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%
110.078482484716846848496884809848000.14
210.088521685097851560.10
单位质量响应值RSD%判断
8421.058448.020.23数据可信
中间条件3月-供试品溶液-2023101322批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193406-9340699.46997.891.9199.4797.891.91
292342-9234298.33698.34
388533-8853394.28094.28
491864-9186497.82797.83
593030-9303099.06999.07
692368-9236898.36498.36
10min194355-94355100.48098.921.94100.6599.091.94
293529-9352999.60099.76
389526-8952695.33795.49
492270-9227098.25998.42
594042-94042100.146100.31
693645-9364599.72499.89
15min193866-9386699.95998.381.78100.2998.711.78
293077-9307799.11999.45
389422-8942295.22695.54
491642-9164297.59197.92
593463-9346399.53099.86
692836-9283698.86299.19
20min194118-94118100.22798.472.10100.7398.962.10
293395-9339599.45799.95
388876-8887694.64595.12
491857-9185797.81998.31
593828-9382899.918100.42
692725-9272598.74499.24
30min193532-9353299.60398.191.83100.2798.851.83
292198-9219898.18398.84
389048-8904894.82895.46
491913-9191397.87998.53
593322-9332299.380100.04
693230-9323099.28299.94
45min193817-9381799.90798.072.08100.7498.892.08
292726-9272698.74599.57
388509-8850994.25495.04
491550-9155097.49398.31
593199-9319999.249100.08
692772-9277298.79499.62
极限192990-9299099.02697.791.89100.0398.781.89
292502-9250298.50699.50
388471-8847194.21495.16
491498-9149897.43798.42
592645-9264598.65999.65
692881-9288198.91099.90
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.715339253526537325351053424535170.25
214.695443754017542270.55
单位质量响应值RSD%判断
3638.143691.421.03数据可信
中间条件3月-供试品溶液-2023101322批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155111-5511194.95291.373.7994.9591.373.79
252556-5255690.55090.55
354972-5497294.71294.71
452820-5282091.00591.00
553130-5313091.53991.54
649600-4960085.45785.46
10min155477-5547795.58393.113.1795.7493.263.17
254515-5451593.92594.08
356430-5643097.22497.38
452117-5211789.79489.95
553093-5309391.47591.63
652610-5261090.64390.79
15min155116-5511694.96192.352.5595.2892.662.54
253966-5396692.97993.29
354801-5480194.41894.74
453752-5375292.61192.91
551750-5175089.16189.47
652204-5220489.94390.24
20min151713-5171389.09792.303.0089.5792.772.99
255040-5504094.83095.29
355170-5517095.05495.53
453695-5369592.51292.97
554306-5430693.56594.02
651524-5152488.77289.22
30min154399-5439993.72592.651.2094.3593.261.20
253846-5384692.77293.39
354027-5402793.08493.72
454172-5417293.33493.94
553604-5360492.35692.97
652585-5258590.60091.19
45min154998-5499894.75792.762.1795.5493.542.16
253028-5302891.36392.14
355567-5556795.73896.53
453208-5320891.67392.44
553545-5354592.25493.02
652697-5269790.79391.54
极限151772-5177289.19991.723.5990.1492.643.56
255165-5516595.04595.97
355895-5589596.30397.25
452958-5295891.24392.16
551071-5107187.99188.91
652542-5254290.52691.42
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