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%
110.146517264961645676467964819648400.37
210.206537864950651640.47
单位质量响应值RSD%判断
6394.486388.630.07数据可信
加速6月-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%
5min118964-1896426.62132.0611.9326.6232.0611.93
225266-2526635.46735.47
326148-2614836.70536.71
421023-2102329.51129.51
521837-2183730.65430.65
623791-2379133.39633.40
10min135399-3539949.69154.515.9049.7454.565.91
240962-4096257.50057.56
341733-4173358.58258.64
438169-3816953.57953.63
537806-3780653.07053.12
638928-3892854.64554.70
15min144982-4498263.14366.173.6063.2766.313.60
248954-4895468.71968.87
349338-4933869.25869.42
446889-4688965.82065.96
546040-4604064.62864.77
646620-4662065.44365.59
20min151424-5142472.18672.632.0672.4272.892.06
252128-5212873.17473.44
353504-5350475.10675.38
451996-5199672.98973.24
550860-5086071.39471.64
650541-5054170.94771.20
30min156948-5694879.94079.651.5180.2980.031.51
256711-5671179.60880.00
357639-5763980.91081.31
457559-5755980.79881.17
555373-5537377.73078.10
656216-5621678.91379.29
45min159998-5999884.22283.461.9084.7183.961.89
260011-6001184.24084.76
360078-6007884.33484.87
460456-6045684.86585.37
557548-5754880.78381.28
658620-5862082.28782.79
60min161549-6154986.39985.251.8187.0385.901.80
260545-6054584.99085.65
361671-6167186.57087.25
461715-6171586.63287.28
559189-5918983.08683.72
659693-5969383.79484.44
90min162194-6219487.30486.261.8788.0787.051.87
261701-6170186.61287.42
361937-6193786.94487.76
462772-6277288.11688.91
559851-5985184.01584.78
660262-6026284.59285.37
120min162900-6290088.29586.282.5389.2187.212.51
261215-6121585.93086.88
361974-6197486.99687.96
463301-6330188.85889.80
559602-5960283.66684.57
659790-5979083.93084.85
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164621-6462190.71190.011.1491.7791.091.14
263848-6384889.62690.72
364413-6441390.41991.53
465145-6514591.44792.53
563237-6323788.76989.82
663483-6348389.11490.18
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%
110.146557065653654306507765539654540.35
210.206742266864671430.59
单位质量响应值RSD%判断
6455.036582.651.39数据可信
加速6月-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%
5min121527-2152729.63127.4010.7929.6327.4010.80
217695-1769524.35724.36
322845-2284531.44531.45
420273-2027327.90527.91
517308-1730823.82423.82
619779-1977927.22527.23
10min137149-3714951.13449.786.2151.1849.826.21
232806-3280645.15645.20
337993-3799352.29652.35
437535-3753551.66651.71
533834-3383446.57146.61
637669-3766951.85051.90
15min146112-4611263.47262.273.7063.6162.403.71
242641-4264158.69458.81
347023-4702364.72664.87
445848-4584863.10863.24
543743-4374360.21160.33
646053-4605363.39063.52
20min150932-5093270.10669.272.6670.3569.502.67
248077-4807766.17666.39
351274-5127470.57770.82
451079-5107970.30970.55
549290-4929067.84668.06
651306-5130670.62170.86
30min155950-5595077.01376.501.7877.3776.851.79
254169-5416974.56274.89
356512-5651277.78778.15
455987-5598777.06477.42
554527-5452775.05575.39
656337-5633777.54677.90
45min159563-5956381.98680.651.7082.4781.131.71
257170-5717078.69379.14
358359-5835980.32980.82
458655-5865580.73781.22
557986-5798679.81680.27
659836-5983682.36282.85
60min160932-6093283.87182.981.7784.4983.591.77
259399-5939981.76182.34
359194-5919481.47982.11
460474-6047483.24083.86
559724-5972482.20882.80
661994-6199485.33385.95
90min162208-6220885.62784.271.6186.3985.021.61
259948-5994882.51683.23
360141-6014182.78283.55
461201-6120184.24185.00
561707-6170784.93885.66
662145-6214585.54086.30
120min162507-6250786.03985.181.8286.9486.071.81
260233-6023382.90983.76
361043-6104384.02484.93
461595-6159584.78385.68
563162-6316286.94087.81
662767-6276786.39787.30
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164374-6437488.60988.390.9389.6689.420.93
263831-6383187.86188.85
363237-6323787.04488.09
464846-6484689.25890.30
564316-6431688.52989.54
664690-6469089.04490.09
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%
110.146595966828664106598666257662880.54
210.206546265482654720.03
单位质量响应值RSD%判断
6537.286418.821.30数据可信
加速6月-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%
5min116218-1621822.46428.2412.1422.4628.2412.15
220763-2076328.75928.76
320545-2054528.45728.46
422479-2247931.13631.14
519228-1922826.63326.63
623101-2310131.99832.00
10min133045-3304545.77150.715.4345.8150.765.44
236814-3681450.99251.04
337572-3757252.04252.09
437727-3772752.25652.31
535836-3583649.63749.68
638658-3865853.54653.60
15min143460-4346060.19763.292.6060.3163.422.61
245343-4534362.80562.94
346624-4662464.58064.71
446140-4614063.90964.05
546074-4607463.81863.94
646534-4653464.45564.60
20min149196-4919668.14269.981.9668.3670.211.96
249508-4950868.57468.81
351527-5152771.37171.61
451514-5151471.35371.60
550574-5057470.05170.28
650807-5080770.37470.62
30min154820-5482075.93277.362.1176.2677.712.11
254207-5420775.08375.43
357275-5727579.33379.69
456030-5603077.60877.97
556894-5689478.80579.16
655880-5588077.40077.77
45min161021-6102184.52183.022.2484.9883.502.22
257781-5778180.03380.51
361314-6131484.92785.42
459377-5937782.24482.74
560737-6073784.12884.61
659389-5938982.26182.76
60min163985-6398588.62785.542.5389.2286.172.50
260041-6004183.16483.77
362595-6259586.70187.34
460238-6023883.43784.07
562621-6262186.73787.36
661081-6108184.60485.24
90min165257-6525790.38887.472.9891.1388.242.95
260763-6076384.16484.91
364422-6442289.23290.01
461098-6109884.62885.40
564426-6442689.23790.00
662955-6295587.20087.97
120min165828-6582891.17987.773.0592.0788.683.02
260864-6086484.30485.19
364654-6465489.55390.48
462236-6223686.20487.12
564600-6460089.47890.39
662031-6203185.92086.84
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166228-6622891.73389.971.5492.7891.031.53
263559-6355988.03789.07
365450-6545090.65691.73
464610-6461089.49290.55
565673-6567390.96592.03
664211-6421188.94090.00
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