非奈利酮卡格列净片项目信息
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对照品来源原料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)20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%
120.146978696974226967136965866966476970470.09
220.236948926951816950360.03
单位质量响应值RSD%判断
34610.0834356.700.52数据可信
供试品溶液-5122202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%
5min121129-2112913.77316.1821.4313.7716.1821.44
223936-2393615.60315.60
320134-2013413.12413.12
421381-2138113.93713.94
528713-2871318.71618.72
633661-3366121.94221.94
10min133303-3330321.70825.5617.9121.7325.5917.92
240113-4011326.14726.17
333131-3313121.59621.62
434717-3471722.63022.65
543061-4306128.06928.10
650993-5099333.24033.28
15min145034-4503429.35533.7314.0229.4133.7914.04
253616-5361634.94935.02
344101-4410128.74728.80
449556-4955632.30332.36
554376-5437635.44535.52
663751-6375141.55641.65
20min151325-5132533.45639.6810.5533.5639.8110.57
263355-6335541.29841.43
356897-5689737.08837.19
460465-6046539.41439.53
562950-6295041.03441.17
670283-7028345.81445.97
30min166920-6692043.62150.387.8343.7950.577.84
278833-7883351.38751.58
376333-7633349.75749.92
477950-7795050.81150.99
577940-7794050.80551.01
685727-8572755.88156.12
45min184639-8463955.17162.566.6155.4162.836.62
296281-9628162.76063.04
396338-9633862.79763.05
497020-9702063.24263.51
597251-9725163.39363.68
6104290-10429067.98168.31
60min198770-9877064.38371.094.7264.7171.474.74
2111175-11117572.46972.86
3110570-11057072.07472.43
4110721-11072172.17372.54
5110051-11005171.73672.13
6113059-11305973.69774.14
90min1119564-11956477.93782.692.9478.3783.192.96
2129952-12995284.70885.22
3128496-12849683.75984.23
4127273-12727382.96283.45
5127130-12713082.86983.38
6128714-12871483.90184.47
120min1129398-12939884.34787.812.0484.9188.442.06
2136732-13673289.12889.78
3136321-13632188.86089.47
4136281-13628188.83489.46
5135125-13512588.08088.73
6134379-13437987.59488.30
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1133614-13361487.09691.642.6187.8092.422.62
2140497-14049791.58292.38
3141302-14130292.10792.87
4144431-14443194.14794.92
5142061-14206192.60293.40
6141605-14160592.30493.16
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121772361177159517695991768930176817017701310.11
211.131762732176367417632030.04
单位质量响应值RSD%判断
159184.44158418.960.35数据可信
供试品溶液-5122202批-卡格列净-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%
5min113175-131753.6555.1624.693.665.1624.64
224870-248706.9006.90
315555-155554.3154.32
415275-152754.2384.24
520634-206345.7245.72
622081-220816.1266.13
10min136634-3663410.16315.3719.5110.1715.3819.51
266405-6640518.42218.43
355355-5535515.35715.36
450759-5075914.08214.09
564045-6404517.76817.78
659175-5917516.41716.43
15min159030-5903016.37622.4313.5116.4022.4613.52
288745-8874524.62024.66
382372-8237222.85222.88
484216-8421623.36323.39
586754-8675424.06824.11
683907-8390723.27823.32
20min170440-7044019.54225.5311.6219.5925.6011.63
297225-9722526.97227.06
396737-9673726.83726.91
497891-9789127.15727.23
596459-9645926.76026.84
693378-9337825.90525.98
30min190403-9040325.08029.587.6425.1629.707.66
2108583-10858330.12330.25
3109650-10965030.41930.54
4113146-11314631.38931.50
5109683-10968330.42930.55
6108377-10837730.06630.19
45min1112123-11212331.10633.093.2531.2333.253.28
2118945-11894532.99833.18
3119517-11951733.15733.32
4123387-12338734.23034.40
5119863-11986333.25333.43
6121776-12177633.78333.95
60min1120796-12079633.51234.321.8733.6934.541.89
2125456-12545634.80435.04
3123388-12338834.23134.45
4127057-12705735.24935.47
5121794-12179433.78834.02
6123790-12379034.34234.57
90min1130278-13027836.14236.381.2236.3736.661.24
2134264-13426437.24837.54
3130563-13056336.22136.50
4131336-13133636.43636.72
5130577-13057736.22536.51
6129897-12989736.03636.32
120min1131262-13126236.41536.300.9636.7136.640.95
2132825-13282536.84937.20
3130810-13081036.29036.63
4129868-12986836.02836.37
5131175-13117536.39136.74
6129244-12924435.85536.20
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1135555-13555537.60638.361.2837.9638.761.31
2138162-13816238.32938.74
3137288-13728838.08738.49
4140572-14057238.99839.40
5139649-13964938.74239.15
6138497-13849738.42238.83
非奈利酮卡格列净片项目信息
