恩格列净二甲双胍片项目信息
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%
110.149402494319938109408794096940670.20
210.149328992754930220.41
单位质量响应值RSD%判断
9276.829173.770.79数据可信
加速6月-供试品溶液-2024120621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%
5min140533-4053339.54443.7714.6839.5443.7714.68
250454-5045449.22349.22
341865-4186540.84440.84
449481-4948148.27448.27
535293-3529334.43234.43
651562-5156250.30450.30
10min175510-7551073.66880.298.9173.7380.368.92
288536-8853686.37786.46
379242-7924277.30977.38
486728-8672884.61384.69
573096-7309671.31371.37
690662-9066288.45188.53
15min192467-9246790.21294.613.0890.4094.823.09
297910-9791095.52295.75
398094-9809495.70195.90
498650-9865096.24496.47
594301-9430192.00192.18
6100435-10043597.98598.22
20min196234-9623493.88797.001.6494.2397.371.64
299903-9990397.46697.85
399983-9998397.54497.90
499399-9939996.97597.36
5100599-10059998.14598.47
6100451-10045198.00198.40
30min195627-9562793.29597.292.2393.7997.812.23
2102056-10205699.567100.11
3100213-10021397.76998.29
499303-9930396.88197.42
5101109-10110998.64399.14
6100010-10001097.57198.13
45min196504-9650494.15096.881.5894.8097.571.58
299111-9911196.69497.41
399809-9980997.37598.06
498997-9899796.58297.29
5100976-10097698.51399.17
6100427-10042797.97798.70
60min196297-9629793.94896.981.7494.7697.831.74
298916-9891696.50397.38
3101017-10101798.55399.40
499272-9927296.85197.72
5100111-10011197.66998.49
6100790-10079098.33299.22
极限196345-9634593.99596.951.6294.9697.961.62
299360-9936096.93797.97
399965-9996597.52798.54
499255-9925596.83497.86
5100784-10078498.32699.31
6100520-10052098.06899.12
恩格列净二甲双胍片项目信息
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%
110.024995894977845006635010985017855001840.32
210.054922904906784914840.24
单位质量响应值RSD%判断
49918.5648903.881.46数据可信
加速6月-供试品溶液-2024120621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%
5min1252434-25243445.98449.2012.1845.9849.2012.19
2297348-29734854.16654.17
3255343-25534346.51446.51
4294346-29434653.61953.62
5219528-21952839.99039.99
6301612-30161254.94354.94
10min1431661-43166178.63383.457.4478.7183.537.44
2485850-48585088.50488.59
3442348-44234880.58080.66
4481322-48132287.68087.77
5411893-41189375.03275.10
6495600-49560090.28190.37
15min1511541-51154193.18495.622.1893.3995.842.20
2527238-52723896.04496.28
3529956-52995696.53996.75
4531487-53148796.81897.05
5510452-51045292.98693.18
6538769-53876998.14498.39
20min1530681-53068196.67197.560.6797.0397.940.66
2533611-53361197.20597.60
3538043-53804398.01298.38
4533200-53320097.13097.53
5539656-53965698.30698.65
6538152-53815298.03298.44
30min1524499-52449995.54597.151.0996.0797.701.08
2529606-52960696.47597.04
3535827-53582797.60898.14
4533060-53306097.10497.66
5541461-54146198.63599.15
6535435-53543597.53798.11
45min1524374-52437495.52297.080.9696.2197.780.96
2531314-53131496.78697.51
3534724-53472497.40798.11
4531522-53152296.82497.54
5538860-53886098.16198.84
6536696-53669697.76798.50
60min1519720-51972094.67496.821.2795.5297.691.26
2531281-53128196.78097.66
3539283-53928398.23899.10
4529643-52964396.48297.36
5535721-53572197.58998.43
6533424-53342497.17198.07
极限1520236-52023694.76896.431.0295.7797.461.02
2529873-52987396.52497.57
3529987-52998796.54597.57
4526862-52686295.97597.02
5535411-53541197.53398.53
6533651-53365197.21298.27
恩格列净二甲双胍片项目信息
