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%
1 9.899293492639927389316493106929160.25
2 9.909294093520932300.44
单位质量响应值RSD%判断
9394.949417.170.17数据可信
供试品溶液-301793A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%
5min135188-3518833.66928.7414.3533.6728.7414.35
229881-2988128.59128.59
327229-2722926.05426.05
430517-3051729.20029.20
533912-3391232.44832.45
623472-2347222.45922.46
10min171986-7198668.87858.6812.5868.9358.7212.58
260546-6054657.93257.98
357314-5731454.84054.88
461671-6167159.00959.06
566797-6679763.91363.97
649630-4963047.48847.52
15min195408-9540891.28981.109.1091.4681.259.11
283803-8380380.18580.33
382135-8213578.58978.72
485058-8505881.38681.53
589712-8971285.83986.00
672463-7246369.33569.45
20min1100726-10072696.37891.184.4196.7091.474.43
296610-9661092.43992.72
394315-9431590.24490.51
496626-9662692.45592.74
595568-9556891.44291.75
687943-8794384.14784.38
30min1101892-10189297.49395.990.9997.9896.421.00
2100304-10030495.97496.41
3100477-10047796.14096.56
499713-9971395.40995.85
598918-9891894.64895.10
6100612-10061296.26996.64
45min1101992-10199297.58996.101.0698.2496.691.07
2100366-10036696.03396.63
3101064-10106496.70197.28
4100487-10048796.14996.74
598915-9891594.64595.26
699762-9976295.45595.99
60min1101417-10141797.03996.340.7197.8597.090.71
2100283-10028395.95496.71
3101071-10107196.70897.45
4100744-10074496.39597.15
599461-9946195.16795.94
6101136-10113696.77097.46
极限1101461-10146197.08196.190.7798.0597.100.77
299669-9966995.36696.28
3101201-10120196.83297.73
4100908-10090896.55297.47
599758-9975895.45296.38
6100180-10018095.85596.71
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%
1 9.999323289289309311259319679313259311350.15
210.089367099365839366460.01
单位质量响应值RSD%判断
93206.7192921.230.22数据可信
供试品溶液-301793A批-二甲双胍-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%
5min1450782-45078243.59438.6611.6443.5938.6611.64
2400492-40049238.73138.73
3367270-36727035.51835.52
4404236-40423639.09339.09
5446271-44627143.15843.16
6329204-32920431.83731.84
10min1805354-80535477.88468.7410.2777.9668.8010.27
2703241-70324168.00968.07
3670589-67058964.85164.91
4710833-71083368.74368.81
5773749-77374974.82874.90
6601070-60107058.12858.18
15min11006063-100606397.29489.077.3697.5089.257.37
2911040-91104088.10588.28
3893929-89392986.45086.62
4927316-92731689.67989.86
5975839-97583994.37194.57
6812099-81209978.53678.69
20min11040943-1040943100.66797.623.21101.0397.953.23
21025054-102505499.13199.46
3997817-99781796.49796.81
41017354-101735498.38698.72
51025507-102550799.17599.53
6949994-94999491.87292.15
30min11046247-1046247101.180101.170.40101.71101.660.39
21049217-1049217101.468101.96
31040825-1040825100.656101.13
41043722-1043722100.936101.43
51044311-1044311100.993101.51
61052492-1052492101.784102.22
45min11046098-1046098101.166101.290.16101.87101.950.18
21046289-1046289101.184101.84
31048064-1048064101.356102.00
41048458-1048458101.394102.06
51049754-1049754101.520102.21
61045569-1045569101.115101.72
60min11028674-102867499.481101.100.87100.35101.920.84
21042716-1042716100.839101.67
31046592-1046592101.214102.02
41051294-1051294101.668102.50
51049276-1049276101.473102.33
61053793-1053793101.910102.68
极限11043123-1043123100.878101.160.32101.91102.160.30
21041637-1041637100.735101.73
31046357-1046357101.191102.17
41049204-1049204101.466102.47
51045856-1045856101.143102.17
61049949-1049949101.538102.48
