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%
111.868146358155448139198141158122898141000.15
211.658109388104508106940.05
单位质量响应值RSD%判断
68642.5069587.470.97数据可信
供试品溶液-F73103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%
5min1237165-23716530.88530.072.8430.8830.072.84
2234783-23478330.57430.57
3234033-23403330.47730.48
4226123-22612329.44729.45
5219875-21987528.63328.63
6233346-23334630.38730.39
10min1431793-43179356.23055.524.2956.4055.694.29
2426737-42673755.57155.74
3454049-45404959.12859.30
4409042-40904253.26753.43
5403367-40336752.52852.69
6433129-43312956.40456.57
15min1567904-56790473.95573.192.7474.4473.662.75
2567002-56700273.83774.32
3579724-57972475.49475.99
4542491-54249170.64571.10
5543604-54360470.79071.24
6571346-57134674.40374.89
20min1674818-67481887.87785.282.7788.7786.162.77
2646393-64639384.17685.06
3668030-66803086.99387.91
4636043-63604382.82883.68
5634211-63421182.58983.43
6669650-66965087.20488.10
30min1745573-74557397.09196.480.7898.4797.830.75
2739308-73930896.27697.63
3740203-74020396.39297.79
4744243-74424396.91898.23
5745322-74532297.05998.36
6730541-73054195.13496.51
45min1714522-71452293.04894.510.9394.9796.400.89
2729252-72925294.96696.86
3720664-72066493.84895.78
4728389-72838994.85496.70
5730600-73060095.14296.98
6731240-73124095.22597.13
60min1742260-74226096.66095.011.8599.1097.431.78
2727559-72755994.74697.16
3714806-71480693.08595.54
4746500-74650097.21299.59
5732141-73214195.34297.71
6714468-71446893.04195.48
极限1703678-70367891.63693.461.4994.6196.411.41
2714564-71456493.05396.00
3712473-71247392.78195.76
4727260-72726094.70797.62
5732969-73296995.45098.35
6715252-71525293.14396.10
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%
111.868073308098408098118093318092498091120.13
211.658103818123118113460.17
单位质量响应值RSD%判断
68221.9269643.431.46数据可信
供试品溶液-F73103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%
5min1218464-21846428.52628.913.2028.5328.913.20
2232128-23212830.31030.31
3222618-22261829.06929.07
4211624-21162427.63327.63
5225563-22556329.45329.45
6217916-21791628.45528.45
10min1407759-40775953.24454.242.5653.4054.402.56
2422237-42223755.13455.30
3407891-40789153.26153.42
4402424-40242452.54752.70
5424705-42470555.45655.62
6427491-42749155.82055.98
15min1526343-52634368.72871.223.0869.1871.683.07
2545083-54508371.17571.65
3544932-54493271.15571.61
4527650-52765068.89869.34
5561939-56193973.37673.85
6566678-56667873.99574.46
20min1624101-62410181.49383.502.1282.3384.362.12
2645311-64531184.26285.13
3637404-63740483.23084.08
4626150-62615081.76082.59
5660497-66049786.24587.12
6643604-64360484.03984.92
30min1679623-67962388.74294.513.8290.0395.833.78
2700075-70007591.41392.75
3737035-73703596.23997.55
4732719-73271995.67696.96
5745822-74582297.38698.74
6747296-74729697.57998.93
45min1710660-71066092.79594.951.5794.5896.801.58
2724414-72441494.59196.44
3739478-73947896.55898.41
4718050-71805093.76095.57
5733639-73363995.79697.70
6736712-73671296.19798.09
60min1719328-71932893.92795.651.1596.2298.021.17
2728762-72876295.15997.53
3739621-73962196.57798.96
4729657-72965795.27697.61
5742220-74222096.91699.35
6735637-73563796.05798.48
极限1676397-67639788.32192.653.0091.1495.552.94
2723895-72389594.52397.42
3712014-71201492.97295.89
4708233-70823392.47895.34
5698442-69844291.20094.17
6738221-73822196.39499.35
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