二甲双胍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2000
标示量(mg)5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%
110.059408794121940029392593892940050.11
210.029410094213941560.09
单位质量响应值RSD%判断
9353.739396.810.33数据可信
长期12月-供试品溶液-2024112921批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140787-4078739.15537.734.6139.1537.734.61
236419-3641934.96134.96
340622-4062238.99639.00
437680-3768036.17236.17
540261-4026138.65038.65
640056-4005638.45338.45
10min179140-7914075.97373.152.5576.0473.222.55
273402-7340270.46470.52
377315-7731574.22174.29
475177-7517772.16872.23
575962-7596272.92272.99
676204-7620473.15473.22
15min197970-9797094.04991.942.1494.2492.122.14
293569-9356989.82490.00
397359-9735993.46293.65
495686-9568691.85692.04
593080-9308089.35589.54
696953-9695393.07393.26
20min1100696-10069696.66696.041.4897.0196.381.48
298957-9895794.99695.32
3101987-10198797.90598.25
499602-9960295.61695.95
597965-9796594.04494.38
6101067-10106797.02297.36
30min1100831-10083196.79596.591.5997.3197.091.59
299433-9943395.45395.94
3102777-10277798.66499.17
4100432-10043296.41296.91
598372-9837294.43594.93
6101868-10186897.79198.29
45min1100504-10050496.48296.451.6997.1597.111.69
299109-9910995.14295.79
3102894-10289498.77699.45
4100426-10042696.40797.06
598215-9821594.28494.93
6101685-10168597.61598.28
60min1100427-10042796.40896.461.6097.2497.281.60
299087-9908795.12195.92
3102481-10248198.37999.22
4100678-10067896.64997.46
598284-9828494.35095.16
6101903-10190397.82598.65
极限1100466-10046696.44596.571.6197.4497.551.61
299284-9928495.31096.27
3102763-10276398.65099.65
4100750-10075096.71897.69
598385-9838594.44795.41
6101904-10190497.82698.82
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939260309268309260569260399262079262320.04
29.949286289290599288440.04
单位质量响应值RSD%判断
93276.1393445.070.13数据可信
长期12月-供试品溶液-2024112921批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1470842-47084245.38944.093.6345.3944.093.63
2429393-42939341.39441.39
3467451-46745145.06345.06
4444989-44498942.89742.90
5468177-46817745.13245.13
6463319-46331944.66444.66
10min1825572-82557279.58677.161.9979.6677.231.99
2777333-77733374.93575.00
3806215-80621577.72077.79
4794129-79412976.55476.63
5802725-80272577.38377.46
6796263-79626376.76076.83
15min1979791-97979194.45293.001.6094.6693.201.60
2946354-94635491.22991.42
3975143-97514394.00494.21
4968051-96805193.32193.52
5944573-94457391.05791.26
6974256-97425693.91994.12
20min11000170-100017096.41796.191.0596.7896.551.06
2988472-98847295.28995.64
31011676-101167697.52697.89
4997731-99773196.18296.54
5983485-98348594.80895.16
61005360-100536096.91797.28
30min1998159-99815996.22396.441.1696.7596.951.16
2990866-99086695.52096.02
31016177-101617797.96098.48
41001281-100128196.52497.04
5985373-98537394.99095.50
61010310-101031097.39497.91
45min1996692-99669296.08296.311.1696.7796.991.16
2988782-98878295.31995.98
31014512-101451297.79998.49
41001177-100117796.51497.19
5984374-98437494.89495.57
61008916-100891697.26097.94
60min1994268-99426895.84896.251.1596.6997.091.15
2988241-98824195.26796.09
31013751-101375197.72698.58
41000555-100055596.45497.29
5984893-98489394.94495.77
61009032-100903297.27198.12
极限1993148-99314895.74096.101.1396.7597.101.12
2987000-98700095.14796.13
31011182-101118297.47898.49
4998653-99865396.27197.27
5983291-98329194.79095.78
61007928-100792897.16598.17
