恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.073148123146933152953147883147893148750.08
211.123151823150653151240.03
单位质量响应值RSD%判断
28443.9928338.490.27数据可信
供试品溶液-25111801-2-2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%
5min113926-1392621.69760.1748.6721.7060.1748.66
245753-4575371.28671.29
351751-5175180.63180.63
451879-5187980.83080.83
515256-1525623.77023.77
653144-5314482.80182.80
10min153238-5323882.94885.527.8383.1986.198.09
254217-5421784.47385.27
358845-5884591.68492.58
458741-5874191.52292.42
547481-4748173.97874.24
656818-5681888.52689.45
15min159459-5945992.64089.955.2693.8091.575.40
260370-6037094.06095.79
358898-5889891.76693.68
458122-5812290.55792.47
551848-5184880.78281.87
657706-5770689.90991.81
20min159785-5978593.14889.345.2495.3491.965.32
260255-6025593.88196.66
357742-5774289.96592.90
457294-5729489.26792.19
551830-5183080.75482.74
657138-5713889.02491.93
30min158017-5801790.39488.383.4493.6291.993.55
259313-5931392.41396.23
357052-5705288.89092.82
456847-5684788.57192.48
553815-5381583.84786.73
655293-5529386.15090.04
45min158814-5881491.63689.053.2895.8793.643.20
259997-5999793.47998.32
357133-5713389.01693.94
455625-5562586.66791.56
555754-5575486.86890.68
655606-5560686.63791.49
60min155947-5594787.16986.832.3392.4292.412.44
258083-5808390.49796.38
355852-5585287.02192.93
455300-5530086.16192.02
554590-5459085.05489.83
654588-5458885.05190.86
极限157574-5757489.70488.422.1395.9294.972.00
257445-5744589.50396.39
355297-5529786.15693.03
458208-5820890.69197.51
556589-5658988.16993.89
655401-5540186.31893.07
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.033952133947443952813949683947923950000.07
211.153947873951883949880.08
单位质量响应值RSD%判断
35811.4235424.930.77数据可信
供试品溶液-25111801-2-2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%
5min19026-902611.40436.7367.8311.4036.7367.84
224195-2419530.56930.57
333820-3382042.72942.73
434129-3412943.12043.12
510593-1059313.38413.38
662669-6266979.17879.18
10min127485-2748534.72656.0740.1334.8556.4840.33
236491-3649146.10446.44
344382-4438256.07456.55
448782-4878261.63362.11
532096-3209640.55140.70
677056-7705697.35598.24
15min141293-4129352.17166.0526.9752.6867.0827.32
246699-4669959.00159.85
349022-4902261.93663.03
453846-5384668.03169.19
543204-4320454.58655.18
679593-79593100.561102.52
20min151776-5177665.41671.9619.5866.5173.7320.03
254660-5466069.05970.57
351306-5130664.82266.61
456921-5692171.91673.84
548207-4820760.90762.11
678883-7888399.664102.74
30min163081-6308179.69979.0011.8781.5281.5612.38
260982-6098277.04779.32
355397-5539769.99172.50
461253-6125377.38980.11
557839-5783973.07674.96
676599-7659996.778100.96
45min174265-7426593.82985.599.4896.5389.049.67
266627-6662784.17987.31
360221-6022176.08579.37
463828-6382880.64384.22
564777-6477781.84284.54
676765-7676596.988102.25
60min173974-7397493.46186.377.2197.2190.767.48
266873-6687384.49088.56
362427-6242778.87383.00
465922-6592283.28887.76
566161-6616183.59087.19
674816-7481694.525100.86
极限178448-7844899.11496.182.22103.90101.531.44
275978-7597895.993101.00
375544-7554495.445100.45
476974-7697497.252102.65
576432-7643296.567101.10
673355-7335592.679100.07
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.073156663156773155993152863154533155360.06
211.123153393149793151590.09
单位质量响应值RSD%判断
28503.7028341.640.41数据可信
供试品溶液-25112401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%
5min144504-4450469.26350.4341.4469.2650.4341.44
220482-2048231.87731.88
312166-1216618.93418.93
442143-4214365.58965.59
532312-3231250.28850.29
642825-4282566.65066.65
10min157312-5731289.19776.6716.8389.9777.2317.00
243026-4302666.96367.32
337771-3777158.78558.99
455267-5526786.01486.74
545412-4541270.67771.24
656797-5679788.39589.14
15min156309-5630987.63682.967.4789.4084.377.62
248177-4817774.98076.08
353804-5380483.73784.60
455726-5572686.72988.41
548585-4858575.61576.96
657231-5723189.07190.79
20min156494-5649487.92484.945.4790.6687.285.55
250702-5070278.91080.84
356982-5698288.68390.48
456318-5631887.65090.30
550785-5078579.03981.22
656183-5618387.44090.15
30min157310-5731089.19486.554.4492.9189.834.53
252434-5243481.60584.41
357967-5796790.21693.00
456678-5667888.21091.83
552533-5253381.75984.82
656739-5673988.30591.99
45min157266-5726689.12588.554.9393.8392.794.96
254490-5449084.80588.52
358895-5889591.66195.44
456565-5656588.03492.64
553262-5326282.89486.86
660898-6089894.77899.44
60min155141-5514185.81885.623.5591.5190.843.68
253945-5394583.95788.61
355866-5586686.94791.75
454783-5478385.26190.84
552245-5224581.31186.20
658086-5808690.40296.12
极限156973-5697388.66988.882.6595.3295.052.35
258519-5851991.07696.67
358865-5886591.61497.38
457469-5746989.44195.97
554962-5496285.54091.33
655856-5585686.93193.65
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.033958573956143957033954123958153956800.05
211.153950573950573950570.00
单位质量响应值RSD%判断
35873.0735431.120.88数据可信
供试品溶液-25112401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%
5min111569-1156914.60316.9481.8014.6016.9481.79
24177-41775.2725.27
32802-28023.5373.54
411239-1123914.18614.19
517945-1794522.65122.65
632807-3280741.41141.41
10min172831-7283191.93154.9754.1492.0955.1654.05
217970-1797022.68322.74
320887-2088726.36526.40
467506-6750685.20985.37
531899-3189940.26440.52
650211-5021163.37963.84
15min174651-7465194.22862.7442.8995.4163.5442.94
224129-2412930.45730.77
332867-3286741.48641.82
473453-7345392.71693.82
538548-3854848.65749.36
654595-5459568.91270.08
20min176120-7612096.08267.7535.4298.3169.2535.61
229758-2975837.56238.21
342053-4205353.08153.87
475072-7507294.75996.89
542313-4231353.40954.65
656751-5675171.63473.56
30min177380-7738097.67374.0827.60100.9776.3327.99
236700-3670046.32447.39
351280-5128064.72866.11
476279-7627996.28399.47
548535-4853561.26363.10
661980-6198078.23480.96
45min176792-7679296.93081.2320.30101.3184.3020.90
244840-4484056.59958.18
359996-5999675.73077.83
476488-7648896.547100.80
555326-5532669.83572.35
672697-7269791.76295.36
60min174369-7436993.87281.7816.1699.3385.7516.94
248632-4863261.38663.60
360977-6097776.96879.91
474100-7410093.53298.86
558493-5849373.83377.12
672147-7214791.06795.68
极限175104-7510494.80093.343.98101.3098.234.85
268495-6849586.45889.35
375036-7503694.71498.51
476535-7653596.606102.98
575691-7569195.54199.65
672846-7284691.95097.58
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