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%
116.297607476215760757603776110761020.09
216.337628076411763460.13
单位质量响应值RSD%判断
4671.704675.200.06数据可信
加速6月-供试品溶液-2025022821批-含0.35%吐温20的pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18248-82489.9089.257.959.919.257.95
26928-69288.3228.32
37007-70078.4178.42
48301-83019.9719.97
58067-80679.6909.69
67670-76709.2139.21
10min126936-2693632.35630.685.5032.3730.705.49
224194-2419429.06229.08
324929-2492929.94529.96
427529-2752933.06833.08
524220-2422029.09329.11
625461-2546130.58430.60
15min143821-4382152.63852.626.4052.7152.686.39
243296-4329652.00752.07
343134-4313451.81351.88
448719-4871958.52158.59
540017-4001748.06848.13
643846-4384652.66852.73
20min158318-5831870.05270.785.1270.2170.935.12
259121-5912171.01671.17
358683-5868370.49070.64
463575-6357576.36676.54
554149-5414965.04465.19
659677-5967771.68471.84
30min174335-7433589.29189.152.1089.5789.422.10
274588-7458889.59589.86
373812-7381288.66388.93
476092-7609291.40291.70
571467-7146785.84686.10
675018-7501890.11290.39
45min179138-7913895.06194.121.2595.4894.541.26
278544-7854494.34794.76
377824-7782493.48293.90
478947-7894794.83195.28
576629-7662992.04792.44
679048-7904894.95395.38
60min179494-7949495.48894.511.0796.0795.091.08
279061-7906194.96895.54
378361-7836194.12794.70
479176-7917695.10695.71
577159-7715992.68393.23
678837-7883794.69995.28
极限179419-7941995.39894.391.0096.1495.131.01
279003-7900394.89895.63
378239-7823993.98194.71
479146-7914695.07095.84
577266-7726692.81293.52
678405-7840594.18094.92
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%
116.297651376428763117672776609765180.21
216.337651576441764780.07
单位质量响应值RSD%判断
4697.244683.280.22数据可信
加速6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%
5min17544-75449.0299.6913.889.039.6913.88
29723-972311.63711.64
37005-70058.3848.38
48701-870110.41410.41
56898-68988.2568.26
68700-870010.41310.41
10min124213-2421328.98029.419.9429.0029.439.94
227745-2774533.20833.23
321051-2105125.19625.21
426714-2671431.97431.99
522964-2296427.48627.50
624750-2475029.62329.64
15min141502-4150249.67449.439.3849.7449.509.38
245842-4584254.86854.94
335529-3552942.52542.58
445113-4511353.99654.07
538779-3877946.41546.47
641047-4104749.12949.20
20min157537-5753768.86667.698.1269.0167.848.12
260737-6073772.69672.86
349250-4925058.94759.07
461780-6178073.94474.10
554150-5415064.81264.95
655869-5586966.86967.02
30min173036-7303687.41787.673.4687.6887.933.48
275520-7552090.39090.68
368841-6884182.39682.62
475898-7589890.84291.13
572645-7264586.94987.19
673538-7353888.01788.28
45min178743-7874394.24793.781.9294.6594.181.93
278382-7838293.81594.25
375805-7580590.73191.09
480198-8019895.98996.42
579250-7925094.85495.24
677732-7773293.03793.44
60min179104-7910494.67994.211.2395.2494.771.24
278688-7868894.18294.78
377135-7713592.32392.84
479068-7906894.63695.23
580013-8001395.76796.32
678258-7825893.66794.23
极限179268-7926894.87694.500.8895.6095.220.88
278842-7884294.36695.12
378366-7836693.79694.46
479270-7927094.87895.63
579950-7995095.69296.40
678034-7803493.39994.12
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%
116.297665877065767667681976657767930.22
216.337687976566767220.29
单位质量响应值RSD%判断
4714.124698.220.24数据可信
加速6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%
5min114774-1477417.62313.2524.1917.6213.2524.18
26893-68938.2228.22
312936-1293615.43115.43
411121-1112113.26613.27
511021-1102113.14613.15
69883-988311.78911.79
10min139874-3987447.56437.5716.8947.5937.5916.90
223824-2382428.41928.43
333752-3375240.26140.29
430444-3044436.31536.34
532021-3202138.19638.22
629056-2905634.66034.68
15min160719-6071972.42960.3712.9872.5460.4512.99
240719-4071948.57248.63
352975-5297563.19163.28
448486-4848657.83757.92
552029-5202962.06362.15
648721-4872158.11758.19
20min171167-7116784.89277.647.0685.1277.827.08
257467-5746768.55068.69
366734-6673479.60479.80
462955-6295575.09675.28
566861-6686179.75579.94
665337-6533777.93778.11
30min177944-7794492.97689.903.3393.3590.223.35
271293-7129385.04285.30
375196-7519689.69890.03
474061-7406188.34488.65
575835-7583590.46090.78
677862-7786292.87893.18
45min179051-7905194.29692.242.3394.8292.702.35
275069-7506989.54689.94
376693-7669391.48391.96
476196-7619690.89191.34
577081-7708191.94692.42
679859-7985995.26095.72
60min178828-7882894.03092.472.1094.7193.082.12
275160-7516089.65590.20
377488-7748892.43293.06
476397-7639791.13091.73
577546-7754692.50193.13
679679-7967995.04595.66
极限179243-7924394.52593.051.7095.3693.831.71
277444-7744492.37993.08
377236-7723692.13192.92
476700-7670091.49292.25
577376-7737692.29893.08
680052-8005295.49096.27
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%
116.297669776857769437674276691767860.15
216.337777277861778160.09
单位质量响应值RSD%判断
4713.694765.220.77数据可信
加速6月-供试品溶液-12412515批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110536-1053612.48011.5021.2712.4811.5021.28
211616-1161613.75913.76
37441-74418.8148.81
47651-76519.0639.06
512286-1228614.55314.55
68719-871910.32810.33
10min130450-3045036.06834.9811.1236.0935.0011.13
231477-3147737.28537.31
327521-2752132.59932.61
424482-2448228.99929.01
533958-3395840.22340.25
629290-2929034.69434.71
15min151540-5154061.04958.999.5761.1359.079.57
250893-5089360.28360.37
348139-4813957.02157.09
441236-4123648.84448.91
555177-5517765.35865.45
651840-5184061.40561.48
20min169707-6970782.56879.519.0382.7579.689.03
267494-6749479.94780.13
365943-6594378.11078.27
455767-5576766.05666.20
572372-7237285.72585.93
671459-7145984.64484.82
30min184401-8440199.97497.094.76100.2997.404.77
283132-8313298.47098.79
383027-8302798.34698.64
474093-7409387.76488.02
583206-8320698.55898.90
683959-8395999.45099.77
45min186467-86467102.421100.512.38102.91100.982.40
285446-85446101.211101.69
385387-85387101.142101.60
481079-8107996.03996.44
584295-8429599.848100.36
686436-86436102.384102.87
60min185832-85832101.66999.872.23102.33100.512.25
285474-85474101.245101.90
385065-85065100.760101.39
480957-8095795.89496.46
583249-8324998.60999.28
685305-85305101.044101.70
极限185516-85516101.29499.801.39102.12100.601.39
284516-84516100.110100.93
384737-84737100.372101.17
483222-8322298.57799.30
582469-8246997.68598.52
685049-85049100.741101.56
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