厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161293031287281289341285271289491288880.23
210.111298851300681299760.10
单位质量响应值RSD%判断
12685.8312856.180.95数据可信
供试品溶液-BXK6BP1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126841-2684118.90114.7827.8918.9014.7827.89
220808-2080814.65314.65
327638-2763819.46219.46
422212-2221215.64115.64
514245-1424510.03110.03
614214-1421410.00910.01
10min150107-5010735.28533.6438.5035.4933.8038.43
243430-4343030.58330.75
381918-8191857.68657.90
447192-4719233.23233.41
532967-3296723.21523.33
631000-3100021.83021.94
15min162886-6288644.28444.4232.2244.8944.9632.24
259518-5951841.91242.41
3100967-10096771.10071.96
463712-6371244.86545.41
547965-4796533.77634.15
643387-4338730.55330.91
20min172836-7283651.29050.7028.0652.3851.7428.15
268376-6837648.15049.12
3109357-10935777.00878.66
472509-7250951.06052.10
557193-5719340.27541.02
651736-5173636.43237.13
30min182698-8269858.23558.7019.6859.9060.3019.98
284928-8492859.80561.31
3111311-11131178.38480.89
486587-8658760.97462.58
571536-7153650.37551.57
663085-6308544.42445.52
45min197531-9753168.68069.3915.0070.9971.6415.37
299721-9972170.22272.39
3122168-12216886.02989.40
4104440-10444073.54575.83
588905-8890562.60664.36
678458-7845855.24956.84
60min1105417-10541774.23374.9310.5977.3177.9511.07
2108996-10899676.75479.70
3122524-12252486.28090.61
4112318-11231879.09382.20
599687-9968770.19872.65
689484-8948463.01465.22
90min1116600-11660082.10882.826.4986.0186.676.99
2119345-11934584.04187.84
3125044-12504488.05593.34
4124610-12461087.74991.73
5115868-11586881.59384.82
6104201-10420173.37776.28
120min1124328-12432887.55087.583.5892.3692.354.07
2125968-12596888.70593.44
3126233-12623388.89295.16
4129632-12963291.28596.24
5123750-12375087.14391.28
6116311-11631181.90585.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1129104-12910490.91491.302.3296.7097.041.85
2130792-13079292.10297.82
3124581-12458187.72994.98
4132749-13274993.48099.45
5132251-13225193.13098.23
6128451-12845190.45495.08
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161317671318341318351319651318851318570.06
210.111327861325511326680.13
单位质量响应值RSD%判断
12978.0513122.450.79数据可信
供试品溶液-BXK6BP1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126047-2604717.94914.2115.3617.9514.2015.36
218546-1854612.78012.78
319249-1924913.26513.26
419620-1962013.52013.52
517570-1757012.10812.11
622654-2265415.61115.61
10min157441-5744139.58336.926.0839.7837.086.10
253033-5303336.54636.69
349850-4985034.35234.50
455830-5583038.47338.62
549736-4973634.27434.41
655583-5558338.30338.48
15min176978-7697853.04651.017.2053.6951.587.20
275764-7576452.21052.76
368151-6815146.96447.49
475919-7591952.31752.89
566902-6690246.10346.62
680461-8046155.44756.05
20min190216-9021662.16960.406.1663.4061.546.17
288552-8855261.02262.15
383144-8314457.29558.35
488635-8863561.07962.24
580026-8002655.14756.17
695320-9532065.68666.90
30min1105792-10579272.90272.064.2674.8273.864.31
2104684-10468472.13973.95
3101507-10150769.95071.64
4107785-10778574.27676.11
597636-9763667.28268.92
6110003-11000375.80477.75
45min1117743-11774381.13881.353.0083.8783.953.07
2118967-11896781.98184.59
3115481-11548179.57982.04
4120985-12098583.37286.04
5112762-11276277.70680.09
6122326-12232684.29687.08
60min1120977-12097783.36785.082.0587.0088.592.04
2123658-12365885.21488.73
3126154-12615486.93490.28
4123698-12369885.24288.83
5120135-12013582.78686.04
6126174-12617486.94890.67
90min1129400-12940089.17189.401.2193.7393.861.30
2130847-13084790.16894.63
3130363-13036389.83594.15
4130465-13046589.90594.44
5126706-12670687.31591.49
6130633-13063390.02194.71
120min1129400-12940089.17189.060.9994.7294.501.03
2127761-12776188.04293.51
3130879-13087990.19095.50
4128990-12899088.88894.42
5127922-12792288.15293.29
6130448-13044889.89395.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1129124-12912488.98189.981.2095.5296.421.26
2130795-13079590.13296.58
3130327-13032789.81096.12
4132759-13275991.48698.01
5128667-12866788.66694.79
6131805-13180590.82897.52
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161327481326761328091326111326961327080.06
210.111324591326961325780.13
单位质量响应值RSD%判断
13061.8113113.550.28数据可信
供试品溶液-BXK6BP1批-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%
5min19119-91196.2666.9014.946.276.9014.96
210136-101366.9656.96
38692-86925.9725.97
411680-116808.0268.03
511985-119858.2358.24
68600-86005.9095.91
10min129511-2951120.27820.1710.2620.3520.2510.27
230584-3058421.01521.09
328992-2899219.92119.99
432172-3217222.10622.20
531203-3120321.44021.53
623669-2366916.26316.33
15min142812-4281229.41729.188.5529.7129.488.57
243706-4370630.03130.34
342587-4258729.26229.55
445232-4523231.08031.41
545033-4503330.94331.27
635406-3540624.32824.57
20min152831-5283136.30135.918.3436.9236.538.36
254363-5436337.35438.00
352552-5255236.11036.72
455513-5551338.14438.82
554643-5464337.54638.22
643665-4366530.00330.52
30min167247-6724746.20745.175.5547.2346.205.62
267990-6799046.71747.78
366053-6605345.38646.40
468005-6800546.72847.83
566702-6670245.83246.92
658456-5845640.16641.02
45min179741-7974154.79253.705.3556.3355.225.41
281635-8163556.09357.67
377562-7756253.29554.81
481077-8107755.71057.33
578707-7870754.08155.68
670183-7018348.22449.52
60min188378-8837860.72659.793.9262.8761.914.02
289360-8936061.40163.60
386451-8645159.40261.51
489628-8962861.58563.83
587782-8778260.31762.52
680467-8046755.29157.12
90min1100110-10011068.78867.293.9671.6170.074.04
2100305-10030568.92271.81
398902-9890267.95870.73
4100031-10003168.73471.66
597961-9796167.31170.18
690240-9024062.00664.45
120min1105785-10578572.68771.493.9876.2775.024.04
2107218-10721873.67277.32
3104435-10443571.76075.29
4103964-10396471.43675.13
5106840-10684073.41277.03
696023-9602365.98069.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1107670-10767073.98273.122.8878.3877.453.01
2108942-10894274.85679.33
3105833-10583372.72077.04
4109046-10904674.92879.41
5106245-10624573.00377.44
6100791-10079169.25673.12
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