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%
110.531068051069951068571067281067131068200.11
210.551066541065301065920.09
单位质量响应值RSD%判断
10144.3510103.510.29数据可信
中间条件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%
5min13026-30262.6823.2711.082.683.2711.04
23483-34833.0873.09
33587-35873.1793.18
44008-40083.5523.55
54111-41113.6443.64
63941-39413.4933.49
10min16845-68456.0676.189.136.086.209.14
26352-63525.6305.65
36411-64115.6825.70
47570-75706.7096.73
57926-79267.0257.05
66759-67595.9916.01
15min19334-93348.2738.117.618.328.167.61
27970-79707.0647.11
38776-87767.7787.83
49620-96208.5268.58
59937-99378.8078.87
69273-92738.2198.27
20min111508-1150810.2009.664.0810.299.754.06
210176-101769.0199.11
310708-107089.4919.58
411057-110579.8009.90
511074-110749.8159.92
610855-108559.6219.72
30min112877-1287711.41311.271.3911.5611.421.45
212452-1245211.03611.17
312588-1258811.15711.30
412827-1282711.36911.53
512881-1288111.41711.58
612670-1267011.23011.38
45min114203-1420312.58812.561.7912.8012.781.79
213931-1393112.34712.55
313943-1394312.35812.57
414513-1451312.86313.09
514008-1400812.41612.64
614425-1442512.78513.00
60min115071-1507113.35813.360.9413.6413.640.98
215089-1508913.37413.64
314947-1494713.24813.52
415301-1530113.56213.86
515115-1511513.39713.69
614901-1490113.20713.49
极限115343-1534313.59913.462.7613.9613.812.69
215459-1545913.70214.04
314682-1468213.01313.36
414809-1480913.12613.49
515021-1502113.31313.68
615782-1578213.98814.35
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%
110.531069591068871068521068481068091068710.06
210.551074041072321073180.12
单位质量响应值RSD%判断
10149.1910172.320.17数据可信
中间条件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%
5min11970-19701.7402.6129.681.742.6129.67
23035-30352.6802.68
33878-38783.4253.42
42120-21201.8721.87
54068-40683.5923.59
62665-26652.3532.35
10min16869-68696.0665.6214.416.085.6414.41
26080-60805.3695.38
37360-73606.5006.52
44854-48544.2874.30
57046-70466.2226.24
65998-59985.2975.31
15min18806-88067.7777.8510.337.827.9010.38
28504-85047.5107.55
310044-100448.8708.93
47435-74356.5666.60
59667-96678.5378.59
68876-88767.8387.88
20min110725-107259.4719.486.159.569.576.19
210411-104119.1949.28
311630-1163010.27110.37
49681-96818.5498.62
511108-111089.8109.91
610864-108649.5949.68
30min112449-1244910.99411.183.1311.1311.323.23
212534-1253411.06911.21
313333-1333311.77411.94
412216-1221610.78810.91
512901-1290111.39311.55
612539-1253911.07311.21
45min114031-1403112.39112.334.1612.5912.544.19
214074-1407412.42912.63
314309-1430912.63612.86
412816-1281611.31811.50
514186-1418612.52812.75
614387-1438712.70512.91
60min114569-1456912.86613.071.7313.1413.341.79
214834-1483413.10013.37
315281-1528113.49513.79
414623-1462312.91413.15
514729-1472913.00713.30
614734-1473413.01213.28
极限115321-1532113.53013.512.6213.8713.862.63
215202-1520213.42513.77
315981-1598114.11314.48
415120-1512013.35313.67
515425-1542513.62213.98
614769-1476913.04313.39
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%
110.531069741068861068341066751066961068130.12
210.551082311081691082000.05
单位质量响应值RSD%判断
10143.6810255.920.78数据可信
中间条件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%
5min12697-26972.3733.3518.832.373.3518.85
23662-36623.2223.22
34582-45824.0314.03
43375-33752.9692.97
54502-45023.9613.96
64011-40113.5293.53
10min16160-61605.4195.6513.155.435.6713.09
26621-66215.8255.84
37489-74896.5886.61
46180-61805.4375.45
55052-50524.4444.47
67041-70416.1946.21
15min18835-88357.7737.779.387.827.829.40
29188-91888.0838.13
39806-98068.6278.69
48571-85717.5407.59
57375-73756.4886.53
69238-92388.1278.18
20min110483-104839.2229.306.959.319.406.98
210835-108359.5329.63
311448-1144810.07110.18
410405-104059.1549.24
59284-92848.1688.25
610983-109839.6629.76
30min112591-1259111.07711.134.3011.2111.274.34
212514-1251411.00911.16
313024-1302411.45811.62
412904-1290411.35211.49
511665-1166510.26210.39
613180-1318011.59511.75
45min114288-1428812.57012.512.6612.7712.722.71
214239-1423912.52712.74
314347-1434712.62212.85
414304-1430412.58412.79
513509-1350911.88512.07
614643-1464312.88213.10
60min115163-1516313.34013.262.6913.6113.542.71
215533-1553313.66513.94
315261-1526113.42613.72
415024-1502413.21713.49
514329-1432912.60612.86
615156-1515613.33313.62
极限115408-1540813.55513.570.5613.9013.920.60
215299-1529913.45913.81
315523-1552313.65614.03
415384-1538413.53413.88
515456-1545613.59713.92
615514-1551413.64814.01
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%
110.531066541066741066601066491066051066480.03
210.551076121075971076040.01
单位质量响应值RSD%判断
10128.0210199.430.50数据可信
中间条件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%
5min13524-35243.1113.3910.633.113.4010.60
24089-40893.6103.61
33258-32582.8762.88
43836-38363.3873.39
53955-39553.4923.49
64406-44063.8903.89
10min17404-74046.5376.694.076.556.704.08
27613-76136.7216.74
37538-75386.6556.67
47574-75746.6876.71
57198-71986.3556.37
68123-81237.1717.19
15min19713-97138.5758.893.248.638.953.24
210059-100598.8818.94
310159-101598.9699.02
410062-100628.8838.94
59788-97888.6418.70
610633-106339.3879.45
20min111448-1144810.10710.373.0710.2110.483.09
211654-1165410.28910.40
312090-1209010.67410.78
411591-1159110.23310.34
511395-1139510.06010.16
612281-1228110.84210.96
30min113150-1315011.61012.052.1511.7712.222.15
213568-1356811.97912.14
314028-1402812.38512.55
413719-1371912.11212.27
513649-1364912.05012.21
613811-1381112.19312.37
45min114965-1496513.21213.251.4113.4313.481.38
214811-1481113.07613.31
315248-1524813.46213.69
414732-1473213.00613.24
515100-1510013.33113.56
615203-1520313.42213.66
60min115064-1506413.29913.832.4913.5914.142.46
215836-1583613.98114.28
315916-1591614.05214.36
416172-1617214.27814.58
515515-1551513.69814.00
615510-1551013.69314.01
极限115828-1582813.97413.901.6414.3414.281.63
215815-1581513.96214.34
315679-1567913.84214.23
415561-1556113.73814.12
515410-1541013.60513.98
616157-1615714.26414.66
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