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 15.903759737703375343771637594376290.21
2 15.983777237820377960.09
单位质量响应值RSD%判断
2366.602365.210.05数据可信
供试品溶液-2025030321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
15min1-0.0000.47244.950.000.47244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
51179-11792.7972.80
6-0.0000.00
20min11821-18214.3214.4013.654.324.4013.62
21985-19854.7104.71
31738-17384.1244.12
41688-16884.0054.01
51598-15983.7923.80
62296-22965.4485.45
30min12569-25696.0966.208.956.106.218.96
22490-24905.9085.92
32455-24555.8255.83
42701-27016.4096.42
52422-24225.7475.76
63046-30467.2277.24
45min13144-31447.4607.596.487.487.616.45
23055-30557.2497.27
32912-29126.9106.93
43420-34208.1158.13
53212-32127.6217.64
63443-34438.1698.19
60min13217-32177.6338.326.527.668.346.51
23420-34208.1158.14
33383-33838.0278.06
43532-35328.3818.41
53586-35868.5098.54
63890-38909.2309.26
120min13765-37658.9338.747.528.988.787.50
23820-38209.0649.11
33672-36728.7138.75
43159-31597.4967.54
53707-37078.7968.84
63970-39709.4209.47
240min14410-441010.4649.526.4210.529.586.37
23905-39059.2669.32
33856-38569.1499.21
44166-41669.8859.94
53679-36798.7298.79
64064-40649.6439.71
极限14062-40629.6389.625.669.719.705.60
23835-38359.1009.17
34296-429610.19310.26
44285-428510.16710.24
53739-37398.8728.95
64118-41189.7719.85
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 15.903764337509376413756037584375870.16
2 15.983748937498374940.02
单位质量响应值RSD%判断
2363.962346.310.53数据可信
供试品溶液-2025030321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
15min11107-11072.6391.7878.272.641.7878.27
2-0.0000.00
3-0.0000.00
41069-10692.5482.55
51037-10372.4722.47
61280-12803.0513.05
20min11863-18634.4414.5810.664.454.5810.66
21690-16904.0284.03
31681-16814.0074.01
42080-20804.9584.96
52105-21055.0185.02
62111-21115.0325.04
30min12619-26196.2435.998.686.256.008.68
22515-25155.9956.00
32428-24285.7885.79
42607-26076.2146.23
52135-21355.0895.10
62773-27736.6106.62
45min13221-32217.6787.4311.987.707.4512.01
22793-27936.6586.67
32535-25356.0436.06
43260-32607.7717.79
53509-35098.3648.39
63378-33788.0528.08
60min13541-35418.4418.199.618.488.229.61
23376-33768.0478.08
33342-33427.9667.99
43768-37688.9829.02
52860-28606.8176.85
63716-37168.8588.90
120min14014-40149.5688.8810.259.628.9310.22
24009-40099.5569.60
33029-30297.2207.26
43547-35478.4558.51
53856-38569.1919.24
63900-39009.2969.35
240min14262-426210.1598.7221.2810.228.7821.16
23953-39539.4239.48
32331-23315.5565.61
43116-31167.4277.49
53994-39949.5209.58
64298-429810.24510.31
极限13935-39359.3809.724.999.469.795.01
24045-40459.6429.71
33804-38049.0679.13
44312-431210.27810.36
54312-431210.27810.36
64052-40529.6599.74
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 15.903797637983379143797937906379520.11
2 15.983815338342382480.35
单位质量响应值RSD%判断
2386.922393.490.20数据可信
供试品溶液-2025030421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
15min11014-10142.3821.20109.562.381.20109.56
2-0.0000.00
31038-10382.4382.44
41021-10212.3982.40
5-0.0000.00
6-0.0000.00
20min12036-20364.7824.4612.644.794.4612.67
22112-21124.9604.96
31685-16853.9573.96
42185-21855.1325.14
51630-16303.8283.83
61746-17464.1014.10
30min12298-22985.3975.916.565.415.926.51
22746-27466.4496.46
32461-24615.7805.79
42429-24295.7055.72
52493-24935.8555.86
62673-26736.2786.28
45min13264-32647.6667.234.907.697.254.89
22864-28646.7276.75
33234-32347.5967.62
42987-29877.0157.04
53061-30617.1897.21
63063-30637.1947.21
60min13926-39269.2218.137.909.258.167.87
23505-35058.2328.26
33287-32877.7207.75
43385-33857.9507.98
53126-31267.3427.37
63547-35478.3318.36
120min13951-39519.2808.606.489.338.656.46
23534-35348.3008.34
33835-38359.0079.05
43314-33147.7837.83
53550-35508.3388.38
63795-37958.9138.96
240min14072-40729.5649.027.839.639.087.81
23698-36988.6858.74
34151-41519.7499.81
43899-38999.1579.22
53318-33187.7937.85
63916-39169.1979.26
极限13725-37258.7499.456.458.839.536.37
23990-39909.3719.44
34247-42479.97510.05
43773-37738.8618.94
54028-40289.4609.53
64389-438910.30810.38
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 15.903785137751379003782637577377810.34
2 15.983787837994379360.22
单位质量响应值RSD%判断
2376.162373.970.07数据可信
供试品溶液-2025030421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
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min11846-18464.3634.018.094.364.018.07
21523-15233.6003.60
31756-17564.1514.15
41601-16013.7843.78
51842-18424.3544.35
61609-16093.8033.80
30min12346-23465.5455.632.805.555.642.79
22395-23955.6615.67
32333-23335.5145.52
42498-24985.9045.91
52319-23195.4815.49
62412-24125.7015.71
45min13253-32537.6897.187.367.717.197.38
22841-28416.7156.73
32761-27616.5266.54
42955-29556.9847.00
53088-30887.2997.32
63317-33177.8407.86
60min13763-37638.8947.9210.078.927.9410.01
23718-37188.7888.81
33199-31997.5617.59
43168-31687.4887.52
53351-33517.9207.95
62896-28966.8456.87
120min13503-35038.2808.655.418.328.695.39
23923-39239.2729.31
33420-34208.0848.12
43792-37928.9639.00
53548-35488.3868.43
63781-37818.9378.98
240min13755-37558.8759.114.958.939.164.93
24007-40079.4719.53
33578-35788.4578.51
44066-40669.6109.67
53740-37408.8408.90
63972-39729.3889.44
极限13899-38999.2169.277.599.299.347.54
23819-38199.0279.10
33999-39999.4529.52
44331-433110.23710.31
53432-34328.1128.18
64055-40559.5849.66
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