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%
111.137534347547607544687545427552357544880.09
211.167515147502717508920.12
单位质量响应值RSD%判断
67788.6867284.230.53数据可信
供试品溶液-F73103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%
5min1175620-17562023.40423.663.4823.4023.663.49
2171182-17118222.81222.81
3174559-17455923.26223.26
4173444-17344423.11423.11
5185577-18557724.73124.73
6185035-18503524.65824.66
10min1325128-32512843.32844.057.4043.4644.187.38
2307019-30701940.91441.04
3307409-30740940.96641.10
4338637-33863745.12845.26
5372984-37298449.70549.84
6332045-33204544.24944.39
15min1477265-47726563.60263.026.3663.9763.406.35
2430784-43078457.40857.76
3452647-45264760.32160.68
4508357-50835767.74568.12
5504127-50412767.18267.60
6464147-46414761.85462.24
20min1589217-58921778.52175.725.7579.2576.455.74
2519775-51977569.26769.94
3541438-54143872.15472.85
4577073-57707376.90377.66
5609823-60982381.26782.05
6571827-57182776.20476.93
30min1753861-753861100.46298.172.38101.6299.322.39
2708581-70858194.42895.49
3733935-73393597.80798.90
4726940-72694096.87498.06
5742294-74229498.920100.16
6754513-754513100.549101.70
45min1715053-71505395.29097.602.0897.0199.292.04
2725035-72503596.62198.20
3754733-754733100.578102.21
4720760-72076096.05197.77
5733190-73319097.70799.50
6745437-74543799.339101.05
60min1705761-70576194.05297.812.4296.30100.042.38
2724485-72448596.54798.67
3755334-755334100.658102.85
4731810-73181097.52399.78
5748575-74857599.758102.09
6737694-73769498.307100.57
极限1722045-72204596.22298.162.4498.99100.932.32
2755766-755766100.716103.37
3762273-762273101.583104.34
4729887-72988797.267100.06
5719949-71994995.94398.83
6729413-72941397.204100.01
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%
111.137525647526657530697525597534597528630.06
211.167518397511307514840.07
单位质量响应值RSD%判断
67642.6867337.280.32数据可信
供试品溶液-E21595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%
5min1181837-18183724.24927.017.6324.2527.017.62
2192414-19241425.65925.66
3200645-20064526.75726.76
4202297-20229726.97726.98
5211295-21129528.17728.18
6226636-22663630.22330.22
10min1382750-38275051.04152.585.6951.1852.735.69
2375913-37591350.12950.27
3390813-39081352.11652.27
4382378-38237850.99251.14
5396124-39612452.82552.98
6437646-43764658.36258.53
15min1499120-49912066.56071.025.3166.9871.465.32
2521274-52127469.51469.93
3530462-53046270.73971.18
4520885-52088569.46269.90
5540446-54044672.07172.52
6583049-58304977.75278.24
20min1630451-63045184.07388.203.3284.8689.043.34
2667644-66764489.03389.84
3651773-65177386.91687.75
4651729-65172986.91187.73
5672357-67235789.66190.51
6694597-69459792.62793.55
30min1723551-72355196.48899.472.9797.74100.802.92
2755948-755948100.809102.11
3759273-759273101.252102.57
4738505-73850598.48299.78
5777201-777201103.643104.99
6720923-72092396.13897.58
45min1761717-761717101.578100.173.08103.37102.053.01
2732907-73290797.73699.60
3777030-777030103.620105.50
4733851-73385197.86299.71
5775774-775774103.452105.38
6725790-72579096.78798.76
60min1733425-73342597.80597.522.18100.1699.962.16
2720689-72068996.10798.51
3730595-73059597.42899.88
4712808-71280895.05697.45
5759610-759610101.297103.80
6730606-73060697.42999.94
极限1721394-72139496.20196.612.9299.1099.582.87
2727129-72712996.96599.90
3728520-72852097.151100.14
4702660-70266093.70296.62
5761416-761416101.538104.60
6705443-70544394.07497.13
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