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对照品来源原料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)20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%
120.146931156927836933486936336929926931740.05
220.236900486912636906560.13
单位质量响应值RSD%判断
34417.7834140.190.58数据可信
供试品溶液-5122203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%
5min124241-2424115.89617.3011.9315.9017.3011.91
220994-2099413.76613.77
327207-2720717.84117.84
428670-2867018.80018.80
528622-2862218.76818.77
628601-2860118.75518.75
10min138412-3841225.18827.4811.2925.2127.5111.30
233832-3383222.18522.21
345245-4524529.66929.70
444311-4431129.05629.09
544266-4426629.02729.06
645363-4536329.74629.78
15min150532-5053233.13635.588.4233.2035.658.43
246959-4695930.79330.85
358805-5880538.56038.64
455561-5556136.43336.51
556044-5604436.75036.83
657648-5764837.80237.88
20min159156-5915638.79141.867.4238.9142.007.43
257087-5708737.43437.55
368638-6863845.00845.15
464232-6423242.11942.26
566017-6601743.29043.43
667924-6792444.54044.68
30min173352-7335248.09951.645.4748.2951.845.48
274062-7406248.56548.74
383743-8374354.91355.13
479777-7977752.31252.52
578835-7883551.69551.91
682695-8269554.22654.44
45min192886-9288660.90865.174.8461.1865.464.85
294467-9446761.94562.20
3102170-10217066.99667.31
4102218-10221867.02867.33
599427-9942765.19865.50
6105137-10513768.94269.25
60min1105305-10530569.05272.393.2269.4272.783.24
2107278-10727870.34670.70
3112714-11271473.91074.33
4111752-11175273.28073.69
5110436-11043672.41772.82
6114867-11486775.32275.75
90min1125936-12593682.58085.482.8783.0786.002.88
2126092-12609282.68383.16
3131033-13103385.92386.47
4131398-13139886.16286.69
5135564-13556488.89489.42
6132150-13215086.65587.20
120min1133818-13381887.74990.311.6788.3790.971.69
2136829-13682989.72390.34
3137927-13792790.44391.13
4138765-13876590.99391.67
5138297-13829790.68691.36
6140676-14067692.24692.94
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1140463-14046392.10695.394.0692.8896.204.05
2142149-14214993.21293.97
3156975-156975102.934103.77
4144169-14416994.53695.36
5143520-14352094.11194.94
6145550-14555095.44296.29
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121759849176171417601071761230176115617608110.05
211.131754741175552117551310.04
单位质量响应值RSD%判断
158346.31157693.710.30数据可信
供试品溶液-5122203批-卡格列净-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%
5min116144-161444.5015.4523.014.505.4523.00
214045-140453.9163.92
327149-271497.5697.57
420651-206515.7575.76
519316-193165.3855.39
619954-199545.5635.56
10min154236-5423615.12116.4613.3615.1316.4613.36
249691-4969113.85413.86
357914-5791416.14616.16
468005-6800518.95918.97
569198-6919819.29219.30
655112-5511215.36515.37
15min181969-8196922.85323.925.0122.8923.965.02
280617-8061722.47622.51
388159-8815924.57824.62
488449-8844924.65924.70
591678-9167825.55925.60
683874-8387423.38423.42
20min194018-9401826.21227.684.0626.2827.754.07
297401-9740127.15527.22
3103161-10316128.76128.84
497409-9740927.15727.24
5104855-10485529.23329.32
698764-9876427.53527.61
30min1105438-10543829.39630.892.8829.5131.022.89
2111949-11194931.21131.32
3115270-11527032.13732.27
4110012-11001230.67130.80
5111282-11128231.02531.16
6110866-11086630.90931.03
45min1116474-11647432.47234.142.6132.6434.312.60
2125084-12508434.87335.04
3123813-12381334.51834.70
4122345-12234534.10934.29
5124914-12491434.82535.01
6122053-12205334.02834.20
60min1120717-12071733.65534.822.6033.8735.052.59
2128770-12877035.90036.12
3124709-12470934.76835.01
4121441-12144133.85734.09
5127264-12726435.48135.72
6126477-12647735.26135.49
90min1128985-12898535.96036.772.3336.2337.062.33
2134045-13404537.37137.65
3131078-13107836.54436.84
4128885-12888535.93236.22
5136814-13681438.14338.44
6131515-13151536.66636.95
120min1128988-12898835.96137.042.5236.2937.392.51
2136059-13605937.93338.28
3130698-13069836.43836.80
4129896-12989636.21436.57
5136396-13639638.02738.39
6135018-13501837.64237.99
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1138719-13871938.67438.990.9539.0739.410.96
2140902-14090239.28339.69
3141596-14159639.47639.90
4138446-13844638.59839.01
5140570-14057039.19039.62
6138941-13894138.73639.15
非奈利酮卡格列净片项目信息
