非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.043071763072683072703072443072793072470.02
211.203087483085163086320.06
单位质量响应值RSD%判断
27830.3427556.430.70数据可信
供试品溶液-1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%
5min149640-4964079.29379.2511.7279.2979.2511.72
255015-5501587.87887.88
350643-5064380.89580.89
453849-5384986.01686.02
549916-4991679.73379.73
638634-3863461.71261.71
10min156799-5679990.72890.882.3891.1791.322.42
257278-5727891.49391.98
356889-5688990.87291.32
458075-5807592.76693.24
557979-5797992.61393.06
654363-5436386.83787.18
15min157469-5746991.79892.151.2292.7493.101.27
258135-5813592.86293.86
357339-5733991.59192.54
458225-5822593.00694.00
558419-5841993.31694.27
656562-5656290.34991.17
20min158279-5827993.09293.811.3794.5595.271.41
259795-5979595.51497.03
358229-5822993.01294.48
459002-5900294.24795.76
559381-5938194.85296.33
657670-5767092.11993.45
30min156511-5651190.26892.871.8792.2494.841.87
258701-5870193.76695.81
357958-5795892.57994.56
458576-5857693.56695.60
559628-5962895.24797.25
657455-5745591.77693.61
45min157542-5754291.91592.141.1194.3994.631.11
257132-5713291.26093.82
357165-5716591.31393.81
458339-5833993.18895.74
558608-5860893.61896.15
657303-5730391.53393.88
60min157677-5767792.13092.431.1995.1195.441.22
257516-5751691.87394.94
357763-5776392.26895.27
458488-5848893.42696.50
558833-5883393.97797.03
656928-5692890.93493.79
极限155686-5568688.95090.902.0392.4594.422.02
257651-5765192.08995.67
355948-5594889.36992.88
457592-5759291.99595.58
558484-5848493.42096.99
656067-5606789.55992.92
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.404012154009184011394008194012954010770.06
211.434033894034694034290.02
单位质量响应值RSD%判断
35182.1935295.630.23数据可信
供试品溶液-1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%
5min118943-1894324.19023.8012.2324.1923.8012.23
220518-2051826.20226.20
317519-1751922.37222.37
420040-2004025.59125.59
520249-2024925.85825.86
614573-1457318.61018.61
10min132309-3230941.25939.127.6941.3939.257.71
231328-3132840.00640.15
328307-2830736.14836.27
431350-3135040.03440.18
533262-3326242.47642.62
627229-2722934.77134.87
15min141035-4103552.40249.746.6452.7750.096.66
239934-3993450.99651.36
335441-3544145.25845.58
439071-3907149.89450.26
541908-4190853.51753.90
636301-3630146.35646.65
20min148075-4807561.39258.236.0962.0558.856.10
246729-4672959.67360.32
341587-4158753.10753.68
445035-4503557.51058.15
548742-4874262.24462.92
643403-4340355.42655.98
30min155521-5552170.90068.955.6871.9069.905.68
255479-5547970.84771.83
349559-4955963.28764.16
452462-5246266.99467.96
558300-5830074.44975.47
652655-5265567.24068.10
45min165764-6576483.98179.515.2185.3780.845.21
262506-6250679.82081.20
356882-5688272.63873.86
460685-6068577.49578.83
565220-6522083.28684.72
662501-6250179.81481.05
60min170561-7056190.10686.483.4091.9688.253.42
267664-6766486.40788.23
364350-6435082.17583.80
465895-6589584.14885.91
569538-6953888.80090.70
668301-6830187.22088.90
极限172028-7202891.98093.014.2394.3495.264.20
275212-7521296.04698.35
366951-6695185.49687.58
474488-7448895.12197.35
573786-7378694.22596.62
674524-7452495.16797.33
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.043077233080293081153075923080413079000.08
211.203099823104333102080.11
单位质量响应值RSD%判断
27889.4927697.140.49数据可信
供试品溶液-1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%
5min151122-5112281.36579.037.8981.3779.037.89
251285-5128581.62581.62
353557-5355785.24185.24
444461-4446170.76470.76
552505-5250583.56683.57
645013-4501371.64271.64
10min158141-5814192.53789.813.6392.9990.253.65
257818-5781892.02292.48
357938-5793892.21392.69
455106-5510687.70688.10
556597-5659790.07990.54
652960-5296084.29184.69
15min158986-5898693.88191.921.6694.8592.861.69
257379-5737991.32492.29
358232-5823292.68193.67
457141-5714190.94591.83
558415-5841592.97393.94
656383-5638389.73990.60
20min157691-5769191.82091.420.6693.3192.870.66
257097-5709790.87592.35
357591-5759191.66193.16
457919-5791992.18393.57
557412-5741291.37692.86
656925-5692590.60191.97
30min158595-5859593.25990.791.6495.2692.751.64
256741-5674190.30892.29
357709-5770991.84993.86
456758-5675890.33592.23
556179-5617989.41491.40
656280-5628089.57591.44