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%
110.149593795930961999590595995959930.13
210.149446494833946480.28
单位质量响应值RSD%判断
9466.779334.121.00数据可信
加速6月-供试品溶液-2024120621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%
5min140370-4037038.65251.2124.8338.6551.2124.83
236276-3627634.73234.73
368121-6812165.22265.22
463350-6335060.65460.65
549891-4989147.76847.77
662894-6289460.21860.22
10min177902-7790274.58785.4113.1674.6585.4913.17
271908-7190868.84868.91
399813-9981395.56695.67
498936-9893694.72694.83
590181-9018186.34486.42
696486-9648692.38092.48
15min198153-9815393.97793.923.0594.1794.153.07
293046-9304689.08789.26
3100214-10021495.95096.22
4101797-10179797.46597.72
597187-9718793.05293.28
698189-9818994.01194.27
20min1100542-10054296.26495.251.3396.6195.641.33
299308-9930895.08295.40
3100445-10044596.17196.60
4100732-10073296.44696.87
597544-9754493.39393.77
698347-9834794.16294.57
30min1101373-10137397.06095.591.4297.5796.131.40
2100428-10042896.15596.63
3100593-10059396.31396.90
4100476-10047696.20196.78
598355-9835594.17094.70
697819-9781993.65794.22
45min1101297-10129796.98795.761.0997.6596.461.07
2100705-10070596.42097.06
3100286-10028696.01996.77
4100409-10040996.13796.88
598811-9881194.60795.30
698557-9855794.36395.09
60min1101077-10107796.77695.871.1497.6196.731.12
2100978-10097896.68197.48
3100851-10085196.56097.47
4100455-10045596.18197.08
598946-9894694.73695.58
698455-9845594.26695.15
极限1101546-10154697.22596.051.3298.2297.081.29
2101565-10156597.24398.21
3100750-10075096.46397.53
4100682-10068296.39897.46
598575-9857594.38195.39
698819-9881994.61495.65
恩格列净二甲双胍片项目信息
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%
110.025027795045915034975036205030065034990.14
210.054980344983994982160.06
单位质量响应值RSD%判断
50249.4049573.730.96数据可信
加速6月-供试品溶液-2024120621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%
5min1247326-24732644.60056.2621.5844.6056.2621.58
2222236-22223640.07540.08
3385045-38504569.43469.43
4360062-36006264.92964.93
5295349-29534953.25953.26
6362040-36204065.28665.29
10min1432272-43227277.95087.4511.5178.0287.5511.52
2402110-40211072.51172.58
3534624-53462496.40796.52
4529025-52902595.39895.51
5488116-48811688.02188.11
6523675-52367594.43394.54
15min1526272-52627294.90195.003.2595.1195.243.28
2499570-49957090.08690.27
3539718-53971897.32697.60
4548657-54865798.93899.20
5518178-51817893.44293.68
6528686-52868695.33695.60
20min1539029-53902997.20295.981.0797.5696.381.07
2528440-52844095.29295.63
3535218-53521896.51496.95
4536654-53665496.77397.21
5524071-52407194.50494.90
6530023-53002395.57896.00
30min1541329-54132997.61696.161.3098.1496.721.29
2532569-53256996.03796.53
3538855-53885597.17097.77
4536285-53628596.70797.30
5524531-52453194.58795.14
6525836-52583694.82395.41
45min1540613-54061397.48796.261.0098.1796.980.98
2536564-53656496.75797.41
3534245-53424596.33997.10
4535686-53568696.59997.35
5525249-52524994.71795.42
6530530-53053095.66996.41
60min1539184-53918497.23096.081.0998.0896.961.08
2535049-53504996.48497.30
3537601-53760196.94497.87
4532934-53293496.10297.02
5524140-52414094.51795.38
6527873-52787395.19096.09
极限1534741-53474196.42895.840.9897.4496.880.98
2533743-53374396.24897.23
3536221-53622196.69597.78
4534129-53412996.31897.39
5523137-52313794.33695.36
6527028-52702895.03796.10
恩格列净二甲双胍片项目信息
