阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531071941067651069661072551067761069910.22
210.551080261079391079820.06
单位质量响应值RSD%判断
10160.5910235.260.52数据可信
加速6月-供试品溶液-2023111721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%
5min13252-32522.8612.7412.082.862.7412.01
22738-27382.4092.41
33755-37553.3043.30
43081-30812.7112.71
53108-31082.7352.73
62748-27482.4182.42
10min15297-52974.6614.667.304.684.687.31
25423-54234.7724.79
34824-48244.2454.26
45956-59565.2415.26
55029-50294.4254.44
65259-52594.6274.64
15min17186-71866.3236.364.656.366.404.63
27487-74876.5886.63
36627-66275.8315.87
47568-75686.6596.70
57325-73256.4456.49
67146-71466.2886.33
20min18465-84657.4487.724.627.537.804.59
28449-84497.4347.51
38476-84767.4587.53
49217-92178.1108.19
59342-93428.2208.30
68676-86767.6347.71
30min110500-105009.2399.253.999.369.373.95
210520-105209.2579.37
310061-100618.8538.97
411247-112479.89610.02
510154-101548.9349.06
610589-105899.3179.43
45min112699-1269911.17410.902.7511.3411.072.74
212490-1249010.99011.16
311905-1190510.47510.64
412679-1267911.15611.34
512540-1254011.03411.20
612030-1203010.58510.75
60min113506-1350611.88411.722.6012.1211.962.54
213127-1312711.55011.78
312868-1286811.32311.55
413276-1327611.68211.92
513283-1328311.68811.92
613884-1388412.21612.44
极限114059-1405912.37012.340.9912.6712.640.98
214160-1416012.45912.75
313924-1392412.25212.54
413969-1396912.29112.60
514208-1420812.50212.80
613852-1385212.18812.48
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531070021067781067471069271069591068830.11
210.551067671069501068580.13
单位质量响应值RSD%判断
10150.3310128.720.16数据可信
加速6月-供试品溶液-2023111821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%
5min12794-27942.4732.8510.252.472.8510.29
23552-35523.1433.14
33673-36733.2503.25
43096-30962.7402.74
53034-30342.6852.68
63197-31972.8292.83
10min15496-54964.8645.004.994.885.024.99
25733-57335.0735.09
35899-58995.2205.24
45866-58665.1915.21
55156-51564.5634.58
65768-57685.1045.12
15min17733-77336.8436.824.346.886.864.32
27809-78096.9116.96
37692-76926.8076.85
48230-82307.2837.33
57216-72166.3866.43
67532-75326.6656.71
20min19059-90598.0178.152.798.108.232.82
29371-93718.2938.38
39482-94828.3918.48
49440-94408.3548.44
58876-88767.8557.93
69007-90077.9718.05
30min110567-105679.3519.933.629.4710.053.62
211511-1151110.18710.32
311176-111769.89010.02
411765-1176510.41110.54
511155-111559.8729.99
611123-111239.8439.97
45min112522-1252211.08111.223.1911.2611.403.17
213291-1329111.76211.95
312590-1259011.14211.33
413032-1303211.53311.72
512262-1226210.85111.03
612349-1234910.92811.11
60min113510-1351011.95612.152.2512.1912.392.26
213416-1341611.87312.12
313693-1369312.11812.37
414297-1429712.65212.91
513669-1366912.09612.33
613788-1378812.20212.44
极限114193-1419312.56012.691.1512.8613.001.18
214212-1421212.57712.89
314420-1442012.76113.08
414481-1448112.81513.14
514163-1416312.53412.84
614540-1454012.86713.18
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531077261072311071141072711070451072770.25
210.551058831056881057860.14
单位质量响应值RSD%判断
10187.7510027.111.13数据可信
加速6月-供试品溶液-2023111921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%
5min16034-60345.3573.5031.235.363.5031.22
23297-32972.9272.93
33949-39493.5063.51
43109-31092.7602.76
52656-26562.3582.36
64598-45984.0824.08
10min14591-45914.0764.4712.414.114.4912.34
25108-51084.5354.55
35526-55264.9064.93
44710-47104.1824.20
54295-42953.8133.83
65957-59575.2895.31
15min16483-64835.7566.366.775.816.406.76
27307-73076.4876.53
37527-75276.6836.73
47500-75006.6596.70
56612-66125.8705.90
67540-75406.6946.75
20min18125-81257.2147.836.177.307.916.16
29272-92728.2328.31
39209-92098.1768.26
48650-86507.6807.76
58284-82847.3557.42
69391-93918.3388.43
30min19916-99168.8049.635.908.939.765.87
210994-109949.7619.88
311385-1138510.10810.24
411222-112229.96310.08
510191-101919.0489.16
611390-1139010.11210.25
45min112623-1262311.20711.402.6611.3811.572.69
212937-1293711.48611.66
313020-1302011.55911.74
413238-1323811.75311.93
512270-1227010.89411.05
612930-1293011.47911.67
60min113875-1387512.31812.262.9212.5512.502.85
213970-1397012.40312.64
313140-1314011.66611.92
414272-1427212.67112.91
513549-1354912.02912.25
614029-1402912.45512.71
极限114265-1426512.66512.761.3712.9713.071.34
214521-1452112.89213.20
314198-1419812.60512.92
414706-1470613.05613.37
514337-1433712.72913.01
614241-1424112.64312.97
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531068921070211070721072621070361070570.13
210.551064071066661065360.18
单位质量响应值RSD%判断
10166.8610098.200.48数据可信
加速6月-供试品溶液批-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%
5min14916-49164.3533.6431.144.353.6431.12
24815-48154.2644.26
33801-38013.3663.37
42340-23402.0722.07
53047-30472.6982.70
65749-57495.0915.09
10min16001-60015.3145.277.125.345.297.20
26402-64025.6695.69
36300-63005.5795.60
45465-54654.8404.85
55405-54054.7874.80
66143-61435.4405.47
15min17755-77556.8687.304.836.927.354.87
28401-84017.4407.49
38478-84787.5087.56
47805-78056.9126.95
58246-82467.3027.34
68774-87747.7707.83
20min19806-98068.6848.692.638.788.782.68
210272-102729.0979.19
39844-98448.7188.81
49549-95498.4568.53
59588-95888.4918.57
69818-98188.6958.80
30min111669-1166910.33410.310.7810.4710.450.83
211739-1173910.39610.54
311743-1174310.39910.54
411511-1151110.19410.32
511584-1158410.25810.39
611625-1162510.29510.44
45min112903-1290311.42711.571.6511.6211.761.68
213161-1316111.65511.86
313310-1331011.78711.98
412749-1274911.29011.47
513005-1300511.51711.70
613240-1324011.72511.93
60min113072-1307211.57611.872.9511.8412.142.96
213413-1341311.87812.15
313691-1369112.12412.39
412805-1280511.34011.58
513655-1365512.09312.34
613814-1381412.23312.51
极限114206-1420612.58012.401.7512.9112.731.68
213994-1399412.39312.73
313898-1389812.30812.64
414367-1436712.72313.03
513694-1369412.12712.44
613861-1386112.27512.62
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