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%
115.47 9848698523984499851298491984920.03
215.509918499484993340.22
单位质量响应值RSD%判断
6366.656408.650.47数据可信
供试品溶液-24070201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%
5min139317-3931739.90141.7820.7139.9041.7820.71
228701-2870129.12829.13
340730-4073041.33541.34
455325-5532556.14756.15
542829-4282943.46643.47
640126-4012640.72240.72
10min166043-6604367.02567.5614.8667.0967.6314.86
252087-5208752.86152.91
366196-6619667.18067.25
481917-8191783.13483.23
571226-7122672.28572.36
661943-6194362.86462.93
15min176725-7672577.86575.1514.4278.0475.3314.42
260705-6070561.60761.74
367049-6704968.04668.23
490754-9075492.10392.33
579806-7980680.99281.19
669258-6925870.28770.46
20min184425-8442585.68080.5212.6185.9980.8312.62
264862-6486265.82666.07
378934-7893480.10780.40
493693-9369395.08695.47
581971-8197183.18983.52
672169-7216973.24273.53
30min187026-8702688.31983.2910.9688.7783.7310.98
269231-6923170.26070.61
381830-8183083.04683.47
495066-9506696.47997.02
583753-8375384.99885.46
675495-7549576.61777.03
45min189978-8997891.31586.109.6391.9186.689.66
275444-7544476.56577.03
383624-8362484.86785.43
496400-9640097.83398.54
587506-8750688.80789.41
676075-7607577.20677.75
极限192532-9253293.90798.374.5994.6699.104.52
2104753-104753106.310106.90
395717-9571797.14097.85
498858-98858100.327101.20
596329-9632997.76198.52
693396-9339694.78495.45
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%
111.583663393665113663263663283664423663890.03
211.663699373698213698790.03
单位质量响应值RSD%判断
31639.8131722.040.19数据可信
供试品溶液-24070201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%
5min1145021-14502137.81141.6917.0037.8141.6917.00
2124181-12418132.37732.38
3159466-15946641.57741.58
4206656-20665653.88053.88
5162964-16296442.48942.49
6161180-16118042.02442.02
10min1244788-24478863.82266.0512.4163.8966.1212.41
2210663-21066354.92554.98
3247717-24771764.58664.66
4305980-30598079.77779.87
5266074-26607469.37269.44
6244697-24469763.79963.87
15min1287366-28736674.92474.9910.8075.0975.1710.80
2244399-24439963.72163.87
3280382-28038273.10373.28
4338501-33850188.25688.48
5299893-29989378.19078.38
6275134-27513471.73471.91
20min1325763-32576384.93579.7910.3685.2380.0910.36
2260116-26011667.81968.07
3296561-29656177.32177.62
4351253-35125391.58191.95
5314291-31429181.94482.26
6288117-28811775.11975.42
30min1347006-34700690.47383.379.6990.9183.809.69
2277167-27716772.26472.63
3308196-30819680.35480.78
4361079-36107994.14294.66
5324587-32458784.62885.08
6300455-30045578.33678.76
45min1355449-35544992.67585.847.8193.2686.417.82
2303395-30339579.10379.59
3314626-31462682.03182.59
4364447-36444795.02195.70
5330441-33044186.15486.75
6306998-30699880.04280.59
极限1371169-37116996.77395.151.9097.5195.871.96
2354996-35499692.55693.17
3362897-36289794.61695.31
4374390-37439097.61398.45
5364054-36405494.91895.66
6362130-36213094.41695.10
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