培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.831909719182190581912319078191080.26
29.901913119129191300.01
单位质量响应值RSD%判断
1943.851932.320.43数据可信
供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25102201122496224252246098.8899.561.9997.49%～101.64%
2231662316023163101.97
322023220442203497.00
4228612291722889100.76
522169222482220897.77
6229782291022944101.01
251023011229442290422924100.9298.412.2696.08%～100.74%
222684227322270899.97
322421223062236498.45
422167221822217497.62
522408225562248298.97
621468214792147494.54
25102302122532226512259299.4698.441.9796.42%～100.47%
2230042308323044101.45
322044220432204497.04
421771217932178295.89
522328222792230498.19
622470223402240598.63
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898000879842797368027180205800120.29
214.088061080654806320.04
单位质量响应值RSD%判断
5760.405726.700.42数据可信
供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25102201185214853778529696.2797.242.0695.14%～99.34%
288002880488802599.35
384167839428405494.87
487467875168749298.75
584363844788442095.28
687840874788765998.94
25102301186145859448604497.1296.261.5794.68%～97.84%
284812846748474395.65
385256851618520896.17
486970870508701098.21
585557857038563096.65
682916832268307193.76
25102302186680870698687498.0596.892.0194.85%～98.93%
288424885408848299.87
384631846218462695.51
483549835378354394.29
585838857518579496.83
685665858618576396.80
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.831915819129190771904719014190850.31
29.901902019289191541.00
单位质量响应值RSD%判断
1941.511934.750.25数据可信
供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25102201122082218862198496.7898.462.3396.06%～100.86%
2230592302323041101.43
3227672272922748100.14
421967217262184696.17
521892218912189296.37
622673227032268899.88
25102301122502226932259899.4897.322.0095.28%～99.36%
222207222192221397.79
321792217812178695.91
422108222222216597.57
522456224862247198.92
621489213342141294.26
25102302122631226082262099.5897.441.3096.12%～98.77%
221902218662188496.34
322095219702203296.99
421857218882187296.28
522317223032231098.21
622152220392209697.27
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898086680538804138039080399805210.26
214.088053980774806560.21
单位质量响应值RSD%判断
5797.055728.410.85数据可信
供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25102201184828844908465995.2496.161.9394.21%～98.10%
287274874868738098.30
386876868088684297.69
483112830278307093.45
584572845188454595.11
686368863328635097.14
25102301185359851848527295.9394.862.2092.68%～97.04%
282829826368273293.07
383137832958321693.61
486769866528671097.54
585780858518581696.54
682163822498220692.48
25102302186420862528633697.1295.211.2293.99%～96.42%
284251842188423494.76
384258837818402094.52
483900838188385994.34
585511854208546696.14
683891838718388194.36
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