依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.391794041796791795311795201796351795540.06
210.431839651843621841640.16
单位质量响应值RSD%判断
17281.4217657.141.53数据可信
供试品溶液-25012201批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17232-72323.7173.8016.143.723.8016.21
27020-70203.6083.61
38382-83824.3084.31
49175-91754.7164.72
55922-59223.0443.04
66601-66013.3933.39
10min114561-145617.4847.633.447.507.653.48
215000-150007.7097.73
315212-152127.8187.84
415541-155417.9878.01
514097-140977.2457.26
614701-147017.5567.57
15min115062-150627.7417.992.147.808.052.13
216008-160088.2278.29
315479-154797.9568.02
415482-154827.9578.03
515815-158158.1288.19
615402-154027.9167.98
20min115290-152907.8587.881.677.967.981.63
215790-157908.1158.22
315033-150337.7267.84
415378-153787.9048.02
515195-151957.8107.91
615282-152827.8547.96
30min114813-148137.6137.741.557.767.891.55
215464-154647.9488.10
314901-149017.6597.81
415173-151737.7987.96
514972-149727.6957.84
615062-150627.7417.89
45min114274-142747.3367.753.737.537.943.67
215862-158628.1528.35
315154-151547.7897.99
415316-153167.8728.07
514603-146037.5057.69
615232-152327.8298.02
60min114540-145407.4737.613.317.707.843.31
215437-154377.9348.18
314852-148527.6337.87
415121-151217.7728.02
514014-140147.2037.43
614821-148217.6177.85
极限114657-146577.5337.713.877.817.993.80
215765-157658.1038.39
315198-151987.8118.09
415350-153507.8898.18
514098-140987.2467.52
614970-149707.6947.97
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.391799311798291799621799671796131798600.09
210.431817241820541818890.13
单位质量响应值RSD%判断
17310.8817439.020.53数据可信
供试品溶液-25012202批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18856-88564.5764.276.364.584.286.39
28546-85464.4164.42
38352-83524.3154.32
47565-75653.9093.91
57689-76893.9733.97
68616-86164.4524.45
10min115527-155278.0237.872.868.057.902.88
215149-151497.8277.85
315258-152587.8847.91
414417-144177.4497.47
515607-156078.0648.09
615451-154517.9848.01
15min115794-157948.1618.281.328.238.341.31
216285-162858.4148.48
315907-159078.2198.29
415813-158138.1718.23
516203-162038.3728.44
616133-161338.3368.40
20min115326-153267.9198.282.738.038.392.72
216268-162688.4068.52
315739-157398.1328.25
415943-159438.2388.35
516340-163408.4438.56
616491-164918.5218.64
30min115311-153117.9118.112.498.078.272.48
215916-159168.2248.39
315300-153007.9058.06
415655-156558.0898.24
515633-156338.0788.24
616326-163268.4368.60
45min115259-152597.8848.142.608.098.342.54
215654-156548.0888.30
315485-154858.0018.20
415779-157798.1538.35
515855-158558.1928.40
616460-164608.5058.71
60min116013-160138.2747.942.538.528.192.45
215606-156068.0648.32
314906-149067.7027.95
415180-151807.8438.09
515223-152237.8668.12
615276-152767.8938.15
极限115614-156148.0688.011.688.368.301.69
215695-156958.1108.41
315239-152397.8748.16
415104-151047.8048.09
515609-156098.0658.36
615721-157218.1238.42
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