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10000
标示量(mg)1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%
19.943125231367316883138831463314320.52
210.003149331378314360.26
单位质量响应值RSD%判断
3162.173143.600.42数据可信
供试品溶液-2025072421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%
5min120108-2010857.22156.626.2357.2256.626.23
220579-2057958.56258.56
320845-2084559.31959.32
420495-2049558.32358.32
517466-1746649.70349.70
619879-1987956.57056.57
10min126676-2667675.91274.481.3776.0174.581.38
226114-2611474.31374.41
326481-2648175.35775.46
426170-2617074.47274.57
525730-2573073.22073.30
625865-2586573.60473.70
15min128724-2872481.74082.121.2281.9682.341.23
229355-2935583.53683.76
328959-2895982.40982.63
429124-2912482.87883.10
528555-2855581.25981.46
628433-2843380.91281.13
20min130433-3043386.60385.770.8486.9686.120.83
229889-2988985.05585.42
330005-3000585.38585.75
430386-3038686.47086.83
530257-3025786.10286.44
629869-2986984.99885.35
30min131635-3163590.02489.810.7090.5390.310.70
231553-3155389.79090.29
331192-3119288.76389.27
431797-3179790.48590.99
531741-3174190.32590.81
631444-3144489.48089.97
45min132439-3243992.31292.730.8092.9693.380.79
232625-3262592.84193.49
332332-3233292.00792.66
432599-3259992.76793.42
533065-3306594.09394.73
632451-3245192.34692.99
60min133116-3311694.23893.920.9095.0494.720.89
232616-3261692.81593.62
332847-3284793.47394.28
433284-3328494.71695.53
533365-3336594.94795.74
632800-3280093.33994.14
90min133427-3342795.12395.901.0996.0996.861.07
233574-3357495.54296.50
333393-3339395.02795.99
434086-3408696.99997.97
534230-3423097.40898.36
633480-3348095.27496.23
120min133327-3332794.83995.670.5595.9696.790.54
233519-3351995.38596.51
333667-3366795.80696.93
433809-3380996.21097.34
533799-3379996.18297.29
633587-3358795.57996.69
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133308-3330894.78595.721.2896.0696.991.26
233471-3347195.24996.53
333459-3345995.21496.49
434351-3435197.75399.04
533954-3395496.62397.90
633267-3326794.66895.94
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10000
标示量(mg)1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%
19.943150331201313993137331025313000.61
210.003133531356313460.05
单位质量响应值RSD%判断
3148.893134.600.33数据可信
供试品溶液-2025072421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%
5min116079-1607945.91838.8021.8545.9238.8021.85
216708-1670847.71447.71
311267-1126732.17632.18
415744-1574444.96144.96
512116-1211634.60134.60
69599-959927.41327.41
10min124399-2439969.67862.0711.1969.7562.1411.20
223686-2368667.64267.72
319341-1934155.23455.29
423338-2333866.64866.72
521063-2106360.15160.21
618588-1858853.08353.13
15min127835-2783579.49173.447.0379.6873.617.04
227008-2700877.12977.32
323843-2384368.09068.24
426766-2676676.43876.62
525465-2546572.72372.88
623378-2337866.76266.90
20min129422-2942284.02379.444.1184.3579.734.14
228540-2854081.50481.82
326673-2667376.17276.43
428350-2835080.96181.27
527391-2739178.22378.50
626534-2653475.77576.02
30min131018-3101888.58185.282.8189.0585.702.84
230050-3005085.81686.27
328962-2896282.70983.10
430468-3046887.01087.46
529790-2979085.07485.48
628880-2888082.47582.85
45min132107-3210791.69188.571.9992.3089.132.02
231182-3118289.04989.65
330432-3043286.90787.43
430783-3078387.91088.50
531088-3108888.78189.33
630483-3048387.05387.56
60min132579-3257993.03989.941.8693.8090.651.88
231227-3122789.17889.93
330930-3093088.32989.00
431652-3165290.39191.13
531154-3115488.96989.67
631415-3141589.71490.37
90min133571-3357195.87192.302.1296.7993.162.14
232470-3247092.72793.62
331726-3172690.60391.42
432345-3234592.37093.26
531745-3174590.65791.50
632066-3206691.57492.38
120min133739-3373996.35192.872.3397.4393.882.34
232202-3220291.96293.01
331599-3159990.24091.21
432943-3294394.07895.12
532036-3203691.48892.49
632600-3260093.09994.05
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133286-3328695.05893.611.1096.3094.781.13
232655-3265593.25694.46
332835-3283593.77094.89
433074-3307494.45295.65
532325-3232592.31393.46
632501-3250192.81693.93
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10000
标示量(mg)1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%
19.943131831320311393104931379312410.45
210.003132531720315220.89
单位质量响应值RSD%判断
3142.963152.200.21数据可信
供试品溶液-2025072421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%
5min117277-1727749.24845.2311.5249.2545.2311.52
216957-1695748.33648.34
315943-1594345.44545.45
412309-1230935.08735.09
515933-1593345.41745.42
616788-1678847.85447.85
10min124411-2441169.58366.535.7069.6766.615.71
224084-2408468.65168.73
323813-2381367.87967.95
420780-2078059.23359.29
523075-2307565.77565.85
623883-2388368.07868.16
15min127590-2759078.64576.773.1478.8476.963.15
227492-2749278.36578.56
327141-2714177.36577.55
425343-2534372.24072.40
526675-2667576.03776.22
627355-2735577.97578.17
20min129843-2984385.06782.392.2585.4082.702.27
229316-2931683.56583.89
328911-2891182.41082.73
427909-2790979.55479.83
528699-2869981.80682.12
628745-2874581.93782.26
30min131157-3115788.81286.831.2489.2887.281.25
230470-3047086.85487.32
330509-3050986.96587.42
430066-3006685.70386.11
530270-3027086.28486.73
630290-3029086.34186.80
45min132347-3234792.20590.291.4492.8290.881.45
231941-3194191.04791.66
331562-3156289.96790.57
431154-3115488.80489.36
531823-3182390.71191.30
631215-3121588.97889.58
60min132703-3270393.21991.690.9393.9992.440.95
232191-3219191.76092.52
332031-3203191.30492.05
431805-3180590.66091.36
532076-3207691.43292.18
632189-3218991.75492.51
90min133113-3311394.38893.310.8295.3294.210.83
232813-3281393.53394.45
332595-3259592.91193.81
432392-3239292.33393.18
532927-3292793.85894.75
632564-3256492.82393.73
120min133686-3368696.02194.650.8597.1195.710.86
233075-3307594.28095.35
333184-3318494.59095.65
433151-3315194.49695.50
533301-3330194.92495.98
632836-3283693.59894.66
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133911-3391196.66394.851.1597.9196.061.17
233320-3332094.97896.21
333230-3323094.72295.94
432784-3278493.45094.61
533385-3338595.16396.37
633011-3301194.09795.31
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