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1000
标示量(mg)15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%
116.603986774001703986803993593987473991270.17
216.663984973983013983990.04
单位质量响应值RSD%判断
24043.8023913.510.39数据可信
中间条件6月-供试品溶液-1批-shui(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1359150-35915089.77888.033.9289.7888.023.92
2338702-33870284.66784.67
3338174-33817484.53584.53
4373637-37363793.40093.40
5357127-35712789.27389.27
6346045-34604586.50286.50
10min1395441-39544198.85098.082.2399.0098.232.23
2387575-38757596.88497.02
3387422-38742296.84696.99
4407823-407823101.945102.10
5392853-39285398.20398.35
6383099-38309995.76595.91
15min1397932-39793299.47399.362.0999.7999.672.09
2395064-39506498.75699.06
3395032-39503298.74899.05
4411748-411748102.926103.25
5398831-39883199.697100.01
6386221-38622196.54596.85
20min1398513-39851399.61899.922.41100.10100.402.41
2396122-39612299.02099.49
3397094-39709499.26399.73
4416973-416973104.232104.73
5401801-401801100.440100.92
6387882-38788296.96097.43
30min1399880-39988099.960100.271.90100.61100.921.90
2401657-401657100.404101.04
3399692-39969299.913100.55
4412944-412944103.225103.90
5403273-403273100.808101.45
6389299-38929997.31597.94
45min1401039-401039100.249100.661.98101.06101.461.98
2401037-401037100.249101.05
3400497-400497100.114100.91
4416118-416118104.019104.86
5405524-405524101.371102.18
6391806-39180697.94198.73
60min1405922-405922101.470101.031.99102.45102.002.00
2403047-403047100.751101.72
3400709-400709100.167101.13
4416691-416691104.162105.18
5406387-406387101.586102.57
6392112-39211298.01898.97
极限1403494-403494100.863101.182.02102.01102.332.02
2403494-403494100.863102.00
3403866-403866100.956102.09
4417080-417080104.259105.45
5408587-408587102.136103.29
6392051-39205198.00399.12
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1000
标示量(mg)15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%
116.603983803981863985933987723981383984140.07
216.663996543996723996630.01
单位质量响应值RSD%判断
24000.8423989.380.04数据可信
中间条件6月-供试品溶液-2批-shui(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1352439-35243988.04085.102.9188.0485.102.91
2349518-34951887.31087.31
3339359-33935984.77284.77
4324419-32441981.04081.04
5340160-34016084.97284.97
6338234-33823484.49184.49
10min1395911-39591198.89995.562.8599.0595.702.85
2391484-39148497.79397.94
3376357-37635794.01494.16
4365999-36599991.42791.56
5386051-38605196.43696.58
6379404-37940494.77594.92
15min1401652-401652100.33397.002.78100.6497.302.78
2397808-39780899.37399.68
3381009-38100995.17695.47
4373444-37344493.28793.57
5392233-39223397.98098.28
6383614-38361495.82796.13
20min1401839-401839100.38097.162.75100.8697.622.75
2398311-39831199.49899.97
3381709-38170995.35195.81
4374470-37447093.54393.99
5393786-39378698.36898.83
6383491-38349195.79696.25
30min1401041-401041100.18097.162.64100.8397.782.65
2397825-39782599.377100.02
3380826-38082695.13195.75
4375416-37541693.77994.38
5394394-39439498.52099.15
6384127-38412795.95596.57
45min1400755-400755100.10997.092.63100.9297.882.63
2397696-39769699.345100.15
3380949-38094995.16195.94
4375080-37508093.69594.45
5393732-39373298.35599.15
6383883-38388395.89496.67
60min1400834-400834100.12996.912.69101.1197.862.69
2396716-39671699.100100.07
3381071-38107195.19296.12
4373626-37362693.33294.24
5392591-39259198.07099.03
6382959-38295995.66496.60
极限1399579-39957999.81596.692.70100.9697.802.70
2395620-39562098.82699.96
3379575-37957594.81895.91
4372581-37258193.07194.14
5392481-39248198.04299.16
6382530-38253095.55696.65
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