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%
114.813323463337343322593326473330733328120.19
214.823395453395203395320.01
单位质量响应值RSD%判断
22472.1122910.391.37数据可信
供试品溶液-by2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%
5min1218759-21875955.94846.7628.5055.9546.7628.49
2211937-21193754.20354.20
3226405-22640557.90357.90
4121597-12159731.09931.10
5207363-20736353.03353.03
6110875-11087528.35628.36
10min1379448-37944897.04487.4917.2297.1487.5617.22
2375657-37565796.07596.16
3391343-391343100.086100.18
4296289-29628975.77675.83
5366138-36613893.64093.73
6243560-24356062.29162.34
15min1427276-427276109.276103.839.69109.53104.059.72
2423328-423328108.266108.52
3436413-436413111.613111.88
4395031-395031101.029101.21
5422916-422916108.161108.41
6330821-33082184.60884.76
20min1431594-431594110.380108.014.75110.82108.414.78
2424957-424957108.683109.11
3437824-437824111.974112.42
4431685-431685110.404110.75
5425402-425402108.797109.22
6382601-38260197.85098.14
30min1429417-429417109.824109.221.65110.44109.801.68
2424700-424700108.617109.23
3435980-435980111.502112.14
4432070-432070110.502111.03
5424196-424196108.488109.09
6416042-416042106.403106.86
45min1428065-428065109.478109.361.21110.28110.121.23
2424087-424087108.461109.25
3435744-435744111.442112.26
4431398-431398110.330111.05
5422931-422931108.165108.95
6423375-423375108.278108.91
极限1428870-428870109.684109.201.19110.67110.141.20
2422367-422367108.021108.99
3434324-434324111.079112.09
4430576-430576110.120111.02
5421784-421784107.872108.84
6423933-423933108.421109.23
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%
114.813428783425403429993425693432773428530.09
214.823426163430873428520.10
单位质量响应值RSD%判断
23150.1023134.410.05数据可信
供试品溶液-2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%
5min1194304-19430448.72049.924.0348.7249.924.03
2200287-20028750.22150.22
3185206-18520646.43946.44
4205870-20587051.62051.62
5203442-20344251.01251.01
6205395-20539551.50151.50
10min1339154-33915485.04186.992.6685.1287.072.65
2351257-35125788.07588.16
3331964-33196483.23883.32
4351803-35180388.21288.30
5355297-35529789.08889.17
6352015-35201588.26588.35
15min1397133-39713399.578100.822.0899.80101.042.08
2410490-410490102.928103.16
3393044-39304498.55398.77
4394325-39432598.87499.11
5412163-412163103.347103.58
6405250-405250101.614101.85
20min1403075-403075101.068101.342.02101.46101.742.02
2411465-411465103.172103.57
3394571-39457198.93699.32
4394765-39476598.98599.38
5413392-413392103.655104.06
6407644-407644102.214102.62
30min1401531-401531100.681101.101.97101.24101.661.97
2410409-410409102.907103.48
3394419-39441998.89899.44
4393734-39373498.72699.29
5411925-411925103.287103.87
6407101-407101102.078102.65
45min1399132-399132100.080100.782.04100.80101.522.04
2409448-409448102.666103.41
3392239-39223998.35199.06
4393727-39372798.72499.45
5411882-411882103.277104.03
6405179-405179101.596102.34
极限1398691-39869199.969100.502.11100.86101.402.11
2408137-408137102.338103.25
3390567-39056797.93298.81
4391820-39182098.24699.14
5410439-410439102.915103.84
6405192-405192101.599102.51
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%
114.816856036861896851136848976869806857560.13
214.826847576863646855600.17
单位质量响应值RSD%判断
46303.5846259.110.07数据可信
供试品溶液-by1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%
5min1186455-18645523.37834.3626.0523.3834.3626.05
2207042-20704225.95925.96
3240647-24064730.17230.17
4350246-35024643.91443.91
5338739-33873942.47142.47
6321015-32101540.24940.25
10min1427147-42714753.55668.1517.1553.5968.2017.16
2451941-45194156.66456.71
3507197-50719763.59263.64
4633352-63335279.41079.48
5630383-63038379.03879.11
6611138-61113876.62576.69
15min1597055-59705574.85987.6512.4274.9987.8212.44
2618166-61816677.50677.64
3648972-64897281.36881.52
4782549-78254998.11698.32
5779009-77900997.67297.87
6768749-76874996.38696.58
20min1710550-71055089.08995.655.8189.3495.965.85
2724580-72458090.84891.11
3733862-73386292.01292.30
4803368-803368100.726101.10
5800522-800522100.370100.73
6804230-804230100.835101.19
30min1803741-803741100.773100.240.64101.17100.720.66
2795809-79580999.779100.20
3790810-79081099.15299.60
4801946-801946100.548101.09
5801819-801819100.532101.06
6802756-802756100.650101.17
45min1802881-802881100.665100.340.25101.23100.990.27
2797489-79748999.989100.57
3798582-798582100.126100.74
4801180-801180100.452101.16
5800406-800406100.355101.06
6801328-801328100.471101.16
极限1804993-804993100.930100.080.47101.67100.890.44
2795269-79526999.711100.46
3797630-797630100.007100.78
4798255-798255100.085100.96
5794609-79460999.628100.50
6798624-798624100.132100.99
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%
114.816854746867596842146863176855006856530.15
214.826839776833106836440.07
单位质量响应值RSD%判断
46296.6246129.820.26数据可信
供试品溶液-by3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%
5min1266710-26671033.49033.533.6833.4933.533.67
2261924-26192432.88932.89
3270812-27081234.00534.00
4257525-25752532.33632.34
5284556-28455635.73035.73
6260496-26049632.70932.71
10min1570946-57094671.69172.532.3671.7572.582.36
2564747-56474770.91370.97
3590250-59025074.11574.17
4565185-56518570.96871.02
5597634-59763475.04275.10
6576977-57697772.44872.50
15min1747768-74776893.89494.601.3694.0794.771.37
2748538-74853893.99094.16
3765155-76515596.07796.26
4739627-73962792.87293.04
5765282-76528296.09396.28
6753766-75376694.64794.82
20min1813246-813246102.116100.981.27102.45101.311.26
2808372-808372101.504101.83
3805299-805299101.118101.46
4814362-814362102.256102.58
5789537-78953799.13999.48
6794369-79436999.745100.08
30min1813920-813920102.200100.961.46102.70101.461.45
2808699-808699101.545102.04
3809410-809410101.634102.14
4813535-813535102.152102.65
5787806-78780698.92199.43
6790650-79065099.27899.78
45min1812235-812235101.989100.651.41102.66101.321.41
2806774-806774101.303101.97
3805106-805106101.093101.77
4810568-810568101.779102.45
5787462-78746298.87899.55
6787267-78726798.85399.52
极限1810121-810121101.723100.571.45102.57101.411.44
2806230-806230101.235102.07
3808094-808094101.469102.32
4808917-808917101.572102.41
5785822-78582298.67299.51
6786387-78638798.74399.57
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