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%
110.176710466963669436712166900670060.15
210.506849768483684900.02
单位质量响应值RSD%判断
6588.596522.860.71数据可信
供试品溶液-1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%
5min128807-2880739.42638.608.3039.4338.608.31
229032-2903239.73439.73
329910-2991040.93640.94
429662-2966240.59640.60
523587-2358732.28232.28
628240-2824038.65038.65
10min142737-4273758.49158.024.2958.5658.094.30
243189-4318959.11059.18
343655-4365559.74759.82
443692-4369259.79859.87
538864-3886453.19053.24
642226-4222657.79257.86
15min149750-4975068.08967.733.0268.2567.893.03
250506-5050669.12469.29
350485-5048569.09569.26
450679-5067969.36169.53
546855-4685564.12764.27
648660-4866066.59766.76
20min154343-5434374.37574.081.4074.6574.351.40
254835-5483575.04975.33
354574-5457474.69174.97
454634-5463474.77375.06
553337-5333772.99873.25
653030-5303072.57872.85
30min158839-5883980.52880.371.3180.9380.771.32
259581-5958181.54481.95
358948-5894880.67881.09
459373-5937381.25981.67
557954-5795479.31779.69
657664-5766478.92079.31
45min162244-6224485.18985.361.0285.7285.891.03
262992-6299286.21286.75
363130-6313086.40186.94
462491-6249185.52786.07
561877-6187784.68685.19
661485-6148584.15084.67
60min163687-6368787.16487.480.7187.8488.150.72
264415-6441588.16088.84
364057-6405787.67088.36
464332-6433288.04688.73
563822-6382287.34887.99
663193-6319386.48787.15
90min165586-6558689.76390.281.3390.5891.101.33
266071-6607190.42691.26
366029-6602990.36991.20
467448-6744892.31193.14
565896-6589690.18790.98
664756-6475688.62789.44
120min166210-6621090.61790.430.6291.5991.400.62
266265-6626590.69291.67
365738-6573889.97190.95
466371-6637190.83791.82
566441-6644190.93391.87
665407-6540789.51890.47
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166583-6658391.12790.900.5892.2592.020.57
266699-6669991.28692.42
365999-6599990.32891.46
466606-6660691.15992.30
566742-6674291.34592.44
665869-6586990.15091.26
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%
110.176788168321683726821467627680830.47
210.506889568958689260.07
单位质量响应值RSD%判断
6694.496564.381.39数据可信
供试品溶液-2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%
5min132137-3213743.49838.856.2243.5038.856.22
228620-2862038.73738.74
328358-2835838.38338.38
428378-2837838.41038.41
527005-2700536.55136.55
627715-2771537.51237.51
10min148190-4819065.22559.085.2065.3059.145.20
243472-4347258.83958.90
342832-4283257.97358.04
442731-4273157.83757.90
542174-4217457.08357.14
642480-4248057.49757.56
15min154592-5459273.89068.353.9974.0768.523.99
249737-4973767.31967.48
349610-4961067.14767.31
449613-4961367.15167.31
549482-4948266.97467.13
649976-4997667.64367.80
20min158402-5840279.04774.173.2779.3574.453.27
254208-5420873.37173.65
353755-5375572.75873.03
454388-5438873.61473.89
553728-5372872.72172.99
654316-5431673.51773.79
30min162171-6217184.14980.222.4684.5880.622.47
259096-5909679.98780.38
358180-5818078.74779.14
458585-5858579.29579.69
558639-5863979.36879.76
658942-5894279.77880.17
45min164845-6484587.76884.661.8388.3485.201.84
261906-6190683.79084.32
361811-6181183.66184.19
462194-6219484.18084.71
562136-6213684.10184.62
662412-6241284.47585.00
60min166033-6603389.37687.021.4990.1087.701.51
264058-6405886.70387.37
363148-6314885.47186.14
464337-6433787.08087.75
563869-6386986.44787.11
664317-6431787.05387.72
90min166839-6683990.46789.000.8491.3489.820.86
265629-6562988.82989.64
365290-6529088.37089.18
465628-6562888.82889.64
565488-6548888.63889.44
665650-6565088.85789.67
120min167167-6716790.91190.030.6791.9391.000.69
266352-6635289.80890.77
365819-6581989.08690.04
466750-6675090.34691.31
566492-6649289.99790.95
666507-6650790.01790.98
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167641-6764191.55290.350.8892.7391.470.90
266754-6675490.35291.46
366303-6630389.74190.84
467135-6713590.86791.98
566001-6600189.33390.44
666682-6668290.25491.36
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