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%
115.943775837659375843771037357376140.42
215.973764237656376490.03
单位质量响应值RSD%判断
2359.722357.480.07数据可信
供试品溶液-KC031批-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16057-605714.41613.9919.5414.4214.0019.53
25913-591314.07414.07
36708-670815.96615.97
47400-740017.61317.61
54977-497711.84611.85
64221-422110.04610.05
10min117790-1779042.34240.1510.9042.3740.1710.90
216925-1692540.28340.31
315466-1546636.81136.84
419689-1968946.86246.89
516943-1694340.32640.35
614395-1439534.26234.28
15min129720-2972070.73767.579.1470.8367.669.14
228437-2843767.68367.77
326390-2639062.81162.90
432159-3215976.54276.65
528896-2889668.77668.86
624730-2473058.86058.93
20min139807-3980794.74588.827.0694.9689.027.06
237696-3769689.72189.92
334432-3443281.95282.14
440318-4031895.96296.20
537631-3763189.56689.77
634023-3402380.97981.15
30min143447-43447103.409100.742.77103.78101.092.79
242508-42508101.174101.53
340944-4094497.45197.78
443584-43584103.735104.13
542549-42549101.272101.62
640911-4091197.37397.68
45min143338-43338103.149101.841.47103.69102.361.50
242717-42717101.671102.19
342027-42027100.029100.52
443541-43541103.633104.20
542996-42996102.335102.86
642101-42101100.205100.67
60min143171-43171102.752101.661.14103.47102.351.17
242757-42757101.767102.46
342036-42036100.051100.71
443215-43215102.857103.60
542868-42868102.031102.72
642236-42236100.527101.16
极限143059-43059102.485101.880.63103.37102.740.66
242702-42702101.636102.50
342778-42778101.817102.64
443054-43054102.474103.39
542892-42892102.088102.95
642342-42342100.779101.58
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%
115.943757137554375713719837340374470.46
215.973759737580375880.04
单位质量响应值RSD%判断
2349.252353.660.14数据可信
供试品溶液-KC031批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16351-635115.16213.899.3615.1613.899.37
24902-490211.70311.70
35937-593714.17414.17
45518-551813.17313.17
55876-587614.02814.03
66319-631915.08615.09
10min115559-1555937.14537.193.5737.1737.223.57
215086-1508636.01636.04
315695-1569537.47037.49
415492-1549236.98537.01
515060-1506035.95435.98
616585-1658539.59439.62
15min125130-2513059.99461.893.7960.0861.973.79
225632-2563261.19361.27
326115-2611562.34662.43
426397-2639763.01963.10
524764-2476459.12059.20
627499-2749965.65065.74
20min133430-3343079.80981.723.0480.0081.913.04
234372-3437282.05882.24
333801-3380180.69580.88
435089-3508983.77083.96
532973-3297378.71878.90
635722-3572285.28185.48
30min141208-4120898.37898.241.7598.7098.571.74
241281-4128198.55298.87
340256-4025696.10596.43
442388-42388101.195101.52
540691-4069197.14497.46
641082-4108298.07798.42
45min142476-42476101.405100.640.74101.89101.130.74
242614-42614101.735102.22
342048-42048100.383100.87
441860-4186099.935100.43
541924-41924100.087100.56
642013-42013100.300100.81
60min142478-42478101.410100.900.63102.06101.560.62
242669-42669101.866102.52
342270-42270100.913101.57
442069-42069100.434101.10
542004-42004100.278100.92
642097-42097100.500101.17
极限142694-42694101.926101.490.80102.75102.320.79
242774-42774102.117102.94
342145-42145100.615101.44
442708-42708101.959102.79
542737-42737102.028102.84
642013-42013100.300101.14
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%
115.947473374454744007444974497745070.18
215.977493375099750160.16
单位质量响应值RSD%判断
4674.224697.310.35数据可信
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%
5min18027-80279.61710.916.909.6210.916.89
29633-963311.54111.54
39019-901910.80510.81
48876-887610.63410.63
59336-933611.18511.19
69753-975311.68511.68
10min126653-2665331.93232.926.3631.9532.946.36
230648-3064836.71836.74
325369-2536930.39330.41
427197-2719732.58332.60
527553-2755333.01033.03
627472-2747232.91332.93
15min144687-4468753.53754.055.5153.6154.125.52
249694-4969459.53659.62
342405-4240550.80350.87
444026-4402652.74552.82
544185-4418552.93653.01
645685-4568554.73354.81
20min159969-5996971.84671.534.6172.0071.694.61
264549-6454977.33377.51
356590-5659067.79867.95
458365-5836569.92470.08
558244-5824469.77969.94
660514-6051472.49972.66
30min180186-8018696.06793.672.7296.3593.952.73
281276-8127697.37397.68
376086-7608691.15591.42
476513-7651391.66791.94
576849-7684992.06992.35
678185-7818593.67093.96
45min184933-84933101.754100.061.32102.19100.501.32
284417-84417101.136101.61
383918-83918100.538100.96
481983-8198398.22098.65
583009-8300999.44999.88
682853-8285399.26299.70
60min184550-84550101.295100.361.23101.90100.971.23
284372-84372101.082101.72
384852-84852101.657102.24
482094-8209498.35398.95
583522-83522100.064100.66
683233-8323399.717100.33
极限184712-84712101.489100.670.98102.27101.450.97
283901-83901100.518101.33
385015-85015101.852102.61
483172-8317299.644100.40
584376-84376101.087101.85
683005-8300599.444100.22
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%
115.947425173911742577456874472742920.35
215.977425574304742800.05
单位质量响应值RSD%判断
4660.734651.220.15数据可信
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%
5min18902-890210.73311.277.3610.7311.277.36
29179-917911.06711.07
39492-949211.44511.44
49040-904010.90010.90
510660-1066012.85312.85
68801-880110.61110.61
10min128167-2816733.96133.987.7133.9834.007.71
227303-2730332.92032.94
330748-3074837.07337.09
424602-2460229.66329.68
530025-3002536.20136.22
628232-2823234.04034.06
15min147813-4781357.64956.368.1757.7256.448.17
245144-4514454.43154.50
350888-5088861.35661.44
440337-4033748.63548.70
550008-5000860.29560.38
646287-4628755.80955.88
20min164982-6498278.34975.318.0078.5275.488.00
259642-5964271.91172.07
366708-6670880.43180.61
454086-5408665.21265.36
567178-6717880.99781.18
662154-6215474.94075.11
30min181864-8186498.70496.514.2699.0196.804.27
278522-7852294.67594.96
382308-8230899.24099.56
474048-7404889.28089.54
583417-83417100.577100.89
680103-8010396.58196.87
45min183182-83182100.293100.931.38100.76101.391.39
283536-83536100.720101.16
383691-83691100.907101.39
482547-8254799.52899.93
585912-85912103.585104.07
683415-83415100.574101.03
60min182952-82952100.016100.711.04100.65101.331.05
283548-83548100.735101.34
383172-83172100.281100.93
483095-83095100.188100.76
585240-85240102.775103.43
683136-83136100.238100.86
极限183059-83059100.145101.561.54100.94102.351.51
283967-83967101.240102.02
382547-8254799.528100.35
484937-84937102.409103.15
584867-84867102.325103.15
686003-86003103.695104.48
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