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2000
标示量(mg)10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%
19.663866738790386203858838707386740.21
29.713868238760387210.15
单位质量响应值RSD%判断
4003.523987.740.28数据可信
长期24月-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
20240301211468964693946918100.19100.110.9899.08%～101.14%
2469884709347040100.45
346132460874611098.46
446671468384675499.84
5475834745747520101.47
6468234707046946100.25
2024030221146540466434659299.4999.451.2698.14%～100.76%
245801459434587297.95
346215463214626898.80
446787466024669499.71
5475394768547612101.67
646252465624640799.09
2024030321146497466774658799.48100.150.7299.40%～100.90%
2469154694546930100.21
346685466564667099.66
446726465174662299.55
5471124734047226100.84
6474544730347378101.17
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2000
标示量(mg)10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%
114.251638421640661641271638671640851639970.09
214.241645291643011644150.10
单位质量响应值RSD%判断
11508.5611546.000.23数据可信
长期24月-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
20240301211179994179737179866101.1599.461.2698.15%～100.76%
217585117570017577698.85
317561217584717573098.82
417539217539217539298.63
5179870179129179500100.94
617463917511517487798.34
2024030221117417217377617397497.8498.091.0397.03%～99.15%
217140317171717156096.48
317386317351517368997.68
417503917516317510198.47
517671217694217682799.44
617549117536017542698.65
2024030321117690917671317681199.4398.680.5098.17%～99.20%
217582417559617571098.81
317488517519417504098.44
417420617437417429098.01
517597117597017597098.96
617503117509517506398.45
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2000
标示量(mg)10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%
19.663881738625387833873938801387530.20
29.713882338766387940.11
单位质量响应值RSD%判断
4011.703995.260.30数据可信
长期24月-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
20240301211476324750547568101.37100.441.0699.33%～101.56%
2473084711047209100.61
346337463244633098.74
4469724702847000100.16
5477044775347728101.72
6470644683546950100.06
20240302211476924756447628101.5099.801.4498.29%～101.30%
245934460964601598.07
346399462444632298.72
4470864695247019100.20
5475554755347554101.34
646426464324642998.95
20240303211471094732647218100.63100.420.7799.62%～101.22%
2470064706247034100.24
346921466594679099.72
446606467084665799.43
5474054756147483101.19
6476494741747533101.30
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2000
标示量(mg)10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%
114.251641881637911641151641141639841640380.10
214.241642171640621641400.07
单位质量响应值RSD%判断
11511.4411526.690.10数据可信
长期24月-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
20240301211178606178368178487100.4599.491.0698.39%～100.59%
217598517637317617999.15
317615517571317593499.01
417552117549517550898.77
5179664179708179686101.12
617497117489517493398.45
20240302211178955178716178836100.6498.651.4797.14%～100.17%
217132417186617159596.57
317344917344417344697.61
417505717541817523898.62
517707717708917708399.66
617590917526817558898.81
20240303211177842178252178047100.2098.880.7698.10%～99.66%
217554317586117570298.88
317469517486817478298.36
417412617454817433798.11
517590717650817620899.16
617512417525917519298.59
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