氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399624096751964709655696359964750.21
215.459682896922968750.07
单位质量响应值RSD%判断
6268.686270.230.02数据可信
供试品溶液-24081403批-氨氯地平-磷酸盐缓冲液（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%
5min121221-2122121.94237.1538.4321.9437.1538.43
237956-3795639.24639.25
348612-4861250.26450.26
10min143403-4340344.87841.666.7744.9141.726.70
238358-3835839.66239.73
339096-3909640.42540.51
15min154342-5434256.18965.7916.5656.3065.9216.55
261459-6145963.54863.68
375071-7507177.62277.77
20min169477-6947771.83868.224.6072.0468.464.54
264128-6412866.30766.54
364338-6433866.52466.80
30min169929-6992972.30578.0610.6972.6378.4110.68
271805-7180574.24574.59
384738-8473887.61888.01
45min180225-8022582.95178.954.5383.4079.434.48
273575-7357576.07576.55
375256-7525677.81378.35
极限175512-7551278.07883.408.1678.6684.018.16
278382-7838281.04681.64
388070-8807091.06391.73
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.333551503563653556043558023556073557060.13
211.303564313578053571180.28
单位质量响应值RSD%判断
31395.0631603.360.47数据可信
供试品溶液-24081403批-阿托伐他汀钙-磷酸盐缓冲液（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%
5min1104755-10475527.47046.6639.2327.4746.6639.23
2185261-18526148.58148.58
3243748-24374863.91863.92
10min1197075-19707551.67949.145.0051.7349.224.96
2178405-17840546.78346.86
3186715-18671548.96349.07
15min1250482-25048265.68475.1515.6565.8275.3015.65
2272450-27245071.44571.60
3336750-33675088.30788.49
20min1283610-28361074.37269.686.3774.6169.976.31
2249963-24996365.54865.83
3263634-26363469.13369.47
30min1302600-30260079.35185.0310.2779.7285.4310.27
2307596-30759680.66181.05
3362583-36258395.08195.53
45min1312413-31241381.92576.826.5782.4277.376.50
2273984-27398471.84772.37
3292484-29248476.69977.31
极限1323814-32381484.91489.738.0685.5590.408.06
2328879-32887986.24286.88
3373892-37389298.04698.78
氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399652196665963279615396184963700.23
215.459723797254972460.02
单位质量响应值RSD%判断
6261.866294.240.37数据可信
供试品溶液-24081403批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146844-4684448.37047.222.5048.3747.222.49
245768-4576847.25947.26
344567-4456746.01946.02
10min150627-5062752.27646.4310.9952.3646.5010.99
242705-4270544.09644.17
341551-4155142.90542.98
15min168068-6806870.28567.194.3670.4567.354.36
262431-6243164.46564.62
364717-6471766.82566.97
20min175613-7561378.07674.084.8278.3674.354.82
270656-7065672.95873.22
368970-6897071.21771.48
30min176969-7696979.47675.944.0479.8976.334.05
271976-7197674.32174.70
371684-7168474.01974.40
45min185621-8562188.41085.013.5188.9685.533.52
281115-8111583.75784.26
380240-8024082.85483.36
极限180459-8045983.08080.123.2383.7780.783.23
275850-7585078.32178.97
376470-7647078.96179.60
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.333592633556453547693551763552283560160.52
211.303576333574323575320.04
单位质量响应值RSD%判断
31422.4231640.000.49数据可信
供试品溶液-24081403批-阿托伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1196354-19635451.43847.507.3151.4447.507.31
2171347-17134744.88744.89
3176286-17628646.18146.18
10min1232144-23214460.81454.729.6560.9054.809.65
2197102-19710251.63451.71
3197412-19741251.71551.79
15min1268505-26850570.33964.737.7670.5364.907.77
2231549-23154960.65860.82
3241201-24120163.18663.35
20min1317163-31716383.08678.685.0183.3978.965.02
2295760-29576077.47977.74
3288159-28815975.48875.76
30min1295176-29517677.32671.427.2377.7771.837.22
2258882-25888267.81868.21
3263816-26381669.11169.51
45min1345683-34568390.55787.203.3691.1387.733.38
2327747-32774785.85986.36
3325195-32519585.19085.70
极限1306676-30667680.33974.486.9281.0675.156.91
2269770-26977070.67171.32
3276440-27644072.41873.07
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