多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 9.813218932114324013206731868321280.61
2 9.883206732305321860.53
单位质量响应值RSD%判断
3275.033257.690.38数据可信
供试品溶液-2025042721批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119720-1972054.16851.453.8854.1751.453.88
217559-1755948.23248.23
318679-1867951.30851.31
418624-1862451.15751.16
518579-1857951.03451.03
619219-1921952.79252.79
10min127450-2745075.40173.232.7775.4973.322.76
225431-2543169.85569.94
327397-2739775.25575.34
426547-2654772.92073.01
526522-2652272.85272.94
626615-2661573.10773.20
15min130114-3011482.71880.621.7282.9380.831.71
229409-2940980.78280.98
329663-2966381.47981.69
428719-2871978.88679.09
529252-2925280.35180.56
628941-2894179.49679.71
20min131025-3102585.22184.471.0985.5784.811.09
230761-3076184.49684.83
330899-3089984.87585.22
430204-3020482.96683.30
530536-3053683.87784.22
631091-3109185.40285.74
30min132238-3223888.55387.901.1889.0588.381.17
232064-3206488.07588.55
332009-3200987.92488.41
431273-3127385.90286.38
532098-3209888.16888.65
632322-3232288.78389.27
45min132827-3282790.17090.571.1290.8191.201.11
232616-3261689.59190.21
333020-3302090.70191.34
432896-3289690.36090.98
532807-3280790.11690.74
633670-3367092.48693.12
60min133380-3338091.68992.301.2392.4893.081.22
233569-3356992.20992.98
333002-3300290.65191.44
433815-3381592.88493.65
533606-3360692.31093.09
634231-3423194.02794.81
90min133672-3367292.49293.981.2493.4494.911.22
234081-3408193.61594.54
334545-3454594.89095.83
434224-3422494.00894.93
533925-3392593.18794.12
634832-3483295.67896.62
120min134094-3409493.65195.451.0694.7596.541.05
234866-3486695.77196.85
335110-3511096.44297.54
434917-3491795.91196.99
534566-3456694.94796.03
634949-3494995.99997.10
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134348-3434894.34895.680.9195.6196.930.89
234858-3485895.74996.99
334751-3475195.45596.71
435327-3532797.03898.28
534797-3479795.58296.83
634920-3492095.92097.18
多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 9.813231032247321613229932295322620.20
2 9.883308633286331860.43
单位质量响应值RSD%判断
3288.693358.911.50数据可信
供试品溶液-2025042721批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119634-1963453.00549.456.0453.0149.456.04
219180-1918051.77951.78
318754-1875450.62950.63
418207-1820749.15349.15
516692-1669245.06345.06
617432-1743247.06047.06
10min127624-2762474.57571.374.6174.6671.454.61
227358-2735873.85773.94
326825-2682572.41872.50
426619-2661971.86271.94
525919-2591969.97270.05
624269-2426965.51865.60
15min130127-3012781.33278.184.5881.5578.384.58
229991-2999180.96581.17
329614-2961479.94880.15
429211-2921178.86079.06
528129-2812975.93976.13
626688-2668872.04872.24
20min131448-3144884.89982.323.9985.2582.663.99
231434-3143484.86185.21
331160-3116084.12184.46
430737-3073782.97983.31
529854-2985480.59580.91
628334-2833476.49276.80
30min132760-3276088.44186.652.9788.9387.122.98
232876-3287688.75489.24
332548-3254887.86888.35
432603-3260388.01788.49
531203-3120384.23784.69
630601-3060182.61283.05
45min133808-3380891.27089.931.6591.9190.541.66
233393-3339390.15090.78
333287-3328789.86390.49
433680-3368090.92491.54
533431-3343190.25290.85
632263-3226387.09987.67
60min134468-3446893.05290.652.1593.8491.412.16
234071-3407191.98092.76
333549-3354990.57191.35
433901-3390191.52192.29
532590-3259087.98288.73
632881-3288188.76789.49
90min134677-3467793.61692.291.6394.5693.211.64
234628-3462893.48494.42
334134-3413492.15093.08
434555-3455593.28794.21
533261-3326189.79390.68
633864-3386491.42192.29
120min134853-3485394.09193.381.4395.1994.441.44
234834-3483494.04095.13
334488-3448893.10694.18
435272-3527295.22296.30
533970-3397091.70792.75
634115-3411592.09993.12
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134786-3478693.91093.510.6195.1794.730.63
234669-3466993.59494.84
334612-3461293.44094.67
434923-3492394.28095.52
534318-3431892.64793.84
634518-3451893.18794.36
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