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%
115.099610196120961479625096226961690.07
215.169823798546983920.23
单位质量响应值RSD%判断
6373.036490.241.29数据可信
供试品溶液-GF9438批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min165397-6539765.92070.365.9665.9270.365.96
264159-6415964.67264.67
374841-7484175.43975.44
472374-7237472.95372.95
570948-7094871.51571.52
671118-7111871.68771.69
10min188959-8895989.67089.301.8289.7889.421.82
288341-8834189.04789.16
388077-8807788.78188.91
488680-8868089.38989.51
591238-9123891.96792.09
686264-8626486.95487.07
15min192980-9298093.72393.271.6793.9893.531.67
291473-9147392.20492.46
391004-9100491.73292.01
493279-9327994.02594.30
595049-9504995.80996.08
691377-9137792.10792.37
20min191942-9194292.67793.661.4793.0994.081.47
293625-9362594.37394.78
391791-9179192.52592.95
493495-9349594.24294.67
595044-9504495.80496.24
691627-9162792.35992.78
30min193061-9306193.80593.192.0294.3793.762.01
293548-9354894.29694.86
391461-9146192.19292.77
490254-9025490.97691.56
595289-9528996.05196.64
691081-9108191.80992.38
45min192337-9233793.07592.132.8493.8092.862.82
292332-9233293.07093.79
386625-8662587.31888.05
492454-9245493.19393.93
594072-9407294.82495.58
690567-9056791.29192.02
极限191712-9171292.44591.272.9893.3392.162.96
291679-9167992.41293.29
389829-8982990.54791.43
491112-9111291.84092.73
593389-9338994.13695.05
685574-8557486.25887.14
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%
111.503604363612703604063610913609933608390.11
211.603666463671593669020.10
单位质量响应值RSD%判断
31377.3031629.480.57数据可信
供试品溶液-GF9438批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min156917-5691714.92416.818.5514.9216.818.55
259067-5906715.48715.49
369807-6980718.30318.30
464286-6428616.85616.86
570477-7047718.47918.48
664060-6406016.79616.80
10min1126205-12620533.09133.873.4133.1233.903.41
2130165-13016534.12934.15
3133888-13388835.10535.14
4128048-12804833.57433.60
5133959-13395935.12435.15
6122823-12282332.20432.23
15min1161186-16118642.26343.254.0542.3443.334.05
2173597-17359745.51745.60
3166947-16694743.77343.86
4159375-15937541.78841.87
5171270-17127044.90745.00
6157282-15728241.23941.32
20min1183909-18390948.22148.724.6948.3748.884.68
2197128-19712851.68751.85
3189812-18981249.76849.93
4175220-17522045.94246.10
5192028-19202850.34950.51
6176873-17687346.37646.53
30min1206728-20672854.20454.326.0354.4354.566.01
2223675-22367558.64758.89
3212843-21284355.80756.05
4190352-19035249.91050.14
5214153-21415356.15156.40
6195267-19526751.19951.43
45min1226292-22629259.33358.576.6859.6558.906.67
2243877-24387763.94464.29
3230086-23008660.32860.67
4201904-20190452.93953.25
5227425-22742559.63059.97
6210685-21068555.24155.55
极限1259147-25914767.94867.063.9968.3767.483.99
2270225-27022570.85371.30
3252971-25297166.32966.77
4241843-24184363.41163.81
5262141-26214168.73369.17
6248191-24819165.07565.48
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%
115.099837898442982729833198586984020.13
215.169683496804968190.03
单位质量响应值RSD%判断
6521.016386.481.48数据可信
供试品溶液-GF9438批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172507-7250772.83868.6510.9972.8468.6510.99
273569-7356973.90573.90
357135-5713557.39657.40
460363-6036360.63960.64
573231-7323173.56573.57
673223-7322373.55773.56
10min186433-8643386.82885.953.4786.9586.063.48
286796-8679687.19287.32
379688-7968880.05280.15
485693-8569386.08486.19
587973-8797388.37588.50
686754-8675487.15087.27
15min190130-9013090.54290.871.9790.8191.131.98
291246-9124691.66391.93
387252-8725287.65087.88
490352-9035290.76591.01
592477-9247792.89993.17
691292-9129291.70991.98
20min191498-9149891.91692.491.1192.3392.901.13
293179-9317993.60594.03
390434-9043490.84791.22
491835-9183592.25492.65
592883-9288393.30793.73
692572-9257292.99593.42
30min191687-9168792.10692.901.0292.6893.461.03
293352-9335293.77894.36
392130-9213092.55193.08
491471-9147191.88992.44
593857-9385794.28694.87
692338-9233892.76093.34
45min191830-9183092.24992.840.9592.9793.560.95
293444-9344493.87194.60
392659-9265993.08293.76
491034-9103491.45092.15
593078-9307893.50394.24
692467-9246792.88993.62
极限190439-9043990.85291.361.0091.7392.241.00
291523-9152391.94192.83
391144-9114491.56092.40
489433-8943389.84190.70
591997-9199792.41793.31
691143-9114391.55992.44
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%
111.503684683686553681153682803686693684370.07
211.603673833668833671330.10
单位质量响应值RSD%判断
32038.0031649.400.87数据可信
供试品溶液-GF9438批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159066-5906615.32215.6916.9315.3215.6916.93
260707-6070715.74715.75
349572-4957212.85912.86
449784-4978412.91412.91
575567-7556719.60219.60
668298-6829817.71717.72
10min1122709-12270931.83131.317.3931.8631.337.39
2125110-12511032.45432.48
3104110-10411027.00627.03
4121380-12138031.48631.51
5130561-13056133.86833.90
6120237-12023731.19031.22
15min1156559-15655940.61240.356.0040.6940.436.01
2160186-16018641.55341.63
3137720-13772035.72535.79
4157218-15721840.78340.86
5165063-16506342.81842.91
6156603-15660340.62340.70
20min1179883-17988346.66245.904.3246.8146.044.33
2181688-18168847.13047.28
3161898-16189841.99742.12
4177378-17737846.01246.15
5182636-18263647.37647.54
6178171-17817146.21846.37
30min1202013-20201352.40351.312.7252.6351.542.73
2198944-19894451.60651.83
3187448-18744848.62448.82
4201310-20131052.22052.44
5200046-20004651.89252.13
6197151-19715151.14151.37
45min1221084-22108457.35055.881.9557.6656.181.96
2217599-21759956.44656.76
3210047-21004754.48754.76
4218178-21817856.59656.90
5212174-21217455.03855.36
6213343-21334355.34255.65
极限1249352-24935264.68263.991.2965.0964.391.27
2246718-24671863.99964.41
3248071-24807164.35064.72
4250093-25009364.87565.27
5243824-24382463.24863.67
6242036-24203662.78563.19
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