精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.863180093171363175523177663176413176210.11
29.923179813175603177700.10
单位质量响应值RSD%判断
32213.0832033.270.40数据可信
长期6月-供试品溶液-2023092221批-pH2.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1239995-23999563.74471.4819.7663.7471.4919.76
2335767-33576789.18189.18
3188385-18838550.03650.04
4289586-28958676.91576.92
5309283-30928382.14782.15
6251822-25182266.88566.89
10min1353727-35372793.95297.002.5994.0697.122.60
2367522-36752297.61697.76
3355367-35536794.38794.47
4370639-37063998.44398.57
5378640-378640100.569100.71
6365415-36541597.05697.17
15min1374257-37425799.40499.100.9999.6799.381.01
2372093-37209398.83099.14
3368106-36810697.77198.01
4375077-37507799.62299.91
5378546-378546100.544100.85
6370492-37049298.40498.68
20min1377422-377422100.24599.420.81100.6799.860.82
2373088-37308899.09499.57
3369980-36998098.26898.67
4375942-37594299.852100.31
5377260-377260100.202100.67
6372161-37216198.84899.28
30min1377276-377276100.20699.650.81100.80100.260.83
2375351-37535199.695100.34
3370252-37025298.34198.91
4377421-377421100.245100.87
5377881-377881100.367101.01
6372970-37297099.06399.66
极限1377675-377675100.312100.041.06101.07100.821.07
2382123-382123101.494102.30
3370280-37028098.34899.08
4378596-378596100.557101.35
5376368-37636899.965100.77
6374917-37491799.580100.35
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.863173373175233178533175473177933176110.07
29.923160783160153160460.02
单位质量响应值RSD%判断
32212.0731859.480.78数据可信
长期6月-供试品溶液-2023092321批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324556-32455686.44161.5429.7086.4461.5429.70
2233481-23348162.18462.18
3117147-11714731.20031.20
4245130-24513065.28765.29
5204697-20469754.51854.52
6261466-26146669.63869.64
10min1375509-375509100.01190.5513.67100.1690.6613.69
2374105-37410599.63799.74
3250118-25011866.61566.67
4355653-35565394.72394.83
5337739-33773989.95290.04
6346825-34682592.37292.49
15min1375747-375747100.07595.196.62100.3995.456.66
2376008-376008100.144100.41
3312011-31201183.10083.26
4364527-36452797.08697.35
5356838-35683895.03995.28
6359411-35941195.72495.99
20min1375328-37532899.96397.094.32100.4497.504.36
2377872-377872100.641101.08
3334066-33406688.97489.28
4365780-36578097.42097.85
5367336-36733697.83598.23
6366843-36684397.70398.13
30min1374594-37459499.76898.732.22100.4199.302.26
2376892-376892100.380100.98
3357584-35758495.23795.69
4366418-36641897.59098.18
5380152-380152101.248101.81
6368437-36843798.12898.72
极限1374677-37467799.790100.181.62100.60100.921.60
2376836-376836100.365101.14
3376298-376298100.221100.83
4370194-37019498.59699.35
5387354-387354103.166103.90
6371483-37148398.93999.69
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