富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.248486784788847248491784904848400.10
210.238495285111850320.14
单位质量响应值RSD%判断
8285.168312.020.23数据可信
供试品溶液-2023101321批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190085-9008597.50498.233.2497.5098.233.25
293923-93923101.658101.66
387545-8754594.75594.75
492769-92769100.409100.41
587150-8715094.32794.33
693072-93072100.737100.74
10min191850-9185099.414100.291.7999.58100.451.79
294680-94680102.477102.65
391117-9111798.62198.78
493236-93236100.914101.08
590767-9076798.24298.40
694286-94286102.051102.22
15min192491-92491100.108100.901.46100.44101.231.46
294703-94703102.502102.84
392159-9215999.749100.07
493669-93669101.383101.72
591564-9156499.10599.43
694759-94759102.563102.90
20min192411-92411100.022100.861.04100.52101.361.04
294353-94353102.123102.63
393001-93001100.660101.15
493116-93116100.785101.29
591959-9195999.532100.02
694255-94255102.017102.53
30min192984-92984100.642101.060.79101.30101.730.79
294280-94280102.044102.73
393331-93331101.017101.67
493343-93343101.030101.70
592256-9225699.854100.51
694045-94045101.790102.47
45min193090-93090100.756101.220.86101.59102.060.86
294216-94216101.975102.83
394003-94003101.745102.57
493171-93171100.844101.69
592291-9229199.892100.71
694339-94339102.108102.96
极限193402-93402101.094101.260.74102.09102.270.74
294231-94231101.991103.01
393757-93757101.478102.47
493342-93342101.029102.04
592394-92394100.003100.99
694224-94224101.984103.00
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.248509584923851578497885013850330.11
210.238497584949849620.03
单位质量响应值RSD%判断
8304.008305.180.02数据可信
供试品溶液-2023101321批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187556-8755694.69898.982.9894.7098.982.98
291229-9122998.67198.67
392559-92559100.109100.11
493222-93222100.826100.83
595092-95092102.849102.85
689419-8941996.71396.71
10min190818-9081898.226100.841.9298.38101.011.92
293108-93108100.703100.87
393617-93617101.253101.42
494446-94446102.150102.32
595718-95718103.526103.70
691713-9171399.19499.36
15min191303-9130398.751100.891.6999.07101.231.69
292953-92953100.535100.87
393712-93712101.356101.69
494101-94101101.777102.12
595669-95669103.473103.82
691971-9197199.47399.80
20min191354-9135498.806100.911.6899.29101.421.69
292923-92923100.503101.00
393603-93603101.238101.74
494080-94080101.754102.26
595779-95779103.592104.11
692083-9208399.594100.09
30min191057-9105798.485100.771.6499.14101.441.64
292802-92802100.372101.04
393479-93479101.104101.78
494247-94247101.935102.61
595309-95309103.083103.77
692102-9210299.615100.27
45min191177-9117798.614100.681.5999.43101.521.59
292475-92475100.018100.85
393382-93382100.999101.84
494153-94153101.833102.68
595237-95237103.006103.87
692104-9210499.617100.44
极限191213-9121398.653100.741.5799.63101.741.58
292705-92705100.267101.27
393360-93360100.975101.99
494111-94111101.788102.80
595318-95318103.093104.13
692140-9214099.656100.65
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.248495585085851158509484874850250.13
210.238475084718847340.03
单位质量响应值RSD%判断
8303.228282.890.18数据可信
供试品溶液-2023101322批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191948-9194899.587100.790.8199.59100.790.81
293409-93409101.169101.17
393602-93602101.378101.38
492251-9225199.91599.91
593492-93492101.259101.26
693631-93631101.410101.41
10min196281-96281104.280102.571.09104.45102.741.09
294736-94736102.606102.77
394149-94149101.971102.14
493163-93163100.903101.07
595064-95064102.962103.13
694820-94820102.697102.87
15min196367-96367104.373102.361.12104.71102.701.11
294126-94126101.946102.29
394142-94142101.963102.30
493183-93183100.924101.26
594616-94616102.476102.82
694636-94636102.498102.84
20min196425-96425104.436102.331.27104.95102.841.27
294149-94149101.971102.48
394058-94058101.872102.38
492779-92779100.487100.99
594490-94490102.340102.85
694959-94959102.848103.36
30min196537-96537104.557102.051.39105.24102.731.39
293922-93922101.725102.40
393556-93556101.328102.01
492598-92598100.291100.96
594377-94377102.217102.90
694362-94362102.201102.88
45min196221-96221104.215101.781.41105.08102.631.40
293861-93861101.659102.51
393295-93295101.046101.89
492219-9221999.880100.72
594012-94012101.822102.67
694232-94232102.060102.91
极限196098-96098104.081101.611.40105.12102.631.39
293861-93861101.659102.68
393032-93032100.761101.78
492187-9218799.846100.85
593737-93737101.524102.55
693975-93975101.782102.80
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.248518585178851208499485082851120.10
210.238484585019849320.15
单位质量响应值RSD%判断
8311.728302.250.09数据可信
供试品溶液-2023101322批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182304-8230488.99299.215.3888.9999.215.38
294004-94004101.643101.64
392627-92627100.154100.15
496783-96783104.648104.65
592846-92846100.391100.39
691961-9196199.43499.43
10min189231-8923196.482101.773.1496.63101.943.14
295687-95687103.462103.63
393983-93983101.620101.79
498152-98152106.128106.30
594438-94438102.112102.28
693257-93257100.835101.00
15min189303-8930396.560101.653.1596.87101.983.16
295291-95291103.034103.38
393621-93621101.229101.56
498447-98447106.447106.80
593706-93706101.320101.66
693673-93673101.285101.62
20min189151-8915196.395101.543.0896.87102.043.08
294737-94737102.435102.95
393756-93756101.375101.88
498178-98178106.156106.68
593944-93944101.578102.08
693664-93664101.275101.78
30min188942-8894296.169101.463.2796.80102.143.27
295300-95300103.044103.73
393548-93548101.150101.82
498349-98349106.341107.05
593670-93670101.282101.96
693203-93203100.777101.45
45min188936-8893696.163101.183.1496.95102.023.15
294470-94470102.147103.00
393168-93168100.739101.58
498086-98086106.056106.94
593689-93689101.302102.15
693085-93085100.649101.49
极限188666-8866695.871100.903.0596.82101.913.06
294619-94619102.308103.33
393118-93118100.685101.70
497393-97393105.307106.37
593453-93453101.047102.06
692634-92634100.161101.17
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