替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.375119365126725126295107185124605120830.16
211.375122915119225121060.06
单位质量响应值RSD%判断
45038.0845040.110.01数据可信
供试品溶液-24121801-1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%
5min1117082-11708223.39624.878.0023.4024.878.00
2132053-13205326.38826.39
3137244-13724427.42527.42
4120481-12048124.07524.08
5128948-12894825.76725.77
6110912-11091222.16322.16
10min1205774-20577441.11943.506.8641.2543.646.87
2224283-22428344.81844.96
3243038-24303848.56548.72
4212581-21258142.47942.61
5218777-21877743.71743.86
6201611-20161140.28740.41
15min1280388-28038856.02957.286.4356.3957.666.43
2289585-28958557.86758.26
3315430-31543063.03163.45
4273571-27357154.66755.04
5297334-29733459.41559.80
6263472-26347252.64953.00
20min1335769-33576967.09667.186.2867.7767.876.27
2340405-34040568.02268.74
3354771-35477170.89371.66
4325184-32518464.98065.65
5359380-35938071.81472.53
6301506-30150660.24960.89
30min1438585-43858587.64185.965.0488.6887.035.03
2442330-44233088.38989.48
3430002-43000285.92687.09
4409993-40999381.92782.96
5459380-45938091.79692.91
6400784-40078480.08781.06
45min1475906-47590695.09995.311.4996.6396.861.46
2487031-48703197.32298.91
3466493-46649393.21894.86
4481497-48149796.21697.71
5478077-47807795.53297.16
6472831-47283194.48495.90
60min1473333-47333394.58495.981.9296.6498.061.86
2480170-48017095.95198.08
3467094-46709493.33895.50
4481614-48161496.23998.26
5492483-49248398.411100.57
6487310-48731097.37799.32
极限1469771-46977193.87391.904.3496.4694.524.26
2468439-46843993.60696.27
3441128-44112888.14990.83
4466410-46641093.20195.76
5483318-48331896.58099.28
6430411-43041186.00788.49
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.375122545142715133415128225120525129480.18
211.375135775140015137890.06
单位质量响应值RSD%判断
45114.1645188.130.12数据可信
供试品溶液-24121801-2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%
5min1173338-17333834.55230.089.1534.5530.089.14
2146079-14607929.11829.12
3158239-15823931.54231.54
4151688-15168830.23630.24
5133477-13347726.60626.61
6142682-14268228.44128.44
10min1280668-28066855.94650.627.1256.1450.797.12
2248638-24863849.56149.72
3269224-26922453.66553.84
4252200-25220050.27150.44
5241152-24115248.06948.22
6231849-23184946.21546.37
15min1377785-37778575.30466.427.6175.8166.887.61
2327727-32772765.32665.76
3346075-34607568.98369.46
4325384-32538464.85965.31
5310972-31097261.98662.40
6311503-31150362.09262.51
20min1422131-42213184.14476.237.0585.0677.047.05
2385330-38533076.80877.61
3391941-39194178.12678.98
4391228-39122877.98478.79
5349100-34910069.58670.35
6354799-35479970.72271.48
30min1474841-47484194.65091.184.9396.0492.424.92
2469599-46959993.60594.83
3457090-45709091.11292.40
4463154-46315492.32193.56
5466862-46686293.06094.21
6413096-41309682.34383.50
45min1489400-48940097.55296.011.4699.4797.761.52
2476985-47698595.07896.82
3488858-48885897.44499.24
4480869-48086995.85297.61
5482625-48262596.20297.86
6471170-47117093.91995.53
60min1490892-49089297.85095.642.45100.3197.922.50
2484793-48479396.63498.91
3491128-49112897.897100.24
4476711-47671195.02397.31
5474897-47489794.66296.86
6460311-46031191.75493.89
极限1468408-46840893.36894.111.3096.3796.931.18
2479080-47908095.49598.31
3465524-46552492.79395.68
4466116-46611692.91195.73
5476627-47662795.00697.73
6477087-47708795.09897.74
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