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800
标示量(mg)12.5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%
19.902346432346662351462352602356182350670.18
29.862353482365572359520.37
单位质量响应值RSD%判断
23744.1423930.220.56数据可信
供试品溶液-3216399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%
45min125498525518825508696.31293.623.4996.3193.623.49
224858724872324865593.88493.88
323988223966523977490.53190.53
426094526105326099998.54598.54
524021923999924010990.65790.66
624314724315424315091.80591.81
120min126292426267126279899.22495.593.5599.3895.753.55
225297925296425297295.51495.67
324482724504824493892.48192.63
4265391265548265470100.233100.40
524561724587824574892.78692.94
624708824728924718893.33093.48
240min1266640266374266507100.62496.703.59100.9597.023.59
225611225598925605096.67696.99
324652824656524654693.08893.39
4268140267818267979101.180101.51
524906424895724901094.01894.32
625062625063125062894.62994.94
720min1-00.0000.00-0.490.483.43
2-00.0000.48
3-00.0000.46
4-00.0000.50
5-00.0000.46
6-00.0000.47
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100664-202507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%
19.699850229880869920739941509944389907540.42
29.699743009802649772820.44
单位质量响应值RSD%判断
102244.99100854.700.97数据可信
供试品溶液-3216399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%
45min143404043425943415038.44038.071.2738.4438.071.27
244199443407543803438.78438.78
343136843154643145738.20238.20
442572242618642595437.71537.71
542477842482842480337.61337.61
642529142544042536637.66337.66
120min162978562942462960455.74655.370.7355.8155.440.73
263033763035663034655.81255.88
362748562780862764655.57355.64
462449162459162454155.29855.36
561951461950861951154.85354.92
662091662060862076254.96355.03
240min197259997152297206086.06885.131.1786.2385.291.18
296961896929896945885.83886.00
396535796515796525785.46685.62
496176896181296179085.15985.31
594053394051094052283.27683.43
695914796024695969684.97385.13
720min1-00.0000.00-0.300.301.37
2-00.0000.30
3-00.0000.30
4-00.0000.30
5-00.0000.29
6-00.0000.30
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800
标示量(mg)12.5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%
19.904775084772744771424772984771634772770.04
29.864776074777464776760.03
单位质量响应值RSD%判断
48209.8048445.840.35数据可信
供试品溶液-3215076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%
45min148741548775948758790.80391.702.9890.8091.702.98
249987749970449979093.07693.08
348764148752048758090.80290.80
449276549315349295991.80391.80
547089847138647114287.74087.74
651523851521751522895.95195.95
120min149835949830249833092.80493.562.9592.9593.722.95
251254951243951249495.44195.60
349802849813749808292.75792.91
450263750198350231093.54593.70
547999847938347969089.33289.48
652365552329352347497.48697.65
240min149813049830749821892.78393.662.9393.0993.972.93
251422251437951430095.77896.09
349868149828849848492.83293.14
450347950338550343293.75494.06
548011948036948024489.43589.73
652278652284352281497.36397.69
720min150173050227550200293.48794.622.7593.9595.082.76
251949552009251979496.80197.27
350370350404950387693.83694.30
450616950620050618494.26694.73
548862648855948859290.99091.43
652815852798352807098.34298.83
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100664-202507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%
19.699180429176689177509176529172219176670.04
29.699191859182759187300.08
单位质量响应值RSD%判断
94702.4894812.180.09数据可信
供试品溶液-3215076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%
45min120561120567420564219.51219.993.0919.5119.993.09
221132121135121133620.05320.05
320308620322220315419.27619.28
421234021258321246220.15920.16
522174722186022180421.04621.05
620971320960820966019.89319.89
120min141678341680741679539.54740.181.2839.5840.221.28
242525942542042534040.35840.39
341994042013942004039.85539.89
442135542121842128639.97440.01
543230943225543228241.01741.05
642516242529842523040.34840.38
240min161205661233461219558.08858.851.1458.1958.951.14
262660262643162651659.44759.55
361638161565461601858.45158.55
461567561553161560358.41158.51
563042363066563054459.82959.93
662082562028462055458.88158.98
720min194813994861094837489.98690.891.2490.1891.091.24
296949296956596952891.99392.19
394770394750994760689.91390.11
494872294843394857890.00590.20
597440497460397450492.46592.67
695899295863895881590.97791.18
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800
标示量(mg)12.5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%
19.904757694760104757464757604756134757800.04
29.864778084774864776470.05
单位质量响应值RSD%判断
48058.5948442.900.57数据可信
供试品溶液-3214157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%
45min146213146293746253486.27690.282.7686.2890.282.75
248153848196848175389.86189.86
349392449406649399592.14492.14
450146650150950148893.54293.54
548021648013148017489.56689.57
648405948422748414390.30790.31
120min147771447761047766289.09892.902.5089.2493.062.50
249386349347249366892.08392.23
350230950263450247293.72593.88
451523351533751528596.11596.27
550258450257950258293.74693.90
649659949687049673492.65592.81
240min148314748288448301690.09693.222.1890.3993.532.18
249343149379349361292.07392.38
350418250432950425694.05894.37
451487051520851503996.06996.39
550392550380350386493.98594.29
649874149878849876493.03493.34
720min149852249890049871193.02494.351.5893.4794.811.58
249691649741849716792.73693.19
350675250651850663594.50294.97
451931351946251938896.88197.36
550787650810450799094.75595.22
650479750496750488294.17594.63
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100664-202507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%
