托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15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%
116.639879998988988639881898937988810.09
216.669879999024989120.17
单位质量响应值RSD%判断
5945.945937.090.11数据可信
供试品溶液-24102501批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112271-1227112.36711.886.3212.3711.886.31
210305-1030510.38610.39
312113-1211312.20812.21
412232-1223212.32812.33
511973-1197312.06712.07
611802-1180211.89411.89
10min123402-2340223.58523.561.9323.6523.621.93
223836-2383624.02224.08
322845-2284523.02423.09
423251-2325123.43323.50
523951-2395124.13824.21
622954-2295423.13423.20
15min131849-3184932.09832.091.7332.3032.281.72
232060-3206032.31132.50
331405-3140531.65131.85
431562-3156231.80932.01
532812-3281233.06933.27
631337-3133731.58231.78
20min138583-3858338.88538.351.6139.2638.731.61
238156-3815638.45538.83
337340-3734037.63238.00
437890-3789038.18638.56
538890-3889039.19439.58
637467-3746737.76038.13
30min146225-4622546.58746.751.6547.1847.341.65
246637-4663747.00247.59
345264-4526445.61846.20
446370-4637046.73347.32
547630-4763048.00348.61
646215-4621546.57747.16
45min156874-5687457.31956.810.8658.1757.650.85
256957-5695757.40358.25
356114-5611456.55357.39
456477-5647756.91957.77
555927-5592756.36557.23
655839-5583956.27657.11
60min163529-6352964.02664.000.8865.2065.160.88
263847-6384764.34765.51
362597-6259763.08764.24
464161-6416164.66365.83
563719-6371964.21865.40
663137-6313763.63164.78
90min172603-7260373.17171.611.5674.7073.131.54
271967-7196772.53074.05
369949-6994970.49672.00
471451-7145172.01073.53
570144-7014470.69372.23
670218-7021870.76772.27
120min177286-7728677.89176.980.7779.8278.900.77
275899-7589976.49378.42
375663-7566376.25578.15
476689-7668977.28979.21
576562-7656277.16179.09
676215-7621576.81178.71
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179476-7947680.09879.920.8982.4682.270.89
279390-7939080.01182.36
378327-7832778.94081.25
480410-8041081.03983.39
579404-7940480.02582.39
678808-7880879.42581.75
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15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%
116.639901699140990929921899050991030.08
216.669839698689985420.22
单位质量响应值RSD%判断
5959.295914.890.53数据可信
供试品溶液-24102901批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19986-998610.07210.453.7410.0710.453.75
29999-999910.08510.08
310259-1025910.34710.35
410251-1025110.33910.34
510874-1087410.96710.97
610800-1080010.89310.89
10min118522-1852218.68119.033.4618.7419.093.46
220029-2002920.20120.26
318258-1825818.41518.47
418930-1893019.09319.15
518386-1838618.54418.60
619097-1909719.26119.32
15min124816-2481625.02925.042.8725.1925.202.86
226088-2608826.31226.48
324903-2490325.11725.28
423974-2397424.18024.34
524801-2480125.01425.18
624365-2436524.57424.74
20min129212-2921229.46329.722.3829.7630.022.37
230786-3078631.05031.36
329607-2960729.86130.16
428975-2897529.22429.52
528866-2886629.11429.42
629337-2933729.58929.89
30min136488-3648836.80136.662.7437.2637.122.73
238009-3800938.33538.82
336374-3637436.68637.15
436081-3608136.39136.85
534908-3490835.20835.67
636221-3622136.53237.00
45min144857-4485745.24244.972.5145.9145.642.51
246635-4663547.03647.74
344378-4437844.75945.43
443590-4359043.96444.63
543623-4362343.99844.66
644440-4444044.82245.49
60min149907-4990750.33649.852.1751.2550.772.16
250918-5091851.35552.32
348208-4820848.62249.54
449042-4904249.46350.37
548355-4835548.77049.68
650118-5011850.54851.47
90min158037-5803758.53558.631.8059.7359.831.81
259749-5974960.26261.51
358018-5801858.51659.70
457726-5772658.22259.40
556599-5659957.08558.26
658683-5868359.18760.39
120min163763-6376364.31164.371.5565.8365.891.56
265121-6512165.68067.26
363775-6377564.32365.84
463673-6367364.22065.72
562152-6215262.68664.18
664424-6442464.97766.51
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168468-6846869.05668.862.1070.9470.752.08
270396-7039671.00172.95
368687-6868769.27771.15
468451-6845169.03970.90
566030-6603066.59768.44
667630-6763068.21170.10
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15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%
116.639925099473993899926099074992890.16
216.669875998998988780.18
单位质量响应值RSD%判断
5970.485935.050.43数据可信
供试品溶液-24102902批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118254-1825418.36218.3511.0718.3618.3411.08
217690-1769017.79517.79
317148-1714817.25017.25
416836-1683616.93616.94
517261-1726117.36317.36
622234-2223422.36622.37
10min129160-2916029.33330.459.8329.4330.559.83
228760-2876028.93029.03
328559-2855928.72828.82
429264-2926429.43729.53
529572-2957229.74729.84
636291-3629136.50636.63
15min136844-3684437.06238.605.2637.3338.875.29
237909-3790938.13438.39
336924-3692437.14337.40
437954-3795438.17938.44
538281-3828138.50838.77
642312-4231242.56342.89
20min142140-4214042.39044.594.1742.8645.084.21
243864-4386444.12444.60
343558-4355843.81644.28
444464-4446444.72845.20
544236-4423644.49844.97
647710-4771047.99348.56
30min151197-5119751.50052.892.1552.2153.632.18
252342-5234252.65253.37
351383-5138351.68852.39
453155-5315553.47054.19
553493-5349353.81054.53
653923-5392354.24355.07
45min157168-5716857.50758.862.3158.5059.892.35
257161-5716157.50058.51
357901-5790158.24459.24
458789-5878959.13860.15
559565-5956559.91860.94
660495-6049560.85461.99
60min163293-6329363.66864.621.3164.9865.971.34
263371-6337163.74765.08
363853-6385364.23265.55
464696-6469665.08066.42
565012-6501265.39766.75
665180-6518065.56667.04
90min169610-6961070.02371.031.3271.6972.741.28
270949-7094971.37073.05
370241-7024170.65772.33
471508-7150871.93273.64
571741-7174172.16673.88
669608-6960870.02171.85
120min173874-7387474.31275.741.4276.3777.861.36
276210-7621076.66278.74
375552-7555276.00078.07
475515-7551575.96378.07
576485-7648576.93879.06
674154-7415474.59476.82
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176769-7676977.22477.902.3879.6980.422.27
277061-7706177.51880.02
379635-7963580.10782.59
479766-7976680.23982.77
575732-7573276.18178.73
675653-7565376.10178.74
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