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%
115.907756077736778567751077488776300.21
215.987814878181781640.03
单位质量响应值RSD%判断
4882.394891.360.13数据可信
供试品溶液-2025030221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
15min11367-13671.5701.8014.581.571.8014.55
21228-12281.4111.41
31639-16391.8831.88
41575-15751.8091.81
51786-17862.0522.05
61795-17952.0622.06
20min12659-26593.0553.035.323.063.035.35
22517-25172.8912.89
32711-27113.1143.12
42823-28233.2433.25
52669-26693.0663.07
62432-24322.7942.80
30min13417-34173.9254.064.383.934.074.39
23298-32983.7893.80
33550-35504.0784.09
43733-37334.2884.30
53623-36234.1624.17
63586-35864.1194.13
45min14127-41274.7414.643.784.764.663.75
24175-41754.7964.81
33978-39784.5704.58
44159-41594.7784.79
53770-37704.3314.35
64043-40434.6444.66
60min14900-49005.6295.088.385.655.108.37
23824-38244.3934.41
34511-45115.1825.20
44204-42044.8294.85
54459-44595.1225.14
64628-46285.3165.34
120min14861-48615.5845.335.115.625.365.13
24575-45755.2555.28
34554-45545.2315.26
44281-42814.9184.95
54940-49405.6755.71
64608-46085.2935.32
240min14970-49705.7095.584.235.755.624.18
24711-47115.4125.45
34973-49735.7135.75
44905-49055.6355.67
55067-50675.8215.86
64515-45155.1875.23
极限15201-52015.9755.903.806.025.953.76
24877-48775.6025.65
34924-49245.6565.71
45155-51555.9225.97
55333-53336.1266.18
65321-53216.1126.16
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%
115.907775777723776367749877722776670.14
215.987760277588775950.02
单位质量响应值RSD%判断
4884.724855.760.43数据可信
供试品溶液-2025030221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
15min11502-15021.7311.858.321.731.858.33
21673-16731.9281.93
31560-15601.7981.80
41841-18412.1222.12
51487-14871.7141.71
61561-15611.7991.80
20min12764-27643.1862.8114.883.192.8214.92
22467-24672.8442.85
32600-26002.9973.00
42806-28063.2343.24
51958-19582.2572.26
62039-20392.3502.35
30min13616-36164.1683.8711.314.183.8811.31
22969-29693.4223.43
33409-34093.9293.94
43835-38354.4214.43
53468-34683.9974.00
62848-28483.2833.29
45min13668-36684.2284.537.754.244.557.70
23932-39324.5324.55
34412-44125.0865.10
43704-37044.2704.29
54170-41704.8074.82
63699-36994.2644.28
60min14333-43334.9954.873.125.024.893.09
24093-40934.7184.74
34416-44165.0905.11
44169-41694.8064.83
54223-42234.8684.89
64091-40914.7164.74
120min14738-47385.4615.385.345.495.415.35
24961-49615.7185.75
34823-48235.5595.59
44752-47525.4785.51
54340-43405.0035.03
64383-43835.0525.08
240min15024-50245.7915.436.185.835.476.11
24993-49935.7555.79
34467-44675.1495.19
44667-46675.3805.42
54821-48215.5575.59
64296-42964.9524.99
极限14906-49065.6555.883.835.705.933.80
25223-52236.0206.07
35287-52876.0946.14
45074-50745.8495.90
55279-52796.0856.13
64835-48355.5735.62
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%
115.907828677950784297846178083782420.29
215.987832578604784640.26
单位质量响应值RSD%判断
4920.884910.140.16数据可信
供试品溶液-12412515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
15min1-0.0000.9677.790.000.9677.78
21298-12981.4821.48
31162-11621.3271.33
41246-12461.4231.42
5-0.0000.00
61342-13421.5331.53
20min12045-20452.3352.317.302.342.327.35
22219-22192.5342.54
32140-21402.4442.45
41938-19382.2132.22
51998-19982.2822.28
61803-18032.0592.06
30min12210-22102.5242.8211.972.532.8312.03
22649-26493.0253.03
32819-28193.2193.23
42074-20742.3692.37
52387-23872.7262.73
62700-27003.0843.09
45min13065-30653.5003.477.303.513.487.24
22919-29193.3343.35
32992-29923.4173.43
43408-34083.8923.90
53098-30983.5383.55
62741-27413.1303.14
60min13430-34303.9173.888.233.933.908.22
23331-33313.8043.82
32966-29663.3873.40
43682-36824.2054.22
53716-37164.2444.26
63268-32683.7323.75
120min13895-38954.4484.129.154.474.149.07
23643-36434.1604.18
33336-33363.8103.83
43718-37184.2464.27
53095-30953.5353.56
63941-39414.5014.52
240min14152-41524.7424.3910.534.774.4210.42
23922-39224.4794.51
33879-38794.4304.46
44275-42754.8824.91
53733-37334.2634.29
63123-31233.5673.60
极限14895-48955.5904.7610.815.634.8010.74
24169-41694.7614.80
34023-40234.5944.63
43523-35234.0234.06
54350-43504.9685.00
64047-40474.6224.66
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%
115.907783177396774597759277102774760.35
215.987822078243782320.03
单位质量响应值RSD%判断
4872.704895.620.34数据可信
供试品溶液-12412515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
15min11001-10011.1511.5415.511.151.5415.52
21375-13751.5801.58
31298-12981.4921.49
41531-15311.7601.76
51260-12601.4481.45
61575-15751.8101.81
20min11482-14821.7032.1815.471.712.1815.33
21839-18392.1142.12
31881-18812.1622.16
42226-22262.5592.56
52228-22282.5612.56
61710-17101.9651.97
30min12866-28663.2943.006.003.303.005.92
22661-26613.0593.06
32523-25232.9002.91
42562-25622.9452.95
52400-24002.7592.77
62634-26343.0273.03
45min12887-28873.3183.656.263.333.666.23
23310-33103.8043.82
33147-31473.6173.63
43439-34393.9533.96
53028-30283.4803.49
63236-32363.7193.73
60min13428-34283.9403.973.383.963.993.39
23661-36614.2084.23
33404-34043.9133.93
43460-34603.9774.00
53306-33063.8003.82
63445-34453.9603.98
120min13661-36614.2084.268.774.234.288.69
23489-34894.0104.03
33422-34223.9333.96
43451-34513.9673.99
54211-42114.8404.86
63984-39844.5794.60
240min14406-44065.0644.609.595.094.639.47
24018-40184.6184.65
34209-42094.8384.87
43442-34423.9563.99
54283-42834.9234.95
63634-36344.1774.21
极限13985-39854.5804.349.754.624.389.64
23980-39804.5754.61
33061-30613.5183.56
43708-37084.2624.30
54035-40354.6384.68
63864-38644.4414.48
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