二甲双胍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2000
标示量(mg)5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%
110.059447694462943709442294252943960.10
210.029497194841949060.10
单位质量响应值RSD%判断
9392.649471.660.60数据可信
长期12月-供试品溶液-2024112921批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144884-4488442.82839.029.3742.8339.029.37
235334-3533433.71633.72
345667-4566743.57543.58
440298-4029838.45238.45
539484-3948437.67637.68
639687-3968737.86937.87
10min177290-7729073.75074.066.0873.8274.126.09
271584-7158468.30568.36
385944-8594482.00882.08
476763-7676373.24773.31
575621-7562172.15872.22
678481-7848174.88774.95
15min196966-9696692.52592.433.0092.7292.623.01
292325-9232588.09788.27
3100494-10049495.89196.10
495548-9554891.17291.36
596428-9642892.01292.19
699411-9941194.85895.05
20min1100628-10062896.01996.191.5196.3796.541.52
298584-9858494.06994.39
3101014-10101496.38896.76
4101350-10135096.70897.05
5100093-10009395.50995.85
6103201-10320198.47498.82
30min1100825-10082596.20796.731.6396.7297.241.63
299121-9912194.58195.05
3101022-10102296.39596.92
4101894-10189497.22797.73
5101253-10125396.61697.11
6104153-10415399.38399.89
45min1100645-10064596.03596.461.5496.7097.121.55
298766-9876694.24394.87
3100696-10069696.08496.77
4101809-10180997.14697.81
5101139-10113996.50797.16
6103503-10350398.76399.44
60min1100694-10069496.08296.471.6596.9197.301.65
298772-9877294.24895.04
3100352-10035295.75696.61
4101811-10181197.14897.97
5101236-10123696.59997.42
6103768-10376899.01599.86
极限1100787-10078796.17196.611.7297.1697.601.72
298642-9864294.12495.07
3100519-10051995.91596.93
4102167-10216797.48898.47
5101591-10159196.93897.92
6103807-10380799.053100.06
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939316589314659304889310339300749309440.08
29.949361849363359362600.02
单位质量响应值RSD%判断
93750.6594191.150.34数据可信
长期12月-供试品溶液-2024112921批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1510728-51072848.91545.207.6048.9145.207.59
2421490-42149040.36840.37
3516304-51630449.44949.45
4466083-46608344.63944.64
5459267-45926743.98643.99
6457515-45751543.81843.82
10min1806875-80687577.27877.664.9077.3677.744.89
2762456-76245673.02473.09
3883035-88303584.57384.65
4801532-80153276.76776.84
5796918-79691876.32576.40
6814528-81452878.01178.08
15min1972318-97231893.12493.102.2793.3393.312.27
2938395-93839589.87590.06
31001324-100132495.90296.13
4960736-96073692.01492.22
5970572-97057292.95693.16
6989193-98919394.74094.94
20min11003296-100329696.09196.091.0996.4696.461.09
2988497-98849794.67395.01
31003343-100334396.09596.48
41006942-100694296.44096.80
5996884-99688495.47695.83
61021038-102103897.79098.15
30min11002965-100296596.05996.341.0796.5896.861.07
2991098-99109894.92295.42
31002390-100239096.00496.55
41010953-101095396.82497.34
51004537-100453796.20996.72
61023300-102330098.00698.53
45min11001133-100113395.88396.111.0296.5796.791.02
2988680-98868094.69195.35
31000213-100021395.79596.50
41008736-100873696.61297.29
51002836-100283696.04696.72
61019374-101937497.63098.32
60min11000447-100044795.81896.091.1196.6696.931.11
2988952-98895294.71795.53
3998013-99801395.58596.45
41007693-100769396.51297.35
51002534-100253496.01896.85
61022186-102218697.90098.75
极限1998439-99843995.62595.811.1396.6396.811.13
2984358-98435894.27795.25
3995188-99518895.31496.34
41006674-100667496.41497.41
5999637-99963795.74096.74
61017859-101785997.48598.50
