美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102034512036802034072031332027032032750.19
218.032030442027192028820.12
单位质量响应值RSD%判断
11230.6611252.470.14数据可信
加速6月-供试品溶液-2025010321批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14166-41662.0741.9616.482.071.9516.52
23543-35431.7641.76
33826-38261.9051.90
45107-51072.5432.54
53278-32781.6321.63
63665-36651.8251.82
10min19462-94624.7114.716.204.734.746.19
29255-92554.6084.63
39249-92494.6054.63
410638-106385.2965.32
59078-90784.5204.54
69135-91354.5484.57
15min112412-124126.1806.184.946.256.254.97
212066-120666.0076.08
312112-121126.0306.10
413606-136066.7746.86
511935-119355.9426.01
612321-123216.1346.21
20min118545-185459.2339.133.139.389.273.22
217969-179698.9469.08
318126-181269.0249.16
419411-194119.6649.83
517956-179568.9409.07
617995-179958.9599.10
30min124340-2434012.11811.942.3012.3612.182.35
223661-2366111.78012.02
323763-2376311.83112.07
424949-2494912.42112.69
523564-2356411.73211.97
623616-2361611.75812.00
45min137566-3756618.70318.511.7219.0818.891.77
237235-3723518.53818.91
336701-3670118.27218.64
438241-3824119.03919.45
536865-3686518.35418.72
636518-3651818.18118.55
60min147537-4753723.66723.092.3724.2623.682.38
246370-4637023.08623.66
345280-4528022.54423.12
447688-4768823.74324.36
546375-4637523.08923.66
645046-4504622.42723.00
极限152323-5232326.05025.511.9526.9026.341.95
250603-5060325.19426.02
351933-5193325.85626.68
452123-5212325.95126.83
550251-5025125.01925.84
650177-5017724.98225.80
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102038212033092035582031882033012034350.13
218.032017172016782016980.02
单位质量响应值RSD%判断
11239.5011186.800.34数据可信
长期6月-供试品溶液-2025010321批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13592-35921.7931.865.591.791.865.57
23664-36641.8291.83
33841-38411.9171.92
43418-34181.7061.71
53982-39821.9881.99
63870-38701.9321.93
10min17740-77403.8633.963.083.883.983.07
27915-79153.9513.97
38156-81564.0714.09
47594-75943.7903.81
58237-82374.1114.13
67993-79933.9904.01
15min114334-143347.1557.271.927.227.341.93
214845-148457.4107.47
314774-147747.3747.44
414130-141307.0537.11
514710-147107.3427.41
614633-146337.3047.37
20min117760-177608.8658.941.679.019.091.68
217998-179988.9839.13
318034-180349.0019.15
417576-175768.7738.91
518412-184129.1909.34
617712-177128.8418.99
30min123634-2363411.79711.832.0012.0412.081.97
223918-2391811.93812.18
324330-2433012.14412.39
422920-2292011.44011.68
523548-2354811.75412.01
623906-2390611.93212.18
45min136895-3689518.41618.171.3518.7918.551.36
236305-3630518.12118.50
336841-3684118.38918.77
435543-3554317.74118.10
536522-3652218.23018.61
636344-3634418.14118.52
60min147879-4787923.89823.641.4724.4724.221.46
247914-4791423.91624.50
347049-4704923.48424.07
446094-4609423.00723.57
547571-4757123.74424.33
647665-4766523.79124.37
极限152881-5288126.39526.141.8627.2426.981.81
253468-5346826.68827.53
350825-5082525.36926.22
451577-5157725.74426.56
552701-5270126.30527.15
652734-5273426.32227.17
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102025392029092029972027922026632027800.10
218.032036972029902033440.25
单位质量响应值RSD%判断
11203.3111278.090.48数据可信
中间条件6月-供试品溶液-2025010321批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12861-28611.4251.3810.341.421.3810.23
23291-32911.6391.64
32582-25821.2861.29
42792-27921.3901.39
52522-25221.2561.26
62586-25861.2881.29
10min17812-78123.8903.812.433.913.822.43
27873-78733.9203.94
37614-76143.7913.81
47352-73523.6613.68
57578-75783.7733.79
67631-76313.8003.81
15min110610-106105.2835.132.665.345.182.68
210569-105695.2625.32
310157-101575.0575.11
49918-99184.9384.99
510140-101405.0495.10
610413-104135.1855.24
20min114626-146267.2837.262.127.407.372.14
214717-147177.3287.45
314792-147927.3657.48
414002-140026.9727.08
514462-144627.2017.31
614828-148287.3837.50
30min125154-2515412.52512.321.1212.7212.511.12
224947-2494712.42212.62
324477-2447712.18812.38
424761-2476112.32912.52
524445-2444512.17212.36
624642-2464212.27012.47
45min134155-3415517.00616.312.8517.3416.652.80
232243-3224316.05416.39
332788-3278816.32616.66
431571-3157115.72016.05
532332-3233216.09916.43
633495-3349516.67817.01
60min142951-4295121.38621.541.2221.9122.061.20
242740-4274021.28121.80
343227-4322721.52322.03
442900-4290021.36121.86
543684-4368421.75122.26
644100-4410021.95822.48
极限148509-4850924.15324.331.0324.9225.080.99
248093-4809323.94624.70
349415-4941524.60525.35
448910-4891024.35325.09
548949-4894924.37325.12
649337-4933724.56625.33
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