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(%)100.0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%
111.163148753149553143853148933152043148620.10
211.133150223155773153000.13
单位质量响应值RSD%判断
28213.4428328.840.29数据可信
供试品溶液-6010901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%
5min122980-2298036.57860.9325.8436.5860.9325.84
250864-5086480.96280.96
333959-3395954.05454.05
434555-3455555.00255.00
545414-4541472.28772.29
641911-4191166.71166.71
10min147154-4715475.05790.229.1975.4690.899.29
261348-6134897.65098.55
356573-5657390.04990.65
458646-5864693.34993.96
560884-6088496.91197.71
655468-5546888.29089.03
15min157425-5742591.40594.262.4992.6595.942.57
259390-5939094.53396.52
360992-6099297.08398.68
460172-6017295.77897.43
559889-5988995.32797.21
657454-5745491.45293.17
20min158101-5810192.48194.031.2694.7496.761.37
259374-5937494.50897.54
360234-6023495.87798.56
459352-5935294.47397.19
558746-5874693.50896.45
658638-5863893.33696.07
30min158436-5843693.01594.671.6196.3098.441.71
259827-5982795.22999.31
360547-6054796.375100.12
459962-5996295.44499.21
559930-5993095.39399.37
658147-5814792.55596.33
45min157758-5775891.93594.361.9896.2599.182.14
261051-6105197.177102.32
359842-5984295.253100.07
458922-5892293.78898.61
559707-5970795.038100.08
658402-5840292.96197.76
60min157669-5766991.79492.611.7697.1398.481.82
259441-5944194.614100.84
359268-5926894.339100.21
457824-5782492.04197.91
558113-5811392.50198.59
656759-5675990.34596.18
90min157454-5745491.45291.321.3797.8198.221.24
256374-5637489.73397.01
358659-5865993.370100.29
457008-5700890.74297.63
557742-5774291.91099.03
656986-5698690.70797.55
120min155966-5596689.08390.471.5496.4698.391.63
257454-5745491.45299.72
358203-5820392.644100.60
456310-5631089.63197.53
556976-5697690.69198.83
656121-5612189.33097.18
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155856-5585688.90889.661.0397.2798.581.14
256600-5660090.09299.38
357228-5722891.092100.08
456412-5641289.79398.68
556312-5631289.63498.78
655577-5557788.46497.30
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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004048794065214062544059114036754054480.29
211.024036684035814036240.02
单位质量响应值RSD%判断
36858.9136626.500.45数据可信
供试品溶液-6010901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%
5min16649-66498.13517.2826.808.1417.2826.79
215332-1533218.75918.76
316179-1617919.79519.80
416872-1687220.64320.64
515698-1569819.20719.21
614001-1400117.13117.13
10min117641-1764121.58435.5821.0221.6735.7721.04
234422-3442242.11642.32
332662-3266239.96340.18
432365-3236539.59939.83
529996-2999636.70136.91
627403-2740333.52833.72
15min126901-2690132.91447.2616.9233.2447.8416.99
243198-4319852.85453.53
344089-4408953.94454.61
442924-4292452.51853.19
538579-3857947.20247.82
636043-3604344.09944.66
20min133764-3376441.31155.7014.5142.0156.8114.60
249774-4977460.90062.16
351206-5120662.65263.91
450404-5040461.67062.92
544631-4463154.60755.75
643374-4337453.06954.12
30min143747-4374753.52568.6212.7454.6870.3512.86
259904-5990473.29475.23
363110-6311077.21679.18
461391-6139175.11377.05
555494-5549467.89869.65
652850-5285064.66366.31
45min159381-5938172.65481.346.7374.4083.846.99
269176-6917684.63887.39
371633-7163387.64490.46
468640-6864083.98286.76
566871-6687181.81884.32
663191-6319177.31579.68
60min167506-6750682.59587.943.9085.1591.344.24
274059-7405990.61394.31
375190-7519091.99795.79
472198-7219888.33692.04
572392-7239288.57391.99
669889-6988985.51188.73
90min174220-7422090.81091.971.2594.2896.341.50
274220-7422090.81095.51
376673-7667393.81198.62
474957-7495791.71196.40
575244-7524492.06396.46
675691-7569192.60996.78
120min176729-7672993.88092.171.4998.3697.571.27
276278-7627893.32899.04
375651-7565192.56198.42
473637-7363790.09695.80
574799-7479991.51896.94
674901-7490191.64396.84
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176323-7632393.38391.291.4098.9197.711.15
274468-7446891.11397.86
375313-7531392.14799.03
474171-7417190.75097.46
573429-7342989.84296.28
673983-7398390.52096.74