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%
1 9.899338693493932479324293216933170.13
2 9.909308093260931700.14
单位质量响应值RSD%判断
9435.499411.110.19数据可信
供试品溶液-301793A批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123220-2322022.17728.0319.0322.1828.0319.02
239778-3977837.99137.99
326442-2644225.25425.25
428696-2869627.40727.41
529349-2934928.03128.03
628592-2859227.30827.31
10min151111-5111148.81557.3912.6048.8557.4412.60
272934-7293469.65869.72
355589-5558953.09253.13
463854-6385460.98661.03
559347-5934756.68156.73
657703-5770355.11155.16
15min174416-7441671.07377.666.6271.1977.806.63
288541-8854184.56484.74
378028-7802874.52374.65
486707-8670782.81282.96
581040-8104077.40077.54
679130-7913075.57675.71
20min189987-8998785.94589.423.7086.1889.693.72
298465-9846594.04294.36
393117-9311788.93489.19
496578-9657892.24092.53
593749-9374989.53889.81
689842-8984285.80686.07
30min1100395-10039595.88595.720.9796.2796.140.98
2100790-10079096.26396.74
3100570-10057096.05296.46
4101379-10137996.82597.26
599474-9947495.00695.43
698712-9871294.27894.68
45min199960-9996095.47096.170.9696.0196.750.97
2101104-10110496.56397.20
3100837-10083796.30796.87
4102109-10210997.52298.12
599335-9933594.87395.45
6100816-10081696.28796.85
60min1100380-10038095.87196.160.8296.5796.900.81
2100339-10033995.83296.63
3101163-10116396.61997.34
4101717-10171797.14897.91
599395-9939594.93095.67
6101116-10111696.57497.30
极限1100670-10067096.14896.180.8697.0197.080.86
2100667-10066796.14597.10
3101082-10108296.54197.43
4101782-10178297.21098.13
599152-9915294.69895.59
6100862-10086296.33197.22
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%
1 9.999387249399489402489376879370219387260.15
210.089337869341719339780.03
单位质量响应值RSD%判断
93966.5792656.551.00数据可信
供试品溶液-301793A批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1314896-31489630.37437.8015.8230.3737.8015.82
2503670-50367048.58248.58
3366773-36677335.37735.38
4388490-38849037.47237.47
5396519-39651938.24738.25
6380920-38092036.74236.74
10min1617683-61768359.57967.469.7559.6367.529.75
2814451-81445178.55978.64
3663376-66337663.98664.05
4732363-73236370.64170.70
5699132-69913267.43567.50
6669198-66919864.54864.61
15min1840237-84023781.04686.335.1681.2086.505.17
2955608-95560892.17492.39
3869287-86928783.84884.01
4943054-94305490.96391.14
5898435-89843586.65986.84
6863458-86345883.28683.45
20min1973808-97380893.92996.423.1094.2196.743.12
21036920-1036920100.017100.38
31002407-100240796.68896.99
41023059-102305998.68099.01
51008031-100803197.23097.55
6953654-95365491.98592.29
30min11056217-1056217101.878101.161.38102.32101.641.38
21051156-1051156101.390101.92
31055818-1055818101.840102.31
41058478-1058478102.096102.59
51051151-1051151101.390101.87
61020060-102006098.39198.85
45min11053571-1053571101.623101.640.75102.23102.290.76
21053147-1053147101.582102.28
31061051-1061051102.345102.98
41061873-1061873102.424103.09
51053181-1053181101.585102.24
61039954-1039954100.310100.93
60min11055282-1055282101.788101.520.66102.57102.330.65
21047854-1047854101.072101.94
31059570-1059570102.202103.01
41058784-1058784102.126102.96
51051535-1051535101.427102.25
61041746-1041746100.482101.27
极限11051327-1051327101.407101.180.64102.36102.160.64
21046521-1046521100.943101.98
31053489-1053489101.615102.59
41055699-1055699101.828102.84
51049683-1049683101.248102.24
61036985-1036985100.023100.98
