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 9.816387463373637736403463793637690.39
2 9.886361063850637300.27
单位质量响应值RSD%判断
6500.416450.400.55数据可信
供试品溶液-2025042722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%
5min132128-3212844.51648.975.1044.5248.975.09
236093-3609350.01050.01
336232-3623250.20350.20
436207-3620750.16850.17
534365-3436547.61647.62
637013-3701351.28551.28
10min147703-4770366.09768.531.8466.1768.621.84
250229-5022969.59769.68
349765-4976568.95469.04
449772-4977268.96369.05
549359-4935968.39168.47
649936-4993669.19169.28
15min154179-5417975.07076.881.3775.2577.081.38
255595-5559577.03277.23
355560-5556076.98377.18
455191-5519176.47276.67
556353-5635378.08278.28
656041-5604177.65077.85
20min157590-5759079.79681.391.1180.1181.711.11
258952-5895281.68382.01
358708-5870881.34581.67
458554-5855481.13281.46
559136-5913681.93882.26
659487-5948782.42482.75
30min161359-6135985.01885.931.0485.4686.401.04
262457-6245786.54087.00
361179-6117984.76985.23
462087-6208786.02786.49
562187-6218786.16586.63
662853-6285387.08887.56
45min164062-6406288.76389.421.6089.3590.031.60
265837-6583791.22391.83
362856-6285687.09287.70
464436-6443689.28289.89
564776-6477689.75390.36
665255-6525590.41691.03
60min165049-6504990.13191.731.3490.8692.481.34
267387-6738793.37094.13
365583-6558390.87191.62
465914-6591491.33092.08
566243-6624391.78592.54
667033-6703392.88093.64
90min166593-6659392.27093.321.0893.1594.221.08
268563-6856395.00095.92
367004-6700492.84093.74
467254-6725493.18694.09
566871-6687192.65693.56
667821-6782193.97294.89
120min167216-6721693.13494.181.2094.1795.241.19
269083-6908395.72096.79
368022-6802294.25095.31
467182-6718293.08694.15
567531-6753193.57094.63
668782-6878295.30396.38
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167620-6762093.69394.580.8394.8895.790.83
269234-6923495.93097.16
368255-6825594.57395.79
468337-6833794.68795.90
567792-6779293.93295.15
668308-6830894.64795.88
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 9.816449364117641666393663974641370.35
2 9.886396263673638180.33
单位质量响应值RSD%判断
6537.926459.310.86数据可信
供试品溶液-2025042722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%
5min135298-3529848.73550.702.7548.7350.702.76
235686-3568649.27149.27
337770-3777052.14852.15
437020-3702051.11251.11
537585-3758551.89251.89
636983-3698351.06151.06
10min150843-5084370.19771.012.0370.2871.102.03
250865-5086570.22870.31
350025-5002569.06869.15
452375-5237572.31272.40
551717-5171771.40471.49
652783-5278372.87672.96
15min156597-5659778.14279.612.4578.3479.812.45
257162-5716278.92279.12
356308-5630877.74377.94
459940-5994082.75782.96
557152-5715278.90879.11
658792-5879281.17281.38
20min159736-5973682.47683.542.0082.8083.871.99
260379-6037983.36383.69
359350-5935081.94382.27
462688-6268886.55186.89
559916-5991682.72483.06
660963-6096384.17084.51
30min163607-6360787.82088.131.8288.2988.601.82
264026-6402688.39988.87
362041-6204185.65886.13
465516-6551690.45690.94
563344-6334487.45787.93
664445-6444588.97789.46
45min165480-6548090.40691.241.9991.0291.861.99
266064-6606491.21291.83
364331-6433188.82089.43
468254-6825494.23694.87
565699-6569990.70891.33
666656-6665692.03092.66
60min167112-6711292.65992.841.6093.4293.621.60
266939-6693992.42193.19
365644-6564490.63391.39
468897-6889795.12495.92
567052-6705292.57793.35
667818-6781893.63494.42
90min168262-6826294.24794.181.2995.1695.111.29
268250-6825094.23195.15
366837-6683792.28093.19
469559-6955996.03896.99
567910-6791093.76194.69
668459-6845994.51995.46
120min168494-6849494.56794.821.4595.6495.901.45
268371-6837194.39895.48
367136-6713692.69293.76
470115-7011596.80697.92
568652-6865294.78695.87
669290-6929095.66696.76
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168563-6856394.66394.911.6695.8996.161.66
268946-6894695.19296.43
367224-6722492.81494.03
470685-7068597.59298.87
568202-6820294.16495.40
668849-6884995.05896.31
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