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%
110.096552265227653906533465113653170.24
210.126547765342654100.15
单位质量响应值RSD%判断
6473.446463.440.11数据可信
供试品溶液-2025072121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%
5min129230-2923040.54435.169.3340.5435.169.33
225602-2560235.51135.51
323804-2380433.01833.02
425162-2516234.90134.90
526067-2606736.15636.16
622207-2220730.80230.80
10min142336-4233658.72354.324.6758.7954.384.67
239082-3908254.20954.27
338489-3848953.38753.44
438665-3866553.63153.69
539607-3960754.93755.00
636780-3678051.01651.07
15min148588-4858867.39463.983.0367.5664.133.03
246005-4600563.81263.96
345998-4599863.80263.95
445519-4551963.13863.29
546316-4631664.24364.39
644333-4433361.49261.63
20min151934-5193472.03669.302.1472.3169.562.15
249610-4961068.81269.07
349896-4989669.20969.46
449500-4950068.65968.91
550088-5008869.47569.73
648755-4875567.62667.86
30min155467-5546776.93675.521.1377.3375.881.15
254442-5444275.51475.88
354628-5462875.77276.14
454277-5427775.28575.65
554265-5426575.26975.64
653582-5358274.32174.67
45min158515-5851581.16480.351.5281.6980.851.52
257974-5797480.41380.91
358529-5852981.18381.68
458612-5861281.29881.79
557635-5763579.94380.44
656323-5632378.12378.60
60min159661-5966182.75382.591.4583.4183.221.45
260263-6026383.58884.22
360001-6000183.22583.85
460298-6029883.63784.27
558899-5889981.69682.33
658130-5813080.63081.24
90min160701-6070184.19684.511.6885.0085.281.68
262316-6231686.43687.21
361505-6150585.31186.08
461424-6142485.19985.97
560131-6013183.40584.17
659503-5950382.53483.27
120min161196-6119684.88285.311.9485.8286.221.93
263029-6302987.42588.34
362099-6209986.13587.04
462218-6221886.30087.21
560816-6081684.35585.26
659684-5968482.78583.66
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162271-6227186.37486.511.4387.4587.561.43
263229-6322987.70288.76
363154-6315487.59888.65
462775-6277587.07388.13
561918-6191885.88486.93
660876-6087684.43985.45
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%
110.096564865584657716544965668656240.19
210.126530965064651860.27
单位质量响应值RSD%判断
6503.876441.300.69数据可信
供试品溶液-2025072221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%
5min130524-3052442.31239.788.3742.3139.788.37
224178-2417833.51633.52
329994-2999441.57841.58
428396-2839639.36339.36
528598-2859839.64339.64
630507-3050742.28942.29
10min143381-4338160.13559.733.0160.2159.793.01
241023-4102356.86656.92
343709-4370960.59060.66
442701-4270159.19259.26
542774-4277459.29359.36
644931-4493162.28362.35
15min149855-4985569.10969.311.7469.2869.471.75
249126-4912668.09968.25
350505-5050570.01070.18
449318-4931868.36568.53
549707-4970768.90469.07
651479-5147971.36071.53
20min153395-5339574.01674.121.5774.3074.401.57
252579-5257972.88573.15
354462-5446275.49575.78
452500-5250072.77673.05
553519-5351974.18874.47
654348-5434875.33775.63
30min156954-5695478.95079.151.3679.3679.561.36
257036-5703679.06379.45
358286-5828680.79681.21
455865-5586577.44077.84
557164-5716479.24179.64
657303-5730379.43479.85
45min158800-5880081.50982.101.3882.0582.641.38
259357-5935782.28182.80
360349-6034983.65684.20
457931-5793180.30480.83
559663-5966382.70583.24
659257-5925782.14282.69
60min159684-5968482.73483.551.7183.4184.221.71
260517-6051783.88984.54
361838-6183885.72086.41
458730-5873081.41282.07
560452-6045283.79984.47
660400-6040083.72784.41
90min159966-5996683.12584.732.1883.9485.542.17
261620-6162085.41886.21
363406-6340687.89488.72
459735-5973582.80583.60
561220-6122084.86385.68
660795-6079584.27485.10
120min160166-6016683.40285.462.9484.3686.422.91
263359-6335987.82888.77
363823-6382388.47289.45
459488-5948882.46283.40
562485-6248586.61787.57
660574-6057483.96884.94
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162968-6296887.28688.181.1388.3889.281.13
263960-6396088.66189.74
364384-6438489.24990.37
462594-6259486.76887.84
564250-6425089.06390.16
663533-6353388.07089.18
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%
110.096754367412674156725867258673770.18
210.126707067014670420.06
单位质量响应值RSD%判断
6677.606624.700.57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%
5min128010-2801037.78535.659.4737.7835.669.47
227129-2712936.59636.60
327051-2705136.49136.49
427952-2795237.70737.71
527034-2703436.46836.47
621408-2140828.87928.88
10min143002-4300258.00955.455.7458.0755.515.74
241795-4179556.38056.44
341177-4117755.54755.61
442667-4266757.55757.62
541478-4147855.95356.01
636509-3650949.25049.30
15min150447-5044768.05265.294.5568.2165.444.56
248373-4837365.25465.41
348816-4881665.85266.00
450398-5039867.98668.14
547902-4790264.61964.77
644447-4444759.95860.09
20min154844-5484473.98371.073.4274.2671.333.43
252629-5262970.99571.26
352731-5273171.13371.40
454161-5416173.06273.33
552033-5203370.19170.45
649701-4970167.04567.28
30min158735-5873579.23276.962.3679.6377.342.37
257032-5703276.93577.32
357038-5703876.94377.32
458304-5830478.65179.04
555991-5599175.53075.91
655186-5518674.44574.79
45min161886-6188683.48381.332.1084.0181.842.11
260141-6014181.12981.64
360285-6028581.32381.83
461577-6157783.06683.59
559129-5912979.76480.27
658731-5873179.22779.69
60min162813-6281384.73383.261.6085.4083.901.62
261714-6171483.25183.90
361730-6173083.27283.92
462832-6283284.75985.42
560555-6055581.68782.32
660684-6068481.86182.46
90min164468-6446886.96685.261.5087.7786.041.50
262984-6298484.96485.75
363274-6327485.35586.14
463973-6397386.29887.10
561814-6181483.38684.16
662689-6268984.56685.30
120min163285-6328585.37084.820.7286.3285.740.72
263156-6315685.19686.12
362247-6224783.97084.90
462819-6281984.74185.69
563298-6329885.38786.30
662456-6245684.25285.13
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163609-6360985.80785.170.6386.9086.230.64
262912-6291284.86785.93
362669-6266984.53985.61
463252-6325285.32586.42
563548-6354885.72586.78
662821-6282184.74485.76
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