美阿沙坦钾片项目信息
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)40供试品稀释倍数2.5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.06210214
210214+0
210309
210309+0
210305
210305+0
210339
210339+0
210228
210228+0
2102790.03
218.09210457
210457+0
210400
210400+0
2104280.02
单位质量响应值RSD%判断
11643.3611632.280.07数据可信
供试品溶液-1245175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%
5min13041.2
2374+834*0.8
-3041.21.4631.0229.421.461.0229.25
22475.2
1772+879*0.8
-2475.21.1901.19
31179.6
454+907*0.8
-1179.60.5670.57
41850.8
1254+746*0.8
-1850.80.8900.89
52041.2
1414+784*0.8
-2041.20.9820.98
62116.6
1611+632*0.8
-2116.61.0181.02
10min15235.6
4442+992*0.8
-5235.62.5182.3912.332.532.3912.39
25134.6
4277+1072*0.8
-5134.62.4692.48
33782.6
3033+937*0.8
-3782.61.8191.82
44849.8
4037+1016*0.8
-4849.82.3322.34
55359.8
4555+1006*0.8
-5359.82.5782.58
65411
4655+945*0.8
-54112.6022.61
15min16079.2
5216+1079*0.8
-6079.22.9242.848.782.952.868.86
25962.8
5042+1151*0.8
-5962.82.8682.89
34882
4062+1025*0.8
-48822.3482.36
46022.6
5133+1112*0.8
-6022.62.8962.91
56192.6
5347+1057*0.8
-6192.62.9783.00
66315.6
5490+1032*0.8
-6315.63.0373.06
20min16377.6
5488+1112*0.8
-6377.63.0673.018.963.113.058.95
26806.4
4980+2283*0.8
-6806.43.2733.31
35200.4
4394+1008*0.8
-5200.42.5012.53
46225.6
5332+1117*0.8
-6225.62.9943.03
56337.6
5472+1082*0.8
-6337.63.0483.08
66621.8
5757+1081*0.8
-6621.83.1853.22
30min16401.2
5466+1169*0.8
-6401.23.0783.006.383.133.056.47
26205.4
5219+1233*0.8
-6205.42.9843.04
35474.2
4579+1119*0.8
-5474.22.6332.67
46343.6
5366+1222*0.8
-6343.63.0513.10
56370.8
5438+1166*0.8
-6370.83.0643.12
66626.8
5702+1156*0.8
-6626.83.1873.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min16446.2
5467+1224*0.8
-6446.23.1003.036.943.173.106.97
26417
5369+1310*0.8
-64173.0863.16
35476.2
4529+1184*0.8
-5476.22.6342.69
46270.4
5232+1298*0.8
-6270.43.0163.08
56486.2
5535+1189*0.8
-6486.23.1193.19
66760.6
5775+1232*0.8
-6760.63.2513.32
60min16358
5342+1270*0.8
-63583.0583.116.713.153.206.76
26373.8
5281+1366*0.8
-6373.83.0653.15
35739.2
4740+1249*0.8
-5739.22.7602.83
46702.2
5627+1344*0.8
-6702.23.2233.31
56632.4
5582+1313*0.8
-6632.43.1903.28
67022.6
5965+1322*0.8
-7022.63.3773.47
极限16599.6
5562+1297*0.8
-6599.63.1743.165.953.283.266.01
26462.4
5364+1373*0.8
-6462.43.1083.21
35850.6
4837+1267*0.8
-5850.62.8142.90
46857.4
5751+1383*0.8
-6857.43.2983.40
56810.4
5740+1338*0.8
-6810.43.2753.38
66877.8
5789+1361*0.8
-6877.83.3083.42
美阿沙坦钾片项目信息
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)40供试品稀释倍数2.5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.06208938
208938+0
209079
209079+0
208932
208932+0
208964
208964+0
209013
209013+0
2089850.03
218.09211171
211171+0
211136
211136+0
2111540.02
单位质量响应值RSD%判断
11571.7111672.420.62数据可信
供试品溶液-1245175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%
5min12255.6
1638+772*0.8
-2255.61.0861.099.071.091.099.09
21875
947+1160*0.8
-18750.9030.90
32418
1882+670*0.8
-24181.1641.16
42365.2
1774+739*0.8
-2365.21.1391.14
52414.4
1848+708*0.8
-2414.41.1631.16
62221
1677+680*0.8
-22211.0701.07
10min14845.4
4059+983*0.8
-4845.42.3332.455.802.342.465.74
25418.4
4640+973*0.8
-5418.42.6092.61
35423.8
4759+831*0.8
-5423.82.6122.62
44716.8
3980+921*0.8
-4716.82.2722.28
55160.4
4386+968*0.8
-5160.42.4852.49
64979.4
4257+903*0.8
-4979.42.3982.40
15min15885.2
5050+1044*0.8
-5885.22.8342.874.912.852.894.90
26009.6
5172+1047*0.8
-6009.62.8942.91
36518.4
5744+968*0.8
-6518.43.1393.16
45770.8
4974+996*0.8
-5770.82.7792.80
55716.4
4902+1018*0.8
-5716.42.7532.77
65848.8
5084+956*0.8
-5848.82.8172.84
20min15975.8
5075+1126*0.8
-5975.82.8782.943.182.912.983.18
26102
5242+1075*0.8
-61022.9392.97
36446.4
5676+963*0.8
-6446.43.1043.14
46224.6
5367+1072*0.8
-6224.62.9983.03
55983.4
5157+1033*0.8
-5983.42.8822.92
65938.8
5138+1001*0.8
-5938.82.8602.89
30min16107.2
5220+1109*0.8
-6107.22.9413.003.852.993.063.80
25988.2
5073+1144*0.8
-5988.22.8842.94
36548.8
5688+1076*0.8
-6548.83.1543.21
46386.4
5484+1128*0.8
-6386.43.0763.13
55991.6
5098+1117*0.8
-5991.62.8852.94
66405.8
5513+1116*0.8
-6405.83.0853.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min16217.4
5267+1188*0.8
-6217.42.9943.083.243.063.153.28
26230.2
5239+1239*0.8
-6230.23.0003.07
36713.6
5832+1102*0.8
-6713.63.2333.31
46499.2
5540+1199*0.8
-6499.23.1303.20
56212.8
5252+1201*0.8
-6212.82.9923.06
66494.4
5548+1183*0.8
-6494.43.1283.20
60min16189.6
5208+1227*0.8
-6189.62.9813.063.443.063.143.43
26186.8
5186+1251*0.8
-6186.82.9793.06
36731.8
5791+1176*0.8
-6731.83.2423.33
46346.6
5369+1222*0.8
-6346.63.0563.14
56179.4
5181+1248*0.8
-6179.42.9763.06
66449.6
5480+1212*0.8
-6449.63.1063.19
极限16495
5483+1265*0.8
-64953.1283.142.253.233.242.30
26361.4
5307+1318*0.8
-6361.43.0643.16
36794.8
5806+1236*0.8
-6794.83.2723.38
46508.8
5500+1261*0.8
-6508.83.1353.24
56509.2
5470+1299*0.8
-6509.23.1353.24
66442
5454+1235*0.8
-64423.1023.20
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