奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20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%
1 9.039902697690973579767997795979090.66
2 9.201010611008961009780.12
单位质量响应值RSD%判断
10842.6410975.870.87数据可信
供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138910-3891040.04741.803.9040.0541.803.90
241196-4119642.39942.40
338950-3895040.08840.09
442775-4277544.02444.02
540012-4001241.18141.18
641840-4184043.06243.06
10min154998-5499856.60559.774.1256.8360.004.12
259229-5922960.95961.19
356044-5604457.68157.90
461694-6169463.49663.74
557726-5772659.41259.64
658771-5877160.48860.73
15min165311-6531167.21969.893.6967.7670.463.69
267930-6793069.91470.49
365793-6579367.71568.26
472383-7238374.49775.09
567880-6788069.86370.42
668167-6816770.15870.73
20min170570-7057072.63175.443.6973.5476.393.69
273809-7380975.96576.93
371275-7127573.35774.28
478224-7822480.50981.52
572697-7269774.82175.77
673214-7321475.35376.32
30min177532-7753279.79782.713.4681.1184.083.47
281212-8121283.58484.97
378283-7828380.57081.90
485376-8537687.87089.33
579798-7979882.12983.49
679986-7998682.32283.71
45min183176-8317685.60688.133.5587.3689.963.55
284466-8446686.93388.78
384041-8404186.49688.27
491608-9160894.28496.23
584960-8496087.44289.26
685549-8554988.04889.89
60min183792-8379286.24090.493.8388.4792.813.81
287016-8701689.55891.89
387617-8761790.17692.43
494044-9404496.79199.26
586954-8695489.49491.80
688118-8811890.69293.02
极限187837-8783790.40393.563.3493.1196.383.35
289685-8968592.30595.13
390140-9014092.77395.53
496732-9673299.558102.57
590155-9015592.78895.59
690851-9085193.50596.34
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20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%
1 9.039941699450993669946199355994100.05
2 9.209952599626995760.08
单位质量响应值RSD%判断
11008.8610823.481.21数据可信
供试品溶液-TNA3004批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136231-3623137.26736.784.1437.2736.784.14
234436-3443635.42135.42
334983-3498335.98335.98
436976-3697638.03338.03
537812-3781238.89338.89
634123-3412335.09935.10
10min154711-5471156.27556.763.0356.4856.973.03
253602-5360255.13555.33
354493-5449356.05156.25
457512-5751259.15759.37
557004-5700458.63458.85
653783-5378355.32155.52
15min163467-6346765.28266.322.3365.8066.842.34
263599-6359965.41865.92
363054-6305464.85765.37
466689-6668968.59669.14
566011-6601167.89968.44
664028-6402865.85966.36
20min169628-6962871.61972.501.9272.5073.381.93
269002-6900270.97571.84
369961-6996171.96172.83
472425-7242574.49675.42
571859-7185973.91474.83
670008-7000872.01072.88
30min177296-7729679.50679.681.2280.7980.971.24
276621-7662178.81280.07
376300-7630078.48279.75
478239-7823980.47681.81
578790-7879081.04382.37
677547-7754779.76481.03
45min182782-8278285.14984.901.0886.8786.631.10
281222-8122283.54485.24
381853-8185384.19485.90
483059-8305985.43487.22
583724-8372486.11887.90
682586-8258684.94786.66
60min184416-8441686.83087.461.8889.0289.671.88
283688-8368886.08188.24
384159-8415986.56588.74
486487-8648788.96091.22
587558-8755890.06292.32
683891-8389186.29088.47
极限186473-8647388.94689.091.3791.6291.781.39
285681-8568188.13190.77
385363-8536387.80490.46
487617-8761790.12292.87
588430-8843090.95993.72
686106-8610688.56891.23
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