奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20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%
110.451032091031191036681030861038831033930.35
210.481035091032981034040.15
单位质量响应值RSD%判断
9894.079866.790.20数据可信
供试品溶液-20201213批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13576-35764.0643.999.154.063.999.15
23390-33903.8523.85
34117-41174.6784.68
43448-34483.9183.92
53301-33013.7513.75
63226-32263.6663.67
10min18110-81109.2169.564.009.249.584.00
28706-87069.8939.91
38945-894510.16510.19
48305-83059.4379.46
58214-82149.3349.35
68183-81839.2999.32
15min110297-1029711.70111.673.1811.7711.753.17
29643-964310.95811.03
310394-1039411.81111.89
410566-1056612.00712.08
510276-1027611.67711.75
610462-1046211.88811.96
20min111908-1190813.53213.253.3913.6713.393.36
210988-1098812.48612.62
311614-1161413.19713.35
412145-1214513.80113.94
511536-1153613.10913.25
611775-1177513.38013.52
30min113542-1354215.38815.462.3115.6015.672.31
213115-1311514.90315.11
313711-1371115.58015.80
414010-1401015.92016.14
513429-1342915.26015.47
613812-1381215.69515.91
45min115389-1538917.48717.582.1717.7917.882.18
215062-1506217.11617.40
315562-1556217.68417.99
415946-1594618.12018.43
515159-1515917.22617.52
615712-1571217.85418.15
60min116833-1683319.12818.883.0719.5219.273.03
216032-1603218.21818.60
316360-1636018.59119.00
416992-1699219.30919.72
516140-1614018.34118.73
617305-1730519.66420.06
极限117991-1799120.44420.282.3420.9520.792.31
217470-1747019.85220.34
317794-1779420.22020.73
418445-1844520.96021.47
517312-1731219.67220.17
618090-1809020.55621.06
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20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%
110.451034541036531033221033801033571034330.13
210.481031251033061032160.13
单位质量响应值RSD%判断
9897.899848.850.36数据可信
供试品溶液-20201214批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1995-9951.1311.6215.851.131.6215.87
21361-13611.5481.55
31556-15561.7691.77
41547-15471.7591.76
51548-15481.7601.76
61566-15661.7811.78
10min15836-58366.6366.875.316.646.885.31
26387-63877.2637.27
36263-62637.1227.13
45524-55246.2826.29
56009-60096.8336.84
66227-62277.0817.09
15min18187-81879.3109.474.529.359.524.51
28720-87209.9169.96
38242-82429.3729.42
47692-76928.7478.79
58534-85349.7049.75
68609-86099.7909.84
20min19676-967611.00311.042.8311.1011.142.83
210001-1000111.37311.48
39642-964210.96411.07
49335-933510.61510.71
59559-955910.87010.97
610058-1005811.43811.54
30min113163-1316314.96815.312.3715.1215.472.39
213960-1396015.87516.04
313434-1343415.27715.44
413096-1309614.89215.04
513479-1347915.32815.49
613649-1364915.52115.69
45min114044-1404415.97015.903.2416.2116.153.23
214574-1457416.57316.83
313837-1383715.73515.98
413342-1334215.17215.41
513715-1371515.59615.84
614390-1439016.36416.62
60min114028-1402815.95216.022.9016.2816.362.88
214725-1472516.74517.09
314020-1402015.94316.28
413451-1345115.29615.62
514187-1418716.13316.47
614107-1410716.04216.39
极限115149-1514917.22717.312.4417.6417.732.44
215831-1583118.00218.44
315362-1536217.46917.89
414715-1471516.73317.14
515035-1503517.09717.52
615234-1523417.32317.76
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20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%
110.451029211029281027691029611030401029240.10
210.481029411033161031280.26
单位质量响应值RSD%判断
9849.199840.460.07数据可信
供试品溶液-20201215批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14607-46075.2545.334.785.255.334.75
24267-42674.8664.87
34909-49095.5985.60
44756-47565.4245.42
54710-47105.3725.37
64800-48005.4745.47
10min16188-61887.0577.574.587.097.604.55
26964-69647.9427.97
36346-63467.2377.27
46697-66977.6387.67
56751-67517.6997.73
66863-68637.8277.86
15min17695-76958.7769.283.708.849.353.70
28097-80979.2349.31
37977-79779.0979.17
48121-81219.2629.33
58421-84219.6049.68
68522-85229.7199.79
20min18956-895610.21410.873.9110.3311.003.91
29554-955410.89611.02
39249-924910.54810.67
49650-965011.00511.13
59914-991411.30611.43
69880-988011.26811.40
30min111101-1110112.66012.953.8712.8313.133.86
211105-1110512.66512.85
310731-1073112.23812.42
411595-1159513.22313.41
511786-1178613.44113.63
611807-1180713.46513.66
45min112596-1259614.36515.124.2314.6115.384.20
212932-1293214.74815.00
312985-1298514.80915.06
413301-1330115.16915.43
514179-1417916.17016.43
613579-1357915.48615.75
60min113564-1356415.46916.564.5715.7916.904.55
214303-1430316.31216.65
314093-1409316.07216.40
414671-1467116.73217.07
515200-1520017.33517.69
615272-1527217.41717.77
极限115589-1558917.77818.072.5918.1918.502.60
215821-1582118.04318.47
315200-1520017.33517.75
416064-1606418.32018.76
516364-1636418.66219.11
616041-1604118.29418.74
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20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%
110.451036161035631034081036451036711035810.11
210.481043431041981042700.10
单位质量响应值RSD%判断
9912.069949.430.27数据可信
供试品溶液-TNA1229批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14410-44104.9865.083.144.995.083.15
24482-44825.0675.07
34549-45495.1435.14
44722-47225.3395.34
54301-43014.8634.86
64505-45055.0935.09
10min17918-79188.9529.032.858.989.062.81
27907-79078.9408.97
37719-77198.7278.76
48028-80289.0769.11
58400-84009.4979.52
67930-79308.9668.99
15min19794-979411.07310.971.2711.1511.041.27
29684-968410.94911.03
39486-948610.72510.80
49657-965710.91811.00
59749-974911.02211.10
69826-982611.10911.19
20min111136-1113612.59012.322.5612.7312.462.54
210915-1091512.34012.48
310413-1041311.77311.91
410862-1086212.28012.42
510871-1087112.29112.43
611206-1120612.66912.81
30min112403-1240314.02313.981.4914.2314.191.48
212077-1207713.65413.86
312262-1226213.86314.07
412342-1234213.95414.16
512595-1259514.24014.45
612508-1250814.14114.35
45min113967-1396715.79115.551.9416.0815.841.92
213491-1349115.25315.54
313519-1351915.28415.56
413535-1353515.30215.59
513989-1398915.81616.10
614038-1403815.87116.16
60min114849-1484916.78816.650.9617.1617.020.97
214521-1452116.41716.79
314609-1460916.51716.88
414680-1468016.59716.97
514841-1484116.77917.16
614843-1484316.78117.16
极限116133-1613318.24017.921.8918.7118.391.86
215681-1568117.72918.19
315372-1537217.37917.84
415840-1584017.90818.37
515915-1591517.99318.46
616172-1617218.28418.75
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