依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031637091659251658831663051660501655740.64
210.091658221655161656690.14
单位质量响应值RSD%判断
16507.8816419.130.39数据可信
供试品溶液-2023121621批-依折麦布-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%
5min19811-98115.3465.254.075.355.254.06
210321-103215.6245.62
39559-95595.2085.21
49259-92595.0455.04
59558-95585.2085.21
69304-93045.0695.07
10min116781-167819.1438.882.829.178.902.80
216360-163608.9148.95
316690-166909.0949.12
416304-163048.8838.91
516101-161018.7738.80
615507-155078.4498.48
15min117139-171399.3389.042.809.429.122.81
216501-165018.9919.07
317016-170169.2719.35
416105-161058.7758.85
516794-167949.1509.23
616032-160328.7358.81
20min116586-165869.0378.951.579.179.081.55
216211-162118.8338.96
316854-168549.1839.31
416261-162618.8608.99
516436-164368.9559.08
616210-162108.8328.96
30min116655-166559.0758.752.559.268.932.54
215945-159458.6888.87
316382-163828.9269.11
415684-156848.5468.72
516063-160638.7528.93
615588-155888.4938.67
45min115968-159688.7008.632.178.938.852.16
215839-158398.6308.86
316261-162618.8609.09
416021-160218.7298.95
515631-156318.5178.74
615276-152768.3238.54
60min116040-160408.7408.362.649.028.642.61
215298-152988.3358.61
315346-153468.3618.64
415060-150608.2068.48
515457-154578.4228.70
614857-148578.0958.36
极限115786-157868.6018.442.028.938.762.01
215528-155288.4618.78
315671-156718.5398.87
415676-156768.5418.86
515281-152818.3268.65
614956-149568.1498.46
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.732834282872592877202878672877472868040.67
210.782861932855812858870.16
单位质量响应值RSD%判断
26729.1726520.130.56数据可信
供试品溶液-2023121621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%
5min138369-3836911.90412.2028.1611.9012.1928.16
261249-6124919.00219.00
334902-3490210.82810.83
432888-3288810.20310.20
531238-312389.6919.69
637203-3720311.54211.54
10min1134412-13441241.70041.095.0141.7741.165.04
2144519-14451944.83644.94
3132578-13257841.13141.19
4128666-12866639.91839.97
5128197-12819739.77239.83
6126313-12631339.18839.25
15min1174083-17408354.00852.883.0754.3153.183.07
2172444-17244453.50053.85
3175907-17590754.57454.86
4164410-16441051.00751.29
5172404-17240453.48753.76
6163457-16345750.71150.99
20min1194161-19416160.23757.523.1560.8458.113.14
2186203-18620357.76858.42
3183126-18312656.81457.41
4179137-17913755.57656.14
5189739-18973958.86559.44
6179992-17999255.84156.40
30min1212947-21294766.06560.725.0867.0061.645.04
2195826-19582660.75461.73
3191421-19142159.38760.29
4186586-18658657.88758.76
5200379-20037962.16663.07
6187216-18721658.08358.96
45min1216393-21639367.13562.424.4268.4363.674.38
2199308-19930861.83463.14
3197289-19728961.20862.45
4199803-19980361.98863.18
5204648-20464863.49164.74
6189765-18976558.87360.07
60min1223122-22312269.22262.176.2970.8963.766.21
2199302-19930261.83263.49
3196771-19677161.04762.62
4190508-19050859.10460.64
5204358-20435863.40165.00
6188224-18822458.39559.92
极限1241217-24121774.83671.982.3476.8973.922.37
2231578-23157871.84673.84
3230258-23025871.43673.35
4232053-23205371.99373.86
5232596-23259672.16174.11
6224365-22436569.60871.46
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