二甲双胍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2000
标示量(mg)5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%
110.059447394502944349441694471944590.04
210.029504695137950920.07
单位质量响应值RSD%判断
9398.919490.220.69数据可信
长期12月-供试品溶液-2024120221批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140988-4098839.06040.129.7339.0640.129.72
243240-4324041.20641.21
349144-4914446.83246.83
436750-3675035.02135.02
542136-4213640.15440.15
640375-4037538.47538.48
10min175887-7588772.31776.616.1872.3876.686.19
280664-8066476.86976.94
387226-8722683.12283.20
473526-7352670.06770.13
582682-8268278.79278.86
682378-8237878.50278.57
15min192964-9296488.59093.523.4588.7893.713.45
298726-9872694.08194.28
398986-9898694.32994.55
495380-9538090.89391.07
5102042-10204297.24197.44
6100708-10070895.97096.16
20min198464-9846493.83196.901.7194.1697.261.72
2102658-10265897.82898.18
3101834-10183497.04397.42
4102040-10204097.23997.57
5101554-10155496.77697.14
6103575-10357598.70299.06
30min198932-9893294.27797.261.6994.7797.781.68
2102445-10244597.62598.14
3102356-10235697.54098.08
4102961-10296198.11798.61
5101696-10169696.91197.43
6103993-10399399.10099.62
45min198950-9895094.29597.341.7894.9498.011.78
2102405-10240597.58798.27
3103306-10330698.44699.14
4102958-10295898.11498.77
5101267-10126796.50397.19
6103963-10396399.07299.76
60min198862-9886294.21197.031.6795.0197.871.67
2102103-10210397.29998.14
3102004-10200497.20598.07
4103000-10300098.15498.97
5101199-10119996.43897.28
6103763-10376398.88199.73
极限199165-9916594.49997.661.7895.4698.661.78
2102328-10232897.51498.52
3102682-10268297.85198.88
4103176-10317698.32299.30
5102847-10284798.00899.01
6104665-10466599.741100.76
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939320969325639315739321349311829319100.06
29.949366479374159370310.06
单位质量响应值RSD%判断
93847.9494268.710.32数据可信
长期12月-供试品溶液-2024120221批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1481794-48179446.10146.537.9046.1046.537.90
2496707-49670747.52847.53
3551686-55168652.78952.79
4435719-43571941.69241.69
5485783-48578346.48346.48
6466125-46612544.60244.60
10min1803704-80370476.90379.974.9076.9880.054.90
2837773-83777380.16380.24
3891887-89188785.34185.43
4776055-77605574.25774.33
5858002-85800282.09982.18
6847341-84734181.07881.15
15min1945203-94520390.44294.012.5190.6594.222.51
2988709-98870994.60594.82
3988301-98830194.56694.80
4961865-96186592.03792.23
51011679-101167996.80397.02
6999339-99933995.62395.83
20min1987576-98757694.49796.631.1694.8596.991.16
21015205-101520597.14197.51
31008057-100805796.45796.84
41014498-101449897.07397.42
51012439-101243996.87697.25
61021168-102116897.71198.08
30min1991189-99118994.84396.861.1395.3697.381.13
21011556-101155696.79297.32
31012930-101293096.92397.47
41021140-102114097.70998.22
51013195-101319596.94897.49
61023332-102333297.91898.45
45min1989442-98944294.67696.751.1895.3597.441.18
21010357-101035796.67797.37
31015265-101526597.14697.86
41021739-102173997.76698.44
51008338-100833896.48497.18
61021292-102129297.72398.42
60min1987908-98790894.52996.471.1295.3697.321.12
21009191-100919196.56597.42
31007186-100718696.37397.25
41018803-101880397.48598.32
51007487-100748796.40297.26
61018591-101859197.46598.32
极限1985094-98509494.25996.451.2595.2597.461.24
21006663-100666396.32397.34
31005603-100560396.22297.25
41017281-101728197.33998.34
51013326-101332696.96197.98
