氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576745716761966749776762046750586754010.12
214.716732556739106735820.07
单位质量响应值RSD%判断
46355.5945790.750.87数据可信
高温30天-供试品溶液-24030401-PVC批-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%
5min1214770-21477027.05123.7114.8527.0523.7114.85
2149770-14977018.86418.86
3208746-20874626.29226.29
4164990-16499020.78120.78
5213703-21370326.91626.92
6177683-17768322.37922.38
10min1404100-40410050.89745.1014.5750.9445.1414.57
2279546-27954635.20935.24
3396789-39678949.97650.02
4323130-32313040.69940.73
5405382-40538251.05851.10
6339360-33936042.74342.78
15min1556841-55684170.13562.5914.2770.2662.7114.27
2386478-38647848.67748.77
3552201-55220169.55069.68
4452734-45273457.02257.12
5558938-55893870.39970.53
6474558-47455859.77159.88
20min1676428-67642885.19776.8513.2985.4477.0613.30
2480371-48037160.50360.67
3673395-67339584.81585.06
4560401-56040170.58370.78
5679367-67936785.56785.81
6590899-59089974.42574.63
30min1804606-804606101.34195.179.57101.7395.529.59
2626991-62699178.97079.24
3811100-811100102.159102.54
4723999-72399991.18991.50
5811237-811237102.176102.57
6755862-75586295.20295.53
45min1792592-79259299.828101.953.25100.39102.463.27
2764847-76484796.33496.74
3819089-819089103.165103.72
4817843-817843103.008103.48
5825095-825095103.922104.48
6837224-837224105.450105.94
极限1807981-807981101.766104.121.48102.49104.791.42
2838790-838790105.647106.21
3818577-818577103.101103.83
4831185-831185104.689105.33
5824362-824362103.830104.56
6838974-838974105.670106.34
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576732336734096736276734276736846734760.03
214.716729436745426737420.17
单位质量响应值RSD%判断
46223.4745801.630.65数据可信
高温30天-供试品溶液-24030401-PVDC批-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%
5min1190584-19058424.03624.4916.5224.0424.4916.51
2203030-20303025.60525.61
3208414-20841426.28426.28
4211050-21105026.61726.62
5220155-22015527.76527.76
6131837-13183716.62716.63
10min1344552-34455243.45344.8514.3043.4944.8914.31
2367203-36720346.31046.35
3373754-37375447.13647.18
4388201-38820148.95849.00
5400791-40079150.54650.59
6259492-25949232.72632.75
15min1468701-46870159.11060.9213.9359.2261.0413.93
2498437-49843762.86162.98
3501136-50113663.20163.32
4530977-53097766.96467.09
5542605-54260568.43168.56
6356507-35650744.96145.04
20min1577251-57725172.80074.3213.3873.0174.5413.38
2610299-61029976.96877.19
3609808-60980876.90677.13
4644194-64419481.24381.48
5655581-65558182.67982.92
6438833-43883355.34455.50
30min1736291-73629192.85893.0711.5793.1993.4111.58
2767614-76761496.80897.16
3760393-76039395.89796.25
4790690-79069099.718100.09
5802313-802313101.184101.57
6570383-57038371.93472.18
45min1807133-807133101.792101.555.75102.28102.055.78
2830865-830865104.785105.30
3817753-817753103.131103.65
4823412-823412103.845104.38
5838754-838754105.780106.33
6713464-71346489.97990.35
极限1808113-808113101.915104.161.62102.57104.821.58
2830732-830732104.768105.46
3815882-815882102.895103.58
4820657-820657103.497104.21
5836423-836423105.486106.21
6843488-843488106.377106.90
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576749856748296748786744576746086747510.04
214.716752196751176751680.02
单位质量响应值RSD%判断
46310.9845898.570.64数据可信
加速1月-供试品溶液-24030401-PVC批-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%
5min1333228-33322841.94140.5311.7341.9440.5311.72
2344287-34428743.33343.33
3341012-34101242.92142.92
4355057-35505744.68844.69
5252789-25278931.81731.82
6305884-30588438.49938.50
10min1628097-62809779.05476.578.9279.1276.638.93
2633611-63361179.74879.82
3646716-64671681.39881.47
4647836-64783681.53881.61
5507511-50751163.87763.93
6586182-58618273.77973.84
15min1791589-79158999.63296.966.2199.8397.156.22
2787534-78753499.12199.33
3802537-802537101.010101.22
4805189-805189101.343101.55
5679668-67966885.54585.70
6755576-75557695.09995.29
20min1821350-821350103.377103.142.19103.75103.502.21
2815491-815491102.640103.01
3834868-834868105.079105.45
4837482-837482105.408105.79
5787398-78739899.10499.41
6820358-820358103.253103.60
30min1821425-821425103.387103.650.72103.93104.180.72
2815607-815607102.655103.20
3833673-833673104.928105.48
4822739-822739103.552104.11
5824890-824890103.823104.29
6822704-822704103.548104.07
45min1817883-817883102.941103.811.05103.65104.521.05
2814110-814110102.466103.18
3831141-831141104.610105.34
4836422-836422105.274106.00
5828894-828894104.327104.97
6820420-820420103.260103.95
极限1816414-816414102.756103.541.01103.64104.411.01
2813292-813292102.363103.25
3830618-830618104.544105.44
4834336-834336105.012105.91
5821876-821876103.444104.26
6819161-819161103.102103.96
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.576738006743746746776745426753226745430.09
214.716739436739596739510.01
单位质量响应值RSD%判断
46296.7145815.840.74数据可信
加速1月-供试品溶液-24030401-PVDC批-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%
5min1332782-33278241.92938.6014.4541.9338.6014.45
2282112-28211235.54535.55
3340564-34056442.91042.91
4339316-33931642.75342.75
5227844-22784428.70828.71
6315674-31567439.77439.77
10min1622267-62226778.40372.3611.8678.4772.4311.86
2532524-53252467.09667.16
3630551-63055179.44779.52
4620161-62016178.13878.21
5456925-45692557.57157.62
6583616-58361673.53373.60
15min1790245-79024599.56893.699.0499.7793.889.05
2705106-70510688.84189.01
3794253-794253100.073100.28
4788825-78882599.38999.59
5624933-62493378.73978.88
6758358-75835895.55095.74
20min1834718-834718105.171102.834.38105.54103.174.40
2807107-807107101.693102.01
3842430-842430106.143106.51
4836974-836974105.456105.82
5747669-74766994.20494.48
6827917-827917104.314104.66
30min1833802-833802105.056105.391.20105.60105.901.19
2821599-821599103.518104.01
3843794-843794106.315106.86
4841227-841227105.991106.53
5848663-848663106.928107.36
6829433-829433104.505105.03
45min1834365-834365105.127105.371.34105.84106.051.32
2823016-823016103.697104.36
3841383-841383106.011106.74
4838027-838027105.588106.31
5854178-854178107.623108.23
6826596-826596104.148104.84
极限1831801-831801104.804105.031.31105.70105.891.28
2821254-821254103.475104.31
3838648-838648105.667106.57
4835420-835420105.260106.16
5850920-850920107.213108.00
6823396-823396103.745104.61
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