贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.502883192887652880682883292885422884050.10
29.642893102891592892340.04
单位质量响应值RSD%判断
30358.4230003.530.84数据可信
供试品溶液-24042801批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min190848-9084830.01830.474.4830.0230.484.49
298293-9829332.47832.48
386268-8626828.50528.50
490810-9081030.00530.01
591919-9191930.37230.37
695237-9523731.46831.47
10min1209014-20901469.06268.640.9569.4068.980.94
2207418-20741868.53568.90
3206824-20682468.33868.66
4209520-20952069.22969.56
5209240-20924069.13769.47
6204364-20436467.52667.88
15min1248131-24813181.98781.251.5483.0982.351.51
2242296-24229680.05981.18
3248748-24874882.19183.27
4248993-24899382.27283.37
5247155-24715581.66582.77
6240097-24009779.33280.43
20min1263515-26351587.07086.491.6189.0888.491.58
2257546-25754685.09887.11
3265027-26502787.57089.56
4264589-26458987.42589.44
5264496-26449687.39489.41
6255329-25532984.36586.35
30min1278399-27839991.98891.101.3994.9794.071.37
2271519-27151989.71592.67
3278990-27899092.18395.15
4278746-27874692.10395.09
5276230-27623091.27194.26
6270435-27043589.35792.28
45min1286302-28630294.59993.751.2898.6097.721.26
2279383-27938392.31396.27
3287046-28704694.84598.83
4286510-28651094.66898.68
5283958-28395893.82597.82
6279115-27911592.22596.14
60min1288617-28861795.36494.511.24100.4299.521.22
2281960-28196093.16598.14
3288938-28893895.470100.51
4289146-28914695.539100.60
5285964-28596494.48899.53
6281486-28148693.00897.94
极限1289130-28913095.53494.821.15101.65100.891.14
2282705-28270593.41199.43
3289760-28976095.742101.84
4289881-28988195.782101.91
5287188-28718894.892100.98
6283172-28317293.56599.53
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.502892952887852892882892202891792891530.08
29.642955652886132920891.69
单位质量响应值RSD%判断
30437.1630299.690.33数据可信
供试品溶液-24042801批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110197-101973.3483.6211.113.353.6211.07
29846-98463.2333.23
310040-100403.2973.30
411467-114673.7653.77
512984-129844.2644.26
611674-116743.8333.83
10min136483-3648311.98012.273.8112.0212.313.82
236679-3667912.04412.08
335468-3546811.64711.68
439309-3930912.90812.95
538510-3851012.64512.69
637755-3775512.39812.44
15min156258-5625818.47318.532.7318.6418.712.73
258064-5806419.06619.24
354072-5407217.75617.92
458147-5814719.09419.28
556449-5644918.53618.72
655657-5565718.27618.46
20min167696-6769622.22922.112.3622.6022.492.37
267562-6756222.18522.57
364648-6464821.22821.59
469585-6958522.85023.25
567035-6703522.01222.41
667403-6740322.13322.52
30min183159-8315927.30727.362.9427.9327.992.93
285648-8564828.12428.75
378966-7896625.93026.53
485588-8558828.10428.76
582817-8281727.19527.83
683758-8375827.50428.13
45min199124-9912432.54932.171.1333.4833.111.14
296997-9699731.85132.79
396868-9686831.80832.70
499471-9947132.66333.63
597953-9795332.16533.11
697435-9743531.99532.93
60min1106243-10624334.88734.971.9836.1736.261.96
2108747-10874735.70937.00
3104955-10495534.46435.70
4109369-10936935.91337.24
5104224-10422434.22435.52
6105413-10541334.61435.90
极限1113786-11378637.36437.942.0239.0439.622.01
2118107-11810738.78340.47
3112597-11259736.97338.60
4118366-11836638.86840.59
5115760-11576038.01239.69
6114622-11462237.63839.31
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