61019808-101980897.58198.60
二甲双胍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2000
标示量(mg)5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%
110.059507995269950099496595021950690.13
210.029543695407954220.03
单位质量响应值RSD%判断
9459.609523.150.48数据可信
长期12月-供试品溶液-2024120221批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159848-5984856.75049.8813.8456.7549.8813.84
248243-4824345.74645.75
356660-5666053.72753.73
447850-4785045.37345.37
560225-6022557.10857.11
642802-4280240.58740.59
10min193986-9398689.12183.997.1289.2284.077.13
288236-8823683.66983.75
392449-9244987.66487.75
485160-8516080.75280.83
593778-9377888.92489.02
677833-7783373.80473.87
15min1101353-10135396.10794.732.0496.3594.962.05
298963-9896393.84194.06
3100395-10039595.19995.43
499674-9967494.51594.73
5102441-10244197.13997.38
696602-9660291.60291.79
20min1101494-10149496.24196.141.2396.6496.521.24
2100019-10001994.84295.21
3100698-10069895.48695.88
4102315-10231597.01997.39
5103308-10330897.96198.37
6100481-10048195.28095.62
30min1101294-10129496.05196.161.2996.6196.701.29
299707-9970794.54695.08
3100511-10051195.30995.86
4102649-10264997.33697.87
5103187-10318797.84698.41
6101084-10108495.85296.35
45min1101004-10100495.77695.961.2796.5096.661.27
299625-9962594.46895.16
3100199-10019995.01395.72
4102261-10226196.96897.66
5103066-10306697.73198.46
6101014-10101495.78596.45
60min1101039-10103995.80996.031.0496.6996.891.04
299647-9964794.48995.33
3101002-10100295.77496.64
4102084-10208496.80097.65
5102700-10270097.38498.28
6101180-10118095.94396.76
极限1100958-10095895.73295.971.0896.7897.001.07
299811-9981194.64595.65
3100206-10020695.01996.05
4102121-10212196.83597.85
5102581-10258197.27198.33
6101597-10159796.33897.32
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939397629400979390439382799386859391730.08
29.949423459422379422910.01
单位质量响应值RSD%判断
94579.3694797.890.17数据可信
长期12月-供试品溶液-2024120221批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1655352-65535262.29055.5611.7662.2955.5611.76
2547237-54723752.01452.01
3626758-62675859.57259.57
4535888-53588850.93550.94
5650770-65077061.85561.85
6491410-49141046.70846.71
10min1951917-95191790.47885.995.8890.5886.085.88
2905323-90532386.05086.14
3944514-94451489.77589.87
4872089-87208982.89182.98
5939326-93932689.28289.38
6814954-81495477.46077.54
15min11006755-100675595.69194.661.3995.9594.901.40
2991810-99181094.27094.50
31005728-100572895.59395.84
4992879-99287994.37294.59
51006776-100677695.69395.94
6971697-97169792.35892.57
20min11006116-100611695.63095.640.6496.0496.040.64
2996448-99644894.71195.10
31006825-100682595.69796.11
41013354-101335496.31896.70
51012555-101255596.24296.65
61002297-100229795.26795.63
30min11005521-100552195.57395.600.6196.1596.160.61
2995260-99526094.59895.14
31004759-100475995.50196.07
41012385-101238596.22696.77
51011361-101136196.12896.70
61005549-100554995.57696.10
45min11002619-100261995.29795.400.5596.0396.120.55
2994660-99466094.54195.24
31001973-100197395.23695.96
41009611-100961195.96296.66
51008830-100883095.88896.62
61004719-100471995.49796.18
60min11000671-100067195.11295.350.6196.0096.220.61
2991875-99187594.27695.14
31005827-100582795.60296.49
41007782-100778295.78896.65
51007503-100750395.76296.65
61005356-100535695.55896.40
极限1997955-99795594.85494.980.5195.9096.010.51
2990610-99061094.15695.17
3997411-99741194.80295.85
41004281-100428195.45596.48
