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%
110.531059791062281061961061111061081061240.10
210.551065511063131064320.16
单位质量响应值RSD%判断
10078.2510088.340.08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%
5min12513-25132.2362.3113.492.242.3113.41
22251-22512.0032.00
33126-31262.7822.78
42265-22652.0162.02
52513-25132.2362.24
62892-28922.5742.57
10min15318-53184.7324.616.334.744.636.31
25002-50024.4514.46
35409-54094.8134.83
45150-51504.5834.59
55581-55814.9664.98
64657-46574.1444.16
15min17834-78346.9716.666.117.016.706.09
27010-70106.2386.27
37454-74546.6336.68
47488-74886.6636.70
58150-81507.2537.29
66981-69816.2126.25
20min19556-95568.5048.184.738.588.254.74
28846-88467.8727.94
39175-91758.1658.24
49511-95118.4648.54
59535-95358.4858.57
68506-85067.5697.64
30min111640-1164010.3589.912.6010.4810.032.60
210884-108849.6869.80
311085-110859.8649.99
411190-111909.95810.08
511167-111679.93710.06
610829-108299.6379.75
45min113226-1322611.77011.422.9711.9511.602.93
213164-1316411.71411.88
313005-1300511.57311.75
412479-1247911.10511.28
512860-1286011.44411.63
612281-1228110.92911.10
60min114064-1406412.51512.072.0712.7612.312.06
213322-1332211.85512.09
313388-1338811.91412.16
413647-1364712.14412.38
513585-1358512.08912.34
613351-1335111.88112.11
极限114263-1426312.69212.541.5413.0112.851.55
213929-1392912.39512.69
314431-1443112.84213.15
414110-1411012.55612.86
513960-1396012.42312.74
613877-1387712.34912.64
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%
110.531063191062881065191064321063631063840.09
210.551066361062851064600.24
单位质量响应值RSD%判断
10102.9410091.000.09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%
5min13144-31442.7942.7122.272.792.7022.35
22881-28812.5602.56
31761-17611.5651.56
43530-35303.1373.14
53440-34403.0573.06
63516-35163.1253.12
10min15829-58295.1804.8012.865.204.8212.90
25142-51424.5704.58
34223-42233.7533.76
45498-54984.8864.90
55449-54494.8424.86
66274-62745.5765.59
15min17781-77816.9156.589.146.966.629.16
27009-70096.2296.27
36432-64325.7165.75
47292-72926.4806.52
57484-74846.6516.69
68417-84177.4807.53
20min19197-91978.1737.946.028.268.026.07
28475-84757.5327.61
38255-82557.3367.40
48872-88727.8847.96
59009-90098.0068.09
69766-97668.6798.77
30min111348-1134810.0859.843.7410.219.963.79
210688-106889.4989.61
310609-106099.4289.53
411152-111529.91110.03
510941-109419.7239.85
611699-1169910.39710.53
45min113006-1300611.55811.252.7811.7411.422.86
212225-1222510.86411.03
312296-1229610.92711.08
412561-1256111.16311.34
512800-1280011.37511.55
613042-1304211.59011.79
60min113615-1361512.09912.141.4512.3512.381.44
213668-1366812.14712.38
313818-1381812.28012.49
413481-1348111.98012.22
513435-1343511.93912.18
613949-1394912.39612.66
极限114575-1457512.95312.672.3313.2712.982.36
214063-1406312.49812.79
314206-1420612.62512.91
413996-1399612.43812.75
513942-1394212.39012.70
614748-1474813.10613.44
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%
110.531063331063631063981067191064121064450.15
210.551071191072831072010.11
单位质量响应值RSD%判断
10108.7410161.230.37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%
5min16207-62075.4954.7319.435.504.7319.45
25727-57275.0705.07
34307-43073.8133.81
44633-46334.1024.10
54401-44013.8963.90
66765-67655.9895.99
10min16306-63065.5835.007.595.615.027.60
25974-59745.2895.32
35544-55444.9084.93
45212-52124.6144.64
55231-52314.6314.65
65595-55954.9544.99
15min18123-81237.1926.785.697.256.835.74
28086-80867.1597.22
37284-72846.4496.50
47300-73006.4636.51
57209-72096.3836.43
67939-79397.0297.09
20min19775-97758.6548.144.948.768.235.01
29683-96838.5738.67
38807-88077.7977.88
48830-88307.8187.90
58787-87877.7807.86
69248-92488.1888.29
30min111209-112099.9249.692.6010.079.832.64
211042-110429.7769.92
311105-111059.8329.96
410715-107159.4879.61
510485-104859.2839.41
611134-111349.85810.00
45min113124-1312411.61911.342.7411.8211.532.76
213343-1334311.81312.01
312700-1270011.24411.43
412667-1266711.21511.40
512417-1241710.99311.17
612597-1259711.15311.35
60min113719-1371912.14612.141.0112.4212.400.96
213730-1373012.15612.42
313703-1370312.13212.38
413920-1392012.32412.57
513711-1371112.13912.38
613486-1348611.94012.20
极限114034-1403412.42512.440.9012.7612.760.94
214067-1406712.45412.79
314024-1402412.41612.73
414041-1404112.43112.74
513863-1386312.27412.58
614258-1425812.62312.95
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%
110.531053241052811051471048831048531050980.21
210.551074281075521074900.09
单位质量响应值RSD%判断
9980.8210188.631.46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%
5min13753-37533.3403.3010.423.343.3010.42
23992-39923.5523.55
34283-42833.8113.81
43497-34973.1123.11
53225-32252.8702.87
63476-34763.0933.09
10min16035-60355.3705.134.555.395.154.53
25794-57945.1565.18
36072-60725.4035.42
45670-56705.0455.06
55374-53744.7824.80
65651-56515.0295.05
15min18288-82887.3757.182.577.427.232.60
28207-82077.3037.35
38267-82677.3567.41
47969-79697.0917.14
57822-78226.9607.00
67876-78767.0097.05
20min19850-98508.7658.613.168.858.693.15
29972-99728.8748.96
310004-100048.9028.99
49322-93228.2958.38
59430-94308.3918.47
69445-94458.4058.49
30min111188-111889.95610.171.6710.0910.301.66
211773-1177310.47610.61
311452-1145210.19110.33
411381-1138110.12710.26
511373-1137310.12010.25
611421-1142110.16310.29
45min112758-1275811.35311.262.3111.5511.452.32
212997-1299711.56511.76
312910-1291011.48811.69
412539-1253911.15811.34
512212-1221210.86711.05
612508-1250811.13011.32
60min113297-1329711.83211.931.0312.0912.191.00
213371-1337111.89812.16
313561-1356112.06712.33
413445-1344511.96412.21
513560-1356012.06612.31
613225-1322511.76812.02
极限114103-1410312.55012.062.3512.8712.382.29
213763-1376312.24712.57
313414-1341411.93712.27
413378-1337811.90412.22
513445-1344511.96412.28
613243-1324311.78412.10
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