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%
110.316628466174659546637666157661890.24
210.256595166194660720.27
单位质量响应值RSD%判断
6419.886446.050.29数据可信
中间条件6月-供试品溶液-2025072121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%
5min19811-981113.68411.3015.5913.6811.3015.58
26639-66399.2599.26
38472-847211.81611.82
49157-915712.77112.77
57611-761110.61510.62
66912-69129.6409.64
10min115923-1592322.20820.288.1422.2320.298.15
213163-1316318.35918.37
314794-1479420.63320.65
415007-1500720.93020.95
515315-1531521.36021.38
613023-1302318.16318.18
15min120581-2058128.70527.374.8528.7627.424.85
218872-1887226.32126.37
319881-1988127.72827.78
420539-2053928.64628.70
519701-1970127.47727.53
618167-1816725.33825.38
20min125367-2536735.38032.744.8635.4932.844.87
222880-2288031.91132.00
323330-2333032.53932.64
423954-2395433.40933.51
523349-2334932.56532.66
621959-2195930.62630.72
30min128393-2839339.60038.792.5339.7738.942.54
228038-2803839.10539.25
327426-2742638.25138.41
428643-2864339.94940.11
527641-2764138.55138.70
626712-2671237.25637.40
45min133016-3301646.04845.072.4446.2845.282.45
232294-3229445.04145.25
332552-3255245.40145.62
432886-3288645.86746.09
532308-3230845.06045.28
630825-3082542.99243.19
60min136101-3610150.35149.932.8050.6650.222.81
236461-3646150.85351.14
335627-3562749.68949.98
437181-3718151.85752.16
534990-3499048.80149.09
634424-3442448.01248.28
90min140243-4024356.12755.921.4356.5256.301.43
240280-4028056.17956.55
340715-4071556.78657.16
440549-4054956.55456.94
539364-3936454.90155.28
639432-3943254.99655.35
120min143339-4333960.44559.411.9660.9359.881.97
242923-4292359.86560.33
343018-4301859.99860.47
443033-4303360.01960.50
542190-4219058.84359.31
641084-4108457.30057.75
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144138-4413861.56061.371.5262.1561.941.52
244767-4476762.43763.00
344254-4425461.72262.29
444421-4442161.95562.54
543492-4349260.65961.22
642948-4294859.90060.44
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%
110.316589866122661356609465649659800.32
210.256600866019660140.02
单位质量响应值RSD%判断
6399.616440.390.45数据可信
中间条件6月-供试品溶液-2025072221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%
5min18515-851511.90011.6010.0911.9011.6010.10
29045-904512.64112.64
38120-812011.34811.35
48553-855311.95311.95
56715-67159.3849.38
68840-884012.35412.35
10min114792-1479220.67221.1510.9520.6921.1710.94
217896-1789625.01025.03
314979-1497920.93420.95
414795-1479520.67720.70
512760-1276017.83317.85
615573-1557321.76421.78
15min119333-1933327.01927.115.3527.0727.165.35
220357-2035728.45028.51
319562-1956227.33927.39
419415-1941527.13327.19
517475-1747524.42224.47
620250-2025028.30028.36
20min122740-2274031.78032.373.3031.8832.463.26
222342-2234231.22431.33
322695-2269531.71731.82
423542-2354232.90133.00
524462-2446234.18734.27
623172-2317232.38432.49
30min127403-2740338.29738.701.1938.4538.861.18
227761-2776138.79738.96
327477-2747738.40038.55
428313-2831339.56839.72
527613-2761338.59038.73
627591-2759138.55938.72
45min132337-3233745.19245.250.8445.4145.470.84
232713-3271345.71845.94
331977-3197744.68944.91
432324-3232445.17445.39
532266-3226645.09345.30
632652-3265245.63245.85
60min134935-3493548.82349.601.2549.1149.891.24
235194-3519449.18549.49
335790-3579050.01850.31
435927-3592750.20950.50
535168-3516849.14949.43
635927-3592750.20950.51
90min139583-3958355.31955.250.4055.6955.620.40
239547-3954755.26855.65
339623-3962355.37555.75
439397-3939755.05955.44
539308-3930854.93455.30
639736-3973655.53355.91
120min142792-4279259.80360.641.5560.2761.111.53
243103-4310360.23860.72
344698-4469862.46762.93
443284-4328460.49160.96
543350-4335060.58361.04
643118-4311860.25960.73
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144138-4413861.68461.191.2562.2561.761.22
243238-4323860.42761.00
343943-4394361.41261.98
443267-4326760.46761.04
544611-4461162.34662.90
643503-4350360.79761.37
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