盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402107782103812101912110212104682105680.16
215.432108982108092108540.03
单位质量响应值RSD%判断
13673.2513665.200.05数据可信
供试品溶液-2024042521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185384-8538441.77141.484.9741.7741.484.97
292369-9236945.18845.19
384392-8439241.28541.29
484621-8462141.39741.40
580029-8002939.15139.15
681978-8197840.10440.10
10min1198064-19806496.89595.673.2597.1395.903.24
2196583-19658396.17096.42
3187312-18731291.63591.86
4188230-18823092.08492.31
5201868-20186898.75698.97
6201267-20126798.46298.68
15min1203969-20396999.783101.142.25100.55101.902.22
2200977-20097798.32099.10
3212955-212955104.179104.92
4211696-211696103.563104.31
5204867-204867100.223100.99
6205960-205960100.757101.53
20min1202750-20275099.187100.122.39100.51101.442.35
2199498-19949897.59698.93
3209957-209957102.713104.03
4211288-211288103.364104.68
5200616-20061698.14399.47
6203815-20381599.708101.04
30min1205150-205150100.361100.692.28102.24102.572.25
2198249-19824996.98598.86
3212275-212275103.847105.73
4208915-208915102.203104.09
5205466-205466100.516102.38
6204865-204865100.222102.11
45min1202399-20239999.015100.331.52101.45102.761.51
2202167-20216798.902101.31
3208431-208431101.966104.43
4209475-209475102.477104.94
5204057-20405799.826102.25
6203948-20394899.773102.21
极限1197498-19749896.61898.981.8299.60101.981.79
2198985-19898597.345100.31
3206840-206840101.188104.22
4205887-205887100.722103.75
5202498-20249899.064102.04
6202255-20225598.945101.94
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402114742109572110272111512109072111030.11
215.432109232108982109100.01
单位质量响应值RSD%判断
13707.9913668.830.21数据可信
供试品溶液-2024042521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178652-7865238.42336.1321.5438.4236.1321.54
278954-7895438.57138.57
363955-6395531.24431.24
446733-4673322.83022.83
588526-8852643.24743.25
686885-8688542.44542.45
10min1183313-18331389.55385.8411.1689.7786.0411.18
2171975-17197584.01484.23
3154568-15456875.51075.68
4153014-15301474.75174.88
5202376-20237698.86599.11
6189014-18901492.33892.57
15min1199793-19979397.60497.852.5698.3198.522.61
2196936-19693696.20896.89
3195816-19581695.66196.25
4197754-19775496.60897.15
5209822-209822102.503103.29
6201653-20165398.51299.26
20min1196436-19643695.96497.832.8497.2299.062.86
2196081-19608195.79097.01
3197110-19711096.29397.42
4200953-20095398.17099.25
5211136-211136103.145104.50
6199880-19988097.64698.94
30min1198768-19876897.10397.692.6098.8999.462.63
2196614-19661496.05197.80
3194911-19491195.21996.88
4201198-20119898.29099.91
5209645-209645102.417104.35
6198708-19870897.07498.91
45min1198936-19893697.18597.341.9999.5199.652.03
2196463-19646395.97798.26
3197127-19712796.30198.49
4198399-19839996.92399.09
5207117-207117101.182103.68
6197508-19750896.48798.87
极限1193763-19376394.65896.072.6897.5298.922.70
2192230-19223093.90996.72
3191733-19173393.66696.39
4199299-19929997.362100.07
5205544-205544100.413103.48
6197365-19736596.41899.33
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402108512109642103952101712101042104970.19
215.432115972121282118620.18
单位质量响应值RSD%判断
13668.6413730.520.32数据可信
供试品溶液-2024042621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182531-8253140.28642.996.8240.2942.996.82
279409-7940938.76238.76
395338-9533846.53746.54
490845-9084544.34444.34
588593-8859343.24543.24
691763-9176344.79244.79
10min1179281-17928187.51290.883.1087.7491.123.11
2179320-17932087.53187.75
3190706-19070693.08993.35
4188969-18896992.24192.49
5186022-18602290.80291.04
6192735-19273594.07994.33
15min1201745-20174598.47796.941.7299.1997.691.68
2202886-20288699.03499.74
3194274-19427494.83095.61
4196122-19612295.73296.49
5196789-19678996.05896.80
6199812-19981297.53498.31
20min1200996-20099698.11295.482.4299.3796.762.37
2200766-20076697.99999.25
3190350-19035092.91594.22
4190631-19063193.05294.34
5194078-19407894.73596.01
6196831-19683196.07897.39
30min1199326-19932697.29694.392.4299.1096.202.37
2198165-19816596.73098.53
3187992-18799291.76493.58
4188809-18880992.16393.97
5192443-19244393.93795.74
6193441-19344194.42496.27
45min1193751-19375194.57594.032.5996.9296.362.55
2193986-19398694.69097.02
3185779-18577990.68493.01
4188173-18817391.85294.17
5194281-19428194.83497.16
6199824-19982497.53999.91
极限1193837-19383794.61792.702.7997.4995.562.71
2197444-19744496.37899.24
3185402-18540290.50093.33
4186299-18629990.93893.77
5192055-19205593.74796.60
6184450-18445090.03592.95
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402109372107112106442114272113902110220.18
215.432122332122662122500.02
单位质量响应值RSD%判断
13702.7313755.670.28数据可信
供试品溶液-2024042621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198468-9846847.96145.924.2847.9645.924.27
299034-9903448.23748.24
395617-9561746.57246.57
489202-8920243.44843.45
591681-9168144.65544.66
691704-9170444.66744.67
10min1189987-18998792.53892.461.3592.8092.711.35
2191178-19117893.11893.39
3192854-19285493.93494.19
4185687-18568790.44390.68
5191078-19107893.06993.32
6188174-18817491.65491.90
15min1192686-19268693.85294.791.8894.6395.561.86
2191971-19197193.50494.29
3194670-19467094.81995.60
4197912-19791296.39897.14
5199913-19991397.37298.14
6190501-19050192.78893.55
20min1190558-19055892.81694.481.6394.1295.771.60
2193255-19325594.12995.43
3191652-19165293.34994.66
4198881-19888196.87098.15
5196609-19660995.76397.07
6192864-19286493.93995.21
30min1190253-19025392.66794.431.6694.4896.241.63
2194948-19494894.95496.78
3190542-19054292.80894.63
4198503-19850396.68598.50
5195861-19586195.39997.24
6193081-19308194.04595.84
45min1188934-18893492.02593.302.8694.3695.642.79
2188955-18895592.03594.39
3188473-18847391.80094.14
4202328-20232898.549100.90
5188355-18835591.74394.11
6192275-19227593.65295.97
极限1189803-18980392.44892.832.2095.2995.702.15
2186598-18659890.88793.75
3188423-18842391.77694.63
4196993-19699395.95098.85
5194407-19440794.69097.57
6187318-18731891.23894.08
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