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%
110.149599196192956649561394860956640.54
210.149456494322944430.19
单位质量响应值RSD%判断
9434.329313.910.91数据可信
长期6月-供试品溶液-2024120621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%
5min134831-3483133.44249.9819.5833.4449.9819.58
261847-6184759.38159.38
350546-5054648.53148.53
447929-4792946.01846.02
555235-5523553.03353.03
661921-6192159.45259.45
10min172065-7206569.19286.0411.5269.2586.1311.53
298312-9831294.39294.49
388259-8825984.74084.82
485032-8503281.64281.72
594137-9413790.38490.47
699892-9989295.90996.01
15min194052-9405290.30295.543.1090.4795.773.12
2100536-10053696.52896.78
3102411-10241198.32898.55
499012-9901295.06495.28
598796-9879694.85795.10
6102238-10223898.16298.42
20min197484-9748493.59796.252.2293.9296.642.23
2100588-10058896.57896.99
3102324-10232498.24498.63
499422-9942295.45895.83
598471-9847194.54594.94
6103194-10319499.08099.50
30min198876-9887694.93496.151.9195.4196.691.92
2101046-10104697.01797.60
3101820-10182097.76098.31
4100427-10042796.42396.95
596923-9692393.05993.61
6101739-10173997.68398.27
45min198394-9839494.47196.641.8595.1197.341.86
2100597-10059796.58697.33
3102446-10244698.36299.07
4100743-10074396.72697.42
598765-9876594.82795.54
6102948-10294898.84499.59
60min199180-9918095.22696.221.7096.0297.081.71
2100188-10018896.19497.09
3101823-10182397.76398.64
499765-9976595.78796.64
597860-9786093.95894.83
6102458-10245898.37399.29
极限199635-9963595.66396.321.0996.6197.351.11
2100384-10038496.38297.44
3101275-10127597.23798.28
499750-9975095.77396.78
598989-9898995.04296.07
6101893-10189397.83198.91
恩格列净二甲双胍片项目信息
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%
110.025022355020625017235012675010125016600.11
210.054988914989014988960.01
单位质量响应值RSD%判断
50065.8749641.390.61数据可信
长期6月-供试品溶液-2024120621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%
5min1222176-22217640.11055.6916.8040.1155.6916.80
2363512-36351265.62565.63
3298392-29839253.86953.87
4287129-28712951.83651.84
5325255-32525558.71958.72
6354287-35428763.96063.96
10min1408588-40858873.76388.449.7673.8388.539.76
2530945-53094595.85295.96
3478494-47849486.38386.47
4472058-47205885.22185.31
5513152-51315292.64092.74
6535971-53597196.76096.87
15min1509222-50922291.93196.062.2892.1296.302.30
2536558-53655896.86697.13
3539095-53909597.32497.56
4536073-53607396.77897.01
5528728-52872895.45295.70
6542779-54277997.98998.26
20min1525636-52563694.89496.771.4495.2497.171.46
2537051-53705196.95597.39
3539078-53907897.32197.72
4536031-53603196.77197.16
5530231-53023195.72496.13
6548058-54805898.94299.37
30min1526197-52619794.99596.011.5495.5096.571.55
2533030-53303096.22996.82
3534361-53436196.46997.03
4536775-53677596.90597.46
5518678-51867893.63894.21
6541719-54171997.79798.39
45min1529322-52932295.55996.861.5896.2297.581.58
2533661-53366196.34397.10
3538442-53844297.20697.92
4549508-54950899.20499.92
5526517-52651795.05395.78
6541689-54168997.79298.55
60min1527455-52745595.22296.011.2096.0496.901.21
2529761-52976195.63996.55
3535284-53528496.63697.52
4533993-53399396.40397.28
5523300-52330094.47295.36
6541273-54127397.71798.64
极限1524443-52444394.67996.001.2195.6697.041.23
2537584-53758497.05198.12
3535228-53522896.62697.67
4531247-53124795.90796.95
5523764-52376494.55695.60
6538344-53834497.18898.27
恩格列净二甲双胍片项目信息