51002745-100274595.30996.36
61002619-100261995.29796.29
二甲双胍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2000
标示量(mg)5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%
110.059342893411934349351893483934550.05
210.029337093474934220.08
单位质量响应值RSD%判断
9299.009323.550.19数据可信
长期12月-供试品溶液-2024120321批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141705-4170540.31138.0110.5940.3138.0110.59
239693-3969338.36638.37
342415-4241540.99741.00
433564-3356432.44232.44
534924-3492433.75733.76
643663-4366342.20342.20
10min178171-7817175.55872.945.1975.6373.005.20
276877-7687774.30774.37
377428-7742874.84074.91
470145-7014567.80067.85
570901-7090168.53168.59
679250-7925076.60176.67
15min196107-9610792.89490.962.4693.0991.152.46
297538-9753894.27794.47
394248-9424891.09791.29
492381-9238189.29389.46
591713-9171388.64788.82
692658-9265889.56189.76
20min1100628-10062897.26495.552.4497.6195.882.44
2102377-10237798.95599.30
398807-9880795.50495.85
498655-9865595.35795.67
596803-9680393.56793.89
695831-9583192.62892.97
30min1100954-10095497.57996.092.3498.0996.582.34
2103079-10307999.633100.14
399224-9922495.90796.41
498987-9898795.67896.15
597515-9751594.25594.73
696714-9671493.48193.98
45min1100575-10057597.21396.082.2497.8996.742.24
2102970-10297099.528100.20
399457-9945796.13296.80
499197-9919795.88196.52
597256-9725694.00594.64
696973-9697393.73194.39
60min1100816-10081697.44696.242.0298.2897.062.02
2102830-10283099.393100.23
399451-9945196.12696.95
499111-9911195.79896.59
597346-9734694.09294.88
697887-9788794.61595.43
极限1101035-10103597.65896.402.0998.6597.382.09
2103145-10314599.697100.70
399592-9959296.26397.25
499181-9918195.86696.82
597816-9781694.54695.49
697643-9764394.37995.35
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.938752478753108761238757128764088757600.06
29.948763188767438765300.04
单位质量响应值RSD%判断
88193.3588182.090.01数据可信
长期12月-供试品溶液-2024120321批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1460970-46097047.04444.888.9147.0444.888.91
2438300-43830044.73144.73
3466536-46653647.61247.61
4383989-38398939.18839.19
5403642-40364241.19441.19
6485423-48542349.54049.54
10min1779427-77942779.54477.364.1079.6277.444.10
2763166-76316677.88577.96
3772450-77245078.83278.91
4714573-71457372.92672.99
5725862-72586274.07874.15
6792663-79266380.89580.98
15min1921653-92165394.05992.591.5294.2792.801.52
2925839-92583994.48794.69
3907511-90751192.61692.83
4893822-89382291.21991.41
5894404-89440491.27891.47
6900347-90034791.88592.10
20min1954369-95436997.39896.241.5097.7796.601.49
2963672-96367298.34898.71
3939885-93988595.92096.29
4942158-94215896.15296.49
5933084-93308495.22695.57
6924993-92499394.40094.77
30min1955619-95561997.52696.571.3298.0697.091.32
2965174-96517498.50199.03
3944219-94421996.36296.89
4945093-94509396.45196.95
5936408-93640895.56596.07
6931104-93110495.02495.55
45min1951383-95138397.09396.441.2097.7997.121.20
2962796-96279698.25898.95
3944058-94405896.34697.03
4944848-94484896.42697.09
5935929-93592995.51696.18
6930796-93079694.99295.68
60min1951878-95187897.14496.471.0998.0097.311.09
2962042-96204298.18199.03
3943137-94313796.25297.10
4943287-94328796.26797.09
5935317-93531795.45496.28
6935749-93574995.49896.34
极限1951491-95149197.10496.201.1998.1297.201.19
2960025-96002597.97598.99
3940092-94009295.94196.95
4940493-94049395.98296.96
5933104-93310495.22896.21