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(%)100.0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%
111.163153923158043159113159043157443157510.07
211.133168703172273170480.08
单位质量响应值RSD%判断
28293.1028485.890.49数据可信
供试品溶液-6010902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%
5min134783-3478355.13564.2510.1555.1364.2410.15
244655-4465570.78370.78
344785-4478570.98970.99
436692-3669258.16158.16
541810-4181066.27466.27
640466-4046664.14364.14
10min156702-5670289.87988.921.7490.4989.631.76
256795-5679590.02690.81
357156-5715690.59991.39
454959-5495987.11687.76
554884-5488486.99787.73
656088-5608888.90689.62
15min160614-6061496.08094.691.9697.6996.391.93
260535-6053595.95597.74
360376-6037695.70397.50
460305-6030595.59097.20
557770-5777091.57293.27
658820-5882093.23694.94
20min160618-6061896.08694.940.9498.7797.690.84
259016-5901693.54796.40
359490-5949094.29897.16
460199-6019995.42298.10
559986-5998695.08497.80
660051-6005195.18897.92
30min160572-6057296.01394.381.5999.7698.181.48
259639-5963994.53498.43
357938-5793891.83895.74
459909-5990994.96298.70
560180-6018095.39299.17
658998-5899893.51897.31
45min157843-5784391.68894.982.0696.5099.841.95
259869-5986994.89999.84
359198-5919893.83598.76
460919-6091996.563101.36
560937-6093796.592101.43
660747-6074796.291101.12
60min158073-5807392.05292.551.0297.8898.471.00
258487-5848792.70898.71
358986-5898693.49999.47
457358-5735890.91996.78
558738-5873893.10699.02
658696-5869693.04098.94
90min156379-5637989.36791.101.3896.2298.051.29
257442-5744291.05298.08
356771-5677189.98897.00
457934-5793491.83298.71
558536-5853692.78699.73
657787-5778791.59998.54
120min157167-5716790.61691.340.6198.4699.290.59
257484-5748491.11999.16
357447-5744791.06099.07
457627-5762791.34599.24
558162-5816292.193100.17
657853-5785391.70399.66
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156873-5687390.15089.381.3999.0098.351.26
256660-5666089.81298.86
357133-5713390.56299.58
456157-5615789.01597.93
556550-5655089.63898.64
654944-5494487.09296.07
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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004026974029794020304018324022574023590.12
211.024029274032214030740.06
单位质量响应值RSD%判断
36578.0936576.590.01数据可信
供试品溶液-6010902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%
5min19353-935311.49513.3134.1511.5013.3234.14
29948-994812.22612.23
318200-1820022.36922.37
49363-936311.50711.51
510245-1024512.59212.59
67889-78899.6969.70
10min119669-1966924.17425.7722.5724.3025.9222.63
220136-2013624.74824.88
330385-3038537.34437.59
418916-1891623.24923.38
519536-1953624.01124.15
617151-1715121.07921.19
15min128130-2813034.57335.5418.5334.9735.9718.62
228862-2886235.47335.88
339421-3942148.45049.11
425819-2581931.73332.12
526389-2638932.43332.84
624856-2485630.54930.89
20min133822-3382241.56942.5113.7842.3543.3413.95
233798-3379841.53942.34
344055-4405554.14555.35
431359-3135938.54139.28
533096-3309640.67641.44
631416-3141638.61239.29
30min147835-4783558.79153.8210.6360.0355.1210.76
243512-4351253.47854.74
350752-5075262.37664.18
439238-3923848.22549.39
542051-4205151.68252.90
639361-3936148.37649.49
45min159745-5974573.42967.057.7475.3268.957.81
255038-5503867.64469.50
357761-5776170.99173.49
449171-4917160.43362.14
555691-5569168.44670.24
649935-4993561.37263.02
60min164980-6498079.86374.615.9282.5777.265.93
263318-6331877.82080.43
360924-6092474.87878.16
456503-5650369.44471.82
562228-6222876.48179.03
656300-5630069.19571.52
90min165443-6544380.43279.342.9184.0382.812.78
266204-6620481.36784.84
362607-6260776.94681.06
462360-6236076.64379.79
566790-6679082.08885.49
663904-6390478.54181.64
120min167274-6727482.68281.762.4787.1786.112.30
267844-6784483.38387.76
364472-6447279.23984.21
464490-6449079.26183.26
568172-6817283.78688.10
666874-6687482.19186.16
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166487-6648781.71580.812.3787.1386.082.39
268036-6803683.61988.93
364838-6483879.68885.54
463818-6381878.43583.31
566616-6661681.87487.12
664722-6472279.54684.43
