坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
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%
113.374387944339440944433644581442460.61
213.504451644364444400.25
单位质量响应值RSD%判断
3309.353291.850.38数据可信
供试品溶液-24092401批-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%
5min150067-5006795.77587.9413.5495.7887.9413.54
249438-4943894.57294.57
340778-4077878.00678.01
435676-3567668.24668.25
549535-4953594.75794.76
650341-5034196.29996.30
10min151414-5141498.35299.582.4599.42100.562.31
250469-5046996.54497.59
353295-53295101.950102.82
453861-53861103.033103.79
551525-5152598.56499.62
651775-5177599.042100.11
15min150425-5042596.46097.701.3698.6299.781.27
250496-5049696.59698.72
350732-5073297.04799.05
452249-5224999.949101.85
551464-5146498.447100.60
651074-5107497.70199.87
20min149723-4972395.11796.150.9298.3599.330.90
249982-4998295.61298.81
350147-5014795.92899.01
450405-5040596.42299.44
551076-5107697.705100.95
650258-5025896.14099.40
30min149561-4956194.80794.730.6599.0998.970.70
249725-4972595.12199.38
349649-4964994.97599.12
448892-4889293.52797.61
549757-4975795.18299.51
649545-4954594.77699.10
45min149458-4945894.61094.930.3599.95100.220.35
249745-4974595.159100.48
349383-4938394.46799.67
449781-4978195.228100.35
549607-4960794.895100.28
649766-4976695.199100.58
60min148903-4890393.54892.850.7999.9499.190.83
248908-4890893.55899.93
348133-4813392.07598.32
448022-4802291.86398.05
548709-4870993.17799.62
648548-4854892.86999.30
极限147240-4724090.36791.681.1297.8099.051.10
247975-4797591.77399.19
347531-4753190.92498.20
447726-4772691.29798.50
548621-4862193.009100.48
648452-4845292.686100.15
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
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%
113.374449444112441814419344186442330.34
213.504426844006441370.42
单位质量响应值RSD%判断
3308.383269.410.84数据可信
供试品溶液-1批-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%
5min151383-5138398.64597.541.2798.6597.551.28
250669-5066997.27497.27
350503-5050396.95696.96
451545-5154598.95698.96
550983-5098397.87797.88
649776-4977695.56095.56
10min150300-5030096.56697.591.0997.6698.671.08
249988-4998895.96797.05
351136-5113698.17199.25
451237-5123798.36599.46
551335-5133598.55399.64
650997-5099797.90498.97
15min149985-4998595.96196.951.1798.1399.121.16
249555-4955595.13697.28
350858-5085897.63799.81
451013-5101397.935100.13
550697-5069797.32899.51
650890-5089097.69999.85
20min149372-4937294.78495.521.2998.0298.771.26
249163-4916394.38397.59
349029-4902994.12697.38
450174-5017496.32499.60
550342-5034296.64799.91
650454-5045496.862100.10
30min148200-4820092.53493.901.3596.8298.211.33
248128-4812892.39696.65
348692-4869293.47997.78
449437-4943794.90999.26
549608-4960895.23799.58
649411-4941194.85999.17
45min147993-4799392.13793.141.1197.4598.481.08
247950-4795092.05497.33
348504-4850493.11898.46
448529-4852993.16698.57
548685-4868593.46698.86
649417-4941794.871100.24
60min147748-4774891.66792.270.7698.0198.650.76
247718-4771891.60997.91
347982-4798292.11698.49
448540-4854093.18799.63
548480-4848093.07299.51
647893-4789391.94598.36
极限147460-4746091.11491.570.8398.4798.980.83
247206-4720690.62697.95
347378-4737890.95698.35
448013-4801392.17599.65
547973-4797392.09999.57
648153-4815392.44499.89
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
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%
113.374447144480443874432944299443930.19
213.504440944628445180.35
单位质量响应值RSD%判断
3320.343297.630.49数据可信
供试品溶液-2批-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%
5min148933-4893393.36994.311.2793.3794.321.27
248905-4890593.31693.32
350253-5025395.88895.89
448876-4887693.26093.26
550087-5008795.57195.57
649516-4951694.48194.48
10min149928-4992895.26895.681.1796.3096.721.16
250026-5002695.45596.49
350900-5090097.12298.19
450659-5065996.66297.70
549247-4924793.96895.03
650090-5009095.57796.63
15min149386-4938694.23395.020.9496.3397.130.93
249227-4922793.93096.03
350392-5039296.15398.30
450276-5027695.93298.04
549800-4980095.02397.13
649701-4970194.83496.95
20min148695-4869592.91593.991.4896.0697.161.46
248762-4876293.04396.18
350545-5054596.44599.66
449553-4955394.55297.73
549319-4931994.10597.27
648676-4867692.87996.04
30min148079-4807991.73992.100.9595.9196.310.94
248440-4844092.42896.60
349116-4911693.71898.00
448116-4811691.81096.04
547991-4799191.57295.78
647866-4786691.33395.53
45min146990-4699089.66290.621.5094.8695.851.46
246476-4647688.68193.88
348287-4828792.13697.46
448233-4823392.03397.28
547637-4763790.89696.12
647326-4732690.30395.51
60min147425-4742590.49290.611.3896.6896.851.34
246823-4682389.34395.53
348242-4824292.05098.40
448296-4829692.15498.42
546822-4682289.34195.58
647317-4731790.28596.50
极限145858-4585887.50289.001.4894.7096.251.43
246603-4660388.92396.10
347898-4789891.39498.77
446757-4675789.21796.51
546365-4636588.46995.70
646382-4638288.50195.72
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