西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.058370383646837398369583677836920.05
214.128363983690836640.05
单位质量响应值RSD%判断
5956.735925.210.38数据可信
供试品溶液-2024050521批-西格列汀-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18856-885610.41214.1122.0810.4114.1122.09
216123-1612318.95718.96
311388-1138813.38913.39
49674-967411.37411.37
513474-1347415.84215.84
612514-1251414.71314.71
10min134489-3448940.55043.4712.2940.5743.4912.30
244573-4457352.40652.44
335581-3558141.83441.86
431168-3116836.64636.66
537141-3714143.66843.69
638872-3887245.70445.73
15min154401-5440163.96267.187.8264.0567.287.82
263595-6359574.77274.89
356516-5651666.44866.54
450960-5096059.91660.00
556798-5679866.78066.88
660561-6056171.20471.31
20min168529-6852980.57383.185.8880.7683.395.89
276850-7685090.35690.60
368208-6820880.19580.40
465593-6559377.12177.30
571259-7125983.78283.99
674051-7405187.06587.28
30min178592-7859292.40494.641.5592.7394.981.56
281143-8114395.40495.80
379490-7949093.46093.80
480437-8043794.57394.88
581475-8147595.79496.14
681807-8180796.18496.55
45min181319-8131995.61096.931.2996.0997.431.27
281033-8103395.27495.83
382648-8264897.17397.67
483799-8379998.52698.99
583072-8307297.67298.18
682762-8276297.30797.83
60min181396-8139695.70196.911.1896.3497.581.16
281132-8113295.39196.10
382652-8265297.17897.83
483687-8368798.39599.02
582907-8290797.47898.15
682775-8277597.32298.01
极限181107-8110795.36196.741.2296.1697.571.20
281062-8106295.30896.18
382617-8261797.13797.95
483595-8359598.28699.08
582695-8269597.22898.06
682628-8262897.14998.00
西格列汀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DA-1142209074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20
标示量(mg)850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%
119.013930992393229239353193931809393168839324200.05
218.913935402393898539371940.07
单位质量响应值RSD%判断
206860.60208206.980.46数据可信
供试品溶液-2024050521批-二甲双胍-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1649619-64961916.55520.5517.2116.5620.5517.20
21018836-101883625.96425.96
3768235-76823519.57819.58
4674489-67448917.18917.19
5887469-88746922.61722.62
6839082-83908221.38421.38
10min11958951-195895149.92352.0610.3249.9552.0910.32
22393981-239398161.00961.05
31980426-198042650.47050.50
41757182-175718244.78144.81
52044933-204493352.11452.15
62120595-212059554.04254.08
15min12821056-282105671.89374.196.4972.0074.316.50
23196978-319697881.47381.62
32885091-288509173.52573.64
42641935-264193567.32867.43
52890682-289068273.66773.79
63032260-303226077.27577.40
20min13383632-338363286.23087.844.9686.4688.084.97
23706902-370690294.46894.75
33346110-334611085.27485.51
43219337-321933782.04382.26
53469135-346913588.40988.66
63555538-355553890.61190.87
30min13742696-374269695.38096.871.2895.7597.261.30
23856424-385642498.27998.72
33760403-376040395.83296.21
43772144-377214496.13196.48
53843982-384398297.96298.36
63832342-383234297.66598.07
45min13834311-383431197.71598.390.5098.2598.940.50
23852448-385244898.17798.78
33857582-385758298.30898.85
43873337-387333798.71099.22
53890792-389079299.15599.71
63856694-385669498.28698.85
60min13829402-382940297.59098.260.5098.2998.980.49
23843240-384324097.94398.71
33854122-385412298.22098.93
43866907-386690798.54699.22
53884336-388433698.99099.71
63857176-385717698.29899.03
极限13821658-382165897.39398.090.4898.2598.970.48
23839168-383916897.83998.77
33846262-384626298.02098.89
43861223-386122398.40199.24
53875468-387546898.76499.65
63850811-385081198.13699.03
