坎地沙坦酯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100685-201903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)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%
115.187052070825707147058770573706440.18
215.207180171666717340.14
单位质量响应值RSD%判断
4653.754719.340.99数据可信
中间条件24月-供试品溶液-2023022521批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110691-1069112.80713.3918.5912.8113.3918.59
212418-1241814.87614.88
39529-952911.41511.41
413610-1361016.30316.30
58171-81719.7889.79
612636-1263615.13715.14
10min130702-3070236.77840.119.4636.8040.149.47
235023-3502341.95441.98
330615-3061536.67436.69
438094-3809445.63345.66
530959-3095937.08637.10
635531-3553142.56342.59
15min148239-4823957.78660.136.1057.8760.226.10
252262-5226262.60562.70
346830-4683056.09856.18
454506-5450665.29365.40
547651-4765157.08157.16
651700-5170061.93262.03
20min159810-5981071.64772.274.1971.8372.464.20
260729-6072972.74772.95
357222-5722268.54668.72
464400-6440077.14577.36
558364-5836469.91470.09
661477-6147773.64373.84
30min170638-7063884.61784.972.8984.9285.282.90
272446-7244686.78387.10
368369-6836981.89982.19
473494-7349488.03988.38
568788-6878882.40182.69
671846-7184686.06486.39
45min178683-7868394.25595.382.7494.6995.832.75
278618-7861894.17794.64
378450-7845093.97594.40
482804-8280499.19199.68
577306-7730692.60593.03
681865-8186598.06698.53
60min182694-8269499.059101.302.5399.66101.912.51
283668-83668100.226100.85
388724-88724106.283106.86
483982-83982100.602101.25
583611-83611100.158100.74
684703-84703101.466102.09
极限187416-87416104.716102.131.79105.48102.901.77
283513-83513100.040100.83
383759-83759100.335101.09
486329-86329103.414104.23
585712-85712102.675103.42
684796-84796101.577102.38
坎地沙坦酯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100685-201903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)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%
115.187067570392707497050370096704830.37
215.207157072052718110.48
单位质量响应值RSD%判断
4643.154724.411.23数据可信
中间条件24月-供试品溶液-2023022521批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112496-1249614.97813.4531.1414.9813.4531.15
28675-867510.39810.40
39243-924311.07911.08
47160-71608.5828.58
513187-1318715.80615.81
616576-1657619.86919.87
10min135323-3532342.34041.5810.9542.3641.6010.96
232697-3269739.19239.21
331148-3114837.33537.35
431030-3103037.19437.21
537350-3735044.76944.80
640576-4057648.63648.67
15min151907-5190762.21862.384.9262.3162.474.93
250835-5083560.93361.02
349647-4964759.50959.59
449690-4969059.56159.64
554198-5419864.96465.06
655963-5596367.08067.19
20min162573-6257375.00375.953.4975.2076.153.50
263256-6325675.82176.01
360557-6055772.58672.77
462092-6209274.42674.60
566814-6681480.08680.30
664882-6488277.77078.00
30min175270-7527090.22290.322.1190.5590.642.10
276332-7633291.49591.81
373819-7381988.48388.78
475197-7519790.13490.43
577843-7784393.30693.65
673625-7362588.25088.61
45min181860-8186098.12196.831.5798.6097.301.56
280851-8085196.91197.37
380752-8075296.79397.24
480988-8098897.07697.53
581852-8185298.11198.61
678401-7840193.97594.48
60min181275-8127597.420100.232.9598.06100.872.93
283806-83806100.453101.08
385915-85915102.981103.59
483933-83933100.606101.22
586513-86513103.698104.36
680293-8029396.24396.90
极限184806-84806101.652102.531.39102.45103.331.37
285695-85695102.718103.51
387549-87549104.940105.72
484003-84003100.690101.47
585523-85523102.511103.35
685632-85632102.642103.46
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