非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 11.123129353127913124443130643118263126120.16
2 11.183137973142113140040.10
单位质量响应值RSD%判断
28112.5928086.230.07数据可信
供试品溶液-6031101批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143310-4331013.87213.0825.0813.8713.0825.09
251567-5156716.51616.52
327771-277718.8958.89
450118-5011816.05216.05
528997-289979.2879.29
643309-4330913.87213.87
10min155276-5527617.70418.436.4117.7318.466.42
260170-6017019.27219.30
360684-6068419.43719.45
461381-6138119.66019.69
552348-5234816.76716.78
655468-5546817.76617.79
15min156277-5627718.02518.835.4918.0818.885.50
259618-5961819.09519.15
363187-6318720.23820.29
461783-6178319.78919.85
555971-5597117.92717.97
655825-5582517.88017.93
20min156538-5653818.10918.975.0918.1919.065.09
260734-6073419.45319.54
363769-6376920.42520.51
460864-6086419.49419.59
556554-5655418.11418.19
656915-5691518.22918.31
30min156151-5615117.98518.764.3418.1018.884.33
258454-5845418.72218.85
362153-6215319.90720.02
460952-6095219.52219.65
557815-5781518.51818.62
655878-5587817.89718.01
45min155764-5576417.86118.703.8118.0018.853.82
258256-5825618.65918.81
362124-6212419.89820.05
459408-5940819.02819.19
558109-5810918.61218.75
656732-5673218.17118.31
60min156793-5679318.19018.913.1418.3619.093.13
258938-5893818.87719.06
361531-6153119.70819.89
460282-6028219.30819.50
559663-5966319.11019.27
657050-5705018.27318.45
90min155395-5539517.74318.594.4917.9518.804.45
258147-5814718.62418.84
361880-6188019.82020.03
459320-5932019.00019.22
558628-5862818.77818.98
654867-5486717.57317.78
120min154367-5436717.41318.424.1017.6518.664.07
257991-5799118.57418.82
360180-6018019.27519.52
459474-5947419.04919.30
558032-5803218.58718.82
654994-5499417.61417.85
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154450-5445017.44018.363.7517.7018.633.73
257326-5732618.36118.64
359673-5967319.11319.39
458307-5830718.67518.96
559088-5908818.92519.18
655047-5504717.63117.89
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.104071694067424059784062404052124062680.19
211.074084144083344083740.02
单位质量响应值RSD%判断
36600.7236890.150.56数据可信
供试品溶液-6031101批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115461-154613.7833.0655.943.783.0655.91
217427-174274.2644.26
38656-86562.1182.12
418240-182404.4634.46
5-0.0000.00
615215-152153.7233.72
10min142216-4221610.33010.2832.1710.3410.2832.18
247805-4780511.69711.70
334523-345238.4478.45
462762-6276215.35715.36
522208-222085.4345.43
642510-4251010.40210.41
15min153323-5332313.04713.1323.3913.0713.1523.40
262276-6227615.23815.26
352403-5240312.82212.84
469791-6979117.07717.11
532530-325307.9607.97
651543-5154312.61212.64
20min160563-6056314.81914.9618.6014.8615.0018.63
270549-7054917.26217.31
360705-6070514.85414.89
472801-7280117.81317.87
540633-406339.9429.96
661518-6151815.05315.10
30min168157-6815716.67716.2813.3316.7516.3513.39
272258-7225817.68117.76
365567-6556716.04316.11
475318-7531818.42918.52
549883-4988312.20612.24
668010-6801016.64116.71
45min172686-7268617.78517.239.8617.8817.329.91
274863-7486318.31818.43
370916-7091617.35217.44
474618-7461818.25818.38
556550-5655013.83713.90
672751-7275117.80117.90
60min177253-7725318.90318.136.5719.0318.256.63
275737-7573718.53218.67
375353-7535318.43818.56
474768-7476818.29518.45
564350-6435015.74615.83
677048-7704818.85318.98
90min175308-7530818.42718.242.2118.5918.402.28
274783-7478318.29818.47
376576-7657618.73718.89
474051-7405118.11918.30
571658-7165817.53417.64
674946-7494618.33818.50
120min173316-7331617.93918.000.6318.1318.190.65
273508-7350817.98618.19
374454-7445418.21818.40
473287-7328717.93218.15
573211-7321117.91418.05
673643-7364318.02018.21
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171060-7106017.38717.641.8017.6117.851.72
271892-7189217.59117.82
373143-7314317.89718.11
472711-7271117.79118.03
573521-7352117.99018.16
670171-7017117.17017.39