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%
110.149412694116934049383594159939280.35
210.149390494621942620.54
单位质量响应值RSD%判断
9263.129296.060.26数据可信
长期6月-供试品溶液-2024120621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%
5min148922-4892247.44851.3316.9847.4551.3316.98
250718-5071849.19049.19
341720-4172040.46340.46
455611-5561153.93653.94
551875-5187550.31250.31
668703-6870366.63366.63
10min184096-8409681.56386.876.9581.6486.966.96
290132-9013287.41787.50
380559-8055978.13278.20
494406-9440691.56291.65
591171-9117188.42488.51
697072-9707294.14894.26
15min197542-9754294.60395.531.6694.8295.761.67
298304-9830495.34295.57
396086-9608693.19193.39
498546-9854695.57795.82
5100628-10062897.59697.83
699882-9988296.87397.14
20min197640-9764094.69896.061.7195.0796.441.72
297758-9775894.81395.20
397909-9790994.95995.31
498786-9878695.81096.21
5101783-10178398.71799.11
6100360-10036097.33797.77
30min197154-9715494.22795.541.5594.7696.091.56
297575-9757594.63595.18
397312-9731294.38094.89
498435-9843595.47096.03
5101049-10104998.00598.56
699513-9951396.51597.11
45min197490-9749094.55395.761.7495.2496.471.75
298179-9817995.22195.92
397436-9743694.50195.17
497496-9749694.55995.28
5101219-10121998.17098.89
6100585-10058597.55598.31
60min197412-9741294.47795.561.1395.3296.431.14
298309-9830995.34796.21
397817-9781794.87095.70
498058-9805895.10495.98
5100473-10047397.44698.33
699123-9912396.13797.05
极限197871-9787194.92396.020.9995.9397.051.00
298505-9850595.53796.56
398709-9870995.73596.72
498529-9852995.56196.60
5100249-10024997.22998.28
6100165-10016597.14798.22
恩格列净二甲双胍片项目信息
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%
110.025063975064165047725063285059775059780.14
210.054970404971154970780.02
单位质量响应值RSD%判断
50496.8149460.501.47数据可信
长期6月-供试品溶液-2024120621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%
5min1297063-29706353.50056.6714.2053.5056.6714.20
2305056-30505654.93954.94
3255854-25585446.07846.08
4330299-33029959.48659.49
5308580-30858055.57455.57
6391081-39108170.43270.43
10min1469870-46987084.62288.445.6784.7188.535.68
2498146-49814689.71489.81
3448164-44816480.71380.79
4514600-51460092.67892.78
5493399-49339988.85988.95
6522206-52220694.04794.16
15min1525064-52506494.56295.061.2694.7995.301.28
2530043-53004395.45995.70
3515547-51554792.84893.06
4530961-53096195.62495.88
5532190-53219095.84596.09
6533007-53300795.99396.27
20min1523435-52343594.26995.270.8894.6695.670.88
2525731-52573194.68295.08
3528189-52818995.12595.49
4527760-52776095.04895.46
5535763-53576396.48996.89
6533046-53304696.00096.43
30min1520384-52038493.71995.061.0194.2695.621.02
2532008-53200895.81396.37
3523572-52357294.29394.82
4525648-52564894.66795.24
5532958-53295895.98496.55
6532273-53227395.86096.45
45min1523478-52347894.27695.110.9194.9895.830.92
2530821-53082195.59996.32
3524935-52493594.53995.22
4523144-52314494.21694.95
5533557-53355796.09296.81
6532791-53279195.95496.71
60min1526045-52604594.73994.940.5195.6095.820.52
2530414-53041495.52696.40
3523690-52369094.31595.15
4526770-52677094.86995.76
5530277-53027795.50196.38
6525727-52572794.68195.60
极限1522365-52236594.07694.970.7695.0996.000.75
2528619-52861995.20296.24
3533254-53325496.03797.03
4523786-52378694.33295.38
5529610-52961095.38196.42
6526359-52635994.79595.87
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