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%
115.399671996682967299635496382965730.20
215.459749797250973740.18
单位质量响应值RSD%判断
6275.056302.520.31数据可信
供试品溶液-24092001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%
5min146315-4631547.74249.865.2547.7449.865.25
251207-5120752.78552.78
347596-4759649.06249.06
10min183232-8323285.79684.451.4385.8884.541.43
280971-8097183.46683.55
381582-8158284.09684.18
15min165380-6538067.39470.307.6067.6270.527.57
274171-7417176.45676.68
365038-6503867.04267.26
20min194780-9478097.70096.231.4098.0496.571.40
293058-9305895.92596.28
392228-9222895.07095.40
30min173147-7314775.40177.786.6875.9078.286.65
281234-8123483.73784.25
371991-7199174.20974.70
45min197609-97609100.61698.911.87101.2499.541.86
296200-9620099.16499.82
394059-9405996.95797.57
极限176819-7681979.18681.906.7979.9882.696.75
285653-8565388.29289.11
375878-7587878.21678.99
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%
111.333580253573173575823566643560323571240.22
211.303568113571703569900.08
单位质量响应值RSD%判断
31520.2131592.040.17数据可信
供试品溶液-24092001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%
5min1172172-17217245.06747.364.2045.0747.364.19
2185302-18530248.50448.50
3185318-18531848.50848.51
10min1148879-14887938.97039.153.2739.0539.233.27
2145064-14506437.97138.05
3154770-15477040.51240.59
15min1230635-23063560.37063.045.5560.5163.195.54
2255957-25595766.99867.14
3235943-23594361.76061.91
20min1237949-23794962.28562.511.3062.5362.761.30
2236207-23620761.82962.08
3242233-24223363.40663.66
30min1255696-25569666.93069.525.4467.2769.875.43
2282162-28216273.85874.22
3258905-25890567.77068.13
45min1279425-27942573.14173.370.5073.6073.840.50
2279565-27956573.17873.66
3281913-28191373.79274.26
极限1267006-26700669.89071.974.7570.4772.564.73
2290007-29000775.91176.52
3267814-26781470.10270.69
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%
115.399688996855967059678296431967320.19
215.459666796603966350.05
单位质量响应值RSD%判断
6285.386254.690.35数据可信
供试品溶液-24092001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%
5min148901-4890150.55848.748.5650.5648.748.56
242524-4252443.96543.97
349992-4999251.68651.69
10min181692-8169284.46183.740.7584.5583.820.76
280647-8064783.38083.45
380651-8065183.38583.47
15min166072-6607268.31166.325.7668.5466.545.75
259889-5988961.91962.13
366469-6646968.72268.95
20min191441-9144194.54094.320.6594.8894.650.66
290569-9056993.63993.95
391687-9168794.79595.13
30min172241-7224174.69072.585.3675.1973.075.35
265867-6586768.09968.57
372503-7250374.96075.46
45min193993-9399397.17996.940.3497.8097.550.36
293410-9341096.57697.16
393892-9389297.07497.70
极限175121-7512177.66775.175.3478.4575.945.32
268226-6822670.53871.28
374761-7476177.29578.08
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%
111.333588753598983587913589603591793591410.13
211.303581913574253578080.16
单位质量响应值RSD%判断
31698.2331664.420.08数据可信
供试品溶液-24092001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%
5min1212905-21290555.50955.555.7455.5155.555.74
2200929-20092952.38752.39
3225377-22537758.76158.76
10min1158752-15875241.39040.303.8941.4840.403.86
2157295-15729541.01041.10
3147702-14770238.50938.61
15min1266157-26615769.39369.063.2869.5569.223.27
2255666-25566666.65866.81
3272854-27285471.13971.30
20min1247208-24720864.45262.592.6064.7362.872.59
2237156-23715661.83262.10
3235835-23583561.48761.77
30min1282033-28203373.53273.443.0373.9273.823.03
2272977-27297771.17171.54
3290015-29001575.61376.00
45min1290810-29081075.82073.832.3676.3374.332.35
2278494-27849472.60973.10
3280216-28021673.05873.57
极限1289218-28921875.40575.023.1376.0475.653.12
2278128-27812872.51473.12
3295911-29591177.15077.78
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