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%
19.936430264480641696461864283643700.28
29.906438164132642560.28
单位质量响应值RSD%判断
6482.386490.510.09数据可信
供试品溶液-25060901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%
5min124101-2410133.33736.474.5433.3436.474.54
226658-2665836.87436.87
326993-2699337.33737.34
426051-2605136.03436.03
527030-2703037.38837.39
627364-2736437.85037.85
10min138667-3866753.48554.801.3353.5454.861.34
240151-4015155.53755.60
339818-3981855.07755.14
439511-3951154.65254.71
539565-3956554.72754.79
639994-3999455.32055.38
15min146217-4621763.92864.140.8364.0764.300.83
246895-4689564.86665.02
346140-4614063.82163.98
445831-4583163.39463.54
546522-4652264.35064.50
646633-4663364.50364.66
20min151028-5102870.58269.981.1870.8370.241.18
251189-5118970.80571.07
350631-5063170.03370.29
449494-4949468.46168.72
550505-5050569.85970.12
650725-5072570.16370.43
30min156182-5618277.71176.311.3978.0876.681.38
255638-5563876.95977.34
354962-5496276.02476.40
453925-5392574.59074.96
554966-5496676.02976.41
655338-5533876.54476.92
45min159787-5978782.69880.721.6083.2081.221.60
258769-5876981.29081.80
358243-5824380.56281.07
456922-5692278.73579.23
558107-5810780.37480.88
658315-5831580.66281.17
60min161702-6170285.34782.901.7085.9883.541.69
260414-6041483.56584.21
359555-5955582.37783.02
458735-5873581.24381.87
559565-5956582.39183.03
659616-5961682.46183.10
90min163957-6395788.46685.122.2589.2485.902.23
261124-6112484.54785.33
361903-6190385.62586.40
459803-5980382.72083.48
560940-6094084.29385.07
661519-6151985.09485.87
120min165590-6559090.72586.222.9091.6587.142.88
261479-6147985.03885.96
362566-6256686.54287.46
460161-6016183.21584.11
562247-6224786.10187.02
661953-6195385.69486.61
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166221-6622191.59788.381.9592.6789.441.93
263143-6314387.34088.41
363986-6398688.50689.57
462635-6263586.63787.68
563884-6388488.36589.42
663513-6351387.85288.92
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%
19.936426864168642296451664290642940.21
29.906479364750647720.05
单位质量响应值RSD%判断
6474.726542.630.74数据可信
供试品溶液-25060902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%
5min132477-3247744.77040.2415.9644.7740.2415.95
219866-1986627.38627.39
329817-2981741.10341.10
431327-3132743.18543.18
531244-3124443.07143.07
630427-3042741.94441.94
10min147391-4739165.32960.878.2265.4060.948.23
237062-3706251.09151.14
344155-4415560.86960.94
445482-4548262.69862.77
545441-4544162.64162.71
645424-4542462.61862.69
15min155231-5523176.13771.455.2976.3271.625.30
246858-4685864.59564.73
351715-5171571.29071.46
452649-5264972.57872.75
551980-5198071.65671.83
652559-5255972.45472.63
20min159256-5925681.68677.034.1982.0077.314.21
251908-5190871.55671.79
355997-5599777.19377.48
456028-5602877.23677.53
555876-5587677.02677.32
656197-5619777.46977.76
30min163364-6336487.34983.303.0587.8083.713.07
257646-5764679.46679.82
360452-6045283.33483.75
460180-6018082.95983.39
559974-5997482.67583.10
660930-6093083.99384.42
45min165748-6574890.63586.772.6191.2387.322.63
260867-6086783.90684.40
363365-6336587.35087.91
462969-6296986.80487.37
561899-6189985.32985.89
662803-6280386.57587.14
60min166960-6696092.30688.512.3693.0589.212.37
262689-6268986.41887.05
364380-6438088.74989.45
464306-6430688.64789.36
563019-6301986.87387.58
663896-6389688.08288.79
90min168168-6816893.97190.082.6494.8790.932.65
263201-6320187.12487.90
366017-6601791.00691.86
465741-6574190.62591.48
564225-6422588.53689.38
664737-6473789.24190.10
120min168888-6888894.96490.702.6896.0291.692.69
263891-6389188.07588.99
366184-6618491.23692.24
466148-6614891.18692.19
565048-6504889.67090.67
664595-6459589.04690.05
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169007-6900795.12891.961.9296.3493.101.94
265310-6531090.03191.10
366671-6667191.90793.06
467005-6700592.36893.53
565857-6585790.78591.93
666386-6638691.51492.67
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%
19.936484664938647916475864955648580.14
29.906530965501654050.21
单位质量响应值RSD%判断
6531.526606.570.81数据可信
供试品溶液-25060903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%
5min128822-2882239.36736.475.4939.3736.475.49
226322-2632235.95235.95
324329-2432933.23033.23
426690-2669036.45536.45
526665-2666536.42136.42
627373-2737337.38837.39
10min142432-4243257.95656.552.2458.0256.602.25
240898-4089855.86155.92
339819-3981954.38754.44
441562-4156256.76856.83
541676-4167656.92456.98
642011-4201157.38157.44
15min150030-5003068.33467.381.1868.5067.531.18
249187-4918767.18367.34
348454-4845466.18166.33
448946-4894666.85367.01
549723-4972367.91568.07
649630-4963067.78867.95
20min154335-5433574.21473.620.7174.4973.890.72
253397-5339772.93373.20
353472-5347273.03573.29
453982-5398273.73274.00
554166-5416673.98374.25
654067-5406773.84874.12
30min159199-5919980.85880.550.7281.2680.940.73
258429-5842979.80680.19
358527-5852779.94080.32
459118-5911880.74781.14
559540-5954081.32381.72
659015-5901580.60681.00
45min162170-6217084.91684.820.6885.4585.350.68
261526-6152684.03684.56
361808-6180884.42184.93
462130-6213084.86185.39
562763-6276385.72586.25
662210-6221084.97085.50
60min163040-6304086.10486.920.7386.7887.580.72
263430-6343086.63687.30
363485-6348586.71287.36
464178-6417887.65888.32
564209-6420987.70088.37
663482-6348286.70887.38
90min164971-6497188.74188.750.7089.5689.560.70
264371-6437187.92288.73
364664-6466488.32289.12
464912-6491288.66189.47
565618-6561889.62590.44
665347-6534789.25590.07
120min165180-6518089.02789.470.5689.9990.420.56
265421-6542189.35690.31
365371-6537189.28890.23
465412-6541289.34490.30
566226-6622690.45591.42
665405-6540589.33490.30
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166032-6603290.19090.370.4891.3191.480.47
266151-6615190.35391.45
365918-6591890.03591.13
466335-6633590.60491.71
566693-6669391.09392.21
665853-6585389.94691.06
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