19.699156479153149151059147989149169151560.04
29.699171289165979168620.05
单位质量响应值RSD%判断
94443.3494619.400.14数据可信
供试品溶液-3214157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%
45min121151721181421166620.13220.112.8620.1320.112.85
222028322014222021220.94520.94
320791520793220792419.77619.78
420308820308620308719.31619.32
520973620977320975419.95019.95
621597621590121593820.53820.54
120min141361441371841366639.34440.041.3539.3840.071.35
242852942874942863940.76840.80
342191042194942193040.13040.16
441501241497241499239.47039.50
542341042340742340840.27140.30
642315842334742325240.25640.29
240min161009260985160997258.01558.650.7558.1158.740.75
262114562084462099459.06459.17
361913661895661904658.87858.98
461157461172961165258.17558.27
561850061900061875058.85058.95
661914961925761920358.89358.99
720min195875495916295895891.20890.680.7491.4090.880.74
295044495038395041490.39590.60
394921994879494900690.26190.46
494588494620294604389.97990.17
595179495139195159290.50790.71
696423596522196472891.75791.96
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800
标示量(mg)12.5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%
19.902350472350722348912350392348312349760.05
29.862357502356132356820.05
单位质量响应值RSD%判断
23734.9523902.840.50数据可信
供试品溶液-3214147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%
45min123586223574023580189.09991.102.3789.1091.102.37
224592724593024592892.92592.93
324661824659724660893.18293.18
423508623486323497488.78688.79
524635124625924630593.06893.07
623693823708423701189.55689.56
120min124136124137024136691.20292.982.2891.3593.132.28
225132825133125133094.96795.12
325091225082625086994.79294.95
424006924027524017290.75090.90
525135725121425128694.95095.11
624140024133024136591.20191.35
240min124195824195124195491.42493.342.0791.7293.652.07
225135025150325142695.00395.32
325136625120325128494.94995.26
424065124058524061890.91991.22
525169825172925171495.11295.43
624519024511624515392.63392.93
720min124584824588324586692.90294.522.0193.3594.982.01
225409025421125415096.03296.50
325370325355725363095.83696.31
424273524238324255991.65292.10
525482725481725482296.28696.76
624968724995224982094.39694.85
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100664-202507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%
19.699698939697509696439698879697529697850.02
29.699715269712669713960.02
单位质量响应值RSD%判断
100081.01100247.270.12数据可信
供试品溶液-3214147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%
45min121074021104221089118.93019.231.9918.9319.231.98
222060422064522062419.80419.80
321628421623221625819.41219.41
421378221385221381719.19319.19
521547621545221546419.34119.34
620846120854020850018.71618.72
120min141577941595541586737.32937.380.9937.3637.410.99
242218942221642220237.89837.93
341833641823341828437.54637.58
441614041658341636237.37437.41
541663341604441633837.37237.40
640945640968840957236.76436.80
240min160473060454660463854.27454.440.5454.3754.540.54
261163861169661166754.90555.00
360844460870760857654.62754.72
460673260668060670654.46054.55
560476460478660477554.28654.38
660283260250460266854.09754.19
720min192800192800292800283.30083.340.4883.4883.520.48
293631693611293621484.03784.22
392942192970892956483.44083.63
492706992703092705083.21583.40
592274392308992291682.84383.03
692563592769092666283.18083.36
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800
标示量(mg)12.5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%
19.902365572367422365642365042364752365680.05
29.862355722353822354770.06
单位质量响应值RSD%判断
23895.7623882.050.05数据可信
供试品溶液-3216399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%
45min122609622584722597285.13487.352.4185.1387.352.41
223527523529223528488.64288.64
323211723226823219287.47787.48
422730122745722737985.66485.66
524099724093024096490.78290.78
622942622939122940886.42886.43
120min123228523217723223187.49289.982.2687.6390.122.26
224093324109724101590.80190.95
323977923963223970690.30890.45
423328423341123334887.91288.06
524702324678024690293.01993.17
623965823993423979690.34290.49
240min123387823416823402388.16790.412.1388.4590.702.13
224196024184924190491.13691.43
324092824099524096290.78191.08
423462923466223464688.40188.69
524789224774224781793.36493.67
624063624041724052690.61790.91
720min123813623819723816689.72891.471.7990.1691.921.79
224434324418624426492.02592.48
324333524334124333891.67692.12
423887923887423887689.99590.43
525017625012325015094.24394.70
624201824201624201791.17891.62
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100664-202507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%
19.699740519743299740089746139740859742170.03
29.699719559721169720360.02
单位质量响应值RSD%判断
100538.39100313.310.16数据可信
供试品溶液-3216399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%
45min120699220631520665418.50118.932.1918.5018.932.19
221717421726421721919.44719.45
320715120718720716918.54818.55
421677721686321682019.41219.41
521055721070721063218.85818.86
620981721008720995218.79718.80
120min141372741413341393037.05937.471.0337.0937.511.03
242331142363142347137.91337.95
341352641334141343437.01437.05
441789641770641780137.40537.44
542268942275542272237.84637.88
642005641996542001037.60337.63
240min160780660765260772954.40954.660.9754.5054.760.98
261536361563161549755.10555.20
360379160391860385454.06254.15
460423960442760433354.10554.20
561611861591761601855.15155.25
661596361591761594055.14455.24
720min193567893574493571183.77383.880.9983.9684.060.99
295282595228095255285.28185.47
392825792827992826883.10783.29
492692092737392714683.00683.19
594048894014094031484.18584.37
693764793706493735683.92084.11
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