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(%)100.0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%
111.163163713158553157643158243159943159620.08
211.133188543192913190720.10
单位质量响应值RSD%判断
28312.0128667.740.89数据可信
供试品溶液-6010903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%
5min129881-2988147.19969.1624.2947.2069.1624.29
252361-5236182.70882.71
352213-5221382.47482.47
435928-3592856.75156.75
554936-5493686.77586.78
637368-3736859.02559.03
10min154115-5411585.47892.936.5986.0093.706.70
261829-6182997.66398.58
362466-6246698.66999.59
453777-5377784.94585.58
560108-6010894.94595.91
660684-6068495.85596.51
15min157454-5745490.75394.052.7792.2395.852.87
261573-6157397.25999.26
358534-5853492.45994.47
458406-5840692.25693.83
560215-6021595.11497.13
661070-6107096.46498.19
20min157918-5791891.48693.462.7093.9796.312.85
261190-6119096.65499.74
359379-5937993.79396.83
456726-5672689.60392.20
559944-5994494.68697.76
659854-5985494.54497.34
30min158472-5847292.36193.712.7795.8697.602.74
259615-5961594.16698.32
360761-6076195.976100.06
458135-5813591.82895.42
557354-5735490.59594.72
661628-6162897.346101.19
45min159665-5966594.24594.330.4498.7799.250.63
260193-6019395.079100.28
359598-5959894.13999.29
459423-5942393.86398.48
559667-5966794.24899.38
659754-5975494.38699.31
60min158020-5802091.64793.392.6497.2299.362.57
259147-5914793.42799.69
359031-5903193.24499.44
458090-5809091.75797.42
558290-5829092.07398.25
662150-6215098.170104.14
90min157935-5793591.51291.861.3098.1098.871.19
258809-5880992.893100.19
358293-5829392.07899.31
458955-5895593.12499.80
556848-5684889.79597.00
658101-5810191.77598.84
120min157855-5785591.38689.932.4798.9997.962.34
258572-5857292.519100.85
357690-5769091.12599.38
456074-5607488.57396.29
556682-5668289.53397.74
654711-5471186.42094.50
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157887-5788791.43790.431.48100.0699.461.13
257017-5701790.06299.42
357096-5709690.18799.45
458434-5843492.301101.00
555974-5597488.41597.61
657074-5707490.15299.20
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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004021434018164017864020804019744019600.04
211.024049504055554052520.11
单位质量响应值RSD%判断
36541.8236774.230.45数据可信
供试品溶液-6010903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%
5min18402-840210.30415.3018.7010.3015.3018.71
212766-1276615.65615.66
313705-1370516.80716.81
411365-1136513.93713.94
515042-1504218.44718.45
613562-1356216.63216.63
10min125371-2537131.11434.886.8031.2335.056.85
228914-2891435.45935.63
329778-2977836.51836.70
426754-2675432.81032.96
529766-2976636.50336.71
630068-3006836.87437.06
15min135907-3590744.03446.364.4244.4946.914.45
238727-3872747.49348.06
336195-3619544.38844.98
436964-3696445.33145.85
539054-3905447.89448.50
639955-3995548.99949.59
20min143765-4376553.67155.103.6054.6256.173.63
246645-4664557.20358.30
343526-4352653.37854.46
443280-4328053.07654.10
545507-4550755.80756.95
646866-4686657.47458.61
30min155150-5515067.63369.173.9569.1870.853.91
257340-5734070.31972.05
356814-5681469.67471.35
455590-5559068.17369.79
553497-5349765.60667.37
660019-6001973.60475.38
45min166161-6616181.13682.182.4383.4384.642.44
269188-6918884.84887.36
365153-6515379.90082.35
466975-6697582.13584.50
565867-6586780.77683.27
668749-6874984.31086.91
60min170040-7004085.89388.023.9689.0991.383.92
273158-7315889.71793.17
369957-6995785.79289.13
471219-7121987.33990.62
569371-6937185.07388.46
676879-7687994.28097.81
90min175028-7502892.01092.752.5796.1697.102.49
276902-7690294.30998.76
374472-7447291.32995.62
478086-7808695.761100.01
572714-7271489.17393.51
676596-7659693.93398.51
120min176317-7631793.59192.072.1598.7797.441.98
277250-7725094.735100.24
374881-7488191.83097.14
475242-7524292.27397.59
574031-7403190.78896.11
672718-7271889.17794.80
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175220-7522092.24692.871.8298.4699.261.71
275274-7527492.31298.86
374945-7494591.90998.24
478450-7845096.207102.55
574728-7472891.64297.98
675737-7573792.88099.49
