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%
114.59 3363833370193368113365203358173365100.14
214.513371583377033374300.12
单位质量响应值RSD%判断
23064.4323255.000.59数据可信
供试品溶液-H322批-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%
5min180248-8024820.10724.5733.1420.1124.5833.14
297716-9771624.48424.48
3119635-11963529.97629.98
452720-5272013.20913.21
591153-9115322.83922.84
6147000-14700036.83236.83
10min1229862-22986257.59458.859.4357.6358.899.45
2233488-23348858.50258.54
3244328-24432861.21861.27
4201115-20111550.39150.41
5231246-23124657.94157.98
6269278-26927867.47067.53
15min1343086-34308685.96385.652.8786.0985.792.89
2339163-33916384.98085.12
3340632-34063285.34885.50
4328490-32849082.30682.41
5340804-34080485.39185.53
6358848-35884889.91290.09
20min1394151-39415198.75899.200.9299.0399.480.94
2393376-39337698.56498.84
3395593-39559399.11999.41
4393366-39336698.56198.80
5396042-39604299.23299.51
6402903-402903100.951101.27
30min1405166-405166101.518101.460.48101.96101.910.46
2402962-402962100.966101.41
3403435-403435101.084101.54
4408372-408372102.321102.73
5405270-405270101.544101.99
6404406-404406101.327101.82
45min1404906-404906101.453101.430.54102.06102.050.51
2403276-403276101.044101.66
3403785-403785101.172101.80
4408615-408615102.382102.96
5405757-405757101.666102.28
6402658-402658100.889101.55
极限1405668-405668101.644101.300.43102.42102.090.40
2403225-403225101.031101.81
3402641-402641100.885101.68
4406987-406987101.974102.72
5404240-404240101.286102.07
6403046-403046100.987101.82
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%
114.59 3371013377603370823371033388203375730.23
214.513372363369983371170.05
单位质量响应值RSD%判断
23137.2923233.430.30数据可信
供试品溶液-H322批-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%
5min1133877-13387733.50631.806.9633.5131.806.96
2132298-13229833.11133.11
3119451-11945129.89629.90
4136644-13664434.19934.20
5125900-12590031.51031.51
6114183-11418328.57828.58
10min1265696-26569666.49864.433.9366.5564.493.92
2246302-24630261.64461.70
3248390-24839062.16762.22
4271882-27188268.04668.10
5259674-25967464.99165.04
6252772-25277263.26363.31
15min1359758-35975890.04088.001.9590.2188.161.95
2343217-34321785.90086.06
3344611-34461186.24986.40
4358313-35831389.67889.85
5352925-35292588.32988.49
6350794-35079487.79687.95
20min1402737-402737100.79699.790.88101.11100.100.89
2393971-39397198.60298.90
3397086-39708699.38299.68
4402592-402592100.760101.08
5399336-39933699.945100.25
6396580-39658099.25599.55
30min1404278-404278101.182101.250.99101.67101.720.98
2401100-401100100.387100.85
3411881-411881103.085103.55
4405714-405714101.541102.03
5402543-402543100.748101.22
6401753-401753100.550101.01
45min1405507-405507101.490100.940.59102.14101.580.58
2400284-400284100.182100.82
3406188-406188101.660102.29
4403717-403717101.042101.70
5402976-402976100.856101.50
6401107-401107100.388101.02
极限1404253-404253101.176100.750.42102.00101.560.43
2400701-400701100.287101.09
3404170-404170101.155101.96
4403778-403778101.057101.88
5401608-401608100.514101.32
6400899-400899100.336101.14
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%
114.59 6756636770846779646782576768186771570.16
214.516766326769726768020.04
单位质量响应值RSD%判断
46412.4146643.830.36数据可信
供试品溶液-H042批-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%
5min1236179-23617929.45525.0920.7929.4625.0920.80
2147944-14794418.45118.45
3213977-21397726.68626.69
4231165-23116528.83028.83
5229761-22976128.65528.65
6148179-14817918.48018.48
10min1450998-45099856.24753.014.3356.3053.054.34
2406623-40662350.71250.74
3410975-41097551.25551.30
4442316-44231655.16455.21
5427260-42726053.28653.33
6411872-41187251.36751.40
15min1609479-60947976.01274.621.9376.1574.741.94
2594030-59403074.08574.20
3584959-58495972.95473.08
4614017-61401776.57876.72
5598821-59882174.68374.82
6588418-58841873.38573.50
20min1723314-72331490.20989.440.9390.4889.690.94
2720526-72052689.86190.10
3709079-70907988.43388.68
4721249-72124989.95190.22
5720406-72040689.84690.11
6708232-70823288.32888.57
30min1797756-79775699.493100.420.6399.91100.820.62
2813648-813648101.475101.86
3805030-805030100.400100.80
4805523-805523100.462100.88
5805032-805032100.400100.81
6804122-804122100.287100.67
45min1797439-79743999.453100.320.63100.04100.890.62
2812707-812707101.358101.92
3805934-805934100.513101.08
4805021-805021100.399100.98
5802024-802024100.025100.60
6803335-803335100.189100.74
极限1795157-79515799.169100.000.5799.92100.740.56
2808714-808714100.860101.59
3804390-804390100.320101.05
4802231-802231100.051100.80
5799919-79991999.763100.51
6800453-80045399.829100.55
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%
114.59 6778706778056789186779096775826780170.08
214.516765496785056775270.21
单位质量响应值RSD%判断
46471.3546693.800.34数据可信
供试品溶液-H042批-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%
5min1216911-21691127.02125.0613.8227.0225.0613.82
2174858-17485821.78221.78
3214669-21466926.74126.74
4214911-21491126.77126.77
5227596-22759628.35228.35
6158132-15813219.69919.70
10min1402922-40292250.19253.986.0750.2454.026.06
2440153-44015354.83054.87
3412871-41287151.43151.48
4468726-46872658.38958.43
5457289-45728956.96557.01
6418103-41810352.08352.12
15min1575352-57535271.67275.844.5771.8075.984.58
2612537-61253776.30476.43
3594643-59464374.07574.21
4647326-64732680.63780.78
5634381-63438179.02579.17
6588838-58883873.35273.47
20min1705518-70551887.88691.283.3288.1391.543.32
2734366-73436691.48091.73
3715623-71562389.14589.40
4768620-76862095.74796.02
5753493-75349393.86394.14
6719051-71905189.57289.81
30min1815876-815876101.634101.130.62102.03101.540.62
2808837-808837100.757101.16
3817281-817281101.809102.21
4815287-815287101.560102.00
5808863-808863100.760101.19
6804861-804861100.262100.65
45min1812884-812884101.261101.050.79101.83101.630.79
2808275-808275100.687101.26
3820545-820545102.215102.79
4815163-815163101.545102.15
5807549-807549100.596101.19
6802645-80264599.986100.54
极限1811984-811984101.149100.820.53101.88101.570.53
2804257-804257100.186100.93
3815578-815578101.597102.34
4811192-811192101.050101.82
5806723-806723100.494101.26
6806521-806521100.468101.19
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