坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.113898038772389073905639235389900.45
216.133878539104389440.58
单位质量响应值RSD%判断
2420.242414.380.18数据可信
供试品溶液-2024102201-1批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13741-37418.7368.8320.318.748.8320.30
23505-35058.1858.19
32425-24255.6635.66
44160-41609.7159.71
54295-429510.03010.03
64571-457110.67510.67
10min19512-951222.21423.8018.9822.3123.9018.97
210006-1000623.36723.46
37373-737317.21817.28
410625-1062524.81324.92
510268-1026823.97924.09
613362-1336231.20531.32
15min117417-1741740.67441.7514.3641.0242.1114.39
216516-1651638.57038.92
314074-1407432.86733.12
419260-1926044.97845.36
518336-1833642.82143.20
621652-2165250.56551.03
20min124549-2454957.33057.3210.0758.1358.1510.15
222926-2292653.54054.32
320708-2070848.36048.98
426405-2640561.66462.55
525075-2507558.55859.41
627615-2761564.49065.52
30min133561-3356178.37676.944.6479.8178.414.77
230998-3099872.39173.76
331246-3124672.97074.13
434266-3426680.02281.59
532982-3298277.02478.53
634636-3463680.88782.63
45min139102-3910291.31689.052.1893.6291.372.26
237112-3711286.66988.85
337676-3767687.98689.95
438948-3894890.95693.41
537465-3746587.49389.85
638491-3849189.88992.53
60min140166-4016693.80190.891.7597.1294.201.75
238185-3818589.17592.32
338880-3888090.79893.74
438753-3875390.50193.97
538510-3851089.93493.27
639024-3902491.13494.78
极限141184-4118496.17892.292.35100.5496.602.26
238726-3872690.43894.57
339842-3984293.04497.00
439232-3923291.62096.09
538691-3869190.35694.69
639430-3943092.08296.74
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.113898338889391403894239094390100.27
216.133897839098390380.22
单位质量响应值RSD%判断
2421.482420.210.04数据可信
供试品溶液-2024102201-2批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15125-512511.9518.7735.6411.958.7735.64
23406-34067.9437.94
35667-566713.21513.21
43203-32037.4697.47
52963-29636.9096.91
62206-22065.1445.14
10min113819-1381932.22523.2132.5032.3623.3132.51
27714-771417.98818.08
314276-1427633.29033.44
47845-784518.29418.38
58999-899920.98521.06
67069-706916.48416.54
15min121683-2168350.56338.9523.7751.0539.3123.84
212813-1281329.87930.17
321482-2148250.09450.61
414476-1447633.75734.04
516382-1638238.20138.51
613394-1339431.23431.47
20min126945-2694562.83452.7216.2963.8953.5116.45
218731-1873143.67944.30
327128-2712863.26064.33
420680-2068048.22448.89
522702-2270252.93953.67
619474-1947445.41246.00
30min134494-3449480.43772.889.3482.1974.259.57
227380-2738063.84864.95
334353-3435380.10881.88
430060-3006070.09771.29
532231-3223175.16076.48
629005-2900567.63768.73
45min136120-3612084.22985.153.7286.8787.333.92
234917-3491781.42483.24
338330-3833089.38292.05
436061-3606184.09186.07
538016-3801688.65090.81
635644-3564483.11984.96
60min138623-3862390.06688.901.8693.6592.032.18
237069-3706986.44289.16
338720-3872090.29293.95
437712-3771287.94190.85
538836-3883690.56293.71
637783-3778388.10790.87
极限138421-3842189.59590.031.0994.1894.151.26
238242-3824289.17792.86
338846-3884690.58695.25
438136-3813688.93092.82
539249-3924991.52595.67
638754-3875490.37194.12
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.113881539078390163895038842389400.29
216.133890639353391300.81
单位质量响应值RSD%判断
2417.132425.910.26数据可信
供试品溶液-2024102201-3批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13564-35648.3097.3721.128.317.3721.12
24039-40399.4169.42
33209-32097.4817.48
42384-23845.5585.56
52367-23675.5185.52
63401-34017.9297.93
10min19901-990123.08220.4520.0723.1720.5320.07
211725-1172527.33427.44
38511-851119.84119.92
47113-711316.58216.64
57272-727216.95317.01
68120-812018.93019.02
15min116392-1639238.21434.7313.2838.5635.0413.33
218081-1808142.15242.56
314162-1416233.01533.32
412861-1286129.98230.23
513359-1335931.14331.39
614540-1454033.89734.20
20min122788-2278853.12548.1711.2153.9048.8711.28
224313-2431356.68057.56
319451-1945145.34646.02
418633-1863343.43944.02
519112-1911244.55545.15
619677-1967745.87246.55
30min131000-3100072.26969.026.3973.6370.256.52
232692-3269276.21477.72
328801-2880167.14368.32
427705-2770564.58865.65
528194-2819465.72866.82
629240-2924068.16669.35
45min136169-3616984.32083.142.9086.4985.143.06
237165-3716586.64289.00
336137-3613784.24586.17
434285-3428579.92881.71
535334-3533482.37384.19
634896-3489681.35283.29
60min138261-3826189.19788.101.3392.3091.021.49
238317-3831789.32792.64
337957-3795788.48891.34
437576-3757687.60090.27
537655-3765587.78490.52
636974-3697486.19689.04
极限137643-3764387.75687.841.2991.8591.741.35
238091-3809188.80093.11
338010-3801088.61292.45
438119-3811988.86692.51
536970-3697086.18789.90
637235-3723586.80590.61
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.113891839053390663912538986390300.21
216.133879038776387830.03
单位质量响应值RSD%判断
2422.722404.400.54数据可信
供试品溶液-24102202批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14426-442610.35210.1915.8110.3510.1915.80
25544-554412.96712.97
34514-451410.55810.56
43582-35828.3788.38
54287-428710.02710.03
63786-37868.8558.86
10min112780-1278029.89228.887.6330.0129.007.66
213870-1387032.44232.59
312255-1225528.66428.78
411042-1104225.82725.92
512239-1223928.62728.74
611897-1189727.82727.93
15min120961-2096149.02847.844.6749.4748.274.70
221359-2135949.95850.46
320791-2079148.63049.07
418619-1861943.55043.93
520507-2050747.96648.40
620476-2047647.89348.30
20min127002-2700263.15762.033.6564.1563.003.67
227533-2753364.39965.46
326188-2618861.25362.23
424897-2489758.23459.10
526232-2623261.35662.32
627279-2727963.80564.75
30min133237-3323777.74177.951.9979.4379.602.02
233363-3336378.03679.81
333549-3354978.47180.13
432163-3216375.22976.74
533438-3343878.21179.86
634203-3420380.00081.65
45min136450-3645085.25686.071.4787.8188.591.38
236046-3604684.31186.95
336729-3672985.90988.44
436995-3699586.53188.88
536932-3693286.38488.90
637640-3764088.04090.58
60min137349-3734987.35987.260.3590.8690.730.30
237061-3706186.68590.26
337315-3731587.27990.76
437365-3736587.39690.70
537304-3730487.25490.73
637436-3743687.56291.08
极限136632-3663285.68286.921.0490.1691.370.94
236784-3678486.03790.58
337556-3755687.84392.30
437383-3738387.43891.72
537498-3749887.70792.15
637124-3712486.83391.32
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