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.058355383572836758355983613835940.07
214.128339583417834060.02
单位质量响应值RSD%判断
5949.755906.940.52数据可信
供试品溶液-2024050621批-西格列汀-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113607-1360716.03314.9113.0216.0314.9113.02
210777-1077712.69812.70
315209-1520917.92017.92
411772-1177213.87013.87
511401-1140113.43313.43
613155-1315515.50015.50
10min138458-3845845.31343.8213.8445.3443.8413.84
230791-3079136.28036.30
344614-4461452.56752.60
439944-3994447.06447.09
531982-3198237.68337.71
637342-3734243.99844.02
15min157705-5770567.99167.4710.3568.0967.5610.35
249734-4973458.59958.68
366629-6662978.50678.62
460194-6019470.92471.03
552575-5257561.94762.03
656720-5672066.83166.93
20min171193-7119383.88483.967.7184.1084.177.72
264016-6401675.42775.61
379597-7959793.78694.03
474859-7485988.20388.42
567336-6733679.33979.53
670541-7054183.11583.33
30min181407-8140795.91895.422.0296.2795.772.03
278169-7816992.10392.41
381060-8106095.50995.91
483120-8312097.93798.30
580535-8053594.89195.21
681617-8161796.16696.51
45min184454-8445499.50897.831.49100.0298.341.46
283499-8349998.38398.84
381120-8112095.58096.14
483445-8344598.32098.85
583678-8367898.59499.07
681990-8199096.60597.11
60min184251-8425199.26997.721.4699.9598.391.43
283583-8358398.48299.10
380983-8098395.41996.14
483217-8321798.05198.74
583567-8356798.46399.11
682023-8202396.64497.31
极限184339-8433999.37397.581.55100.2298.421.52
283495-8349598.37899.17
380926-8092695.35296.23
483032-8303297.83398.69
583477-8347798.35799.16
681653-8165396.20897.04
西格列汀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DA-1142209074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20
标示量(mg)850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%
119.013928678392835039334133932004393272339310340.06
218.913935082393665239358670.03
单位质量响应值RSD%判断
206787.69208136.810.46数据可信
供试品溶液-2024050621批-二甲双胍-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1896290-89629022.84921.3611.2822.8521.3611.28
2737017-73701718.78918.79
3980947-98094725.00725.01
4795086-79508620.26920.27
5749437-74943719.10619.11
6868725-86872522.14722.15
10min12101205-210120553.56652.3610.9553.6052.4010.95
21758484-175848444.82944.86
32382103-238210360.72760.77
42167316-216731655.25255.29
51847792-184779247.10647.14
62067235-206723552.70052.74
15min12923136-292313674.52074.448.1974.6574.578.19
22603500-260350066.37266.48
33306026-330602684.28184.42
43027278-302727877.17577.30
52764902-276490270.48670.60
62895919-289591973.82673.95
20min13436135-343613587.59888.395.9587.8588.645.96
23191447-319144781.36081.58
33796308-379630896.78097.06
43587287-358728791.45191.71
53357319-335731985.58985.82
63435854-343585487.59187.84
30min13822175-382217597.44097.431.3197.8497.821.33
23726191-372619194.99395.34
33829519-382951997.62798.07
43873395-387339598.74599.15
53838809-383880997.86498.23
63840556-384055697.90898.30
45min13912569-391256999.74499.031.12100.3099.581.09
23909502-390950299.666100.18
33827160-382716097.56798.17
43877128-387712898.84099.41
53938696-3938696100.410100.94
63842454-384245497.95798.51
60min13898614-389861499.38898.801.07100.1199.521.04
23900626-390062699.439100.12
33819998-381999897.38498.15
43863101-386310198.48399.22
53930194-3930194100.193100.89
63840887-384088797.91798.64
极限13896176-389617699.32698.631.12100.2299.521.09
23894882-389488299.293100.14
33814790-381479097.25198.18
43857332-385733298.33699.24
53924266-3924266100.042100.91
63826561-382656197.55198.43
