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%
110.531068251064551065191066481068671066630.18
210.551066241069151067700.20
单位质量响应值RSD%判断
10129.4410120.380.07数据可信
长期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%
5min12260-22602.0032.5538.212.002.5538.26
22724-27242.4142.41
32718-27182.4092.41
43357-33572.9752.98
51471-14711.3041.30
64720-47204.1834.18
10min16195-61955.4905.3923.535.505.4023.52
25723-57235.0725.09
36460-64605.7255.74
46239-62395.5295.55
53715-37153.2923.30
68160-81607.2327.25
15min18958-89587.9397.6914.357.987.7314.44
28330-83307.3827.42
38974-89747.9538.00
49051-90518.0218.07
56484-64845.7465.77
610261-102619.0949.16
20min110573-105739.3709.4310.419.469.5210.49
29880-98808.7568.84
311510-1151010.20110.29
410927-109279.6849.78
58950-89507.9327.99
611999-1199910.63410.75
30min112485-1248511.06510.905.3611.2011.045.49
211882-1188210.53010.66
312648-1264811.20911.36
412398-1239810.98711.13
511235-112359.95710.06
613132-1313211.63811.81
45min114520-1452012.86812.553.3713.0712.753.50
213977-1397712.38712.58
314498-1449812.84913.06
413875-1387512.29612.50
513442-1344211.91312.07
614671-1467113.00213.24
60min114568-1456812.91113.234.9013.1813.504.98
214387-1438712.75013.01
315387-1538713.63613.92
414488-1448812.84013.11
514519-1451912.86713.09
616223-1622314.37714.69
极限115649-1564913.86913.931.2714.2114.271.40
215627-1562713.84914.18
315518-1551813.75314.11
415719-1571913.93114.28
515670-1567013.88714.18
616097-1609714.26614.66
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%
110.531065051069341069901069981068641068580.20
210.551078301077861078080.03
单位质量响应值RSD%判断
10147.9610218.770.50数据可信
长期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%
5min15759-57595.0755.3124.695.075.3124.71
26851-68516.0376.04
37544-75446.6476.65
46150-61505.4195.42
53257-32572.8702.87
66594-65945.8105.81
10min17157-71576.3066.068.776.336.098.85
26979-69796.1506.18
37300-73006.4326.47
46872-68726.0556.09
55695-56955.0185.03
67266-72666.4026.43
15min18953-89537.8897.965.507.958.025.57
29343-93438.2338.30
39206-92068.1128.18
49103-91038.0218.08
58088-80887.1277.17
69481-94818.3548.42
20min110907-109079.6119.573.399.729.683.49
211228-112289.89410.01
310960-109609.6579.78
410623-106239.3609.47
510260-102609.0419.12
611198-111989.8679.98
30min112499-1249911.01411.382.3211.1711.542.34
213054-1305411.50311.67
312811-1281111.28811.46
412851-1285111.32411.48
512865-1286511.33611.47
613404-1340411.81111.98
45min114276-1427612.57912.952.5012.8013.172.43
215152-1515213.35113.58
314692-1469212.94613.18
414319-1431912.61712.84
515073-1507313.28213.48
614661-1466112.91913.15
60min115206-1520613.39913.642.0113.6913.931.89
215343-1534313.52013.83
315620-1562013.76414.07
415308-1530813.48913.78
516041-1604114.13514.40
615328-1532813.50613.81
极限115355-1535513.53013.811.7413.9014.181.67
215516-1551613.67214.05
315594-1559413.74114.12
416151-1615114.23214.60
515763-1576313.89014.24
615670-1567013.80814.19
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%
110.531069181063721066691067511066021066620.19
210.551066171069551067860.23
单位质量响应值RSD%判断
10129.3410121.900.06数据可信
长期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%
5min14282-42823.7953.507.833.793.507.80
23499-34993.1013.10
34199-41993.7213.72
44146-41463.6743.67
53833-38333.3973.40
63726-37263.3023.30
10min16874-68746.0926.124.196.116.144.20
26779-67796.0076.02
36781-67816.0096.03
47322-73226.4896.51
56515-65155.7735.79
67145-71456.3326.35
15min19327-93278.2658.263.398.328.313.37
29090-90908.0558.11
39073-90738.0408.09
49646-96468.5488.60
59027-90277.9998.05
69755-97558.6458.70
20min110841-108419.6079.794.919.719.894.85
210863-108639.6269.72
310716-107169.4969.59
410813-108139.5829.69
510904-109049.6639.76
612146-1214610.76310.86
30min113601-1360112.05311.015.6812.2111.165.61
212716-1271611.26911.42
312632-1263211.19411.35
411934-1193410.57610.73
511942-1194210.58310.73
611716-1171610.38210.54
45min114122-1412212.51412.752.1912.7412.962.15
214508-1450812.85713.07
314364-1436412.72912.94
414886-1488613.19113.41
513991-1399112.39812.61
614439-1443912.79513.01
60min115738-1573813.94713.641.8914.2413.931.87
215369-1536913.62013.90
314977-1497713.27213.56
415716-1571613.92714.22
515290-1529013.55013.83
615275-1527513.53613.83
极限115453-1545313.69413.821.1614.0614.181.11
215848-1584814.04414.40
315378-1537813.62713.99
415506-1550613.74114.11
515677-1567713.89214.24
615724-1572413.93414.30
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%
110.531060941059301062591061561057731060420.19
210.551056021058471057240.17
单位质量响应值RSD%判断
10070.4710021.230.35数据可信
长期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%
5min12221-22211.9842.4614.601.982.4614.62
22693-26932.4052.41
33239-32392.8932.89
42618-26182.3382.34
53210-32102.8672.87
62518-25182.2492.25
10min16428-64285.7426.034.985.756.045.00
27328-73286.5456.56
36616-66165.9095.93
46961-69616.2186.23
56558-65585.8585.87
66583-65835.8805.89
15min19052-90528.0858.643.588.138.683.57
210029-100298.9589.01
39801-98018.7548.80
49836-98368.7868.83
59788-97888.7438.79
69508-95088.4938.54
20min111116-111169.92910.323.5810.0210.413.59
212299-1229910.98611.09
311589-1158910.35110.45
411618-1161810.37710.47
511278-1127810.07410.17
611397-1139710.18010.27
30min113683-1368312.22212.161.6112.3612.311.61
213933-1393312.44512.61
313601-1360112.14912.30
413501-1350112.05912.21
513276-1327611.85812.01
613673-1367312.21312.36
45min114749-1474913.17413.242.3213.3813.452.29
214728-1472813.15513.38
315461-1546113.81014.03
414419-1441912.87913.10
514758-1475813.18213.40
614791-1479113.21113.43
60min114993-1499313.39213.672.2613.6813.962.24
215634-1563413.96414.27
314872-1487213.28413.58
415552-1555213.89114.18
515634-1563413.96414.26
615117-1511713.50313.79
极限115343-1534313.70514.011.5114.0614.381.52
216005-1600514.29614.68
315769-1576914.08514.46
415606-1560613.93914.31
515536-1553613.87714.25
615835-1583514.14414.51
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