坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.947367373969736287396373598737660.25
215.977419773764739800.42
单位质量响应值RSD%判断
4627.734632.440.08数据可信
供试品溶液-2025010921批-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116131-1613119.55824.4527.5319.5624.4527.53
216499-1649920.00420.00
314876-1487618.03618.04
426151-2615131.70731.71
527906-2790633.83533.83
619416-1941623.54123.54
10min139953-3995348.44156.3618.2148.4756.4018.21
256420-5642068.40768.44
336242-3624243.94243.97
456756-5675668.81468.87
544313-4431353.72753.78
645200-4520054.80354.84
15min162535-6253575.82180.2211.7975.9380.3611.79
274055-7405589.78889.94
355292-5529267.03967.14
474831-7483190.72990.90
561080-6108074.05774.20
669204-6920483.90784.04
20min177815-7781594.34793.585.3694.5993.855.37
279512-7951296.40496.70
369905-6990584.75684.97
481204-8120498.45698.77
575070-7507091.01991.29
679603-7960396.51596.79
30min183149-83149100.814100.601.87101.21101.031.89
281605-8160598.94299.40
381053-8105398.27398.63
485068-85068103.141103.62
584350-84350102.270102.69
682623-82623100.176100.61
45min182990-82990100.621100.701.31101.19101.291.30
281403-8140398.69799.32
382622-82622100.175100.70
482969-82969100.596101.25
584646-84646102.629103.22
683698-83698101.480102.08
60min183153-83153100.819100.661.15101.55101.421.15
281693-8169399.04999.84
382474-8247499.996100.68
483094-83094100.747101.57
584586-84586102.556103.32
683147-83147100.812101.58
极限183961-83961101.799101.271.15102.70102.201.13
282032-8203299.460100.41
383417-83417101.139101.99
483236-83236100.920101.91
584964-84964103.015103.95
683551-83551101.302102.24
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.943738937202368673692836851370470.65
215.973751837772376450.48
单位质量响应值RSD%判断
2324.152357.231.00数据可信
供试品溶液-2025011621批-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114358-1435834.43733.2413.0534.4433.2413.05
215536-1553637.26237.26
313245-1324531.76731.77
414739-1473935.35135.35
510500-1050025.18425.18
614779-1477935.44735.45
10min131479-3147975.50171.1211.4975.5671.1811.49
231498-3149875.54675.61
328371-2837168.04668.10
431735-3173576.11576.17
523216-2321655.68255.72
631615-3161575.82775.89
15min140025-4002595.99892.285.2896.1892.465.30
238930-3893093.37293.56
337800-3780090.66190.83
439623-3962395.03495.22
534672-3467283.15983.29
639806-3980695.47395.66
20min141459-4145999.43797.612.0099.7897.942.02
240500-4050097.13797.48
340150-4015096.29896.62
441399-4139999.29399.64
539429-3942994.56894.84
641236-4123698.90299.25
30min140876-4087698.03999.011.2598.5599.501.25
241096-4109698.56799.07
341030-4103098.40898.89
442262-42262101.363101.87
541004-4100498.34698.78
641420-4142099.34499.85
45min141686-4168699.98299.061.37100.6599.721.36
240634-4063497.45998.13
340821-4082197.90798.55
441247-4124798.92999.61
541263-4126398.96799.56
642168-42168101.138101.81
60min141392-4139299.27798.170.81100.1298.990.82
240672-4067297.55098.38
340499-4049997.13597.94
441162-4116298.72599.57
540841-4084197.95598.71
641027-4102798.40199.24
极限141762-41762100.164100.482.61101.17101.472.60
241079-4107998.52699.52
341543-4154399.639100.61
441409-4140999.317100.33
541497-4149799.528100.45
644074-44074105.709106.72
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