坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987487175040752847546975575752480.39
216.077624876183762160.07
单位质量响应值RSD%判断
4708.894742.750.51数据可信
供试品溶液-24122001批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11656-16561.9671.997.981.971.987.89
21621-16211.9261.93
31492-14921.7721.77
41608-16081.9101.91
51797-17972.1352.13
61855-18552.2042.20
10min12324-23242.7613.0612.032.763.0612.06
22633-26333.1283.13
32577-25773.0613.06
42977-29773.5363.54
52129-21292.5292.53
62803-28033.3303.33
15min14574-45745.4335.397.885.445.407.87
24350-43505.1675.18
34719-47195.6065.61
44875-48755.7915.80
53910-39104.6454.65
64785-47855.6845.69
20min16386-63867.5867.775.597.607.785.57
26585-65857.8227.84
36698-66987.9577.97
46922-69228.2238.24
55887-58876.9937.01
66746-67468.0148.03
30min19521-952111.31011.454.8011.3411.484.78
29617-961711.42411.45
310033-1003311.91811.95
410085-1008511.98012.01
58813-881310.46910.50
69767-976711.60211.63
45min112975-1297515.41315.353.9715.4615.403.96
212144-1214414.42614.48
313197-1319715.67715.73
413465-1346515.99516.05
512460-1246014.80114.85
613266-1326615.75915.81
60min115329-1532918.20918.491.4718.2818.571.48
215569-1556918.49418.57
315765-1576518.72718.80
415700-1570018.65018.73
515256-1525618.12318.19
615788-1578818.75518.83
极限117413-1741320.68520.771.2120.7920.881.22
217492-1749220.77920.88
317420-1742020.69320.80
417743-1774321.07721.19
517164-1716420.38920.49
617690-1769021.01421.12
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987649976414767097666376526765620.16
216.077676576653767090.11
单位质量响应值RSD%判断
4791.114773.430.27数据可信
供试品溶液-24122401批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11435-14351.6852.1121.681.682.1121.68
21761-17612.0672.07
31462-14621.7161.72
41624-16241.9061.91
52444-24442.8692.87
62052-20522.4092.41
10min12820-28203.3103.4712.643.313.4812.66
23055-30553.5863.59
32750-27503.2283.23
42546-25462.9892.99
53635-36354.2674.27
62953-29533.4663.47
15min14498-44985.2805.4711.595.295.4811.60
24608-46085.4095.42
34709-47095.5285.54
44076-40764.7854.79
55674-56746.6616.67
64417-44175.1855.19
20min16224-62247.3067.457.747.327.467.73
26569-65697.7117.73
36480-64807.6077.62
45851-58516.8686.88
57123-71238.3618.38
65824-58246.8376.86
30min19015-901510.58210.935.5810.6110.965.59
29526-952611.18211.21
39685-968511.36911.40
48700-870010.21310.24
510046-1004611.79311.83
68908-890810.45710.49
45min112236-1223614.36314.623.7914.4114.663.79
212541-1254114.72214.77
312888-1288815.12915.18
411964-1196414.04414.09
513091-1309115.36715.42
611987-1198714.07114.12
60min114752-1475217.31717.352.3617.3917.422.36
214709-1470917.26617.34
314968-1496817.57017.64
414293-1429316.77816.85
515333-1533317.99918.08
614636-1463617.18117.25
极限116339-1633919.18019.272.7619.2819.382.77
216606-1660619.49319.60
316901-1690119.84019.94
415780-1578018.52418.62
516854-1685419.78419.90
616031-1603118.81818.92
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987655076360765457651576471764880.11
216.077667776434765560.23
单位质量响应值RSD%判断
4786.484763.910.34数据可信
供试品溶液-24122002批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12391-23912.8112.5555.962.812.5655.95
22364-23642.7792.78
32235-22352.6272.63
42271-22712.6702.67
53777-37774.4404.44
6-0.0000.00
10min14161-41614.8924.8511.724.904.8611.73
23823-38234.4944.50
33862-38624.5404.54
43944-39444.6374.64
55083-50835.9765.98
63890-38904.5734.57
15min16505-65057.6477.397.457.667.407.46
26313-63137.4227.43
36061-60617.1257.14
46065-60657.1307.14
57057-70578.2968.31
65693-56936.6936.70
20min18346-83469.8129.726.039.849.756.06
28499-84999.99210.02
38039-80399.4519.47
47811-78119.1839.21
59118-911810.71910.75
67820-78209.1939.21
30min111214-1121413.18313.203.6713.2313.243.68
211334-1133413.32413.37
311139-1113913.09513.13
411021-1102112.95613.00
511946-1194614.04414.09
610712-1071212.59312.63
45min114453-1445316.99116.972.6117.0617.032.64
214709-1470917.29217.36
314421-1442116.95417.01
414164-1416416.65116.71
514953-1495317.57917.65
613896-1389616.33616.39
60min116652-1665219.57619.581.8019.6719.671.82
216710-1671019.64419.74
316780-1678019.72719.82
416682-1668219.61219.70
517003-1700319.98920.09
616100-1610018.92719.01
极限118259-1825921.46621.361.8121.5921.491.83
218385-1838521.61421.74
318345-1834521.56721.69
418147-1814721.33421.46
518374-1837421.60121.74
617527-1752720.60520.72
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987641376513764147635776450764290.08
216.077766777891777790.21
单位质量响应值RSD%判断
4782.794840.010.85数据可信
供试品溶液-24122402批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11004-10041.1711.0449.221.171.0449.23
2-0.0000.00
31122-11221.3091.31
41064-10641.2411.24
51038-10381.2111.21
61098-10981.2811.28
10min13087-30873.6023.804.303.603.804.29
23223-32233.7613.76
33271-32713.8173.82
43245-32453.7863.79
53186-31863.7173.72
63506-35064.0914.09
15min15539-55396.4636.421.846.476.431.83
25407-54076.3096.32
35532-55326.4556.46
45431-54316.3376.35
55425-54256.3306.34
65671-56716.6176.63
20min17335-73358.5588.782.448.588.802.45
27401-74018.6358.65
37669-76698.9488.97
47441-74418.6828.70
57507-75078.7598.78
67823-78239.1289.15
30min110510-1051012.26312.361.9612.3012.391.96
210413-1041312.15012.18
310665-1066512.44412.48
410379-1037912.11012.14
510643-1064312.41812.45
610943-1094312.76812.80
45min113580-1358015.84516.052.0215.9016.102.01
213578-1357815.84315.89
313993-1399316.32716.38
413416-1341615.65415.71
513846-1384616.15616.21
614130-1413016.48716.54
60min115886-1588618.53618.842.1918.6218.922.17
216168-1616818.86518.94
315901-1590118.55318.64
415819-1581918.45818.54
516345-1634519.07119.15
616736-1673619.52819.61
极限117498-1749820.41720.482.2620.5320.602.25
217391-1739120.29220.40
317416-1741620.32120.43
417028-1702819.86819.98
517821-1782120.79420.91
618175-1817521.20721.32
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