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%
1 14.228239482319819638212482330822260.22
2 14.218224482127821860.11
单位质量响应值RSD%判断
5782.425783.670.02数据可信
加速6月-供试品溶液-2024050721批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113605-1360516.43315.6613.5516.4315.6613.56
216009-1600919.33619.34
311450-1145013.83013.83
411784-1178414.23314.23
513336-1333616.10816.11
611586-1158613.99413.99
10min139271-3927147.43345.964.3547.4645.984.36
240546-4054648.97349.01
336350-3635043.90543.93
438265-3826546.21846.24
536427-3642743.99844.02
637439-3743945.22045.24
15min160093-6009372.58369.632.6172.6969.732.61
258551-5855170.72070.83
357367-5736769.29069.39
456773-5677368.57368.67
555766-5576667.35767.46
657344-5734469.26369.36
20min172223-7222387.23483.422.8787.4683.642.87
269466-6946683.90484.14
368133-6813382.29482.51
466805-6680580.69080.91
567583-6758381.63081.84
670202-7020284.79385.01
30min178119-7811994.35694.031.6394.7394.391.63
278276-7827694.54594.92
376394-7639492.27292.62
476755-7675592.70893.06
577615-7761593.74794.10
679951-7995196.56896.92
45min179848-7984896.44496.670.5596.9797.190.54
279502-7950296.02696.56
379704-7970496.27096.77
480138-8013896.79497.30
580635-8063597.39597.90
680406-8040697.11897.63
60min180056-8005696.69596.950.5897.3997.630.58
280549-8054997.29197.98
380017-8001796.64897.31
480620-8062097.37698.04
580804-8080497.59998.27
679573-7957396.11296.79
极限179894-7989496.49996.550.7097.3597.390.69
279295-7929595.77696.63
379981-7998196.60597.43
480473-8047397.19998.03
580640-8064097.40198.23
679349-7934995.84196.68
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%
1 19.004279511427999342793914282246428395642810190.05
2 19.024281392427168342765380.17
单位质量响应值RSD%判断
225316.79224844.270.15数据可信
加速6月-供试品溶液-2024050721批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11065445-106544525.03523.4911.5725.0423.5011.57
21190622-119062227.97727.98
3907203-90720321.31721.32
4924831-92483121.73121.73
51018631-101863123.93523.94
6892426-89242620.97020.97
10min12482675-248267558.33756.534.2058.3856.564.20
22560413-256041360.16360.21
32312454-231245454.33754.37
42408806-240880656.60156.64
52301008-230100854.06854.11
62368164-236816455.64655.68
15min13455623-345562381.19878.562.1981.3478.692.19
23403751-340375179.98080.13
33322429-332242978.06978.19
43303813-330381377.63177.76
53255584-325558476.49876.63
63317714-331771477.95878.09
20min13981410-398141093.55390.322.3093.8390.582.30
23900073-390007391.64291.92
33789502-378950289.04489.30
43745809-374580988.01788.28
53781022-378102288.84589.10
63863756-386375690.78991.05
30min14211736-421173698.96598.611.2399.4099.021.24
24257141-4257141100.032100.47
34134398-413439897.14897.55
44142467-414246797.33897.74
54186450-418645098.37198.78
64246685-424668599.786100.20
45min14266726-4266726100.257100.450.46100.85101.020.46
24285088-4285088100.689101.29
34276540-4276540100.488101.05
44257322-4257322100.036100.61
54307278-4307278101.210101.78
64255452-425545299.992100.57
60min14269708-4269708100.327100.400.96101.09101.150.96
24328493-4328493101.709102.48
34258871-4258871100.073100.81
44269749-4269749100.328101.06
54302056-4302056101.088101.83
64208506-420850698.88999.63
极限14257020-4257020100.029100.090.62100.96101.000.61
24274712-4274712100.445101.38
34267211-4267211100.269101.17
44255700-425570099.998100.90
54289528-4289528100.793101.70
64212878-421287898.99299.90
