阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.455149051522514875145451451514810.06
212.435159051561515760.04
单位质量响应值RSD%判断
4135.024149.320.25数据可信
供试品溶液-24051503批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min147800-4780093.26196.282.0393.2696.282.03
249265-4926596.12096.12
350414-5041498.36298.36
450466-5046698.46398.46
548924-4892495.45495.45
649204-4920496.00196.00
10min150963-5096399.433100.020.8099.95100.560.81
251302-51302100.094100.63
351947-51947101.353101.90
451448-51448100.379100.93
551139-5113999.776100.31
650791-5079199.09799.63
15min150889-5088999.28898.981.35100.36100.071.34
251128-5112899.755100.84
351541-51541100.560101.67
450807-5080799.128100.23
549546-4954696.66897.75
650470-5047098.47199.55
20min150211-5021197.96598.320.8499.5999.970.84
250749-5074999.015100.66
351037-5103799.577101.25
450345-5034598.22799.88
549935-4993597.42799.05
650094-5009497.73799.37
30min149664-4966496.89897.410.6099.0699.600.61
250296-5029698.131100.33
350288-5028898.116100.34
449834-4983497.23099.43
549619-4961996.81098.97
649856-4985697.27399.45
45min149987-4998797.52897.330.84100.23100.050.82
249533-4953396.64399.38
350472-5047298.475101.24
449973-4997397.501100.24
550043-5004397.638100.34
649295-4929596.17898.89
60min149456-4945696.49294.632.1699.7497.902.08
248405-4840594.44297.72
349034-4903495.66998.98
446480-4648090.68693.97
548791-4879195.19598.44
648832-4883295.27598.52
极限147307-4730792.30095.212.1696.0899.002.09
249518-4951896.613100.41
350001-5000197.556101.40
447737-4773793.13996.93
549013-4901395.62899.40
649217-4921796.02699.80
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.053882653889453888593885703883383885950.08
211.153894753896523895640.04
单位质量响应值RSD%判断
35166.9734938.480.47数据可信
供试品溶液-24051503批-阿齐沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18578-85782.1962.166.502.202.166.45
28163-81632.0902.09
38826-88262.2592.26
47914-79142.0262.03
59274-92742.3742.37
67902-79022.0232.02
10min119868-198685.0865.078.505.105.088.49
219415-194154.9704.98
319585-195855.0145.03
418303-183034.6854.70
523033-230335.8965.91
618677-186774.7814.79
15min128626-286267.3287.137.827.377.177.85
226855-268556.8756.91
327082-270826.9336.97
426167-261676.6986.74
531917-319178.1708.22
626389-263896.7556.79
20min134765-347658.8998.557.068.988.637.06
232412-324128.2978.37
332431-324318.3028.38
431313-313138.0168.09
537589-375899.6229.71
631947-319478.1788.25
30min143234-4323411.06710.576.4111.2010.696.41
239791-3979110.18610.31
339695-3969510.16110.29
439158-3915810.02410.14
545784-4578411.72011.86
640012-4001210.24310.36
45min151575-5157513.20312.495.9013.3912.685.90
246952-4695212.01912.20
347560-4756012.17512.36
446359-4635911.86712.04
553251-5325113.63213.84
647082-4708212.05212.23
60min156735-5673514.52413.795.1514.7914.045.18
251653-5165313.22313.47
353996-5399613.82214.07
451251-5125113.12013.36
557660-5766014.76015.05
651871-5187113.27813.52
极限159357-5935715.19515.202.5615.5415.542.63
258641-5864115.01115.33
360117-6011715.38915.72
457884-5788414.81815.13
562038-6203815.88116.25
658312-5831214.92715.25
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