培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.444289343308429544336643211431460.50
210.434296843286431270.53
单位质量响应值RSD%判断
4132.764134.900.04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
2022081001142487418104214896.6699.292.2396.97%～101.61%
242316423384232797.07
3439534412144037100.99
4439084377543842100.54
542911429594293598.46
6444294453444482102.01
2022081101141982417504186696.0198.501.9296.52%～100.47%
2441724428644229101.43
342816428714284498.25
442430424304243097.30
542827428934286098.29
643602433404347199.69
2022081201142747427844276698.0796.591.0395.55%～97.63%
242194422354221496.81
342081420144204896.43
442146422114217896.73
542062421244209396.53
641325414974141194.97
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
113.981614121613141614711597611600811608080.51
213.991610821601301606060.42
单位质量响应值RSD%判断
11502.7211480.060.14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
2022081001115520315526615523497.30101.162.6298.38%～103.94%
215819915785115802599.05
3162954163394163174102.28
4164092163959164026102.81
5161023161026161024100.93
6166873166826166850104.58
2022081101115508315501915505197.19100.452.0498.30%～102.59%
2163560164043163802102.67
3160329159925160127100.37
415896515912415904499.69
5159638159900159769100.14
6163696163758163727102.62
2022081201115772315737815755098.7598.260.6297.63%～98.89%
215676115645515660898.16
315671515683815677698.27
415813015789415801299.04
515618815668215643598.05
615488315561315524897.31
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