6930768-93076894.99095.99
二甲双胍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2000
标示量(mg)5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%
110.059381393694938769409293868938690.16
210.029436494254943090.09
单位质量响应值RSD%判断
9340.209412.080.55数据可信
长期12月-供试品溶液-2024120321批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147531-4753145.62546.1212.0245.6246.1212.02
243149-4314941.41941.42
343948-4394842.18642.19
443696-4369641.94441.94
552658-5265850.54650.55
657280-5728054.98354.98
10min182934-8293479.60881.296.5179.6881.366.51
278598-7859875.44675.52
386831-8683183.34983.42
478725-7872575.56875.64
589186-8918685.60985.69
691833-9183388.15088.24
15min196044-9604492.19292.562.5192.4092.772.52
293264-9326489.52489.72
398737-9873794.77794.99
493999-9399990.22990.43
599035-9903595.06395.29
697464-9746493.55593.79
20min198140-9814094.20494.731.1294.5795.101.12
297239-9723993.33993.68
399758-9975895.75796.12
498703-9870394.74595.09
5100171-10017196.15496.54
698133-9813394.19894.59
30min197725-9772593.80694.731.0094.3395.261.00
298238-9823894.29894.80
399523-9952395.53296.06
498961-9896194.99295.50
5100048-10004896.03696.58
697647-9764793.73194.28
45min197472-9747293.56394.681.2094.2495.361.20
298010-9801094.08094.74
3100339-10033996.31597.00
498887-9888794.92195.58
599613-9961395.61896.32
697478-9747893.56994.28
60min197453-9745393.54594.401.0294.3895.241.01
297822-9782293.89994.71
399346-9934695.36296.21
498917-9891794.95095.77
599389-9938995.40396.27
697135-9713593.24094.10
极限197467-9746793.55894.810.9094.5595.810.90
297936-9793694.00994.98
399312-9931295.32996.33
499083-9908395.11096.09
599785-9978595.78396.81
699067-9906795.09496.11
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.938787498785508792998787358791398788940.04
29.948815368818598816980.03
单位质量响应值RSD%判断
88508.9688702.010.16数据可信
长期12月-供试品溶液-2024120321批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1521599-52159952.98153.2010.3252.9853.2010.32
2476586-47658648.40948.41
3486864-48686449.45349.45
4481907-48190748.94948.95
5564986-56498657.38857.39
6610662-61066262.02762.03
10min1826421-82642183.94385.075.3484.0385.165.34
2787686-78768680.00880.09
3856606-85660687.00987.09
4788604-78860480.10280.18
5867339-86733988.09988.19
6898457-89845791.26091.36
15min1928600-92860094.32294.322.0094.5594.542.01
2902873-90287391.70891.92
3949660-94966096.46196.69
4909985-90998592.43192.65
5941501-94150195.63295.87
6938586-93858695.33695.59
20min1943037-94303795.78895.990.7596.1796.380.75
2934798-93479894.95195.32
3955684-95568497.07397.46
4946306-94630696.12096.49
5948751-94875196.36896.77
6941544-94154495.63696.05
30min1940193-94019395.49995.870.7596.0496.420.75
2936839-93683995.15895.68
3954521-95452196.95497.50
4946050-94605096.09496.62
5948528-94852896.34696.91
6937116-93711695.18795.76
45min1936360-93636095.11095.680.8895.8196.390.87
2936344-93634495.10895.79
3956644-95664497.17097.88
4944908-94490895.97896.67
5943050-94305095.78996.51
6934759-93475994.94795.68
60min1934820-93482094.95395.450.7495.8296.320.73
2934632-93463294.93495.78
3950161-95016196.51297.39
4943888-94388895.87496.72
5942515-94251595.73596.62
6932471-93247194.71595.61
极限1933690-93369094.83995.410.5695.8696.430.57
2933243-93324394.79395.79
3947272-94727296.21897.25
4940571-94057195.53896.55
5940871-94087195.56896.61
6940054-94005495.48596.53
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