氨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500
标示量(mg)20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%
114.586709686697066709826710646708256707090.09
214.636699016705766702380.08
单位质量响应值RSD%判断
46001.9945812.580.30数据可信
长期25℃3月--供试品溶液-2025011021批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1254320-25432032.14730.214.0732.1530.214.07
2240709-24070930.42630.43
3226815-22681528.67028.67
4234866-23486629.68829.69
5244499-24449930.90530.91
6232843-23284329.43229.43
10min1535913-53591367.74164.823.4367.7964.873.42
2526654-52665466.57066.62
3507145-50714564.10464.15
4500675-50067563.28663.34
5518205-51820565.50265.55
6488197-48819761.70961.76
15min1715874-71587490.48888.062.3290.6588.222.31
2711943-71194389.99190.15
3700744-70074488.57688.73
4682633-68263386.28686.44
5693785-69378587.69687.86
6674946-67494685.31585.47
20min1797433-797433100.79797.542.21101.1197.852.21
2773816-77381697.81298.12
3784111-78411199.11399.42
4751715-75171595.01995.32
5764624-76462496.65096.96
6758478-75847895.87396.17
30min1804377-804377101.67599.322.12102.1699.792.12
2785809-78580999.32899.80
3801427-801427101.302101.77
4781227-78122798.74999.21
5783580-78358099.04699.51
6758081-75808195.82396.28
45min1804342-804342101.67198.951.68102.3399.581.69
2782568-78256898.91899.56
3785424-78542499.27999.92
4778382-77838298.38999.01
5782510-78251098.91199.54
6763540-76354096.51397.13
极限1798984-798984100.99398.611.70101.8299.411.71
2781789-78178998.82099.63
3785093-78509399.238100.04
4773480-77348097.77098.56
5782394-78239498.89699.69
6759056-75905695.94696.72
氨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500
标示量(mg)20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%
114.586711246716996720756712456708506713990.08
214.636705706706596706140.01
单位质量响应值RSD%判断
46049.3145838.280.33数据可信
长期25℃3月--供试品溶液-2025011121批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1252736-25273631.92130.529.0331.9230.529.03
2234928-23492829.67229.67
3218302-21830227.57227.57
4219263-21926327.69327.69
5249956-24995631.57031.57
6274760-27476034.70334.70
10min1519813-51981365.65365.404.2865.7165.464.29
2517559-51755965.36965.42
3503263-50326363.56363.61
4484049-48404961.13661.18
5539601-53960168.15368.21
6542770-54277068.55368.61
15min1701124-70112488.55388.873.8588.7289.033.85
2714844-71484490.28690.44
3706136-70613689.18689.34
4651699-65169982.31182.46
5723529-72352991.38391.55
6724530-72453091.51091.68
20min1793519-793519100.22399.842.22100.53100.152.22
2799725-799725101.007101.32
3795991-795991100.535100.84
4756051-75605195.49195.78
5792535-792535100.099100.42
6805257-805257101.706102.03
30min1798672-798672100.874101.131.20101.35101.601.21
2800614-800614101.119101.60
3812415-812415102.610103.08
4789571-78957199.724100.17
5791509-79150999.969100.45
6811238-811238102.461102.96
45min1798325-798325100.830100.731.08101.48101.381.09
2797623-797623100.741101.39
3805494-805494101.735102.37
4789881-78988199.764100.37
5785908-78590899.26299.91
6808152-808152102.071102.74
极限1797047-797047100.669100.711.11101.48101.521.12
2795839-795839100.516101.33
3808790-808790102.152102.96
4788000-78800099.526100.30
5788149-78814999.545100.36
6806607-806607101.876102.71
氨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500
标示量(mg)20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%
114.586716636716916728036723616725626722160.08
214.636729106729606729350.01
单位质量响应值RSD%判断
46105.3545996.920.17数据可信
长期25℃3月--供试品溶液-2025011221批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1238637-23863730.07030.302.2630.0730.302.25
2239305-23930530.15430.15
3248502-24850231.31331.31
4245310-24531030.91130.91
5237167-23716729.88529.88
6233919-23391929.47529.48
10min1497666-49766662.70965.232.6262.7665.282.61
2513828-51382864.74664.80
3534185-53418567.31167.36
4531797-53179767.01067.06
5513098-51309864.65464.70
6515289-51528964.93064.98
15min1680016-68001685.68788.392.2085.8488.552.20
2702697-70269788.54588.70
3721296-72129690.88891.05
4706119-70611988.97689.14
5687143-68714386.58586.74
6711570-71157089.66389.82
20min1752543-75254394.82698.362.2395.1298.662.22
2798755-798755100.649100.95
3797043-797043100.433100.75
4782922-78292298.65498.97
5770231-77023197.05597.36
6781967-78196798.53398.84
30min1771775-77177597.24999.221.8297.7099.691.81
2806550-806550101.631102.10
3801315-801315100.971101.45
4789651-78965199.50299.98
5774922-77492297.64698.11
6780254-78025498.31898.79
45min1767728-76772896.73999.051.7997.3699.681.78
2804719-804719101.400102.04
3797909-797909100.542101.19
4789758-78975899.515100.16
5775312-77531297.69598.32
6780886-78088698.39799.03
极限1766114-76611496.53699.472.4997.31100.282.48
2802789-802789101.157101.97
3792805-79280599.899100.72
4785665-78566598.99999.81
5770922-77092297.14297.93
6818290-818290103.110103.91
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