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%
1 14.228380384041838798402484185839860.18
2 14.218501584715848650.25
单位质量响应值RSD%判断
5906.195972.200.79数据可信
加速6月-供试品溶液-2024050621批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117185-1718520.21215.4418.6720.2115.4418.67
213296-1329615.63815.64
39738-973811.45311.45
412087-1208714.21614.22
513898-1389816.34616.35
612545-1254514.75414.75
10min141469-4146948.77343.6110.5948.8143.6410.60
238680-3868045.49245.52
329726-2972634.96134.98
437191-3719143.74143.76
537262-3726243.82543.85
638143-3814344.86144.89
15min158270-5827068.53366.186.6168.6566.286.62
258548-5854868.86068.96
348827-4882757.42757.50
457308-5730867.40167.50
556563-5656366.52566.63
658088-5808868.31968.42
20min167583-6758379.48680.035.1879.7280.245.18
271015-7101583.52283.74
361711-6171172.58072.75
468441-6844180.49580.70
567939-6793979.90580.12
671591-7159184.20084.41
30min175905-7590589.27491.312.1389.6491.662.13
280067-8006794.16994.52
375812-7581289.16489.46
478594-7859492.43692.78
577272-7727290.88191.23
678193-7819391.96592.32
45min179810-7981093.86695.410.8394.3895.910.82
281571-8157195.93896.45
381642-8164296.02196.46
481207-8120795.51096.01
581358-8135895.68796.18
681159-8115995.45395.96
60min180100-8010094.20895.430.7294.8796.080.71
281653-8165396.03496.71
381719-8171996.11296.71
481161-8116195.45596.11
581116-8111695.40396.06
681062-8106295.33996.00
极限180339-8033994.48995.720.9395.3196.530.91
282037-8203796.48697.32
382455-8245596.97797.74
481259-8125995.57196.39
581113-8111395.39996.21
681121-8112195.40896.23
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%
1 19.003928240393533039148693921786393202639264500.21
2 19.023928375392059439244840.15
单位质量响应值RSD%判断
206655.26206334.600.11数据可信
加速6月-供试品溶液-2024050621批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11114146-111414628.53622.8015.2528.5422.8015.26
2906743-90674323.22423.22
3702971-70297118.00518.00
4823148-82314821.08321.08
5929685-92968523.81123.81
6865569-86556922.16922.17
10min12314493-231449359.28053.688.7459.3353.728.74
22161685-216168555.36655.40
31760610-176061045.09345.12
42075619-207561953.16253.20
52125957-212595754.45154.49
62136032-213603254.70954.75
15min13033833-303383377.70474.895.2777.8575.015.27
22990612-299061276.59776.73
32615206-261520666.98267.09
42967165-296716575.99676.12
52947940-294794075.50475.63
62987967-298796776.52976.66
20min13421074-342107487.62287.223.6987.9087.473.70
23495014-349501489.51689.77
33165878-316587881.08681.30
43413510-341351087.42887.68
53416241-341624187.49887.75
63519821-351982190.15190.41
30min13710176-371017695.02696.331.2695.4596.731.27
23827949-382794998.04398.45
33701787-370178794.81295.16
43777468-377746896.75097.15
53774822-377482296.68297.08
63773949-377394996.66097.07
45min13843054-384305498.43099.090.3899.0199.650.36
23875378-387537899.25899.83
33883488-388348899.46599.98
43870414-387041499.13199.69
53877167-387716799.30399.87
63862903-386290398.93899.51
60min13863435-386343598.95299.400.4199.70100.120.39
23889028-388902899.607100.34
33905035-3905035100.017100.69
43881391-388139199.412100.13
53881912-388191299.425100.15
63864011-386401198.96799.70
极限13848564-384856498.57199.080.8099.4899.970.77
23876744-387674499.293100.20
33925047-3925047100.530101.37
43848841-384884198.57899.47
53867731-386773199.06299.96
63843248-384324898.43599.33
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