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%
115.159783897775979899800798129979480.15
215.399890298862988820.03
单位质量响应值RSD%判断
6465.216425.080.45数据可信
供试品溶液-24061201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%
5min144305-4430544.56245.596.6344.5645.596.62
246506-4650646.77646.78
347805-4780548.08348.08
443980-4398044.23544.24
540570-4057040.80640.81
648793-4879349.07649.08
10min164691-6469165.06766.298.4165.1466.378.41
267041-6704167.43067.51
372839-7283973.26273.34
466313-6631366.69866.77
556113-5611356.43956.51
668475-6847568.87368.95
15min171306-7130671.72074.089.6071.9074.269.60
274770-7477075.20475.39
383642-8364284.12884.33
473101-7310173.52573.71
562156-6215662.51762.68
676934-7693477.38177.58
20min176064-7606476.50677.0410.7176.8177.3410.70
277843-7784378.29578.61
384678-8467885.17085.51
476747-7674777.19377.50
561412-6141261.76962.03
682806-8280683.28783.61
30min178905-7890579.36380.5711.8279.7981.0111.80
279190-7919079.65080.10
392641-9264193.17993.66
477904-7790478.35678.79
564825-6482565.20165.57
687163-8716387.66988.13
45min176554-7655476.99981.8910.7977.5682.4610.78
280899-8089981.36981.95
393477-9347794.02094.66
479612-7961280.07480.64
568963-6896369.36369.84
688999-8899989.51690.13
极限182451-8245182.93087.008.5283.6287.718.52
283235-8323583.71884.43
397044-9704497.60898.40
482531-8253183.01083.71
579214-7921479.67480.27
694526-9452695.07595.83
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%
111.55 3713473708233709693712753712463711320.07
211.803758853753333756090.11
单位质量响应值RSD%判断
32132.6431831.270.67数据可信
供试品溶液-24061201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%
5min1192107-19210749.61752.5111.4049.6252.5111.40
2245627-24562763.44063.44
3197907-19790751.11551.11
4212836-21283654.97154.97
5189438-18943848.92748.93
6181937-18193746.99046.99
10min1266054-26605468.71574.479.5968.8074.569.59
2330459-33045985.35085.46
3290126-29012674.93375.02
4311131-31113180.35880.45
5261590-26159067.56367.64
6270714-27071469.91970.00
15min1298925-29892577.20583.658.1377.4083.868.14
2361986-36198693.49293.74
3331624-33162485.65185.86
4343696-34369688.76988.99
5296272-29627276.52076.71
6310712-31071280.25080.44
20min1313814-31381481.05187.447.7981.3887.797.79
2374651-37465196.76497.17
3349312-34931290.21990.57
4357559-35755992.34992.72
5307195-30719579.34179.66
6328798-32879884.92185.25
30min1325714-32571484.12490.337.1184.5990.827.12
2381976-38197698.65599.22
3362566-36256693.64294.15
4366662-36666294.70095.23
5318515-31851582.26582.72
6342913-34291388.56689.04
45min1335267-33526786.59292.166.2887.1992.806.30
2386337-38633799.782100.51
3367378-36737894.88595.54
4372632-37263296.24296.93
5329143-32914385.01085.60
6350102-35010290.42391.04
极限1383012-38301298.923100.271.8499.67101.071.86
2400308-400308103.390104.29
3382895-38289598.89399.71
4389373-389373100.566101.41
5391754-391754101.181101.91
6382088-38208898.68499.45
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