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)5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%
5min1239995-239995127.488142.9719.76127.49142.9719.76
2335767-335767178.363178.36
3188385-188385100.072100.07
4289586-289586153.831153.83
5309283-309283164.294164.29
6251822-251822133.770133.77
10min1353727-353727187.903194.012.59188.12194.242.60
2367522-367522195.231195.53
3355367-355367188.774188.94
4370639-370639196.887197.14
5378640-378640201.137201.41
6365415-365415194.112194.33
15min1374257-374257198.809198.190.99199.33198.751.01
2372093-372093197.659198.28
3368106-368106195.541196.02
4375077-375077199.244199.83
5378546-378546201.087201.70
6370492-370492196.809197.36
20min1377422-377422200.490198.840.81201.35199.730.83
2373088-373088198.188199.14
3369980-369980196.537197.34
4375942-375942199.704200.62
5377260-377260200.404201.35
6372161-372161197.695198.57
30min1377276-377276200.413199.310.81201.60200.530.83
2375351-375351199.390200.67
3370252-370252196.681197.82
4377421-377421200.490201.74
5377881-377881200.734202.01
6372970-372970198.125199.33
极限1377675-377675200.625200.091.06202.15201.641.07
2382123-382123202.987204.60
3370280-370280196.696198.16
4378596-378596201.114202.70
5376368-376368199.930201.54
6374917-374917199.159200.69
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)5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%
5min1324556-324556172.881123.0929.70172.88123.0929.70
2233481-233481124.368124.37
3117147-11714762.40162.40
4245130-245130130.574130.57
5204697-204697109.036109.04
6261466-261466139.275139.28
10min1375509-375509200.023181.1013.67200.31181.3113.69
2374105-374105199.275199.48
3250118-250118133.231133.33
4355653-355653189.446189.66
5337739-337739179.904180.09
6346825-346825184.744184.98
15min1375747-375747200.149190.396.62200.77190.906.65
2376008-376008200.288200.83
3312011-312011166.199166.53
4364527-364527194.173194.71
5356838-356838190.077190.56
6359411-359411191.448191.99
20min1375328-375328199.926194.184.32200.88195.004.36
2377872-377872201.281202.15
3334066-334066177.947178.55
4365780-365780194.840195.70
5367336-367336195.669196.47
6366843-366843195.407196.27
30min1374594-374594199.535197.452.22200.82198.602.26
2376892-376892200.759201.97
3357584-357584190.475191.37
4366418-366418195.180196.36
5380152-380152202.496203.62
6368437-368437196.256197.44
极限1374677-374677199.579200.361.62201.20201.841.60
2376836-376836200.729202.27
3376298-376298200.443201.66
4370194-370194197.191198.70
5387354-387354206.332207.79
6371483-371483197.878199.39
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)5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%
19.863170493173913176063166973174643172410.12
29.923178893180083179480.03
单位质量响应值RSD%判断
32174.5432051.210.28数据可信
长期6月-供试品溶液-2023091921批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1128660-12866068.36767.8415.6168.3767.8415.61
2123182-12318265.45665.46
3116541-11654161.92761.93
4165719-16571988.05988.06
5123621-12362165.68965.69
6108270-10827057.53257.53
10min1183249-18324997.37496.481.5197.4996.601.53
2180340-18034095.82995.94
3178108-17810894.64394.75
4186042-18604298.85999.01
5180736-18073696.03996.15
6180920-18092096.13796.23
15min1185729-18572998.69298.670.5998.9798.940.59
2184238-18423897.90098.17
3187331-18733199.54399.80
4186272-18627298.98199.29
5184858-18485898.22998.50
6185688-18568898.67098.93
20min1185944-18594498.80698.880.6699.2599.320.66
2184917-18491798.26198.69
3188442-188442100.134100.56
4185698-18569898.67699.15
5185452-18545298.54598.98
6186008-18600898.84099.26
30min1185491-18549198.56698.950.7599.1799.550.74
2184934-18493498.27098.87
3188742-188742100.293100.89
4185431-18543198.53499.17
5185915-18591598.79199.39
6186771-18677199.24699.83
极限1185802-18580298.73198.890.9199.5099.650.89
2185092-18509298.35499.11
3189166-189166100.519101.28
4184736-18473698.16598.97
5184963-18496398.28599.05
6186803-18680399.263100.01
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)5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%
19.863170713169623171773167453169283169770.06
29.923171103175323173210.10
单位质量响应值RSD%判断
32147.7731988.000.36数据可信
长期6月-供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1133580-13358071.08168.0615.4571.0868.0515.45
2129598-12959868.96268.96
3129928-12992869.13869.14
4145554-14555477.45377.45
5139166-13916674.05474.05
689535-8953547.64447.64
10min1189825-189825101.01199.263.34101.1399.383.35
2190880-190880101.572101.69
3193332-193332102.877102.99
4184604-18460498.23298.36
5184605-18460598.23398.36
6176021-17602193.66593.74
15min1191394-191394101.845101.651.71102.13101.921.71
2192183-192183102.265102.55
3195457-195457104.007104.29
4187280-18728099.65699.95
5192657-192657102.517102.80
6187146-18714699.58599.82
20min1190785-190785101.521101.961.34101.98102.411.34
2191227-191227101.757102.21
3195254-195254103.899104.36
4187531-18753199.790100.25
5193049-193049102.726103.18
6191804-191804102.064102.47
30min1189913-189913101.057101.971.49101.68102.591.48
2190336-190336101.282101.91
3195334-195334103.942104.58
4187673-18767399.865100.49
5193987-193987103.225103.85
6192557-192557102.464103.04
极限1189253-189253100.706101.591.49101.50102.381.49
2189631-189631100.907101.70
3194815-194815103.666104.47
4187293-18729399.663100.45
5193660-193660103.051103.85
6190812-190812101.536102.28
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