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%
110.386657566751669966605065917664580.70
210.406789968003679510.11
单位质量响应值RSD%判断
6402.506533.751.44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%
5min134259-3425947.52642.906.9347.5342.906.93
227521-2752138.17938.18
330838-3083842.78142.78
430585-3058542.43042.43
531131-3113143.18743.19
631206-3120643.29143.29
10min147115-4711565.36161.563.2565.4461.643.25
243082-4308259.76659.83
344386-4438661.57561.65
444317-4431761.48061.55
543358-4335860.14960.22
644006-4400661.04861.12
15min152879-5287973.35770.721.9673.5570.901.96
250916-5091670.63470.80
350499-5049970.05670.23
451060-5106070.83471.01
550065-5006569.45469.63
650449-5044969.98670.16
20min156031-5603177.73075.601.5578.0475.891.56
254647-5464775.81076.09
354127-5412775.08975.38
454558-5455875.68775.98
553978-5397874.88275.17
653613-5361374.37674.67
30min159511-5951182.55880.781.3383.0081.201.34
258662-5866281.38081.79
357903-5790380.32780.74
458269-5826980.83581.25
557658-5765879.98780.40
657379-5737979.60080.01
45min161260-6126084.98483.870.9185.5684.420.91
260485-6048583.90984.45
360619-6061984.09584.64
460566-6056684.02184.57
559586-5958682.66283.21
660229-6022983.55484.10
60min162081-6208186.12385.520.7286.8486.210.72
261626-6162685.49286.17
361245-6124584.96385.65
462281-6228186.40087.09
561250-6125084.97085.65
661395-6139585.17185.86
90min163207-6320787.68586.760.8788.5587.590.87
262594-6259486.83587.66
362407-6240786.57587.41
462941-6294187.31688.15
561629-6162985.49686.32
662453-6245386.63987.47
120min163117-6311787.56087.361.2988.5788.341.28
263254-6325487.75088.72
362276-6227686.39387.37
464114-6411488.94389.92
561832-6183285.77886.75
663253-6325387.74988.72
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164052-6405288.85789.360.4190.0190.480.40
264310-6431089.21590.33
364721-6472189.78590.91
464546-6454689.54390.67
564204-6420489.06890.18
664636-6463689.66790.79
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%
110.386750467732673066759768077676430.43
210.406837068014681920.37
单位质量响应值RSD%判断
6516.676556.920.44数据可信
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%
5min130648-3064842.06645.594.0242.0745.594.02
233444-3344445.90445.90
333784-3378446.37146.37
433098-3309845.42945.43
534443-3444347.27547.28
633856-3385646.47046.47
10min144446-4444661.00564.022.8361.0864.092.83
246398-4639863.68463.76
346542-4654263.88263.96
446478-4647863.79463.87
547706-4770665.48065.56
648269-4826966.25266.33
15min151280-5128070.38572.311.9870.5672.491.98
252168-5216871.60471.79
352109-5210971.52371.71
452926-5292672.64472.83
553411-5341173.31073.50
654185-5418574.37374.56
20min153897-5389773.97776.472.1074.2776.782.10
255035-5503575.53975.84
355714-5571476.47176.77
455794-5579476.58176.88
556717-5671777.84878.16
657140-5714078.42878.74
30min157015-5701578.25780.842.1878.6781.262.18
258093-5809379.73780.16
358696-5869680.56480.99
458948-5894880.91081.34
560210-6021082.64283.08
660406-6040682.91183.35
45min159391-5939181.51883.802.1082.0684.372.10
259972-5997282.31682.88
360957-6095783.66884.23
461019-6101983.75384.32
562625-6262585.95786.53
662375-6237585.61486.19
60min160437-6043782.95485.392.0883.6386.102.08
260914-6091483.60984.31
362237-6223785.42486.13
462750-6275086.12986.83
563677-6367787.40188.12
663261-6326186.83087.55
90min161491-6149184.40087.122.3385.2287.972.33
261926-6192684.99885.83
363425-6342587.05587.90
464198-6419888.11688.96
564913-6491389.09789.96
664886-6488689.06089.93
120min161708-6170884.69887.762.3985.6688.752.39
262643-6264385.98286.96
363861-6386187.65388.65
464482-6448288.50689.50
565354-6535489.70390.72
665579-6557990.01291.03
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163373-6337386.98488.461.7988.0889.601.79
263108-6310886.62087.74
363876-6387687.67488.81
464996-6499689.21190.35
565560-6556089.98591.15
665794-6579490.30791.47
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%
110.386884568401687796818668203684830.46
210.406865568723686890.08
单位质量响应值RSD%判断
6597.596604.710.08数据可信
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%
5min134118-3411846.37246.023.9746.3746.023.97
234097-3409746.34446.34
333437-3343745.44745.45
432730-3273044.48644.49
536234-3623449.24849.25
632521-3252144.20244.20
10min147276-4727664.25663.392.8164.3363.472.81
245759-4575962.19462.27
346059-4605962.60262.68
445066-4506661.25261.33
548753-4875366.26466.35
646932-4693263.78963.86
15min153671-5367172.94871.841.9773.1372.021.96
251749-5174970.33670.52
352851-5285171.83472.01
451505-5150570.00470.18
554062-5406273.48073.67
653305-5330572.45172.63
20min156713-5671377.08376.671.2477.3976.971.24
255496-5549675.42975.73
357067-5706777.56477.86
455691-5569175.69475.99
557145-5714577.67077.98
656351-5635176.59176.89
30min160790-6079082.62481.581.4183.0682.011.41
258768-5876879.87680.30
360816-6081682.65983.09
459421-5942180.76381.18
560597-6059782.36282.81
659746-5974681.20581.63
45min163148-6314885.82985.060.9186.4085.620.91
262262-6226284.62585.18
363445-6344586.23386.80
462127-6212784.44184.99
562268-6226884.63385.21
662236-6223684.58985.15
60min164134-6413487.16986.410.9287.8887.110.92
263021-6302185.65686.35
364257-6425787.33688.05
463881-6388186.82587.52
562984-6298485.60686.33
663157-6315785.84186.55
90min165721-6572189.32688.170.9590.1989.020.95
264609-6460987.81588.66
365485-6548589.00589.86
464865-6486588.16389.00
564294-6429487.38788.25
664241-6424187.31588.16
120min166662-6666290.60588.681.3991.6189.681.38
264570-6457087.76288.75
365991-6599189.69390.70
465185-6518588.59889.58
564411-6441187.54688.56
664638-6463887.85488.85
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167186-6718691.31789.511.1592.4890.651.14
265495-6549589.01990.15
365861-6586189.51690.67
466144-6614489.90191.03
565036-6503688.39589.55
665406-6540688.89890.04
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