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%
115.943750437093369533727537297372240.57
215.973811637912380140.38
单位质量响应值RSD%判断
2335.262380.341.36数据可信
供试品溶液-2025030321批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16974-697416.60614.2213.6616.6114.2213.67
27046-704616.77816.78
35687-568713.54213.54
45350-535012.73912.74
55371-537112.78912.79
65391-539112.83712.84
10min118671-1867144.45839.6510.7944.4939.6810.79
219135-1913545.56345.59
315042-1504235.81735.84
415252-1525236.31736.34
515558-1555837.04637.07
616264-1626438.72738.75
15min126999-2699964.28961.755.1864.3961.845.19
227887-2788766.40366.51
324575-2457558.51758.60
424564-2456458.49058.57
525412-2541260.51060.59
626148-2614862.26262.35
20min132741-3274177.96176.703.5878.1776.893.59
233703-3370380.25280.47
330940-3094073.67373.85
430744-3074473.20673.39
532345-3234577.01877.20
632785-3278578.06678.26
30min137909-3790990.26790.311.7690.6190.631.76
238354-3835491.32791.67
338105-3810590.73491.04
436705-3670587.40087.70
537861-3786190.15390.46
638629-3862991.98192.30
45min139788-3978894.74195.822.6195.2396.292.61
240832-4083297.22797.73
339542-3954294.15594.61
438784-3878492.35092.80
540842-4084297.25197.71
641649-4164999.17299.65
60min140118-4011895.52796.982.0296.1797.612.03
241940-4194099.865100.53
340154-4015495.61396.22
439896-3989694.99895.60
540831-4083197.22597.85
641439-4143998.67299.31
极限140603-4060396.68296.861.3597.4997.651.35
240700-4070096.91397.74
340564-4056496.58997.36
439778-3977894.71795.48
541431-4143198.65399.44
640981-4098197.58298.38
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%
115.943827338193380443768938394381190.72
215.973737937735375570.68
单位质量响应值RSD%判断
2391.412351.721.19数据可信
供试品溶液-2025030321批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15853-585313.85613.2815.5113.8613.2815.51
24828-482811.42911.43
36903-690316.34116.34
45410-541012.80712.81
54541-454110.75010.75
66117-611714.48114.48
10min117841-1784142.23539.1415.2942.2639.1615.29
214411-1441134.11534.13
320245-2024547.92547.95
415066-1506635.66535.69
513727-1372732.49632.51
617912-1791242.40342.43
15min127474-2747465.03961.029.3765.1361.119.38
223940-2394056.67356.75
328785-2878568.14268.25
424520-2452058.04658.13
522627-2262753.56453.64
627313-2731364.65764.75
20min133379-3337979.01775.435.0279.2275.625.04
230612-3061272.46772.64
333430-3343079.13879.36
431647-3164774.91775.09
529461-2946169.74269.90
632662-3266277.32077.52
30min138025-3802590.01688.511.6890.3588.821.71
236680-3668086.83287.12
337803-3780389.49089.84
437807-3780789.50089.80
536547-3654786.51786.79
637475-3747588.71489.05
45min139892-3989294.43593.621.3094.9294.081.29
239469-3946993.43493.87
339342-3934293.13393.64
440343-4034395.50395.95
539388-3938893.24293.66
638845-3884591.95792.44
60min140335-4033595.48494.071.2996.1394.691.28
239446-3944693.38093.97
339509-3950993.52994.19
440309-4030995.42296.03
539777-3977794.16394.74
639048-3904892.43793.07
极限140043-4004394.79394.531.0895.5995.311.07
239479-3947993.45894.20
339759-3975994.12094.93
440574-4057496.05096.82
540235-4023595.24795.98
639512-3951293.53694.32
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%
115.943719237318371433697537446372150.48
215.973693337114370240.35
单位质量响应值RSD%判断
2334.692318.350.50数据可信
供试品溶液-2025030421批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14365-436510.53312.9116.8910.5312.9116.90
25455-545513.16313.16
35060-506012.21012.21
46167-616714.88114.88
56596-659615.91615.92
64459-445910.75910.76
10min111968-1196828.87835.6314.3328.9035.6514.33
214964-1496436.10836.13
314355-1435534.63834.66
416080-1608038.80138.83
517979-1797943.38343.41
613251-1325131.97431.99
15min119409-1940946.83357.0211.4846.9057.1011.48
224149-2414958.27158.35
324016-2401657.95058.03
424647-2464759.47259.56
527509-2750966.37866.48
622064-2206453.24053.31
20min125659-2565961.91472.678.3162.0672.858.32
231144-3114475.14975.33
330959-3095974.70374.88
430861-3086174.46774.66
532963-3296379.53979.75
629111-2911170.24470.40
30min133153-3315379.99788.254.7380.2488.544.75
237647-3764790.84191.15
337075-3707589.46189.76
437113-3711389.55389.87
537814-3781491.24491.59
636627-3662788.38088.66
45min137070-3707089.44994.592.7789.8395.032.79
240119-4011996.80697.26
339533-3953395.39295.84
439535-3953595.39795.86
539221-3922194.63995.13
639721-3972195.84696.27
60min138024-3802491.75196.072.3192.2896.672.33
240536-4053697.81298.43
339775-3977595.97696.58
439965-3996596.43497.06
540308-4030897.26297.91
640275-4027597.18297.77
极限138950-3895093.98596.431.5694.6797.191.58
240703-4070398.21599.00
339628-3962895.62196.39
439921-3992196.32897.11
540410-4041097.50898.32
640166-4016696.91997.67
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%
115.943693337339373603692037042371190.59
215.973772237782377520.12
单位质量响应值RSD%判断
2328.672363.931.07数据可信
供试品溶液-2025030421批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15808-580813.89712.3318.2313.9012.3318.23
25362-536212.83012.83
36353-635315.20115.20
43967-39679.4929.49
55316-531612.72012.72
64120-41209.8589.86
10min116132-1613238.60035.2316.0538.6235.2516.05
215614-1561437.36037.38
317554-1755442.00242.03
411615-1161527.79227.81
515350-1535036.72836.75
612067-1206728.87328.89
15min126012-2601262.24057.2413.5462.3357.3213.55
225179-2517960.24760.33
327662-2766266.18866.28
419647-1964747.01047.07
524787-2478759.30959.39
620252-2025248.45848.52
20min132287-3228777.25472.3310.0677.4572.5010.07
231167-3116774.57474.76
333417-3341779.95880.16
425942-2594262.07262.21
531597-3159775.60375.78
626965-2696564.52064.67
30min137845-3784590.55387.744.8990.8788.034.91
236938-3693888.38388.69
338427-3842791.94592.28
434125-3412581.65281.90
537888-3788890.65690.96
634792-3479283.24883.50
45min139768-3976895.15494.602.0195.6395.042.05
239519-3951994.55895.01
340610-4061097.16997.66
438483-3848392.07992.46
540058-4005895.84896.31
638785-3878592.80293.19
60min139945-3994595.57895.571.7996.2196.171.82
239646-3964694.86295.48
341249-4124998.69899.35
439346-3934694.14494.68
540128-4012896.01596.63
639336-3933694.12094.67
极限139977-3997795.65496.170.6696.4496.930.64
239848-3984895.34696.12
340502-4050296.91097.73
440220-4022096.23696.93
540136-4013696.03596.81
640472-4047296.83997.54
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