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%
1 9.899279992605931509289493033928960.23
2 9.909328293074931780.16
单位质量响应值RSD%判断
9392.929411.920.15数据可信
供试品溶液-301793A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%
5min139706-3970638.00740.9212.1438.0140.9212.14
248191-4819146.12846.13
340664-4066438.92438.92
435517-3551733.99734.00
548962-4896246.86646.87
643430-4343041.57141.57
10min176568-7656873.29176.656.2073.3576.726.21
286064-8606482.38182.46
379036-7903675.65375.72
473442-7344270.29970.36
585531-8553181.87081.95
679833-7983376.41676.49
15min193549-9354989.54592.442.5689.7392.642.57
298905-9890594.67294.89
395198-9519891.12491.31
494788-9478890.73190.91
599801-9980195.53095.74
697199-9719993.03993.24
20min198862-9886294.63196.501.6694.9796.851.67
2102166-10216697.79398.17
399231-9923194.98495.33
499887-9988795.61295.94
5102242-10224297.86698.24
6102493-10249398.10698.46
30min1101438-10143897.09797.221.3097.5997.741.31
2102142-10214297.77098.31
399744-9974495.47595.98
4100548-10054896.24596.73
5102046-10204697.67998.22
6103489-10348999.06099.58
45min199946-9994695.66896.781.3496.3297.451.35
2101950-10195097.58798.28
399337-9933795.08695.75
4100637-10063796.33096.97
5101892-10189297.53198.23
6102876-10287698.47399.15
60min199088-9908894.84796.461.5395.6697.291.54
2101291-10129196.95697.82
399041-9904194.80295.62
4100541-10054196.23897.04
5101703-10170397.35098.21
6102959-10295998.55299.40
极限199456-9945695.19996.471.5596.1797.471.56
2102056-10205697.68898.71
398789-9878994.56195.54
4100104-10010495.82096.79
5101644-10164497.29498.32
6102676-10267698.28299.29
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%
1 9.999327109312809328729341819337859329660.13
210.089336689349539343100.10
单位质量响应值RSD%判断
93389.9992689.480.54数据可信
供试品溶液-301793A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%
5min1500410-50041048.40750.9110.1148.4150.9210.11
2585536-58553656.64156.64
3512507-51250749.57749.58
4448134-44813443.35043.35
5586772-58677256.76156.76
6524609-52460950.74850.75
10min1833696-83369680.64782.944.8480.7383.024.84
2905106-90510687.55587.65
3858926-85892683.08883.17
4798039-79803977.19877.27
5902909-90290987.34287.44
6845407-84540781.78081.86
15min1968038-96803893.64295.411.5493.8695.641.55
21001702-100170296.89997.14
3989943-98994395.76195.98
4972725-97272594.09694.30
51004980-100498097.21697.46
6980568-98056894.85495.08
20min11008405-100840597.54798.350.8197.9298.730.83
21026055-102605599.25599.66
31019542-101954298.62599.01
41004840-100484097.20297.56
51021349-102134998.79999.20
61019799-101979998.64999.03
30min11013325-101332598.02398.420.6398.5698.960.64
21024839-102483999.13799.70
31016773-101677398.35798.90
41007872-100787297.49698.02
51017805-101780598.45799.02
61023771-102377199.03499.58
45min11011716-101171697.86898.140.5398.5698.840.54
21020935-102093598.75999.49
31014239-101423998.11298.82
41005887-100588797.30497.99
51015847-101584798.26799.00
61018319-101831998.50699.21
60min11010217-101021797.72397.920.5198.5898.790.52
21017307-101730798.40899.31
31012297-101229797.92498.80
41003816-100381697.10397.95
51012134-101213497.90898.80
61017549-101754998.43299.30
极限11007665-100766597.47697.740.5498.5098.780.55
21016530-101653098.33399.39
31010706-101070697.77098.81
41001877-100187796.91697.92
51009730-100973097.67598.73
61015834-101583498.26699.30
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