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%
114.513341663340373342843339923349053342770.12
214.533349013346663347840.05
单位质量响应值RSD%判断
23037.7023040.880.01数据可信
影响因素30天-供试品溶液-2025011421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%
5min1142445-14244535.87738.578.7735.8838.588.77
2153522-15352238.66738.67
3152131-15213138.31638.32
4141650-14165035.67735.68
5150574-15057437.92437.92
6178594-17859444.98144.98
10min1280117-28011770.55174.367.0170.6174.427.01
2295216-29521674.35474.42
3289581-28958172.93573.00
4277360-27736069.85769.92
5294395-29439574.14774.21
6334706-33470684.30084.38
15min1348432-34843287.75792.293.6787.9392.483.68
2369104-36910492.96493.15
3358292-35829290.24190.43
4362611-36261191.32991.50
5372469-37246993.81194.00
6387716-38771697.65297.87
20min1393789-39378999.18199.791.0699.50100.131.06
2402713-402713101.429101.77
3390822-39082298.43498.77
4398915-398915100.472100.80
5394447-39444799.34799.69
6396587-39658799.886100.26
30min1395457-39545799.60199.941.15100.09100.441.15
2402507-402507101.377101.89
3391799-39179998.68099.18
4402275-402275101.318101.81
5393251-39325199.04699.55
6395432-39543299.595100.14
45min1394485-39448599.35699.831.35100.01100.511.34
2403628-403628101.659102.34
3391137-39113798.51399.18
4402398-402398101.349102.01
5391956-39195698.72099.39
6394637-39463799.395100.11
极限1393758-39375899.17399.751.3599.99100.591.34
2401812-401812101.202102.05
3390024-39002498.23399.06
4403376-403376101.596102.43
5392574-39257498.87599.71
6394752-39475299.424100.30
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%
114.516714646703916698496714316713896709050.12
214.536699616709406704500.11
单位质量响应值RSD%判断
46237.4246142.460.15数据可信
影响因素30天-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%
5min1262591-26259132.98930.645.3132.9930.645.30
2243126-24312630.54430.54
3227401-22740128.56828.57
4246284-24628430.94030.94
5252112-25211231.67231.67
6232003-23200329.14629.15
10min1535578-53557867.28464.414.4567.3464.464.46
2492205-49220561.83561.89
3489656-48965661.51561.56
4520393-52039365.37665.43
5541323-54132368.00668.06
6496913-49691362.42662.47
15min1717121-71712190.09188.392.7590.2688.542.76
2692114-69211486.94987.10
3685193-68519386.08086.23
4697197-69719787.58887.75
5736290-73629092.49992.67
6693369-69336987.10787.26
20min1789203-78920399.14698.811.5299.4699.111.53
2777128-77712897.62997.93
3782184-78218498.26598.56
4782179-78217998.26498.57
5809341-809341101.676102.00
6779021-77902197.86798.16
30min1790705-79070599.33599.940.9999.82100.410.99
2795959-79595999.995100.46
3794110-79411099.763100.22
4788536-78853699.06399.53
5810593-810593101.833102.32
6793167-79316799.644100.11
45min1790924-79092499.36399.801.08100.01100.441.08
2795681-79568199.960100.59
3793744-79374499.717100.34
4785804-78580498.71999.35
5810413-810413101.811102.47
6789894-78989499.23399.86
极限1789932-78993299.23899.621.03100.05100.421.03
2794611-79461199.826100.62
3790681-79068199.332100.12
4784617-78461798.57099.37
5808191-808191101.532102.36
6789771-78977199.218100.01
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%
114.516707376708846701096711916706136707070.06
214.536693956710216702080.18
单位质量响应值RSD%判断
46223.7846125.810.16数据可信
影响因素30天-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%
5min1241599-24159930.36232.756.3230.3632.756.32
2252150-25215031.68831.69
3250752-25075231.51231.51
4281474-28147435.37335.37
5257547-25754732.36632.37
6280081-28008135.19835.20
10min1515919-51591964.83569.354.7064.8969.414.70
2540361-54036167.90767.96
3543173-54317368.26068.31
4593596-59359674.59774.66
5557068-55706870.00770.06
6561044-56104470.50670.56
15min1719510-71951090.42193.652.5190.5893.822.51
2746768-74676893.84694.01
3742615-74261593.32493.49
4775618-77561897.47297.65
5751820-75182094.48194.65
6734780-73478092.34092.52
20min1806333-806333101.332100.800.93101.64101.130.93
2814858-814858102.403102.73
3795223-79522399.935100.26
4795511-79551199.972100.32
5800345-800345100.579100.91
6800335-800335100.578100.91
30min1825593-825593103.752101.241.46104.23101.731.44
2813192-813192102.194102.69
3795292-79529299.944100.43
4796151-796151100.052100.56
5801258-801258100.694101.19
6801935-801935100.779101.28
45min1816694-816694102.634100.790.98103.28101.450.97
2802703-802703100.875101.54
3795384-79538499.956100.61
4795238-79523899.937100.62
5800403-800403100.586101.25
6801736-801736100.754101.42
极限1821553-821553103.244100.741.45104.07101.571.43
2808269-808269101.575102.41
3791017-79101799.407100.23
4792103-79210399.543100.39
5799220-799220100.438101.27
6797525-797525100.225101.06
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%
114.516715056725926720916727606722176722330.08
214.536696396684366690380.13
单位质量响应值RSD%判断
46328.9546045.290.44数据可信
影响因素30天-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%
5min1254233-25423331.94129.9911.4631.9429.9911.46
2271335-27133534.09034.09
3235485-23548529.58629.59
4209585-20958526.33226.33
5203891-20389125.61625.62
6257717-25771732.37932.38
10min1574080-57408072.12671.003.7672.1871.053.77
2587757-58775773.84473.90
3553151-55315169.49669.55
4550239-55023969.13069.17
5537327-53732767.50867.55
6588032-58803273.87973.93
15min1801464-801464100.69498.281.91100.8798.451.92
2792677-79267799.59099.77
3774595-77459597.31897.48
4771279-77127996.90197.06
5762672-76267295.82095.98
6790951-79095199.37399.55
20min1826786-826786103.875102.300.88104.22102.630.88
2809129-809129101.657102.00
3813977-813977102.266102.59
4817494-817494102.708103.03
5807445-807445101.445101.76
6810633-810633101.846102.19
30min1822664-822664103.357102.110.82103.87102.610.82
2806176-806176101.286101.80
3816261-816261102.553103.05
4814925-814925102.385102.88
5805104-805104101.151101.63
6811195-811195101.916102.43
45min1819397-819397102.947101.840.70103.63102.510.70
2804216-804216101.039101.72
3812219-812219102.045102.71
4812998-812998102.143102.81
5804858-804858101.120101.77
6809840-809840101.746102.43
极限1819781-819781102.995101.530.89103.85102.370.89
2798917-798917100.374101.23
3809962-809962101.761102.60
4810861-810861101.874102.71
5804247-804247101.043101.86
6804903-804903101.126101.98
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