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%
116.063829163839463836523838353835113835720.11
216.073843273846143844700.06
单位质量响应值RSD%判断
23883.6923924.700.13数据可信
供试品溶液-24121701批-pH1.2(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15346-53461.2551.3621.161.261.3621.20
28205-82051.9271.93
35783-57831.3581.36
45416-54161.2721.27
54940-49401.1601.16
65019-50191.1791.18
10min112847-128473.0173.2914.553.023.2914.56
218082-180824.2464.25
313141-131413.0863.09
413853-138533.2533.26
513237-132373.1093.11
612819-128193.0103.01
15min122326-223265.2435.569.225.255.579.23
227856-278566.5426.55
321992-219925.1655.17
423872-238725.6065.61
522385-223855.2575.26
623711-237115.5685.58
20min131553-315537.4107.687.007.437.706.99
237054-370548.7028.72
330889-308897.2547.27
432801-328017.7037.72
531095-310957.3027.32
632760-327607.6937.71
30min147602-4760211.17911.203.8611.2111.243.86
250876-5087611.94811.98
347977-4797711.26711.30
446869-4686911.00711.04
545249-4524910.62610.65
647681-4768111.19811.23
45min162856-6285614.76114.753.5514.8114.803.57
266808-6680815.68915.75
360831-6083114.28614.33
462463-6246314.66914.72
560683-6068314.25114.30
663296-6329614.86514.91
60min175817-7581717.80518.037.2817.8818.107.25
277730-7773018.25418.34
372575-7257517.04417.11
473162-7316217.18217.25
587527-8752720.55520.62
673920-7392017.36017.43
极限183688-8368819.65419.432.5119.7519.532.50
286450-8645020.30220.41
381149-8114919.05719.16
481721-8172119.19219.29
581003-8100319.02319.13
682286-8228619.32419.43
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%
116.063853943851353847063851853854123851660.08
216.073896553899463898000.06
单位质量响应值RSD%判断
23982.9424256.380.81数据可信
供试品溶液-24121702批-pH1.2(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16550-65501.5251.557.341.521.557.39
26905-69051.6071.61
36241-62411.4531.45
47168-71681.6681.67
56001-60011.3971.40
67175-71751.6701.67
10min117827-178274.1494.174.724.154.184.79
218724-187244.3584.36
317189-171894.0014.00
418786-187864.3734.38
516721-167213.8923.89
618361-183614.2744.28
15min129246-292466.8076.932.356.826.942.34
230393-303937.0747.08
329161-291616.7876.80
430435-304357.0847.09
529019-290196.7546.76
630404-304047.0777.09
20min138841-388419.0409.352.489.069.372.50
241112-411129.5699.59
339543-395439.2049.22
441523-415239.6659.69
539918-399189.2919.31
640105-401059.3359.36
30min155353-5535312.88412.861.6412.9212.901.62
255927-5592713.01713.05
354611-5461112.71112.75
456612-5661213.17713.21
554137-5413712.60112.64
654884-5488412.77412.81
45min173634-7363417.13916.641.9017.2016.701.90
272138-7213816.79016.85
369861-6986116.26016.32
471885-7188516.73116.79
570384-7038416.38216.44
671143-7114316.55916.62
60min182839-8283919.28119.392.6219.3719.482.61
283697-8369719.48119.57
380740-8074018.79318.88
486081-8608120.03620.12
581154-8115418.88918.97
685408-8540819.87919.97
极限190508-9050821.06620.791.4321.1820.911.43
291171-9117121.22021.34
387977-8797720.47720.59
489361-8936120.79920.92
588375-8837520.57020.68
688537-8853720.60720.73
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