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%
19.946375563631633206389663444636090.37
210.006404163540637900.56
单位质量响应值RSD%判断
6399.306379.000.23数据可信
供试品溶液-2025072321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%
5min130987-3098743.51445.654.1443.5145.654.15
232320-3232045.38645.39
333568-3356847.13947.14
432491-3249145.62645.63
534478-3447848.41748.42
631205-3120543.82043.82
10min146032-4603264.64265.714.0764.7165.794.07
250331-5033170.67970.75
346923-4692365.89365.97
445968-4596864.55264.63
546803-4680365.72465.80
644712-4471262.78862.86
15min153073-5307374.52974.831.5974.7175.011.60
254857-5485777.03477.23
353317-5331774.87275.06
453339-5333974.90375.09
552648-5264873.93274.12
652474-5247473.68873.87
20min156115-5611578.80179.011.2079.1179.321.20
257339-5733980.52080.84
356271-5627179.02079.33
456457-5645779.28179.59
556154-5615478.85679.17
655254-5525477.59277.89
30min159489-5948983.53983.851.2983.9784.291.29
260797-6079785.37685.83
359767-5976783.92984.37
459925-5992584.15184.59
559865-5986584.06784.51
658429-5842982.05082.48
45min162524-6252487.80187.041.3488.3887.621.34
262353-6235387.56188.16
362083-6208387.18287.77
462771-6277188.14888.73
561675-6167586.60987.19
660477-6047784.92685.49
60min163013-6301388.48888.711.5189.2189.441.50
263137-6313788.66289.41
363472-6347289.13289.86
464727-6472790.89591.62
562896-6289688.32389.05
661794-6179486.77687.48
90min164793-6479390.98790.711.0791.8691.581.06
263861-6386189.67890.57
364706-6470690.86591.74
465667-6566792.21593.09
564710-6471090.87191.75
663823-6382389.62590.48
120min165375-6537591.80491.661.8692.8392.691.85
264728-6472890.89691.94
365940-6594092.59893.63
466920-6692093.97495.01
565356-6535691.77892.81
663304-6330488.89689.90
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166655-6665593.60294.400.5794.7895.580.57
267340-6734094.56495.76
367669-6766995.02696.21
467580-6758094.90196.09
567060-6706094.17195.35
667050-6705094.15795.31
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%
19.943160831140314973126431292313600.61
210.003208732045320660.10
单位质量响应值RSD%判断
3154.933206.601.15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%
5min116473-1647346.46947.953.0946.4747.953.09
217668-1766849.84049.84
317402-1740249.09049.09
417294-1729448.78548.79
516714-1671447.14947.15
616436-1643646.36546.36
10min123917-2391767.46868.111.9367.5568.191.93
224230-2423068.35168.43
324675-2467569.60669.69
423414-2341466.04966.13
524587-2458769.35869.44
624044-2404467.82667.90
15min127148-2714876.58277.261.7876.7777.451.77
227262-2726276.90477.10
327449-2744977.43277.63
426794-2679475.58475.78
528251-2825179.69479.89
627425-2742577.36477.55
20min128360-2836080.00181.351.8680.3281.671.86
229087-2908782.05282.38
328619-2861980.73281.06
428245-2824579.67779.99
529679-2967983.72284.05
629032-2903281.89782.22
30min129858-2985884.22786.291.7284.6886.751.71
230568-3056886.23086.69
330522-3052286.10086.56
430282-3028285.42385.87
531379-3137988.51888.98
630932-3093287.25787.71
45min131410-3141088.60589.351.8089.2089.951.80
231739-3173989.53390.14
331583-3158389.09389.70
430866-3086687.07187.66
532597-3259791.95492.57
631847-3184789.83890.44
60min132089-3208990.52190.811.8891.2691.561.87
232503-3250391.68892.44
332251-3225190.97891.73
431092-3109287.70888.45
532886-3288692.76993.54
632328-3232891.19591.95
90min132213-3221390.87092.832.5591.7693.732.54
233445-3344594.34695.25
332331-3233191.20392.11
431953-3195390.13791.02
533545-3354594.62895.55
633954-3395495.78296.68
120min133370-3337094.13494.381.9595.1895.441.95
234015-3401595.95497.02
333065-3306593.27494.33
432450-3245091.53992.57
534243-3424396.59797.68
633605-3360594.79795.86
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133615-3361594.82594.951.6896.0296.171.68
233902-3390295.63596.86
333560-3356094.67095.88
432662-3266292.13793.32
534345-3434596.88598.13
633881-3388195.57696.80
