
4822.974864.460.61数据可信
长期3月-供试品溶液-12412515批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110960-1096012.70312.3416.5212.7012.3416.51
29534-953411.05011.05
38650-865010.02510.03
411960-1196013.86213.86
59461-946110.96510.97
613292-1329215.40515.41
10min129753-2975334.48433.2512.3234.5033.2712.33
226800-2680031.06131.08
324126-2412627.96227.98
431765-3176536.81636.84
526321-2632130.50630.52
633365-3336538.67038.70
15min148208-4820855.87353.5411.1955.9553.6111.19
243743-4374350.69850.77
339535-3953545.82145.88
450371-5037158.38058.46
542293-4229349.01749.09
653003-5300361.43061.52
20min164030-6403074.21171.5511.1274.3871.7211.12
258475-5847567.77267.93
353729-5372962.27262.41
468412-6841279.28979.47
555542-5554264.37364.52
670240-7024081.40881.60
30min180699-8069993.53089.315.1093.8389.605.12
274840-7484086.73987.01
372709-7270984.27084.51
480459-8045993.25293.57
573062-7306284.67984.94
680568-8056893.37893.71
45min183120-8312096.33694.431.6196.7994.861.63
279772-7977292.45692.87
381383-8138394.32394.71
481577-8157794.54895.02
580292-8029293.05893.46
682710-8271095.86196.34
60min181492-8149294.44994.421.1495.0695.011.15
279882-7988292.58393.15
381164-8116494.06994.61
482574-8257495.70396.33
582118-8211895.17595.73
681562-8156294.53095.17
极限183163-8316396.38694.491.3197.1695.241.32
279844-7984492.53993.26
381212-8121294.12594.82
481716-8171694.70995.50
581709-8170994.70195.41
681532-8153294.49595.30
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