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4000
标示量(mg)4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%
116.117679876785767627673977011768190.15
216.157738377421774020.04
单位质量响应值RSD%判断
4768.404792.690.36数据可信
长期3月-供试品溶液-2025022821批-含0.35%吐温20的pH6.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113329-1332915.65220.3827.3715.6520.3827.37
219425-1942522.81122.81
315600-1560018.31918.32
416999-1699919.96219.96
525743-2574330.23030.23
613027-1302715.29815.30
10min139938-3993846.89950.8015.4746.9350.8315.47
249442-4944258.06058.10
342415-4241549.80849.84
443656-4365651.26551.30
551283-5128360.22160.27
632805-3280538.52338.55
15min163410-6341074.46273.9611.1674.5774.0811.17
268241-6824180.13580.27
363501-6350174.56974.68
461433-6143372.14172.26
570786-7078683.12483.27
650511-5051159.31559.40
20min175585-7558588.75986.016.8688.9986.256.88
276866-7686690.26490.53
373620-7362086.45286.69
471459-7145983.91484.15
577822-7782291.38691.68
664116-6411675.29175.48
30min180458-8045894.48292.423.7894.8692.803.80
279939-7993993.87294.29
378198-7819891.82892.21
477144-7714490.59090.97
582497-8249796.87697.32
673969-7396986.86287.18
45min181509-8150995.71693.623.2996.2594.163.31
281066-8106695.19695.77
379270-7927093.08793.62
478046-7804691.64992.18
582807-8280797.24097.84
675638-7563888.82289.28
60min181831-8183196.09493.763.1196.7994.463.14
280676-8067694.73895.47
379226-7922693.03593.72
478425-7842592.09492.78
582878-8287897.32398.09
676031-7603189.28389.89
极限181720-8172095.96494.491.9096.8295.341.94
280712-8071294.78095.67
379659-7965993.54394.39
479522-7952293.38294.22
582642-8264297.04697.97
678536-7853692.22592.98
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4000
标示量(mg)4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%
116.117725277507774537735677401773940.13
216.157723677221772280.02
单位质量响应值RSD%判断
4804.104781.920.33数据可信
长期3月-供试品溶液-2025030121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111150-1115013.05916.4818.9713.0616.4818.97
213026-1302615.25715.26
313826-1382616.19416.19
413808-1380816.17316.17
513505-1350515.81815.82
619125-1912522.40022.40
10min131335-3133536.70141.4611.3436.7241.4911.35
232725-3272538.32938.35
335583-3558341.67641.70
435355-3535541.40941.44
534528-3452840.44140.47
642887-4288750.23150.27
15min149097-4909757.50563.2710.1357.5963.3710.13
250165-5016558.75558.84
354542-5454263.88263.98
454082-5408263.34363.44
551943-5194360.83860.93
664305-6430575.31775.44
20min163267-6326774.10178.746.3974.2878.956.40
262967-6296773.75073.94
368503-6850380.23480.44
467455-6745579.00679.21
566471-6647177.85478.05
674719-7471987.51487.76
30min176350-7635089.42490.481.8489.7390.811.87
276423-7642389.51089.82
376438-7643889.52889.86
476993-7699390.17890.51
577223-7722390.44790.77
680055-8005593.76494.16
45min180169-8016993.89793.431.3594.3593.921.37
279498-7949893.11293.57
378067-7806791.43591.92
479577-7957793.20493.69
579954-7995493.64694.12
681379-8137995.31595.86
60min180582-8058294.38193.881.1994.9994.521.19
280139-8013993.86294.48
378405-7840591.83192.47
480041-8004193.74894.39
580594-8059494.39595.03
681177-8117795.07895.79
极限181175-8117595.07694.661.4195.8495.461.41
281554-8155495.52096.29
378566-7856692.02092.81
480797-8079794.63395.43
581512-8151295.47096.26
681329-8132995.25696.12
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4000
标示量(mg)4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%
116.117793777820779757811078120779920.17
216.157828878358783230.07
单位质量响应值RSD%判断
4841.224849.720.13数据可信
长期3月-供试品溶液-2025030221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113751-1375115.93114.3715.9315.9314.3715.93
210779-1077912.48812.49
312890-1289014.93414.93
410679-1067912.37212.37
515477-1547717.93117.93
610851-1085112.57212.57
10min135401-3540141.01438.489.3041.0438.509.30
231926-3192636.98837.01
333076-3307638.32038.35
430066-3006634.83334.85
538168-3816844.22044.25
630626-3062635.48235.50
15min153111-5311161.53259.936.2261.6360.026.22
252302-5230260.59560.68
350532-5053258.54458.63
448144-4814455.77855.86
557087-5708766.13966.24
649196-4919656.99657.08
20min167758-6775878.50276.084.9578.7076.274.96
267412-6741278.10178.28
363861-6386173.98774.17
461694-6169471.47671.65
570133-7013381.25381.47
663151-6315173.16473.34
30min177969-7796990.33289.231.0890.6689.551.11
277462-7746289.74490.06
376789-7678988.96489.27
475916-7591687.95388.24
577731-7773190.05690.41
676256-7625688.34788.64
45min180750-8075093.55492.430.9994.0392.900.98
279007-7900791.53492.00
379170-7917091.72392.18
480289-8028993.01993.46
579056-7905691.59192.09
680432-8043293.18593.63
60min181098-8109893.95792.841.1594.5993.461.14
279086-7908691.62692.24
379514-7951492.12292.73
480457-8045793.21493.81
579429-7942992.02392.68
681230-8123094.11094.71
极限181233-8123394.11392.941.1394.9093.711.12
279135-7913591.68292.45
379889-7988992.55693.32
480430-8043093.18393.93
579400-7940091.98992.79
681241-8124194.12294.88
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