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%
115.159687295904964799600096035962580.43
215.399679396826968100.03
单位质量响应值RSD%判断
6353.666290.450.71数据可信
供试品溶液-24061204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%
5min152705-5270554.04443.5620.9254.0443.5620.91
236632-3663237.56337.56
338110-3811039.07839.08
10min132523-3252333.34929.3012.4533.4429.3712.47
225636-2563626.28726.35
327551-2755128.25128.32
15min178367-7836780.35870.9711.9280.5071.0911.93
262352-6235263.93664.04
366928-6692868.62868.74
20min156708-5670858.14958.591.6258.4358.831.58
258199-5819959.67859.89
356504-5650457.94058.17
30min182584-8258484.68277.808.9085.0678.148.90
269093-6909370.84871.16
375945-7594577.87478.20
45min165382-6538267.04366.181.5867.5666.651.60
264819-6481966.46666.90
363413-6341365.02465.48
极限188128-8812890.36783.298.7991.0083.878.78
273881-7388175.75876.30
381679-8167983.75484.32
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%
111.553630453616373621293621723618053621580.16
211.80 3675553672123673840.07
单位质量响应值RSD%判断
31355.6731134.240.51数据可信
供试品溶液-24061204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%
5min1249852-24985266.05256.3015.6866.0556.3015.68
2184780-18478048.85048.85
3204293-20429354.00854.01
10min1207731-20773154.91751.247.6255.0351.347.63
2178347-17834747.14947.23
3195428-19542851.66551.75
15min1312885-31288582.71675.969.8782.9276.149.88
2256832-25683267.89868.06
3292300-29230077.27477.45
20min1271868-27186871.87369.952.7472.2170.252.77
2257412-25741268.05168.32
3264510-26451069.92770.23
30min1339031-33903189.62884.459.0490.0984.879.04
2286292-28629275.68676.07
3332979-33297988.02888.45
45min1297872-29787278.74777.291.7479.3677.851.79
2287908-28790876.11376.63
3291272-29127277.00277.57
极限1352163-35216393.10088.809.3793.8489.499.34
2299651-29965179.21879.86
3355870-35587094.08094.78
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%
115.159802098025982019778497773979610.19
215.399953299264993980.20
单位质量响应值RSD%判断
6466.076458.610.09数据可信
供试品溶液-24061204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%
5min146824-4682446.97036.3739.6546.9736.3739.65
242056-4205642.18742.19
319890-1989019.95219.95
10min178809-7880979.05564.1126.4979.1364.1726.50
267414-6741467.62467.69
345508-4550845.65045.68
15min186045-8604586.31471.1423.8486.5271.3123.85
274039-7403974.27074.45
352679-5267952.84352.95
20min190417-9041790.69975.0722.0791.0575.3522.09
276553-7655376.79277.10
357528-5752857.70857.90
30min192759-9275993.04978.6619.5093.5579.0719.53
280147-8014780.39780.83
362337-6233762.53262.83
45min193209-9320993.50080.6517.1194.1681.1917.17
282135-8213582.39182.96
365861-6586166.06766.46
极限193131-9313193.42289.943.6194.2490.613.75
289089-8908989.36790.07
386745-8674587.01687.52
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%
111.553705723702863702383684993685813696350.28
211.80 3757973759733758850.04
单位质量响应值RSD%判断
32003.0331854.660.33数据可信
供试品溶液-24061204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%
5min1235446-23544660.91050.3630.1460.9150.3630.14
2221139-22113957.20957.21
3127432-12743232.96732.97
10min1326065-32606584.35470.4324.9284.4670.5224.92
2294646-29464676.22576.32
3196073-19607350.72450.78
15min1359504-35950493.00478.7521.3593.2578.9621.37
2320999-32099983.04383.27
3232744-23274460.21160.35
20min1373275-37327596.56782.1920.3096.9682.5320.32
2332883-33288386.11786.48
3246988-24698863.89664.14
30min1381043-38104398.57685.2117.9799.1385.6817.99
2342269-34226988.54689.05
3264843-26484368.51568.86
45min1382913-38291399.06087.2015.6699.7887.8215.70
2348953-34895390.27590.93
3279390-27939072.27972.74
极限1388513-388513100.509100.641.49101.40101.401.58
2395033-395033102.196103.00
3383542-38354299.22399.80
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