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 9.813074730675307693081530701307410.19
2 9.913081630785308000.08
单位质量响应值RSD%判断
3133.643107.970.59数据可信
加速6月-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%
5min115404-1540444.28640.6512.8644.2940.6512.86
216000-1600046.00046.00
311350-1135032.63132.63
412841-1284136.91836.92
515495-1549544.54844.55
613747-1374739.52239.52
10min122221-2222163.88561.365.3663.9661.425.37
222735-2273565.36365.44
320432-2043258.74258.80
419730-1973056.72356.78
521891-2189162.93663.01
621038-2103860.48460.55
15min125496-2549673.30071.683.6973.4871.863.69
225907-2590774.48274.67
324765-2476571.19971.35
423285-2328566.94467.10
525359-2535972.90773.09
624791-2479171.27471.44
20min127623-2762379.41677.723.2879.7278.013.28
227693-2769379.61779.93
327212-2721278.23478.50
425292-2529272.71472.98
527269-2726978.39878.70
627104-2710477.92378.21
30min129601-2960185.10284.162.8885.5484.582.88
229697-2969785.37885.82
329687-2968785.35085.75
427580-2758079.29279.68
529341-2934184.35584.79
629730-2973085.47385.89
45min131192-3119289.67688.702.8090.2589.262.80
231309-3130990.01390.60
331354-3135490.14290.69
429140-2914083.77784.30
530824-3082488.61889.19
631298-3129889.98190.54
60min131912-3191291.74690.782.4992.4791.492.50
232422-3242293.21393.95
331867-3186791.61792.31
430243-3024386.94887.61
531069-3106989.32390.04
631949-3194991.85392.56
90min132642-3264293.84591.433.1694.7292.293.16
232156-3215692.44893.34
332188-3218892.54093.39
430024-3002486.31887.12
531238-3123889.80990.68
632565-3256593.62494.48
120min132842-3284294.42092.053.2495.4693.063.24
232463-3246393.33094.37
332599-3259993.72194.72
430087-3008786.50087.45
531594-3159490.83291.85
632518-3251893.48994.51
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132844-3284494.42693.321.6695.6294.481.67
232701-3270194.01595.21
332699-3269994.00995.17
431697-3169791.12892.22
531863-3186391.60592.78
632952-3295294.73695.91
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 9.813121931082311823116331200311690.18
2 9.913125831328312930.16
单位质量响应值RSD%判断
3177.273157.720.44数据可信
加速6月-供试品溶液-2025072521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%
5min114154-1415440.09240.1913.3440.0940.1913.34
213442-1344238.07638.08
312667-1266735.88035.88
412371-1237135.04235.04
517521-1752149.63049.63
614983-1498342.44142.44
10min122522-2252263.79560.476.8963.8660.536.90
220831-2083159.00659.07
320926-2092659.27559.33
419207-1920754.40554.46
523437-2343766.38766.47
621157-2115759.92960.00
15min125143-2514371.22070.903.6171.3971.073.62
224835-2483570.34770.51
324695-2469569.95170.11
423754-2375467.28567.43
526522-2652275.12675.32
625241-2524171.49771.67
20min127344-2734477.45476.884.0677.7577.164.07
226980-2698076.42376.70
326854-2685476.06676.34
425962-2596273.53973.80
529177-2917782.64682.96
626532-2653275.15475.44
30min128590-2859080.98482.422.5881.4082.842.58
229186-2918682.67283.08
329804-2980484.42284.82
428255-2825580.03580.42
530141-3014185.37785.83
628614-2861481.05181.47
45min130205-3020585.55886.472.9886.1187.022.98
230730-3073087.04587.59
331484-3148489.18189.72
429275-2927582.92483.44
531569-3156989.42290.02
629892-2989284.67285.22
60min131893-3189390.34089.522.6991.0490.222.70
231761-3176189.96690.65
331978-3197890.58091.27
430098-3009885.25585.91
532596-3259692.33193.08
631298-3129888.65489.35
90min131104-3110488.10589.313.6388.9590.153.63
231739-3173989.90390.74
332384-3238491.73092.57
429960-2996084.86485.66
533148-3314893.89494.80
630834-3083487.34088.18
120min131429-3142989.02590.123.7690.0291.113.76
232239-3223991.32092.31
332893-3289393.17294.17
430124-3012485.32986.27
533249-3324994.18195.24
630955-3095587.68388.67
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132278-3227891.43091.851.8692.5792.991.88
232400-3240091.77692.92
332687-3268792.58993.74
431329-3132988.74289.82
532991-3299193.45094.66
632871-3287193.11094.24
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 9.813155031611316113163431685316180.16
2 9.913200732009320080.01
单位质量响应值RSD%判断
3223.043229.870.15数据可信
加速6月-供试品溶液-2025072522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%
5min19532-953226.50732.0119.1326.5132.0119.13
214469-1446940.23540.24
39346-934625.98925.99
412578-1257834.97734.98
59874-987427.45827.46
613263-1326336.88236.88
10min119160-1916053.28056.226.2753.3256.276.28
220874-2087458.04658.11
318733-1873352.09352.14
421635-2163560.16360.22
519413-1941353.98454.03
621487-2148759.75159.81
15min124220-2422067.35168.953.1567.4869.093.16
224610-2461068.43568.60
323942-2394266.57866.71
425946-2594672.15172.31
524517-2451768.17768.31
625529-2552970.99171.15
20min127093-2709375.34075.902.1075.5976.162.10
226651-2665174.11174.39
326806-2680674.54274.78
428211-2821178.44978.73
527412-2741276.22776.48
627588-2758876.71777.00
30min129760-2976082.75782.621.6483.1383.001.63
228850-2885080.22680.63
329730-2973082.67383.04
430289-3028984.22884.64
530018-3001883.47483.85
629609-2960982.33782.74
45min131480-3148087.53987.421.8788.0587.951.86
230360-3036084.42584.96
331493-3149387.57688.08
432009-3200989.01189.56
531908-3190888.73089.25
631371-3137187.23687.78
60min132227-3222789.61789.242.1790.2789.912.15
230718-3071885.42186.10
332326-3232689.89290.54
432631-3263190.74091.44
532492-3249290.35491.02
632156-3215689.41990.11
90min132841-3284191.32490.632.3692.1391.462.34
231071-3107186.40287.22
332816-3281691.25592.05
433010-3301091.79492.64
533182-3318292.27293.09
632638-3263890.76091.60
120min132771-3277191.12991.362.0092.0992.331.99
231642-3164287.99088.95
332902-3290291.49492.44
433510-3351093.18494.19
533329-3332992.68193.65
632969-3296991.68092.67
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132916-3291691.53391.901.2192.6493.031.21
232315-3231589.86190.97
333116-3311692.08993.19
433397-3339792.87094.03
533325-3332592.67093.79
633229-3322992.40393.55
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