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%
110.141045241042851043111042281045741043840.15
210.121056551041331048941.03
单位质量响应值RSD%判断
10294.2810365.020.49数据可信
中间条件24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%
5min12854-28542.4792.287.372.482.287.46
22318-23182.0142.01
32605-26052.2632.26
42491-24912.1642.16
52713-27132.3572.36
62743-27432.3832.38
10min15560-55604.8304.915.004.844.925.03
25192-51924.5104.52
36028-60285.2365.25
45607-56074.8714.88
55840-58405.0735.09
65659-56594.9164.93
15min17673-76736.6656.903.296.716.943.29
27746-77466.7296.76
38150-81507.0807.12
48354-83547.2577.30
57947-79476.9036.94
67814-78146.7886.83
20min19495-94958.2488.552.608.338.632.57
29637-96378.3718.45
39910-99108.6098.69
410041-100418.7228.80
59808-98088.5208.60
610187-101878.8498.93
30min111718-1171810.17910.412.1210.3010.542.11
211899-1189910.33610.46
312321-1232110.70310.83
411800-1180010.25010.38
512283-1228310.67010.80
611911-1191110.34710.47
45min113967-1396712.13311.921.3312.3112.101.27
213882-1388212.05912.24
313597-1359711.81112.00
413742-1374211.93712.12
513644-1364411.85212.04
613483-1348311.71211.90
60min114554-1455412.64312.852.6512.8913.102.62
215034-1503413.06013.30
315405-1540513.38213.64
414300-1430012.42212.67
514619-1461912.69912.95
614855-1485512.90413.15
极限115337-1533713.32313.441.1713.6413.761.15
215493-1549313.45813.78
315483-1548313.45013.78
415257-1525713.25313.57
515782-1578213.70914.03
615507-1550713.47113.79
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%
110.141040241037111040651045161035161039660.37
210.121034031034061034040.01
单位质量响应值RSD%判断
10253.0610217.790.25数据可信
中间条件24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%
5min12844-28442.4932.3612.712.492.3612.69
22267-22671.9871.99
32619-26192.2962.30
42615-26152.2922.29
53284-32842.8792.88
62548-25482.2342.23
10min16248-62485.4774.858.355.494.878.34
24926-49264.3184.33
35454-54544.7814.79
45549-55494.8654.88
55822-58225.1045.12
65220-52204.5764.59
15min18295-82957.2726.864.427.326.904.44
27255-72556.3606.40
37660-76606.7156.75
47918-79186.9416.98
57920-79206.9436.99
67908-79086.9336.97
20min19498-94988.3278.212.478.418.292.47
29290-92908.1448.21
39285-92858.1408.22
49739-97398.5388.62
59324-93248.1748.26
69056-90567.9398.02
30min111570-1157010.14310.252.4310.2710.372.42
211612-1161210.18010.30
311533-1153310.11110.23
411488-1148810.07110.20
512251-1225110.74010.87
611690-1169010.24810.37
45min113511-1351111.84511.931.0912.0312.111.04
213803-1380312.10112.27
313434-1343411.77711.96
413758-1375812.06112.24
513624-1362411.94412.13
613518-1351811.85112.03
60min114408-1440812.63112.571.6712.8812.821.63
214205-1420512.45312.69
314750-1475012.93113.17
414401-1440112.62512.87
514195-1419512.44412.70
614078-1407812.34212.58
极限115030-1503013.17613.251.2913.5013.571.28
215036-1503613.18213.49
315020-1502013.16713.48
415491-1549113.58013.90
515147-1514713.27913.60
614960-1496013.11513.43
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%
110.141030591032211025591028491027271028830.26
210.121023401034531028960.77
单位质量响应值RSD%判断
10146.2510167.590.15数据可信
长期24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%
5min14008-40083.5413.0210.103.543.0210.02
23216-32162.8412.84
33028-30282.6752.68
43604-36043.1843.18
53348-33482.9582.96
63300-33002.9152.92
10min17534-75346.6566.176.506.686.196.54
26980-69806.1666.18
36359-63595.6185.63
47326-73266.4726.49
57153-71536.3196.34
66548-65485.7855.80
15min19431-94318.3328.275.058.398.325.04
29840-98408.6938.74
38628-86287.6227.67
49789-97898.6488.70
59490-94908.3848.44
68983-89837.9367.98
20min110933-109339.6599.714.419.769.804.42
211339-1133910.01710.12
310384-103849.1749.26
411590-1159010.23910.34
511211-112119.90410.00
610470-104709.2509.34
30min112691-1269111.21211.563.5211.3711.713.52
213882-1388212.26412.42
312751-1275111.26511.40
413369-1336911.81111.97
512971-1297111.45911.61
612836-1283611.34011.48
45min114302-1430212.63512.721.4412.8512.941.46
214606-1460612.90313.13
314153-1415312.50312.71
414579-1457912.88013.10
514576-1457612.87713.09
614205-1420512.54912.76
60min115241-1524113.46413.491.7913.7513.781.80
215533-1553313.72214.02
315286-1528613.50413.78
415606-1560613.78714.08
515053-1505313.29813.59
614893-1489313.15713.43
极限115378-1537813.58613.912.1613.9514.282.11
216037-1603714.16814.54
315802-1580213.96014.31
415386-1538613.59313.96
516214-1621414.32414.69
615687-1568713.85814.21
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%
110.141034321031741025271032821024871029800.43
210.121026401022391024400.28
单位质量响应值RSD%判断
10155.8210122.530.24数据可信
长期24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%
5min13002-30022.6573.0412.572.663.0412.59
23011-30112.6652.66
33919-39193.4683.47
43719-37193.2913.29
53128-31282.7682.77
63829-38293.3893.39
10min16186-61865.4755.8313.805.495.8513.82
26090-60905.3905.40
37772-77726.8786.90
47490-74906.6296.65
55362-53624.7454.76
66629-66295.8675.89
15min18949-89497.9207.998.707.968.048.72
28521-85217.5417.59
39848-98488.7158.77
49856-98568.7228.78
57828-78286.9286.97
69195-91958.1378.19
20min110379-103799.1859.437.509.279.537.53
210343-103439.1539.24
311526-1152610.20010.31
411524-1152410.19910.30
59433-94338.3488.43
610751-107519.5149.61
30min112385-1238510.96111.074.4711.1011.224.52
212232-1223210.82510.96
313355-1335511.81911.98
412840-1284011.36311.52
511706-1170610.36010.49
612529-1252911.08811.24
45min113790-1379012.20412.342.8412.4112.552.92
213798-1379812.21112.41
314321-1432112.67412.90
414434-1443412.77413.00
513348-1334811.81312.00
613964-1396412.35812.57
60min114921-1492113.20513.292.4813.4713.562.51
215396-1539613.62513.89
315408-1540813.63613.93
415084-1508413.34913.64
514420-1442012.76113.01
614870-1487013.16013.44
极限115444-1544413.66813.740.9114.0114.090.95
215730-1573013.92114.26
315677-1567713.87414.25
415429-1542913.65414.02
515390-1539013.62013.94
615511-1551113.72714.08
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