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%
110.141037931040381038291044701035521039360.34
210.121033241035781034510.18
单位质量响应值RSD%判断
10250.1010222.430.20数据可信
长期24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%
5min13149-31492.7602.687.082.762.687.14
22839-28392.4892.49
32811-28112.4642.46
43000-30002.6302.63
53136-31362.7492.75
63385-33852.9672.97
10min16685-66855.8605.712.545.885.722.59
26240-62405.4705.48
36453-64535.6575.67
46620-66205.8035.82
56444-64445.6495.66
66626-66265.8085.82
15min19027-90277.9137.904.317.967.954.31
28499-84997.4507.49
39363-93638.2088.25
49217-92178.0808.13
58597-85977.5367.58
69403-94038.2438.29
20min110237-102378.9749.048.399.079.138.33
210307-103079.0359.12
38673-86737.6037.69
411100-111009.7309.82
510716-107169.3949.48
610827-108279.4919.59
30min112439-1243910.90411.203.1911.0511.343.17
212290-1229010.77310.91
312933-1293311.33711.47
413303-1330311.66111.81
512559-1255911.00911.15
613137-1313711.51611.66
45min114109-1410912.36812.551.9412.5712.761.96
213971-1397112.24712.44
314547-1454712.75212.95
414461-1446112.67612.89
514155-1415512.40812.61
614665-1466512.85513.07
60min115213-1521313.33613.261.5113.6113.541.53
215013-1501313.16013.42
315173-1517313.30113.57
415476-1547613.56613.85
514788-1478812.96313.23
615116-1511613.25113.53
极限116618-1661814.56714.042.4614.9114.382.41
215753-1575313.80914.15
315742-1574213.79914.14
416349-1634914.33114.69
516005-1600514.03014.37
615621-1562113.69314.05
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%
110.141038161035341033311032331041391036110.36
210.121036451036341036400.01
单位质量响应值RSD%判断
10218.0510241.110.16数据可信
长期24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%
5min13431-34313.0102.6926.333.012.6826.36
22909-29092.5522.55
32433-24332.1342.13
44436-44363.8913.89
52996-29962.6282.63
62167-21671.9011.90
10min17706-77066.7596.0712.226.786.0812.26
26435-64355.6455.66
36728-67285.9025.91
48147-81477.1467.17
56587-65875.7785.79
65888-58885.1655.18
15min19411-94118.2558.116.458.318.166.49
28768-87687.6917.74
39273-92738.1348.18
410070-100708.8338.89
59587-95878.4098.46
68395-83957.3647.40
20min110914-109149.5739.544.149.679.634.19
210695-106959.3819.47
310979-109799.6309.72
411620-1162010.19310.30
510797-107979.4719.56
610240-102408.9829.06
30min113135-1313511.52211.262.6411.6711.402.63
212793-1279311.22211.36
313186-1318611.56611.71
412968-1296811.37511.54
512281-1228110.77210.92
612652-1265211.09811.23
45min114100-1410012.36812.342.2412.5912.552.25
213969-1396912.25312.46
314352-1435212.58912.80
414356-1435612.59312.82
513507-1350711.84812.05
614145-1414512.40712.60
60min115554-1555413.64313.462.5713.9313.742.61
215144-1514413.28413.55
315241-1524113.36913.65
416031-1603114.06214.36
514902-1490213.07113.34
615220-1522013.35013.61
极限116270-1627014.27114.001.1914.6314.351.17
215862-1586213.91414.26
316016-1601614.04914.40
415823-1582313.87914.26
515741-1574113.80714.15
616025-1602514.05714.39
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%
110.141037871031291035911033971039791035770.32
210.121026571020121023340.45
单位质量响应值RSD%判断
10214.6910112.060.72数据可信
长期24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%
5min11209-12091.0671.8542.821.071.8542.71
21673-16731.4771.48
31783-17831.5741.57
41809-18091.5971.60
52298-22982.0292.03
63775-37753.3333.33
10min14809-48094.2465.0514.524.255.0614.61
25440-54404.8034.81
35352-53524.7254.73
45592-55924.9374.95
55839-58395.1555.17
67259-72596.4096.43
15min17803-78036.8897.467.776.927.507.80
28390-83907.4087.44
37873-78736.9516.99
48548-85487.5477.58
58476-84767.4837.52
69628-96288.5018.55
20min19453-94538.3468.995.138.419.075.20
210242-102429.0439.12
310030-100308.8558.93
410396-103969.1799.26
59956-99568.7908.87
611024-110249.7339.83
30min111820-1182010.43611.043.3510.5511.173.42
212644-1264411.16311.29
312521-1252111.05511.18
412456-1245610.99711.13
512437-1243710.98111.11
613119-1311911.58311.74
45min113799-1379912.18312.521.5912.3612.711.63
214079-1407912.43012.62
314421-1442112.73212.92
414271-1427112.60012.79
514149-1414912.49212.68
614351-1435112.67012.89
60min115093-1509313.32613.251.4813.5713.511.47
214807-1480713.07313.33
315299-1529913.50713.76
414947-1494713.19713.46
514722-1472212.99813.26
615173-1517313.39613.69
极限115490-1549013.67613.841.6813.9914.171.61
216109-1610914.22314.55
315562-1556213.74014.07
415775-1577513.92814.26
515748-1574813.90414.24
615367-1536713.56813.93
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%
110.141030401029481029331026521025511028250.21
210.121035621031671033640.28
单位质量响应值RSD%判断
10140.5310213.830.51数据可信
长期24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%
5min12451-24512.1611.9521.052.161.9521.03
22500-25002.2042.20
31956-19561.7251.72
41810-18101.5961.60
51676-16761.4781.48
62866-28662.5272.53
10min16513-65135.7425.4314.475.755.4414.45
27016-70166.1866.20
36150-61505.4225.43
45361-53614.7274.74
54863-48634.2884.30
67049-70496.2156.23
15min18948-89487.8897.719.537.937.759.53
29718-97188.5688.61
38586-85867.5707.61
47741-77416.8256.86
57888-78886.9556.99
69588-95888.4548.50
20min110399-103999.1699.077.589.269.167.63
211323-113239.98310.08
310311-103119.0919.17
49564-95648.4328.51
59255-92558.1608.23
610891-108919.6029.70
30min112843-1284311.32411.063.3511.4611.193.42
212996-1299611.45811.61
312302-1230210.84710.98
412051-1205110.62510.75
512151-1215110.71310.83
612903-1290311.37611.53
45min114241-1424112.55612.532.3312.7612.722.38
214655-1465512.92113.13
314422-1442212.71612.91
413975-1397512.32212.50
513712-1371212.09012.27
614231-1423112.54712.76
60min115058-1505813.27613.341.2913.5513.611.19
215021-1502113.24413.53
315121-1512113.33213.60
415523-1552313.68613.93
515020-1502013.24313.49
615054-1505413.27313.55
极限115815-1581513.94413.822.1314.2914.162.05
215688-1568813.83214.19
315559-1555913.71814.06
415245-1524513.44113.76
516227-1622714.30714.62
615501-1550113.66714.02
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