45min156724-5672490.28189.540.5392.8092.000.57
256442-5644289.83292.31
356291-5629189.59292.11
456047-5604789.20491.60
556119-5611989.31891.80
655908-5590888.98391.35
60min157873-5787392.11089.282.2995.1392.242.26
255674-5567488.61091.59
357462-5746291.45694.47
455773-5577388.76891.66
555038-5503887.59890.58
654768-5476887.16890.03
极限156432-5643289.81788.892.1393.3592.342.10
257181-5718191.00994.48
356936-5693690.61994.14
455525-5552588.37391.76
554323-5432386.46089.93
654691-5469187.04690.39
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.404020534026034023534021624023614023060.06
211.434053824053484053650.01
单位质量响应值RSD%判断
35290.0035465.000.35数据可信
供试品溶液-1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%
5min117423-1742322.16221.6913.0022.1621.6913.00
216374-1637420.82820.83
320559-2055926.15126.15
414377-1437718.28818.29
518259-1825923.22523.23
615305-1530519.46819.47
10min132430-3243041.25138.506.6941.3738.626.70
230780-3078039.15239.27
331680-3168040.29740.44
429096-2909637.01037.11
530790-3079039.16539.29
626818-2681834.11334.22
15min142389-4238953.91951.018.6954.2751.358.69
239981-3998150.85651.19
344823-4482357.01557.38
437247-3724747.37847.69
541012-4101252.16752.51
635182-3518244.75245.05
20min148751-4875162.01158.857.1262.6659.477.13
246629-4662959.31259.93
350554-5055464.30564.99
443932-4393255.88256.45
546365-4636558.97659.61
641366-4136652.61853.16
30min159278-5927875.40269.796.6976.4070.736.70
255774-5577470.94571.89
358106-5810673.91174.95
452728-5272867.07067.95
554015-5401568.70769.67
649287-4928762.69363.53
45min161767-6176778.56879.534.5279.9880.864.49
263716-6371681.04782.39
363335-6333580.56282.02
465652-6565283.51084.76
563320-6332080.54381.89
657350-5735072.94974.14
60min170867-7086790.14386.284.6591.9988.054.66
268942-6894287.69489.48
369109-6910987.90789.81
469147-6914787.95589.67
567027-6702785.25987.05
661895-6189578.73180.32
极限173678-7367893.71994.672.2196.0796.922.21
277145-7714598.129100.41
375661-7566196.24198.63
472839-7283992.65194.86
573305-7330593.24495.51
673914-7391494.01996.05
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.043092193091693090303089083089093090470.05
211.203108363108643108500.01
单位质量响应值RSD%判断
27993.3927754.460.61数据可信
供试品溶液-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%
5min153009-5300984.12581.925.3484.1381.925.34
246498-4649873.79273.79
353652-5365285.14685.15
453622-5362285.09885.10
550583-5058380.27580.28
652359-5235983.09483.09
10min157003-5700390.46489.621.9990.9390.082.00
254884-5488487.10187.51
356985-5698590.43590.91
457961-5796191.98492.46
555479-5547988.04588.49
656529-5652989.71190.17
15min157411-5741191.11189.702.1692.0890.662.18
254687-5468786.78887.68
357950-5795091.96692.94
457235-5723590.83291.82
555787-5578788.53489.47
656076-5607688.99289.95
20min157014-5701490.48188.872.1491.9690.322.14
254733-5473386.86188.24
357702-5770291.57393.06
456184-5618489.16490.65
554867-5486787.07488.50
655482-5548288.05089.50
30min155345-5534587.83288.531.7389.8190.481.72
255715-5571588.41990.28
355692-5569288.38390.38
457327-5732790.97892.96
554416-5441686.35888.27
656221-5622189.22391.17
45min155323-5532387.79787.741.6790.2690.181.69
254346-5434686.24788.60
356276-5627689.31091.80
456457-5645789.59792.09
554318-5431886.20288.59
655000-5500087.28589.72
60min156003-5600388.87786.632.2391.8389.552.20
253976-5397685.66088.49
355989-5598988.85491.84
454681-5468186.77989.77
553037-5303784.17087.04
653819-5381985.41188.33
极限155104-5510487.45086.471.5990.9089.871.57
254684-5468486.78390.09
354685-5468586.78590.26
455252-5525287.68591.15
552862-5286283.89287.23
654318-5431886.20289.60
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.404039554038864037874034604033374036850.07
211.434061124062434061780.03
单位质量响应值RSD%判断
35410.9635536.130.25数据可信
供试品溶液-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%
5min118692-1869223.71225.5014.8623.7125.5014.86
217685-1768522.43422.43
319357-1935724.55524.56
425171-2517131.93131.93
517577-1757722.29722.30
622126-2212628.06828.07
10min131602-3160240.08943.7911.0440.2243.9411.05
232535-3253541.27241.40
334309-3430943.52343.66
440413-4041351.26651.44
530597-3059738.81438.94
637674-3767447.79247.95
15min140293-4029351.11454.838.4451.4755.228.47
