厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.909665696812970909724296892969380.24
212.869696797436972020.35
单位质量响应值RSD%判断
7514.577558.480.42数据可信
供试品溶液-FA4456批-氢氯噻嗪-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%
5min134651-3465136.67232.5411.1236.6732.5411.11
225660-2566027.15727.16
330833-3083332.63132.63
432382-3238234.27134.27
527797-2779729.41829.42
633168-3316835.10235.10
10min180181-8018184.85781.782.3385.0481.942.33
278600-7860083.18483.32
376315-7631580.76680.93
476785-7678581.26381.43
575229-7522979.61679.76
676533-7653380.99781.17
15min188533-8853393.69691.642.1594.3092.212.15
287963-8796393.09393.64
384496-8449689.42489.99
488314-8831493.46594.04
585211-8521190.18190.73
685042-8504290.00290.58
20min188075-8807593.21293.062.1594.2994.092.14
287495-8749592.59893.62
385393-8539390.37391.39
490977-9097796.28397.33
588793-8879393.97294.97
686865-8686591.93192.96
30min188603-8860393.77095.621.4995.3197.111.45
291929-9192997.29098.77
390462-9046295.73897.20
490491-9049195.76997.29
591629-9162996.97398.44
688991-8899194.18195.67
45min191172-9117296.48994.971.3998.5096.941.36
289214-8921494.41796.38
389762-8976294.99796.94
488813-8881393.99396.00
591235-9123596.55698.51
688224-8822493.36995.33
60min191337-9133796.66495.092.0399.1697.542.00
291245-9124596.56799.01
386867-8686791.93394.35
490191-9019195.45197.93
591034-9103496.34398.78
688449-8844993.60796.04
极限192089-9208997.46096.971.19100.4499.891.17
292690-9269098.096101.02
391812-9181297.167100.05
491474-9147496.80999.76
592120-9212097.493100.41
689558-8955894.78197.68
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.432650852656222660912652852654652655100.15
215.522660732665632663180.14
单位质量响应值RSD%判断
17207.3917159.660.20数据可信
供试品溶液-FA4456批-厄贝沙坦-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%
5min13603-36031.3981.1349.891.401.1349.90
2-0.0000.00
33267-32671.2671.27
43625-36251.4061.41
53092-30921.2001.20
63855-38551.4961.50
10min19381-93813.6403.555.083.653.565.06
29043-90433.5083.51
38982-89823.4853.49
49907-99073.8443.85
58508-85083.3013.31
69143-91433.5473.55
15min112605-126054.8904.633.914.924.653.97
211822-118224.5874.60
311945-119454.6344.66
412275-122754.7624.79
511309-113094.3884.41
611590-115904.4974.52
20min113107-131075.0855.222.245.135.262.22
213589-135895.2725.31
313458-134585.2215.27
413925-139255.4025.45
513478-134785.2295.27
613151-131515.1025.15
30min115170-151705.8856.021.475.966.091.46
215507-155076.0166.08
315538-155386.0286.10
415859-158596.1536.23
515426-154265.9856.06
615622-156226.0616.13
45min116295-162956.3226.492.856.436.592.80
216347-163476.3426.44
317260-172606.6966.80
416898-168986.5566.66
517245-172456.6916.79
616262-162626.3096.41
60min117520-175206.7977.003.126.937.133.11
217580-175806.8206.95
318163-181637.0477.18
419015-190157.3777.52
518190-181907.0577.19
617717-177176.8747.01
极限118113-181137.0277.242.267.207.402.18
218620-186207.2247.39
319179-191797.4417.61
418514-185147.1837.36
519110-191107.4147.58
618359-183597.1237.29
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.909696197249970809680896963970120.17
212.869694797188970680.18
单位质量响应值RSD%判断
7520.317548.060.27数据可信
供试品溶液-FA4456批-氢氯噻嗪-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%
5min136463-3646338.60132.1016.1638.6032.1016.16
233712-3371235.68935.69
323343-2334324.71224.71
426579-2657928.13828.14
529016-2901630.71830.72
632845-3284534.77134.77
10min177119-7711981.64280.603.0981.8380.763.08
278576-7857683.18483.36
375180-7518079.58979.71
476440-7644080.92381.06
577562-7756282.11182.26
671944-7194476.16376.34
15min183574-8357488.47590.662.5089.0891.222.49
288242-8824293.41794.01
383424-8342488.31688.84
487503-8750392.63593.18
586817-8681791.90892.47
684251-8425189.19289.75
20min185173-8517390.16893.883.0191.2194.892.97
290760-9076096.08397.14
389531-8953194.78295.74
492254-9225497.66498.67
587747-8774792.89393.92
686582-8658291.66092.66
30min185821-8582190.85494.383.0392.3595.862.98
288572-8857293.76695.31
389145-8914594.37395.81
494090-9409099.608101.10
588750-8875093.95595.44
688521-8852193.71295.17
45min185164-8516490.15894.183.1892.1196.143.15
291592-9159296.96398.97
387866-8786693.01994.93
492693-9269398.129100.12
589334-8933494.57396.53
687130-8713092.24094.17
60min188055-8805593.21995.263.6495.6297.693.59
290735-9073596.05698.55
388365-8836593.54795.92
495997-95997101.627104.11
589976-8997695.25397.68
686767-8676791.85594.24
极限187643-8764392.78396.252.4595.6599.162.41
291227-9122796.57799.55
392585-9258598.015100.86
493992-9399299.504102.50
589805-8980595.07297.98
690271-9027195.56598.41
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.432672012665962664912658762663872665100.18
215.522656672652082654380.13
单位质量响应值RSD%判断
17272.2017102.960.70数据可信
供试品溶液-FA4456批-厄贝沙坦-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%
5min13546-35461.3751.2017.981.381.2018.04
23719-37191.4431.44
32358-23580.9150.91
42619-26191.0161.02
52871-28711.1141.11
63467-34671.3451.34
10min18568-85683.3233.434.993.333.435.00
29573-95733.7133.72
38317-83173.2263.23
49021-90213.4993.50
58924-89243.4613.47
68624-86243.3453.35
15min111370-113704.4104.563.324.434.583.33
212036-120364.6694.69
311257-112574.3664.39
411802-118024.5784.60
512280-122804.7634.79
611813-118134.5824.61
20min112982-129825.0365.234.755.085.284.73
214357-143575.5695.62
314162-141625.4935.54
413405-134055.2005.25
513180-131805.1125.16
612794-127944.9635.01
30min115043-150435.8355.891.865.915.961.85
215206-152065.8985.98
315091-150915.8545.92
415409-154095.9776.05
515563-155636.0376.11
614769-147695.7295.80
45min116474-164746.3906.432.896.496.532.84
217295-172956.7086.81
315905-159056.1696.27
416757-167576.5006.60
516759-167596.5016.60
616266-162666.3096.41
60min116997-169976.5936.832.806.726.962.77
217509-175096.7926.93
317333-173336.7236.85
418247-182477.0787.21
517372-173726.7386.87
618148-181487.0397.17
极限117400-174006.7497.042.566.917.212.54
218714-187147.2597.43
318320-183207.1067.27
418439-184397.1527.32
518222-182227.0687.24
617865-178656.9307.10
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