非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 11.123133663135213140373141473130513136240.15
2 11.183160943166423163680.13
单位质量响应值RSD%判断
28203.6028297.670.24数据可信
供试品溶液-6031101批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158439-5843918.61715.0319.7818.6215.0319.78
239363-3936312.54012.54
340222-4022212.81412.81
448761-4876115.53415.53
538283-3828312.19612.20
658007-5800718.48018.48
10min164514-6451420.55319.346.3520.5819.366.37
255556-5555617.69917.72
357637-5763718.36218.38
460913-6091319.40619.43
560043-6004319.12819.15
665535-6553520.87820.91
15min163040-6304020.08319.612.1020.1519.662.13
259476-5947618.94819.00
360986-6098619.42919.48
461279-6127919.52219.58
561737-6173719.66819.72
662734-6273419.98620.05
20min164606-6460620.58219.903.0820.6819.993.11
260262-6026219.19819.28
360530-6053019.28419.37
461933-6193319.73019.82
562792-6279220.00420.09
664682-6468220.60620.71
30min161434-6143419.57219.601.7519.7019.721.74
262964-6296420.05920.17
360611-6061119.30919.43
460014-6001419.11919.24
562069-6206919.77419.89
662063-6206319.77219.91
45min162953-6295320.05519.742.3020.2219.902.30
263400-6340020.19820.35
361668-6166819.64619.79
459787-5978719.04719.20
560946-6094619.41619.57
663047-6304720.08520.25
60min161296-6129619.52819.422.0119.7319.611.98
262781-6278120.00120.18
360313-6031319.21419.40
459104-5910418.82919.02
560954-6095419.41919.60
661341-6134119.54219.74
90min160255-6025519.19619.252.7719.4319.472.74
263414-6341420.20220.42
359384-5938418.91819.13
458530-5853018.64618.87
560069-6006919.13719.35
660813-6081319.37419.61
120min160646-6064619.32018.881.8419.5819.141.83
258902-5890218.76519.01
358974-5897418.78819.03
457689-5768918.37818.63
560389-6038919.23919.49
659070-5907018.81819.08
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160239-6023919.19119.132.5019.4919.422.47
262682-6268219.96920.25
359135-5913518.83919.12
458297-5829718.57218.85
559564-5956418.97619.26
660400-6040019.24219.54
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.104065554074514077134087204065544073990.23
211.074108734106404107560.05
单位质量响应值RSD%判断
36702.6137105.330.78数据可信
供试品溶液-6031101批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118846-188464.5923.9715.394.593.9715.38
214336-143363.4933.49
314859-148593.6203.62
417598-175984.2884.29
513175-131753.2103.21
619057-190574.6434.64
10min144417-4441710.8228.8019.3710.838.8119.36
231853-318537.7617.77
336876-368768.9848.99
431859-318597.7627.77
527512-275126.7036.71
644159-4415910.75910.77
15min150728-5072812.35910.9213.0212.3910.9413.04
241829-4182910.19110.21
348571-4857111.83411.85
440100-401009.7709.79
537217-372179.0689.08
650501-5050112.30412.33
20min157509-5750914.01112.639.8614.0612.679.88
248092-4809211.71711.75
354348-5434813.24113.28
447866-4786611.66211.70
546000-4600011.20711.24
657137-5713713.92113.97
30min162293-6229315.17714.594.5715.2514.654.61
258318-5831814.20914.26
361678-6167815.02715.09
457599-5759914.03314.09
556482-5648213.76113.81
662892-6289215.32315.39
45min172297-7229717.61416.834.2117.7116.924.23
268036-6803616.57616.66
369278-6927816.87916.97
468377-6837716.65916.74
564470-6447015.70715.78
672057-7205717.55617.65
60min174434-7443418.13517.532.7918.2617.652.82
270847-7084717.26117.37
370812-7081217.25317.37
471448-7144817.40817.51
569789-6978917.00317.10
674482-7448218.14718.27
90min174022-7402218.03518.010.6218.1918.150.64
274510-7451018.15418.29
373306-7330617.86018.00
473638-7363817.94118.08
573643-7364317.94218.07
674293-7429318.10118.26
120min173724-7372417.96217.831.6318.1518.001.61
271421-7142117.40117.57
373883-7388318.00118.18
472423-7242317.64517.81
574767-7476718.21618.37
672859-7285917.75117.94
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173210-7321017.83718.000.9118.0518.200.87
274971-7497118.26618.46
374064-7406418.04518.25
473209-7320917.83718.03
574158-7415818.06818.26
673719-7371917.96118.18
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