盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794046758404648640484024047628405400040486550.08
29.754056563405507040558160.03
单位质量响应值RSD%判断
413550.05415981.130.42数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113234241323340132338231.9132.572.8631.59%～33.54%
213958541392978139441633.62
313729111370757137183433.08
412916841291041129136231.14
513791111379201137915633.25
613427891344721134375532.40
2025081921批124608002459938246036959.3260.841.7459.73%～61.94%
225437912545162254447661.35
325620232561932256197861.77
424766932479507247810059.75
525389332526726253283061.07
625634252560428256192661.77
2025081922批138827343880188388146193.5896.522.1794.33%～98.71%
239964783998281399738096.38
340857024080844408327398.45
439219393928951392544594.64
540940124102879409844698.81
640339384035695403481697.28
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794031020403287140300014036184403257740325310.06
29.754076013407447240752420.03
单位质量响应值RSD%判断
411903.06417973.541.04数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113409171341830134137432.3332.332.8031.38%～33.28%
213376691338822133824632.25
312860261286445128623631.00
413333761334127133375232.15
514040361404359140419833.84
613456851344344134501432.42
2025081921批125184012520001251920160.7260.062.1058.74%～61.38%
224906402488609248962460.00
324393242438528243892658.78
424332462433790243351858.65
525731392573546257334262.02
624963332499129249773160.20
2025081922批140059604007216400658896.5695.162.4292.74%～97.57%
239470083944390394569995.10
338045493808637380659391.74
438685323875473387200293.32
540680854069131406860898.06
639882073992499399035396.17
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794033406403287040357614029570403483940332890.06
29.754034094403362540338600.01
单位质量响应值RSD%判断
411980.49413729.230.30数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113552671356942135610432.8532.582.7731.64%～33.53%
213661411365913136602733.09
313639911364563136427733.05
413345441337383133596432.36
513744091373875137414233.28
612741331274087127411030.86
2025081921批125155562515761251565860.9361.261.4360.34%～62.17%
225206792547580253413061.38
325885102594716259161362.77
424796032482337248097060.09
525251922523272252423261.14
625279132528965252843961.24
2025081922批139572423955031395613695.8296.190.8595.34%～97.04%
240182034017046401762497.31
339878094002482399514696.77
439332323933209393322095.27
539830343987117398507696.53
639368063942647393972695.43
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794073898405757740700394058295407095840661530.19
29.754097215409286740950410.08
单位质量响应值RSD%判断
415337.39420004.210.80数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批112861171293150128963430.8832.242.4531.41%～33.06%
213562251353562135489432.44
313637571358484136112032.59
413368251335652133623831.99
513865641390595138858033.25
613474601348140134780032.27
2025081921批124775982477005247730259.3160.711.6459.67%～61.75%
225043112489098249670459.78
325789912580863257992761.77
425792682571197257523261.66
525446262547663254614460.96
625316802543694253768760.76
2025081922批139144423919672391705793.7996.662.1394.51%～98.82%
240554464053831405463897.08
341474354088591411801398.60
441287654137547413315698.96
540182674064859404156396.77
639612193955054395813694.77
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794072009405623040766334070965406583240683340.20
29.754078074408551240817930.13
单位质量响应值RSD%判断
415560.16418645.440.53数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113343411327110133072631.9032.212.1731.48%～32.94%
213656421370373136800832.80
313488051343286134604632.27
413007311290988129586031.07
513434211341155134228832.18
613825041373933137821833.04
2025081921批125315972525580252858860.6260.872.3559.37%～62.37%
225282282542890253555960.79
326353292627605263146763.09
424437212450466244709458.67
525279382528751252834460.62
625619522563394256267361.44
2025081922批139861234013496399981095.9096.131.4094.72%～97.54%
240670504103312408518197.94
340664324072188406931097.56
439347753948238394150694.50
539893733974665398201995.47
639826133975180397889695.39
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
19.794068960407638640935804088509409323640841340.27
29.754179451416512441722880.25
单位质量响应值RSD%判断
417174.06427926.971.80数据可信
长期3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113263991328536132746831.4232.301.9531.64%～32.96%
213882871389838138906232.88
313405361334525133753031.66
413820061390455138623032.81
513625691367142136485632.31
613829261383213138307032.74
2025081921批124712862474213247275058.5359.912.3958.41%～61.41%
224755592479679247761958.64
324712902489814248055258.71
426097972597336260356661.63
525676292574117257087360.85
625784752585338258190661.11
2025081922批140069104005987400644894.8395.510.7694.75%～96.27%
240220524022058402205595.20
339953264005694400051094.69
440529174047317405011795.86
540418994062082405199095.91
640702184088595407940696.56
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