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对照品来源原料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)20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%
120.147019257023087018207018217023717020490.04
220.236938136944626941380.07
单位质量响应值RSD%判断
34858.4434312.311.12数据可信
供试品溶液批-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%
5min110848-108487.0517.469.717.057.469.74
213580-135808.8268.83
311160-111607.2537.25
410776-107767.0047.00
510662-106626.9306.93
611847-118477.7007.70
10min130311-3031119.70120.949.8119.7120.969.81
235736-3573623.22723.24
335703-3570323.20523.22
429124-2912418.92918.94
528965-2896518.82618.84
633486-3348621.76421.78
15min146223-4622330.04331.338.2730.0931.388.26
250722-5072232.96733.02
353823-5382334.98235.03
444037-4403728.62228.67
544212-4421228.73628.78
650246-5024632.65832.71
20min158273-5827337.87538.586.3037.9738.686.31
260883-6088339.57139.68
363724-6372441.41841.53
455679-5567936.18936.28
554713-5471335.56135.65
662850-6285040.85040.95
30min174741-7474148.57849.466.3248.7449.626.32
277835-7783550.58950.76
382129-8212953.38053.56
471071-7107146.19346.34
570502-7050245.82345.97
680285-8028552.18252.35
45min193043-9304360.47462.025.3060.7162.265.31
294670-9467061.53161.79
3103304-10330467.14367.41
491137-9113759.23559.46
590662-9066258.92659.15
699714-9971464.81065.07
60min1107645-10764569.96470.564.5570.3070.914.55
2107809-10780970.07170.43
3114326-11432674.30774.69
4103776-10377667.45067.78
5103239-10323967.10167.43
6114539-11453974.44574.81
90min1129840-12984084.39083.623.9084.8584.093.91
2127589-12758982.92783.40
3133870-13387087.00987.51
4124182-12418280.71381.15
5122092-12209279.35479.79
6134377-13437787.33987.83
120min1136581-13658188.77190.833.1189.3791.443.12
2141562-14156292.00992.62
3143973-14397393.57694.22
4135798-13579888.26288.84
5135444-13544488.03288.60
6145143-14514394.33694.97
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1145053-14505394.27893.624.0195.0294.384.01
2139489-13948990.66191.43
3153068-15306899.487100.29
4138233-13823389.84590.57
5140373-14037391.23691.95
6148020-14802096.20697.00
非奈利酮卡格列净片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121780390178215417829291781199178251717818380.06
211.131761144176192317615340.04
单位质量响应值RSD%判断
160237.23158269.000.88数据可信
供试品溶液批-卡格列净-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%
5min142012-4201211.62212.3113.8511.6212.3113.86
244097-4409712.19912.20
340077-4007711.08711.09
442296-4229611.70111.70
556781-5678115.70815.71
641652-4165211.52311.52
10min171838-7183819.87420.524.8519.8920.544.85
274722-7472220.67220.69
368761-6876119.02219.04
475937-7593721.00821.03
579301-7930121.93821.96
674485-7448520.60620.63
15min184988-8498823.51224.102.8723.5624.162.89
287589-8758924.23124.29
383913-8391323.21423.26
487097-8709724.09524.15
590999-9099925.17425.24
688099-8809924.37224.43
20min194126-9412626.04026.213.5326.1326.303.53
294013-9401326.00826.10
388765-8876524.55624.65
496328-9632826.64926.74
598197-9819727.16627.27
696923-9692326.81326.91
30min1101723-10172328.14128.601.9128.2828.741.92
2103656-10365628.67628.81
3100404-10040427.77627.91
4104359-10435928.87029.01
5105714-10571429.24529.40
6104513-10451328.91329.05
45min1108108-10810829.90830.682.9030.0930.862.91
2109582-10958230.31530.50
3107552-10755229.75429.93
4113002-11300231.26231.45
5116045-11604532.10332.30
6111029-11102930.71630.90
60min1113510-11351031.40231.652.0531.6331.882.06
2114019-11401931.54331.78
3110632-11063230.60630.83
4115217-11521731.87432.11
5117647-11764732.54732.80
6115347-11534731.91032.15
90min1119749-11974933.12833.541.4533.4133.831.46
2121294-12129433.55533.84
3118612-11861232.81333.09
4121983-12198333.74634.04
5122941-12294134.01134.32
6122906-12290634.00134.29
120min1118806-11880632.86734.533.1833.2134.883.17
2128500-12850035.54935.89
3121244-12124433.54233.87
4125236-12523634.64634.99
5128066-12806635.42935.79
6127136-12713635.17235.52
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1129883-12988335.93236.031.2236.3336.431.23
2128187-12818735.46235.87
3129414-12941435.80236.19
4129665-12966535.87136.28
5132482-13248236.65137.07
6131723-13172336.44136.85
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