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%
110.141030581030531030361030571030101030430.02
210.121027061024791025920.16
单位质量响应值RSD%判断
10162.0310137.550.18数据可信
中间条件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%
5min11461-14611.2921.5431.161.291.5431.11
22244-22441.9841.98
32561-25612.2642.26
41627-16271.4381.44
51455-14551.2861.29
61124-11240.9940.99
10min15217-52174.6124.8214.904.624.8314.94
25941-59415.2525.26
36655-66555.8835.90
45231-52314.6254.63
55467-54674.8334.84
64222-42223.7323.74
15min17891-78916.9767.128.837.017.168.87
28240-82407.2857.32
39167-91678.1048.15
47917-79176.9997.03
58173-81737.2257.26
66961-69616.1546.18
20min19491-94918.3918.695.768.468.765.83
210038-100388.8748.95
310725-107259.4829.57
49852-98528.7108.78
59824-98248.6858.76
69031-90317.9848.04
30min111576-1157610.23410.343.4910.3510.473.56
211632-1163210.28310.41
312377-1237710.94211.08
411849-1184910.47510.60
511646-1164610.29610.42
611128-111289.8389.94
45min113574-1357412.00012.001.9912.1812.182.07
213690-1369012.10312.29
314001-1400112.37812.58
413542-1354211.97212.15
513475-1347511.91312.09
613179-1317911.65111.81
60min114175-1417512.53212.712.4912.7712.962.56
214428-1442812.75513.01
315031-1503113.28813.56
414326-1432612.66512.91
514317-1431712.65712.90
613976-1397612.35612.58
极限115007-1500713.26713.361.4513.5813.681.51
215090-1509013.34013.67
315459-1545913.66714.01
414872-1487213.14813.46
515273-1527313.50213.82
614961-1496113.22613.52
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%
110.141025941027901025761026971027091026730.09
210.121026121023391024760.19
单位质量响应值RSD%判断
10125.5410126.090.01数据可信
中间条件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%
5min12032-20321.8011.8821.071.801.8821.06
22876-28762.5492.55
31723-17231.5271.53
41825-18251.6171.62
52411-24112.1372.14
61829-18291.6211.62
10min15775-57755.1185.227.225.135.237.23
26560-65605.8135.83
35633-56334.9925.00
45920-59205.2465.25
56117-61175.4215.43
65323-53234.7174.73
15min18086-80867.1657.496.577.207.536.61
29355-93558.2908.34
38029-80297.1157.15
48573-85737.5977.64
58752-87527.7567.80
67902-79027.0027.04
20min19876-98768.7528.924.678.839.004.71
210751-107519.5279.62
39777-97778.6648.74
410196-101969.0359.12
510380-103809.1989.28
69433-94338.3598.43
30min111759-1175910.42010.542.7710.5510.682.79
212276-1227610.87811.02
311663-1166310.33510.46
412230-1223010.83810.97
512012-1201210.64410.78
611449-1144910.14610.27
45min113367-1336711.84511.991.3812.0312.181.45
213837-1383712.26212.47
313383-1338311.85912.04
413553-1355312.01012.20
513655-1365512.10012.30
613413-1341311.88612.06
60min114123-1412312.51512.801.3012.7713.061.32
214650-1465012.98213.26
314429-1442912.78613.03
414616-1461612.95213.21
514431-1443112.78813.05
614429-1442912.78613.03
极限114972-1497213.26713.431.3513.5913.751.38
215368-1536813.61813.96
315378-1537813.62713.95
415166-1516613.43913.77
515153-1515313.42813.76
614873-1487313.18013.49
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%
110.141031841028281032231027601031011030190.21
210.121020821016801018810.28
单位质量响应值RSD%判断
10159.6610067.290.65数据可信
中间条件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%
5min12616-26162.3212.374.092.322.364.01
22808-28082.4912.49
32688-26882.3852.38
42487-24872.2072.21
52671-26712.3702.37
62733-27332.4252.42
10min15459-54594.8435.027.144.865.047.17
26291-62915.5825.60
35954-59545.2835.30
45674-56745.0345.05
55405-54054.7964.81
65184-51844.6004.61
15min17724-77246.8537.144.356.897.184.34
28572-85727.6067.65
38325-83257.3867.43
48108-81087.1947.23
57783-77836.9056.95
67767-77676.8916.93
20min19455-94558.3898.633.488.478.723.49
210143-101438.9999.09
310138-101388.9959.08
49713-97138.6188.70
59570-95708.4918.57
69365-93658.3098.39
30min111650-1165010.33610.532.2010.4610.662.21
212278-1227810.89411.03
312031-1203110.67510.81
411909-1190910.56610.69
511576-1157610.27110.40
611772-1177210.44510.57
45min113086-1308611.61112.012.1511.7912.202.16
213581-1358112.05012.25
313928-1392812.35812.55
413710-1371012.16412.35
513555-1355512.02712.21
613355-1335511.84912.03
60min114092-1409212.50312.811.5412.7513.071.54
214504-1450412.86913.13
314476-1447612.84413.11
414781-1478113.11413.37
514384-1438412.76213.01
614422-1442212.79613.04
极限114676-1467613.02113.291.3713.3413.611.39
215170-1517013.46013.80
315136-1513613.42913.76
415125-1512513.42013.75
514943-1494313.25813.58
614797-1479713.12913.45
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%
110.141022431020911024041022971021521022370.12
210.121021191022891022040.12
单位质量响应值RSD%判断
10082.5410099.210.12数据可信
中间条件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%
5min12836-28362.5222.5010.362.522.5010.45
22265-22652.0142.01
32798-27982.4882.49
42948-29482.6212.62
53121-31212.7752.78
62914-29142.5912.59
10min15549-55494.9345.145.034.955.155.08
25592-55924.9734.98
35612-56124.9905.00
46054-60545.3835.40
56231-62315.5415.56
65621-56214.9985.01
15min17611-76116.7687.093.796.817.133.79
27664-76646.8156.85
37998-79987.1127.15
48275-82757.3587.40
58341-83417.4177.46
67933-79337.0547.10
20min19322-93228.2898.632.458.378.712.45
29555-95558.4968.57
39742-97428.6638.74
49774-97748.6918.78
510017-100178.9078.99
69792-97928.7078.79
30min111664-1166410.37210.491.2510.5010.621.27
211599-1159910.31410.44
311894-1189410.57610.71
411809-1180910.50110.63
511995-1199510.66610.80
611851-1185110.53810.67
45min113004-1300411.56311.941.9411.7512.131.91
213399-1339911.91512.10
313725-1372512.20512.39
413409-1340911.92412.12
513684-1368412.16812.36
613374-1337411.89212.08
60min114176-1417612.60612.851.4412.8513.111.42
214532-1453212.92213.17
314437-1443712.83813.09
414709-1470913.08013.34
514254-1425412.67512.94
614615-1461512.99613.25
极限114689-1468913.06213.261.1313.3813.591.12
214875-1487513.22713.55
314936-1493613.28113.61
414830-1483013.18713.52
514948-1494813.29213.63
615197-1519713.51313.84
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