替米沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.663921903920273918263912093921073918720.11
211.563919893915623917760.08
单位质量响应值RSD%判断
33608.2333890.660.60数据可信
加速6月-供试品溶液-2024050921批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134861-13486135.96442.439.5635.9642.439.56
2168446-16844644.92044.92
3146182-14618238.98338.98
4172134-17213445.90445.90
5162359-16235943.29743.30
6170606-17060645.49645.50
10min1241166-24116664.31374.338.1664.5174.578.15
2300773-30077380.20980.46
3299390-29939079.84080.06
4267865-26786571.43371.69
5289519-28951977.20877.45
6273730-27373072.99773.25
15min1312606-31260683.36489.716.0783.9290.366.06
2355601-35560194.83095.53
3355681-35568194.85195.51
4319384-31938485.17285.82
5353099-35309994.16394.83
6322080-32208085.89186.55
20min1350088-35008893.36093.731.7594.3894.871.76
2353355-35335594.23195.45
3359672-35967295.91697.10
4345918-34591892.24893.37
5356153-35615394.97796.17
6343602-34360291.63092.77
30min1340591-34059190.82793.851.9592.3795.521.96
2346628-34662892.43794.18
3354654-35465494.57896.30
4355928-35592894.91796.55
5358507-35850795.60597.33
6355290-35529094.74796.39
45min1355032-35503294.67893.950.9796.7296.140.91
2346837-34683792.49394.75
3349998-34999893.33695.58
4352431-35243193.98596.15
5356016-35601694.94197.19
6353463-35346394.26096.43
60min1353280-35328094.21195.141.5296.7897.851.48
2348475-34847592.93095.70
3355723-35572394.86397.63
4363084-36308496.82699.51
5361349-36134996.36399.14
6358661-35866195.64698.34
极限1353798-35379894.34992.481.5097.4495.721.38
2338618-33861890.30193.59
3345367-34536792.10195.39
4349113-34911393.10096.32
5344497-34449791.86995.18
6349354-34935493.16496.39
替米沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.663896353895973898703896103894833896390.04
211.563889353882663886000.13
单位质量响应值RSD%判断
33416.7233615.920.43数据可信
中间条件6月-供试品溶液-2024050921批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1143451-14345138.52140.304.0638.5240.304.06
2157938-15793842.41142.41
3144618-14461838.83438.83
4156230-15623041.95241.95
5146880-14688039.44139.44
6151306-15130640.63040.63
10min1260317-26031769.90271.242.4170.1271.462.41
2271594-27159472.93173.17
3260924-26092470.06570.28
4268553-26855372.11472.35
5257795-25779569.22569.44
6272557-27255773.18973.41
15min1321592-32159286.35787.321.8686.9687.941.85
2324719-32471987.19687.84
3320184-32018485.97886.58
4320189-32018985.98086.61
5329032-32903288.35488.96
6335376-33537690.05890.69
20min1352568-35256894.67495.421.8795.7696.521.87
2355040-35504095.33896.46
3348289-34828993.52594.61
4351916-35191694.49995.61
5356677-35667795.77896.87
6367573-36757398.70499.84
30min1341971-34197191.82995.613.2193.4497.253.18
2349515-34951593.85595.51
3349796-34979693.93095.53
4368115-36811598.849100.49
5355874-35587495.56297.19
6371073-37107399.644101.32
45min1356484-35648495.72695.622.1897.8497.792.16
2356237-35623795.66097.84
3343888-34388892.34494.47
4367427-36742798.665100.85
5352944-35294494.77596.93
6359644-35964496.57598.81
60min1358386-35838696.23796.953.0698.8999.653.02
2353011-35301194.79397.50
3351444-35144494.37397.01
4361948-36194897.19399.93
5359435-35943596.51899.20
6382048-382048102.591105.36
极限1348103-34810393.47595.162.2996.6698.402.27
2346536-34653693.05596.29
3346718-34671893.10496.26
4363077-36307797.496100.77
5359028-35902896.40999.63
6362806-36280697.424100.76
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