氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.989124149113159099699098029098549106710.13
213.999168289081239124760.68
单位质量响应值RSD%判断
65140.9965223.450.09数据可信
长期12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
2023101921批189691389671389681399.1097.781.8595.88%～99.67%
289179689154489167098.53
389830989828589829799.26
485400085377985389094.36
588469888499288484597.78
688436588255588346097.62
2023102021批181211281208581209889.7494.514.5390.03%～99.00%
281111881023581067689.58
387156587165387160996.31
4911687911211911449100.72
586904186937186920696.05
685684785668085676494.67
2023102121批186802687000686901696.0397.933.3494.51%～101.36%
285658585606885632694.63
3906185905343905764100.09
4929607929160929384102.70
589859289850689854999.29
685414886254885834894.85
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948214498213348204208199398201658206610.09
29.968179658189728184680.09
单位质量响应值RSD%判断
82561.4782175.500.34数据可信
长期12月-供试品溶液-贝那普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023101921批182802782828182815499.7499.651.3598.24%～101.06%
2833434832583833008100.32
380801480753380777497.28
482381482316582349099.18
5831166832020831593100.15
6841225839870840548101.23
2023102021批1832594831976832285100.24100.740.8599.85%～101.64%
2832139832223832181100.22
3845439845008845224101.79
482716982701482709299.61
5839401838982839192101.07
6842550843513843032101.53
2023102121批1842836842290842563101.47101.581.06100.45%～102.71%
282997483016983007299.97
3857769857257857513103.27
4844806844700844753101.74
5839288840132839710101.13
6846116845732845924101.88
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.989154159143049140929138029116089138440.16
213.999102329105239103780.03
单位质量响应值RSD%判断
65367.9565073.480.32数据可信
中间条件12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
2023101921批189238989376189307598.6398.473.3195.06%～101.88%
288236488268788252697.46
387972588009487991097.18
486265286141486203395.20
5947483948653948068104.70
688494288345888420097.65
2023102021批185867385959985913694.8897.063.4193.58%～100.53%
288427488409988418697.65
3936883936886936884103.47
485775685871585823694.78
586716286512286614295.65
686822886852286837595.90
2023102121批186316486160486238495.2495.042.7892.28%～97.81%
289449789522289486098.83
382070782028682049690.61
486005985957585981794.96
585821685873585847694.81
686802786693186747995.80
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948245128250908243398243928222498241160.14
29.968198978218998208980.18
单位质量响应值RSD%判断
82909.0582419.480.42数据可信
中间条件12月-供试品溶液-贝那普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023101921批182591482696382643899.1899.131.3097.79%～100.48%
281406681488381447497.74
381217881277481247697.50
482949182931682940499.53
5835069834386834728100.17
6839004838862838933100.68
2023102021批182364382234082299298.7699.000.4398.56%～99.45%
282225282273682249498.70
382415482441982428698.92
482138182155282146698.58
582991183020683005899.61
682873082857082865099.44
2023102121批1840361839593839977100.80101.541.08100.39%～102.68%
2834963834815834889100.19
3844826845555845190101.43
4849854850835850344102.05
5860915861668861292103.36
6845289844316844802101.38
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