241028-4102852.04652.40
344998-4499857.08257.46
449153-4915362.35362.82
539536-3953650.15450.49
644326-4432656.23056.65
20min146496-4649658.98362.496.9859.6263.187.01
247383-4738360.10860.75
351501-5150165.33266.03
454169-5416968.71669.52
545218-4521857.36257.98
650808-5080864.45365.19
30min153687-5368768.10572.705.8969.0773.745.93
256337-5633771.46772.44
357695-5769573.18974.25
462894-6289479.78480.97
554331-5433168.92269.86
658917-5891774.73975.83
45min161298-6129877.76081.563.3479.1083.003.41
263980-6398081.16282.54
365051-6505182.52183.99
467570-6757085.71687.35
562853-6285379.73281.05
664999-6499982.45583.96
60min167239-6723985.29686.141.6587.0788.031.72
268539-6853986.94588.77
368625-6862587.05588.98
469301-6930187.91290.02
566269-6626984.06685.83
667439-6743985.55087.52
极限172144-7214491.51992.661.5693.7795.041.62
273488-7348893.22495.53
371628-7162890.86493.27
474636-7463694.68097.28
572529-7252992.00794.24
673846-7384693.67896.12
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.043080913078423079893077413078623079050.05
211.203085843082763084300.08
单位质量响应值RSD%判断
27889.9527538.390.90数据可信
供试品溶液-3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%
5min145362-4536272.40666.4120.8772.4166.4120.87
230301-3030148.36648.37
348731-4873177.78377.78
438180-3818060.94260.94
552611-5261183.97783.98
634440-3444054.97254.97
10min156103-5610389.55088.443.0789.9588.813.14
254133-5413386.40686.67
356183-5618389.67890.11
454124-5412486.39286.73
558130-5813092.78693.25
653775-5377585.83586.14
15min157258-5725891.39491.572.3992.2992.422.36
256014-5601489.40890.16
356460-5646090.12091.05
456877-5687790.78691.60
557703-5770392.10493.09
659882-5988295.58296.36
20min157278-5727891.42690.740.9692.8392.111.04
255957-5595789.31790.56
356975-5697590.94292.37
456817-5681790.69092.01
557483-5748391.75393.25
656595-5659590.33691.65
30min156025-5602589.42690.121.2091.3492.001.19
256644-5664490.41492.16
355431-5543188.47890.41
456465-5646590.12891.95
557407-5740791.63293.64
656799-5679990.66192.48
45min156251-5625189.78789.030.9492.2091.400.95
255975-5597589.34691.59
355114-5511487.97290.40
455679-5567988.87491.20
556380-5638089.99392.51
655252-5525288.19290.51
60min155435-5543588.48488.590.9991.4091.461.06
254882-5488287.60290.34
355468-5546888.53791.45
455430-5543088.47691.30
556529-5652990.23093.24
655257-5525788.20091.01
极限155758-5575889.00088.091.1492.4091.461.19
254818-5481887.49990.73
355015-5501587.81491.22
454772-5477287.42690.74
556168-5616889.65493.17
654611-5461187.16990.47
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)5补液体积(ml)5
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%
111.404024634020994024354020974021254022440.05
211.434029784026504028140.06
单位质量响应值RSD%判断
35284.5635241.820.09数据可信
供试品溶液-3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%
5min121523-2152327.46621.3638.6827.4721.3638.68
29460-946012.07212.07
317043-1704321.74921.75
412400-1240015.82415.82
526840-2684034.25134.25
613171-1317116.80816.81
10min137284-3728447.57940.1823.9547.7340.3023.99
223818-2381830.39530.46
330395-3039538.78838.91
426730-2673034.11134.20
543665-4366555.72255.91
627046-2704634.51434.61
15min146373-4637359.17752.7316.8159.5953.0716.88
233331-3333142.53442.77
338645-3864549.31649.65
436313-3631346.34046.62
552254-5225466.68267.18
641019-4101952.34552.63
20min152290-5229066.72860.0014.1467.4760.6314.22
239278-3927850.12350.60
345349-4534957.87158.48
445293-4529357.79958.33
557363-5736373.20274.07
642511-4251154.24954.83
30min158633-5863374.82369.789.9675.9470.7510.09
248710-4871062.16062.91
353097-5309767.75868.69
453087-5308767.74568.60
563540-6354081.08582.36
651038-5103865.13166.01
45min164806-6480682.70080.487.0184.2381.837.07
257664-5766473.58674.68
361418-6141878.37779.68
468151-6815186.96988.20
567452-6745286.07787.80
658888-5888875.14876.39
60min167261-6726185.83387.044.3587.8288.844.32
269379-6937988.53690.04
366671-6667185.08086.82
472249-7224992.19893.91
569935-6993589.24591.45
663731-6373181.32882.98
极限171656-7165691.44292.571.3393.9194.851.09
273974-7397494.40096.40
371837-7183791.67393.89
472855-7285592.97295.20
571677-7167791.46894.17
673225-7322593.44495.55
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