托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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)7.5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%
116.482001832005572003662002652006812004100.11
216.552048212029272038740.66
单位质量响应值RSD%判断
12160.8012318.670.92数据可信
供试品溶液-2025051121批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180172-18017288.23788.063.5288.2488.063.52
2179765-17976588.03888.04
3169944-16994483.22883.23
4176137-17613786.26186.26
5186997-18699791.57991.58
6185894-18589491.03991.04
10min1192553-19255394.30097.262.0994.4597.402.08
2200705-20070598.29398.44
3199414-19941497.66097.80
4195394-19539495.69295.84
5199132-19913297.52297.67
6204352-204352100.079100.23
15min1193309-19330994.67198.142.3094.9798.452.30
2202215-20221599.03299.34
3202081-20208198.96799.27
4196210-19621096.09196.39
5203408-20340899.61699.93
6205161-205161100.475100.79
20min1194086-19408695.05198.042.1095.5198.512.10
2202665-20266599.25399.73
3203124-20312499.47799.94
4196619-19661996.29296.75
5199615-19961597.75998.24
6204989-204989100.391100.88
30min1193089-19308994.56397.982.2595.1898.622.25
2202616-20261699.22999.87
3203065-20306599.448100.08
4196606-19660696.28596.91
5199998-19999897.94698.59
6205043-205043100.417101.07
45min1193075-19307594.55697.902.2995.3398.702.29
2202421-20242199.13399.94
3203143-20314399.487100.28
4196086-19608696.03196.81
5199686-19968697.79498.60
6205033-205033100.412101.23
60min1192712-19271294.37897.932.3395.3198.902.33
2202166-20216699.00899.98
3202976-20297699.405100.37
4195760-19576095.87196.82
5201604-20160498.73399.70
6204599-204599100.200101.19
极限1195971-19597195.97497.691.8197.0798.821.81
2201197-20119798.53499.67
3202113-20211398.982100.11
4194767-19476795.38596.49
5198823-19882397.37198.51
6203963-20396399.888101.04
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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)7.5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%
116.482022722025592024302019562013162021070.25
216.552032102031242031670.03
单位质量响应值RSD%判断
12263.7712275.950.08数据可信
供试品溶液-2025051121批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181881-18188188.85186.296.1688.8586.296.16
2189183-18918392.41992.42
3185813-18581390.77290.77
4160508-16050878.41078.41
5169894-16989482.99683.00
6172552-17255284.29484.29
10min1201286-20128698.33198.111.6398.4898.261.63
2203850-20385099.58499.74
3204385-20438599.845100.00
4201449-20144998.41198.54
5198004-19800496.72896.87
6196040-19604095.76895.91
15min1202811-20281199.07698.551.6599.3998.861.65
2203180-20318099.25699.58
3204292-20429299.800100.12
4204793-204793100.044100.34
5198876-19887697.15497.45
6196443-19644395.96596.27
20min1201691-20169198.52998.611.4299.0199.081.42
2203256-20325699.29399.78
3203752-20375299.536100.02
4204343-20434399.824100.29
5201558-20155898.46498.93
6196500-19650095.99396.45
30min1201568-20156898.46998.411.7999.1199.051.78
2203481-20348199.403100.05
3203725-20372599.523100.17
4205582-205582100.430101.06
5198073-19807396.76197.39
6196301-19630195.89696.52
45min1205658-205658100.46798.561.93101.2799.361.93
2202873-20287399.10699.92
3203435-20343599.381100.20
4204588-20458899.944100.74
5198029-19802996.74097.53
6195899-19589995.69996.48
60min1201560-20156098.46598.041.7199.4499.001.71
2202354-20235498.85399.83
3203275-20327599.303100.28
4204049-20404999.681100.64
5197297-19729796.38297.33
6195606-19560695.55696.50
极限1201803-20180398.58497.781.5899.7298.911.57
2201295-20129598.33599.48
3202062-20206298.71099.86
4203239-20323999.285100.41
5197271-19727196.37097.48
6195263-19526395.38996.49
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