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%
19.946508965049649666484464821649540.19
210.006400363956639800.06
单位质量响应值RSD%判断
6534.616398.001.50数据可信
供试品溶液-2025072321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%
5min130336-3033642.09642.774.4542.1042.774.44
230527-3052742.36142.36
329987-2998741.61241.61
433347-3334746.27546.27
529486-2948640.91740.92
631259-3125943.37743.38
10min145647-4564763.34364.872.8063.4164.942.81
246864-4686465.03265.10
345878-4587863.66463.73
449172-4917268.23568.31
545942-4594263.75263.82
646977-4697765.18965.26
15min153275-5327573.92875.022.1674.1075.202.17
253492-5349274.22974.41
354063-5406375.02275.20
456149-5614977.91678.11
552907-5290773.41873.59
654482-5448275.60375.78
20min156834-5683478.86780.791.4979.1781.101.49
258003-5800380.48980.79
358571-5857181.27781.58
459502-5950282.56982.89
558227-5822780.80081.10
658201-5820180.76481.07
30min161274-6127485.02886.091.0585.4686.531.05
262008-6200886.04786.48
362903-6290387.28987.72
462738-6273887.06087.52
561751-6175185.69086.12
661578-6157885.45085.89
45min163409-6340987.99189.100.8488.5689.680.84
264332-6433289.27289.85
364800-6480089.92190.50
464768-6476889.87790.48
563903-6390388.67689.25
664040-6404088.86689.45
60min163469-6346988.07490.641.5588.7991.361.55
265422-6542290.78491.51
366082-6608291.70092.43
466115-6611591.74692.50
565878-6587891.41792.14
664921-6492190.08990.82
90min165641-6564191.08892.100.7591.9592.980.76
266480-6648092.25293.13
366347-6634792.06892.95
467178-6717893.22194.13
566346-6634692.06692.94
666240-6624091.91992.80
120min166011-6601191.60292.990.9992.6294.030.99
267413-6741393.54794.58
367147-6714793.17894.22
467881-6788194.19695.26
567108-6710893.12494.15
666526-6652692.31693.35
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166631-6663192.46292.931.3893.6394.121.38
265882-6588291.42392.61
367909-6790994.23595.43
467833-6783394.13095.35
567585-6758593.78694.97
665990-6599091.57292.76
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%
19.943213732270319383224431844320870.59
210.003206031982320210.18
单位质量响应值RSD%判断
3228.073202.100.58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%
5min116234-1623445.30444.325.1745.3044.325.17
214576-1457640.67740.68
315725-1572543.88343.88
415621-1562143.59343.59
516073-1607344.85444.85
617070-1707047.63747.64
10min123780-2378066.36266.962.4666.4467.032.46
223229-2322964.82564.89
324136-2413667.35667.43
423545-2354565.70665.78
524460-2446068.26068.33
624812-2481269.24269.32
15min127421-2742176.52376.761.8776.7176.941.88
227040-2704075.46075.64
327686-2768677.26377.45
426909-2690975.09475.28
527633-2763377.11577.30
628338-2833879.08279.28
20min128978-2897880.86881.621.6381.1881.931.63
228741-2874180.20780.51
329501-2950182.32882.64
429141-2914181.32381.63
529047-2904781.06181.38
630077-3007783.93584.26
30min131075-3107586.72086.730.9587.1787.180.95
231282-3128287.29887.73
331348-3134887.48287.93
430621-3062185.45385.90
530840-3084086.06486.52
631312-3131287.38287.85
45min132446-3244690.54689.301.3391.1489.891.32
232227-3222789.93590.52
332137-3213789.68490.28
431625-3162588.25588.84
531337-3133787.45188.05
632216-3221689.90490.52
60min132364-3236490.31790.491.0091.0691.241.00
232308-3230890.16190.89
332699-3269991.25292.00
431948-3194889.15689.89
532370-3237090.33491.08
632871-3287191.73292.49
90min133090-3309092.34391.791.5293.2492.681.51
233333-3333393.02193.90
332834-3283491.62992.53
431977-3197789.23790.12
532809-3280991.55992.45
633299-3329992.92793.84
120min132942-3294291.93092.931.1592.9893.981.14
233457-3345793.36894.40
333309-3330992.95594.01
433194-3319492.63493.66
532947-3294791.94492.99
633957-3395794.76395.83
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133033-3303392.18493.242.1293.3994.442.10
233633-3363393.85995.05
332935-3293591.91193.12
432833-3283391.62692.81
533309-3330992.95594.15
634725-3472596.90698.13
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