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%
115.973776137778375253761637804376970.33
215.943766237720376910.11
单位质量响应值RSD%判断
2360.492364.550.13数据可信
供试品溶液-2025030321批-含0.35%吐温20的磷酸盐缓冲液(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%
5min16513-651315.47623.7018.6515.4823.7018.65
211727-1172727.86527.87
310020-1002023.80923.81
410271-1027124.40624.41
59883-988323.48423.48
611439-1143927.18127.18
10min118375-1837543.66257.7913.2243.6957.8313.23
227378-2737865.05565.10
324718-2471858.73458.77
424558-2455858.35458.39
523992-2399257.00957.05
626902-2690263.92463.97
15min128787-2878768.40380.077.4968.5080.207.50
235155-3515583.53483.69
334139-3413981.12081.26
433606-3360679.85479.99
534699-3469982.45182.58
635794-3579485.05385.20
20min135285-3528583.84388.753.5184.0689.023.52
237619-3761989.38989.68
338056-3805690.42890.70
436543-3654386.83287.10
537507-3750789.12389.39
639094-3909492.89493.19
30min138289-3828990.98192.642.1491.3393.062.14
238027-3802790.35990.80
339269-3926993.31093.73
438684-3868491.92092.34
539351-3935193.50593.92
640306-4030695.77496.22
45min138974-3897492.60993.462.0093.1194.032.01
238580-3858091.67392.27
339692-3969294.31594.89
438729-3872992.02792.60
539301-3930193.38693.96
640712-4071296.73997.35
60min139092-3909292.88993.611.9893.5594.341.98
239088-3908892.88093.63
339601-3960194.09994.83
438734-3873492.03992.76
538982-3898292.62893.36
640874-4087497.12497.89
极限139585-3958594.06194.692.1194.8795.572.11
239046-3904692.78093.68
340011-4001195.07395.97
439597-3959794.08994.96
539426-3942693.68394.57
641437-4143798.46199.39
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%
115.973794537906378823773037701378330.30
215.943768737737377120.10
单位质量响应值RSD%判断
2369.002365.870.10数据可信
供试品溶液-2025030421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15908-590814.00916.3410.1214.0116.3410.12
27464-746417.69917.70
37075-707516.77616.78
46475-647515.35415.35
56610-661015.67415.67
67811-781118.52218.52
10min116983-1698340.27143.909.7640.2943.929.76
218775-1877544.52044.55
318595-1859544.09344.12
416984-1698440.27340.30
517882-1788242.40242.43
621853-2185351.81951.85
15min126939-2693963.87967.267.9763.9767.367.98
227895-2789566.14666.25
328708-2870868.07368.17
426628-2662863.14163.23
527296-2729664.72564.82
632726-3272677.60177.72
20min135377-3537783.88782.763.7584.0882.983.75
234402-3440281.57581.79
335341-3534183.80284.02
433056-3305678.38478.58
534314-3431481.36781.57
636927-3692787.56387.81
30min138965-3896592.39590.492.0592.7390.842.05
238599-3859991.52791.88
337897-3789789.86390.22
436750-3675087.14387.47
538225-3822590.64090.98
638535-3853591.37691.77
45min139411-3941193.45392.261.2493.9492.761.24
239481-3948193.61994.12
338636-3863691.61592.12
438208-3820890.60091.07
538884-3888492.20392.69
638826-3882692.06692.61
60min139601-3960193.90392.581.3094.5593.231.30
239492-3949293.64594.30
339159-3915992.85593.51
438207-3820790.59891.22
538992-3899292.45993.10
638801-3880192.00692.70
极限139667-3966794.06093.081.1894.8693.881.16
239801-3980194.37895.19
339225-3922593.01293.82
438750-3875091.88592.66
539380-3938093.37994.18
638690-3869091.74392.59
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%
115.973772237701377953783037851377800.18
215.943833338084382080.47
单位质量响应值RSD%判断
2365.692396.990.93数据可信
供试品溶液-2025030422批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113129-1312930.95224.2422.8430.9524.2422.83
27838-783818.47818.48
37827-782718.45218.45
410016-1001623.61323.61
59907-990723.35623.36
612971-1297130.57930.58
10min127079-2707963.83954.9515.3463.8955.0015.34
218793-1879344.30444.34
319554-1955446.09846.13
423709-2370955.89455.93
523554-2355455.52855.57
627172-2717264.05864.11
15min134013-3401380.18676.607.5080.3476.747.52
228736-2873667.74567.85
330165-3016571.11471.22
433454-3345478.86879.00
533849-3384979.79979.93
634745-3474581.91182.07
20min137676-3767688.82187.962.8689.1188.222.88
235956-3595684.76684.98
335972-3597284.80485.03
438127-3812789.88490.15
538288-3828890.26490.53
637839-3783989.20589.50
30min139000-3900091.94292.510.8792.3892.920.88
238760-3876091.37791.74
339160-3916092.32092.69
439567-3956793.27993.69
539652-3965293.47993.89
639302-3930292.65493.10
45min139853-3985393.95393.240.6194.5593.800.64
239279-3927992.60093.11
339271-3927192.58193.10
439758-3975893.72994.30
539583-3958393.31793.89
639563-3956393.27093.87
60min139157-3915792.31293.290.8593.0694.000.86
239378-3937892.83393.50
339518-3951893.16493.84
439424-3942492.94293.67
540011-4001194.32695.05
639941-3994194.16194.91
极限139520-3952093.16893.290.5094.0794.170.50
239796-3979693.81994.64
339316-3931692.68793.52
439698-3969893.58894.47
539387-3938792.85593.74
639725-3972593.65294.56
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