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%
19.921031881029721036041029191034071032180.29
29.851028481030861029670.17
单位质量响应值RSD%判断
10405.0410453.500.33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%
5min13266-32663.5163.0450.543.523.0450.55
2-0.0000.00
34064-40644.3754.38
43315-33153.5693.57
53189-31893.4333.43
63083-30833.3193.32
10min18013-80138.6268.833.268.658.853.25
28404-84049.0479.05
38631-86319.2929.32
48142-81428.7658.79
57908-79088.5138.53
68131-81318.7538.77
15min110108-1010810.88210.843.3210.9510.913.35
29500-950010.22710.28
310041-1004110.81010.89
410545-1054511.35211.42
510096-1009610.86910.94
610141-1014110.91710.98
20min111799-1179912.70212.353.1712.8312.483.20
210850-1085011.68011.79
311490-1149012.36912.51
411792-1179212.69512.83
511280-1128012.14312.27
611633-1163312.52312.65
30min113244-1324414.25814.322.6414.4614.512.65
212852-1285213.83614.01
313494-1349414.52714.73
413806-1380614.86315.06
512980-1298013.97414.17
613415-1341514.44214.64
45min115158-1515816.31816.362.7216.6016.642.73
214768-1476815.89816.15
315288-1528816.45816.74
415886-1588617.10217.39
514783-1478315.91516.19
615311-1531116.48316.76
60min116576-1657617.84517.562.6218.2117.932.62
215784-1578416.99217.33
316132-1613217.36717.74
416558-1655817.82518.21
515949-1594917.17017.53
616891-1689118.18418.55
极限117650-1765019.00118.952.3319.4719.412.34
217115-1711518.42518.86
317743-1774319.10119.57
418174-1817419.56520.04
517137-1713718.44918.90
617779-1777919.14019.61
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%
19.921033071033981030001029681031031031550.19
29.851029811028711029260.08
单位质量响应值RSD%判断
10398.6910449.340.35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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min15717-57176.1586.293.886.166.303.89
26036-60366.5016.50
35875-58756.3286.33
45452-54525.8725.87
55943-59436.4016.40
66041-60416.5076.51
15min17997-79978.6138.734.178.658.774.18
28541-85419.1999.24
38004-80048.6218.66
47555-75558.1378.17
58259-82598.8968.93
68281-82818.9198.96
20min19280-92809.99510.213.7010.0810.293.68
29950-995010.71710.80
39325-932510.04410.13
49056-90569.7549.83
59400-940010.12510.21
69857-985710.61710.70
30min113049-1304914.05514.372.5514.1914.512.57
213937-1393715.01115.16
313332-1333214.36014.50
413004-1300414.00614.14
513255-1325514.27714.42
613472-1347214.51114.66
45min113919-1391914.99214.812.4815.2115.042.48
214203-1420315.29815.53
313623-1362314.67314.89
413237-1323714.25714.47
513588-1358814.63514.86
613950-1395015.02515.25
60min113972-1397215.04914.933.0715.3515.233.07
214449-1444915.56315.88
313875-1387514.94515.24
413161-1316114.17614.46
513700-1370014.75615.06
614024-1402415.10515.41
极限115060-1506016.22116.262.5816.6016.652.57
215684-1568416.89317.29
315267-1526716.44416.83
414575-1457515.69916.07
514794-1479415.93416.32
615222-1522216.39516.79
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%
19.921028091027101025411026001025411026400.12
29.851025701027081026390.10
单位质量响应值RSD%判断
10346.7710420.200.51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%
5min14591-45914.9644.834.594.964.834.60
24125-41254.4604.46
34741-47415.1265.13
44434-44344.7944.79
54484-44844.8494.85
64440-44404.8014.80
10min15980-59806.4666.935.156.496.965.15
26553-65537.0867.11
36004-60046.4926.52
46611-66117.1487.18
56601-66017.1387.16
66722-67227.2687.30
15min17394-73947.9958.634.418.068.704.38
28045-80458.6998.76
37764-77648.3958.46
48114-81148.7748.84
58375-83759.0569.12
68202-82028.8698.94
20min18705-87059.41310.074.669.5210.184.63
29297-929710.05310.17
38897-88979.6209.73
49516-951610.29010.40
59744-974410.53610.65
69725-972510.51610.63
30min110902-1090211.78812.073.6711.9512.243.67
210917-1091711.80511.97
310601-1060111.46311.63
411389-1138912.31512.49
511515-1151512.45112.63
611630-1163012.57512.75
45min112458-1245813.47114.104.2913.7014.334.26
212720-1272013.75413.99
312648-1264813.67613.90
413067-1306714.12914.37
513965-1396515.10015.34
613370-1337014.45714.70
60min113366-1336614.45315.504.6014.7515.814.58
214091-1409115.23715.55
313955-1395515.09015.39
414501-1450115.68016.00
514958-1495816.17416.50
615116-1511616.34516.67
极限115453-1545316.70916.952.9417.0917.352.96
215622-1562216.89217.29
314913-1491316.12516.51
415882-1588217.17317.58
516247-1624717.56817.99
615914-1591417.20817.62
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%
19.921030601031641033181031771034631032360.16
29.851038291036921037600.10
单位质量响应值RSD%判断
10406.8510534.010.86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%
5min14279-42794.5894.662.754.594.662.78
24437-44374.7584.76
34406-44064.7254.72
44491-44914.8164.82
54171-41714.4734.47
64290-42904.6004.60
10min17705-77058.2628.313.698.298.343.66
27816-78168.3818.41
37646-76468.1998.23
47572-75728.1208.15
58288-82888.8888.91
67485-74858.0278.05
15min19623-962310.31910.221.7810.3910.301.79
29528-952810.21710.29
39207-92079.8739.94
49544-954410.23410.31
59681-968110.38110.46
69617-961710.31310.38
20min110873-1087311.66011.472.2811.7911.602.25
210795-1079511.57611.71
310231-1023110.97111.10
410628-1062811.39711.53
510755-1075511.53311.66
610870-1087011.65611.78
30min112232-1223213.11713.042.0413.3113.232.02
211817-1181712.67212.87
311956-1195612.82113.01
412155-1215513.03413.23
512527-1252713.43313.63
612253-1225313.13913.33
45min113791-1379114.78914.571.9315.0614.831.92
213312-1331214.27514.54
313384-1338414.35214.61
413351-1335114.31714.58
513802-1380214.80115.07
613873-1387314.87715.14
60min114394-1439415.43515.510.6315.7815.860.63
214361-1436115.40015.74
314469-1446915.51615.85
414443-1444315.48815.83
514504-1450415.55315.91
614615-1461515.67216.02
极限115870-1587017.01816.761.5717.4517.201.54
215589-1558916.71717.15
315192-1519216.29116.72
415595-1559516.72317.15
515746-1574616.88517.32
615809-1580916.95317.39
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