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.058347383510834298342683430834540.05
214.128330283335833180.03
单位质量响应值RSD%判断
5939.795900.710.47数据可信
供试品溶液-2024050721批-西格列汀-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113518-1351815.94914.0215.3815.9514.0215.38
212809-1280915.11315.11
310330-1033012.18812.19
412541-1254114.79714.80
58936-893610.54310.54
613158-1315815.52515.52
10min137065-3706543.73242.6211.3343.7642.6411.33
237314-3731444.02544.05
331736-3173637.44437.46
439972-3997247.16247.19
530534-3053436.02636.04
640127-4012747.34447.37
15min157256-5725667.55466.967.8767.6567.057.88
259517-5951770.22270.32
350963-5096360.12960.21
461930-6193073.06973.17
551685-5168560.98161.06
659144-5914469.78269.89
20min171046-7104683.82584.154.8584.0484.364.86
274653-7465388.08088.30
366674-6667478.66678.85
474867-7486788.33388.56
567864-6786480.07080.25
672841-7284185.94386.16
30min181777-8177796.48695.831.3196.8496.181.32
282645-8264597.51097.87
380605-8060595.10395.42
481962-8196296.70497.08
579931-7993194.30894.62
680395-8039594.85595.22
45min182088-8208896.85397.590.9997.3798.100.97
283072-8307298.01498.54
384134-8413499.26799.74
482323-8232397.13097.66
582745-8274597.62898.10
681902-8190296.63397.16
60min181965-8196596.70897.551.0497.3898.221.02
282805-8280597.69998.39
384237-8423799.388100.03
482162-8216296.94097.64
582889-8288997.79898.43
682028-8202896.78297.47
极限182104-8210496.87297.420.9397.7198.250.90
282417-8241797.24198.09
384069-8406999.19099.99
482302-8230297.10597.96
582503-8250397.34298.14
681998-8199896.74797.59
西格列汀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DA-1142209074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20
标示量(mg)850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%
119.013928837393117139296073928396392741639290850.04
218.913930706393262939316680.04
单位质量响应值RSD%判断
206685.17207914.750.42数据可信
供试品溶液-2024050721批-二甲双胍-0.025mol(内含%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1900426-90042622.97320.5812.1722.9720.5812.17
2855705-85570521.83221.83
3736436-73643618.78918.79
4842582-84258221.49721.50
5640832-64083216.35016.35
6863678-86367822.03522.04
10min12072698-207269852.88151.678.9852.9251.708.98
22073722-207372252.90752.94
31837699-183769946.88546.92
42213716-221371656.47956.51
51770140-177014045.16245.19
62183237-218323755.70155.74
15min12938768-293876874.97774.476.0775.1074.606.07
23025333-302533377.18677.31
32702703-270270368.95469.06
43144903-314490380.23680.37
52713711-271371169.23569.34
62988963-298896376.25876.39
20min13487907-348790788.98789.283.5289.2489.533.53
23618677-361867792.32492.58
33339709-333970985.20685.43
43637529-363752992.80593.07
53376142-337614286.13686.35
63536691-353669190.23290.49
30min13866056-386605698.63598.430.7599.0398.820.76
23884191-388419199.09899.50
33864459-386445998.59498.96
43888067-388806799.19799.62
53820524-382052497.47497.83
63825300-382530097.59598.00
45min13867840-386784098.68199.471.0199.24100.020.99
23890355-389035599.25599.83
33972091-3972091101.340101.87
43888214-388821499.20099.78
53908792-390879299.726100.25
63865068-386506898.61099.18
60min13859446-385944698.46799.341.0999.20100.071.06
23876469-387646998.90199.64
33972515-3972515101.351102.05
43881758-388175899.03699.78
53907650-390765099.696100.39
63864801-386480198.60399.34
极限13858649-385864998.44699.191.0099.34100.080.97
23870606-387060698.75199.65
33962086-3962086101.085101.95
43884419-388441999.104100.02
53889705-388970599.239100.09
63860777-386077798.50099.40
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