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%
1 15.907573075505754007540675582755250.19
2 15.987502574971749980.06
单位质量响应值RSD%判断
4750.004693.240.86数据可信
供试品溶液-2025022821批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11753-17532.0841.907.622.081.907.59
21481-14811.7611.76
31428-14281.6981.70
41620-16201.9261.93
51678-16781.9952.00
61625-16251.9321.93
20min12581-25813.0692.888.423.072.898.39
22585-25853.0743.08
32430-24302.8892.89
42267-22672.6952.70
52099-20992.4962.50
62590-25903.0793.08
30min13379-33794.0183.906.304.033.916.34
23414-34144.0594.07
33417-34174.0634.07
43428-34284.0764.08
52932-29323.4863.49
63125-31253.7163.72
45min13697-36974.3964.547.764.414.557.73
23995-39954.7504.76
33751-37514.4604.47
44300-43005.1135.13
53735-37354.4414.45
63432-34324.0814.10
60min14301-43015.1144.897.795.144.917.79
24106-41064.8824.90
34411-44115.2455.27
43516-35164.1804.20
54281-42815.0905.11
64062-40624.8304.85
120min14508-45085.3605.318.635.395.348.61
24266-42665.0725.10
34965-49655.9035.93
43873-38734.6054.63
54402-44025.2345.26
64775-47755.6775.71
240min15038-50385.9905.4610.116.035.5010.07
24503-45035.3545.39
34729-47295.6235.66
43713-37134.4154.45
54800-48005.7075.75
64782-47825.6865.72
极限14654-46545.5345.5510.245.585.6010.18
24749-47495.6475.69
35377-53776.3936.44
44813-48135.7235.77
53900-39004.6374.68
64522-45225.3775.42
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%
1 15.907583875595757327571575597756950.14
2 15.987594375677758100.25
单位质量响应值RSD%判断
4760.694744.060.25数据可信
供试品溶液-2025022821批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11183-11831.3971.2450.881.401.2450.84
21049-10491.2391.24
3-0.0000.00
41230-12301.4531.45
51443-14431.7051.70
61397-13971.6501.65
20min12363-23632.7912.7310.452.792.7310.37
22061-20612.4352.44
31971-19712.3282.33
42550-25503.0123.01
52405-24052.8412.84
62523-25232.9802.98
30min13041-30413.5923.7610.533.603.7710.49
22882-28823.4043.41
33081-30813.6393.64
43748-37484.4274.43
52927-29273.4583.47
63418-34184.0384.05
45min13764-37644.4464.495.334.464.515.34
23801-38014.4904.50
33636-36364.2954.30
43660-36604.3234.34
53774-37744.4584.47
64196-41964.9574.97
60min14560-45605.3874.995.915.415.015.90
24226-42264.9925.01
34410-44105.2095.23
44129-41294.8774.90
53835-38354.5304.55
64173-41734.9294.95
120min14083-40834.8235.347.414.855.367.36
24651-46515.4945.52
34191-41914.9514.98
44997-49975.9035.93
54543-45435.3665.39
64640-46405.4815.51
240min13885-38854.5895.129.534.635.169.45
24764-47645.6285.66
33822-38224.5154.55
44621-46215.4595.50
54252-42525.0235.06
64672-46725.5195.56
极限14426-44265.2285.294.455.275.344.44
24562-45625.3895.44
34528-45285.3495.39
44772-47725.6375.69
54167-41674.9224.97
64425-44255.2275.28
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%
1 15.907528975179754037527075054752390.18
2 15.987630476388763460.08
单位质量响应值RSD%判断
4732.014777.600.68数据可信
供试品溶液-2025030121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11126-11261.3291.2353.351.331.2353.37
2-0.0000.00
31125-11251.3281.33
41037-10371.2241.22
51652-16521.9501.95
61319-13191.5571.56
20min11859-18592.1952.8215.492.202.8215.40
22412-24122.8482.85
32477-24772.9252.93
42814-28143.3223.32
52709-27093.1983.20
62055-20552.4262.43
30min13318-33183.9173.875.893.923.885.90
23356-33563.9623.97
33195-31953.7723.78
43601-36014.2524.26
53092-30923.6513.66
63098-30983.6583.66
45min13979-39794.6984.2316.144.714.2416.16
23741-37414.4174.43
33841-38414.5354.55
44041-40414.7714.79
53386-33863.9984.01
62500-25002.9522.96
60min14058-40584.7914.928.514.814.948.55
24325-43255.1065.13
33952-39524.6664.69
44475-44755.2845.31
54571-45715.3975.42
63631-36314.2874.30
120min14353-43535.1395.212.715.175.242.67
24638-46385.4765.50
34294-42945.0705.10
44450-44505.2545.29
54378-43785.1695.20
64387-43875.1805.20
240min14152-41524.9025.218.024.945.257.91
24763-47635.6245.66
34935-49355.8275.86
44106-41064.8484.89
54159-41594.9104.95
64360-43605.1485.18
极限14580-45805.4075.403.625.455.453.62
24421-44215.2205.27
34870-48705.7505.80
44619-46195.4545.50
54555-45555.3785.43
64420-44205.2195.26
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%
1 15.907676776364768127654076924766810.30
2 15.987561075550755800.06
单位质量响应值RSD%判断
4822.704729.661.38数据可信
供试品溶液-2025030121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11787-17872.1011.1381.132.101.1281.16
21192-11921.4011.40
3-0.0000.00
41185-11851.3931.39
51580-15801.8571.86
6-0.0000.00
20min12792-27923.2822.6413.953.292.6514.01
22118-21182.4902.49
31911-19112.2462.25
42023-20232.3782.38
52282-22822.6822.69
62364-23642.7792.78
30min13799-37994.4663.7511.184.473.7611.16
22931-29313.4453.45
32806-28063.2983.30
43382-33823.9753.98
53174-31743.7313.74
63074-30743.6133.62
45min14134-41344.8594.377.814.884.387.83
23729-37294.3834.40
33540-35404.1614.17
43915-39154.6024.61
53298-32983.8773.89
63688-36884.3354.35
60min14097-40974.8164.782.124.844.802.11
24138-41384.8644.88
33989-39894.6894.71
44110-41104.8314.85
53925-39254.6144.63
64123-41234.8464.86
120min14789-47895.6295.156.245.665.186.22
24405-44055.1785.21
34002-40024.7044.73
44177-41774.9104.94
54381-43815.1505.18
64523-45235.3175.34
240min14789-47895.6295.249.015.675.278.95
24072-40724.7874.82
34562-45625.3635.39
44268-42685.0175.05
54024-40244.7304.77
65017-50175.8975.93
极限14692-46925.5155.582.995.575.632.98
24802-48025.6455.69
34540-45405.3375.38
44935-49355.8015.85
54676-46765.4975.54
64854-48545.7065.75
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