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(%)100.0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%
111.163156743161673158283158163157433158460.07
211.133172613167763170180.11
单位质量响应值RSD%判断
28301.6128483.200.46数据可信
供试品溶液-6010904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%
5min147994-4799476.06870.648.6476.0770.648.64
245610-4561072.28972.29
343754-4375469.34869.35
443803-4380369.42569.43
537846-3784659.98459.98
648415-4841576.73576.74
10min159210-5921093.84589.844.0594.6990.624.08
258426-5842692.60293.41
356149-5614988.99389.76
454227-5422785.94786.72
553829-5382985.31685.98
658247-5824792.31893.17
15min159031-5903193.56193.090.7095.4594.880.73
259098-5909893.66795.50
358240-5824092.30794.07
458193-5819392.23393.96
558984-5898493.48795.10
658866-5886693.29995.18
20min158298-5829892.39992.781.4995.3395.601.39
257987-5798791.90694.78
357366-5736690.92293.71
458873-5887393.31196.06
559907-5990794.94997.60
658800-5880093.19596.11
30min157984-5798491.90293.151.0195.8697.000.89
259259-5925993.92297.82
358949-5894993.43197.23
459096-5909693.66497.45
559270-5927093.94097.65
658063-5806392.02795.98
45min157189-5718990.64292.010.9795.6296.890.87
258238-5823892.30497.24
357821-5782191.64396.48
457959-5795991.86296.69
558887-5888793.33398.08
658208-5820892.25797.23
60min156588-5658889.68991.091.3995.6797.001.23
257166-5716690.60596.57
357358-5735890.90996.76
457518-5751891.16397.01
558963-5896393.45399.24
657252-5725290.74196.74
90min155937-5593788.65790.421.4895.6497.341.33
257074-5707490.45997.43
356727-5672789.90996.77
457141-5714190.56597.43
558521-5852192.75399.58
656912-5691290.20397.21
120min155464-5546487.90888.431.4195.8796.361.27
256886-5688690.16198.14
356027-5602788.80096.66
456057-5605788.84796.72
555826-5582688.48196.34
654512-5451286.39994.41
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155280-5528087.61686.802.7796.5695.702.52
254158-5415885.83894.81
354276-5427686.02594.87
452369-5236983.00291.86
556705-5670589.87498.72
655804-5580488.44697.41
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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004021614022284015374019354023474020420.08
211.024038804031244035020.14
单位质量响应值RSD%判断
36549.2736615.430.13数据可信
供试品溶液-6010904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%
5min117686-1768621.73417.5123.8221.7317.5123.81
216069-1606919.74719.75
315829-1582919.45219.45
412595-1259515.47815.48
58210-821010.08910.09
615089-1508918.54218.54
10min139712-3971248.80135.8422.1949.0436.0322.18
231335-3133538.50738.73
327738-2773834.08634.30
426494-2649432.55832.73
520009-2000924.58924.70
629699-2969936.49636.70
15min151313-5131363.05748.5117.9663.8449.1018.00
241267-4126750.71251.36
338171-3817146.90747.50
436823-3682345.25145.78
529532-2953236.29136.68
639726-3972648.81849.43
20min158541-5854171.93957.6014.7373.4258.7314.83
248180-4818059.20760.42
344762-4476255.00756.12
445704-4570456.16457.20
537143-3714345.64446.43
646907-4690757.64358.80
30min168798-6879884.54471.4411.9086.8373.2212.04
259976-5997673.70375.57
357597-5759770.77972.51
458396-5839671.76173.42
547173-4717357.97059.27
656886-5688669.90671.70
45min172865-7286589.54281.957.3892.7684.517.62
268178-6817883.78286.47
366113-6611381.24483.76
468149-6814983.74686.20
557858-5785871.10073.04
666940-6694082.26184.83
60min175397-7539792.65388.583.3096.8792.053.67
273007-7300789.71693.33
371160-7116087.44790.86
473082-7308289.80893.20
568323-6832383.96086.69
671509-7150987.87591.36
90min177115-7711594.76493.791.29100.0198.251.48
277648-7764895.419100.03
374962-7496292.11996.51
475974-7597493.36297.75
576512-7651294.02397.69
675700-7570093.02697.49
120min176888-7688894.48693.182.09100.7998.682.28
278448-7844896.403102.08
375406-7540692.66498.08
475131-7513192.32697.75
575043-7504392.21896.93
674016-7401690.95696.45
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175659-7565992.97592.493.25100.3399.033.02
275445-7544592.71299.46
374593-7459391.66598.11
470907-7090787.13693.59
577128-7712894.780100.51
677855-7785595.674102.18
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