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%
115.219548895503953849539095576954680.09
215.209520995174951920.03
单位质量响应值RSD%判断
6276.666262.630.16数据可信
供试品溶液-24092901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%
5min148523-4852350.17147.464.9750.1747.454.97
244702-4470246.22046.22
344465-4446545.97545.97
10min176536-7653679.13578.922.0279.2279.002.01
274693-7469377.22977.31
377747-7774780.38780.46
15min165104-6510467.31464.813.5867.5365.023.57
262239-6223964.35264.56
360690-6069062.75162.96
20min184364-8436487.22888.331.6987.5688.651.68
284860-8486087.74188.05
387069-8706990.02590.34
30min170613-7061373.01171.052.6373.4871.522.61
268519-6851970.84571.30
367027-6702769.30369.77
45min186648-8664889.59091.041.6690.1891.621.65
287937-8793790.92391.50
389558-8955892.59993.18
极限172979-7297975.45773.582.3076.2074.312.29
270684-7068473.08473.81
369815-6981572.18572.92
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%
111.763612943610993604993609093618023611210.14
211.703615103610193612640.10
单位质量响应值RSD%判断
30707.5730877.260.39数据可信
供试品溶液-24092901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%
5min1204823-20482354.94453.891.7054.9453.891.69
2199186-19918653.43253.43
3198718-19871853.30653.31
10min1144159-14415938.67136.256.0338.7636.346.01
2128340-12834034.42734.52
3132899-13289935.65035.74
15min1251293-25129367.40966.021.8467.5766.171.85
2244009-24400965.45565.60
3243041-24304165.19665.34
20min1217789-21778958.42257.002.4358.6957.262.43
2207505-20750555.66355.92
3212157-21215756.91157.17
30min1264914-26491471.06369.711.7171.4370.071.71
2258071-25807169.22869.58
3256626-25662668.84069.19
45min1254301-25430168.21667.241.6468.7067.711.64
2246242-24624266.05466.52
3251441-25144167.44967.92
极限1269971-26997172.42071.091.6473.0271.671.65
2263189-26318970.60071.17
3261884-26188470.25070.83
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%
115.219588096021959659609796184960290.13
215.209588595829958570.05
单位质量响应值RSD%判断
6313.546306.380.09数据可信
供试品溶液-24092901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%
5min134448-3444835.39038.416.9335.3938.416.93
238374-3837439.42339.42
339339-3933940.41540.41
10min176907-7690779.01078.530.5479.0778.600.53
276150-7615078.23278.30
376271-7627178.35778.42
15min154403-5440355.89158.654.2056.0858.854.19
257888-5788859.47159.67
358985-5898560.59860.80
20min189131-8913191.56888.333.6791.8588.623.64
285976-8597688.32788.62
382836-8283685.10185.40
30min161918-6191863.61166.264.0464.0566.714.02
264460-6446066.22366.67
367122-6712268.95769.40
45min192403-9240394.93092.182.8295.4792.732.80
289397-8939791.84292.39
387377-8737789.76690.32
极限166564-6656468.38470.723.0869.0871.423.05
269199-6919971.09171.80
370744-7074472.67973.38
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%
111.763636793638953636183642303645123639870.11
211.703639593638703639140.02
单位质量响应值RSD%判断
30951.2831103.760.35数据可信
供试品溶液-24092901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%
5min1202032-20203253.78456.774.7253.7856.774.72
2216262-21626257.57357.57
3221451-22145158.95458.95
10min1128206-12820634.13136.757.3234.2236.847.31
2137507-13750736.60736.70
3148386-14838639.50339.60
15min1262358-26235869.84470.891.5269.9971.041.53
2266071-26607170.83370.99
3270392-27039271.98372.15
20min1215015-21501557.24157.650.8957.5057.930.91
2215971-21597157.49557.77
3218725-21872558.22858.51
30min1280668-28066874.71975.681.6475.0876.051.65
2282640-28264075.24475.61
3289533-28953377.07977.46
45min1258734-25873468.87969.330.5869.3669.830.59
2261026-26102669.49069.99
3261516-26151669.62070.13
极限1288720-28872076.86277.721.7977.4678.331.79
2289156-28915676.97877.59
3297935-29793579.31579.94
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