氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.346517966521216522736523676502666517650.14
214.286526876532976529920.07
单位质量响应值RSD%判断
45450.8445727.730.43数据可信
长期6月-供试品溶液-2025011021批-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%
5min1218745-21874527.84327.812.6127.8427.812.61
2226181-22618128.78928.79
3212813-21281327.08827.09
4213811-21381127.21527.21
5224503-22450328.57628.58
6214991-21499127.36527.37
10min1472966-47296660.20159.241.7060.2559.281.70
2466321-46632159.35659.40
3463511-46351158.99859.04
4459466-45946658.48358.53
5475429-47542960.51560.56
6454802-45480257.88957.93
15min1651538-65153882.93181.861.2583.0882.001.25
2643712-64371281.93582.08
3644365-64436582.01882.16
4637634-63763481.16181.30
5650824-65082482.84082.99
6630577-63057780.26380.40
20min1744419-74441994.75393.590.9895.0493.880.98
2729758-72975892.88793.17
3741177-74117794.34094.62
4734917-73491793.54493.82
5736710-73671093.77294.06
6724931-72493192.27392.55
30min1768556-76855697.82597.251.4198.2797.691.40
2771615-77161598.21598.65
3765761-76576197.47097.91
4776212-77621298.80099.23
5748766-74876695.30695.75
6753350-75335095.89096.32
45min1767792-76779297.72897.121.4798.3397.721.46
2770197-77019798.03498.64
3765109-76510997.38797.99
4775791-77579198.74699.34
5746339-74633994.99795.60
6752801-75280195.82096.41
极限1766353-76635397.54597.021.4498.3197.781.43
2769385-76938597.93198.70
3763683-76368397.20597.97
4775538-77553898.71499.48
5746806-74680695.05795.82
6751614-75161495.66996.42
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.346526546531056527576515316520446524180.10
214.286637656631986634820.07
单位质量响应值RSD%判断
45496.3746462.321.49数据可信
长期6月-供试品溶液-2025011121批-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%
5min1251580-25158031.75429.445.6531.7529.445.65
2225069-22506928.40828.41
3243592-24359230.74630.75
4227512-22751228.71628.72
5236182-23618229.81029.81
6215490-21549027.19927.20
10min1494491-49449162.41360.503.6762.4760.553.67
2467136-46713658.96159.01
3502726-50272663.45363.50
4483711-48371161.05361.10
5472182-47218259.59859.65
6455889-45588957.54157.59
15min1663761-66376183.77883.252.1583.9483.402.15
2646549-64654981.60681.75
3680837-68083785.93486.09
4665847-66584784.04284.19
5658531-65853183.11883.27
6641757-64175781.00181.14
20min1745471-74547194.09294.832.1994.3995.122.19
2728955-72895592.00792.29
3775351-77535197.86398.16
4761847-76184796.15896.45
5755418-75541895.34795.63
6740701-74070193.48993.77
30min1767750-76775096.90497.751.7297.3698.191.72
2750755-75075594.75895.19
3787659-78765999.41699.88
4779777-77977798.42298.87
5779879-77987998.43498.88
6780800-78080098.55198.98
45min1769423-76942397.11597.741.6897.7398.351.68
2750200-75020094.68895.28
3785759-78575999.17799.81
4779585-77958598.39799.01
5780314-78031498.48999.10
6780905-78090598.56499.16
极限1768001-76800196.93597.521.6297.7198.291.62
2749585-74958594.61195.36
3784530-78453099.02199.82
4777221-77722198.09998.88
5777452-77745298.12898.90
6778961-77896198.31999.08
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.346522546528406515406505016512536516780.14
214.286514706518546516620.05
单位质量响应值RSD%判断
45444.7745634.590.30数据可信
长期6月-供试品溶液-2025011221批-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%
5min1228360-22836029.09829.503.2129.1029.503.21
2238200-23820030.35230.35
3236414-23641430.12530.12
4219993-21999328.03228.03
5238420-23842030.38030.38
6227525-22752528.99228.99
10min1474881-47488160.51162.232.4460.5662.282.44
2496691-49669163.29063.34
3483527-48352761.61261.66
4478625-47862560.98861.03
5489926-48992662.42862.48
6506754-50675464.57264.62
15min1663674-66367484.56786.041.4184.7286.191.41
2682585-68258586.97787.13
3671253-67125385.53385.69
4667308-66730885.03085.18
5677961-67796186.38886.54
6688515-68851587.73287.89
20min1765039-76503997.48397.850.9297.7798.140.92
2771325-77132598.28498.59
3765110-76511097.49297.79
4759570-75957096.78697.08
5766317-76631797.64697.94
6780006-78000699.39099.69
30min1776441-77644198.93699.610.7199.39100.070.71
2784052-78405299.906100.37
3785021-785021100.029100.49
4773915-77391598.61499.07
5782339-78233999.688100.15
6788608-788608100.487100.95
45min1776827-77682798.98599.420.7099.60100.040.70
2783843-78384399.879100.51
3781965-78196599.640100.26
4771398-77139898.29498.91
5780722-78072299.482100.11
6786580-786580100.228100.86
极限1776205-77620598.90699.220.6899.69100.010.68
2783243-78324399.803100.60
3779326-77932699.304100.09
4769726-76972698.08198.86
5779565-77956599.334100.13
6784104-78410499.913100.71
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.346519826520266519976512286518806518230.06
214.286510036509096509560.02
单位质量响应值RSD%判断
45454.8845585.150.21数据可信
长期6月-供试品溶液-H043批-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%
5min1207192-20719226.41231.069.7826.4131.069.78
2252087-25208732.13532.14
3269346-26934634.33634.34
4259441-25944133.07333.07
5222120-22212028.31528.32
6251519-25151932.06332.06
10min1555054-55505470.75773.752.8170.8073.802.81
2588909-58890975.07375.13
3595358-59535875.89575.95
4592954-59295475.58875.64
5569117-56911772.55072.60
6569705-56970572.62572.68
15min1777186-77718699.07499.441.9299.2499.611.92
2787770-787770100.423100.60
3788824-788824100.557100.74
4796700-796700101.561101.74
5775581-77558198.86999.04
6754122-75412296.13496.31
20min1794811-794811101.320101.990.89101.65102.330.89
2797799-797799101.701102.05
3800156-800156102.002102.35
4811574-811574103.457103.81
5804144-804144102.510102.84
6791814-791814100.938101.27
30min1795604-795604101.422101.930.72101.92102.440.72
2796828-796828101.578102.09
3799681-799681101.941102.46
4809396-809396103.180103.70
5802519-802519102.303102.81
6793750-793750101.185101.69
45min1792219-792219100.990101.720.91101.66102.400.91
2793223-793223101.118101.80
3796780-796780101.571102.26
4811264-811264103.418104.11
5800644-800644102.064102.74
6793628-793628101.170101.84
极限1789673-789673100.665101.480.66101.50102.330.66
2793099-793099101.102101.96
3795680-795680101.431102.29
4804465-804465102.551103.42
5799326-799326101.896102.74
6793931-793931101.208102.05
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