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0100320240115对照品来源原料药对照品使用方法直接使用
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%
111.017464147453507454627449407446887453710.09
211.047416497436387426440.19
单位质量响应值RSD%判断
67699.4667268.480.46数据可信
供试品溶液-24101501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%
5min1168599-16859922.48525.207.3622.4925.207.36
2194760-19476025.97425.97
3211072-21107228.15028.15
4184116-18411624.55524.55
5186472-18647224.86924.87
6188884-18888425.19125.19
10min1282419-28241937.66541.447.9737.7941.587.97
2329468-32946843.94044.08
3348508-34850846.47946.64
4289310-28931038.58438.72
5306212-30621240.83840.98
6308574-30857441.15341.29
15min1370432-37043249.40354.649.2049.7455.019.18
2456953-45695360.94261.33
3451938-45193860.27360.69
4373503-37350349.81350.16
5394825-39482552.65653.02
6410710-41071054.77555.14
20min1456180-45618060.83965.769.6961.4566.439.67
2549290-54929073.25773.98
3544865-54486572.66773.42
4433502-43350257.81558.44
5470111-47011162.69763.35
6504304-50430467.25767.93
30min1589733-58973378.65185.406.3179.6086.446.33
2692015-69201592.29293.43
3668508-66850889.15690.31
4621211-62121182.84983.80
5606021-60602180.82381.83
6664487-66448788.62089.67
45min1723724-72372496.52098.812.0397.90100.332.07
2750497-750497100.091101.74
3758145-758145101.111102.76
4734681-73468197.98299.39
5753295-753295100.464101.92
6725206-72520696.71898.26
60min1730430-73043097.41599.091.6299.33101.161.65
2749824-749824100.001102.20
3756027-756027100.829103.04
4741059-74105998.832100.79
5753114-753114100.440102.45
6727631-72763197.04299.12
极限1697916-69791693.07997.282.5395.5499.892.55
2737992-73799298.423101.18
3744605-74460599.305102.08
4730415-73041597.41399.92
5746479-74647999.555102.13
6719003-71900395.89198.51
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0100320240115对照品来源原料药对照品使用方法直接使用
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%
111.017413147398827405177361467411157397950.29
211.047400237394277397250.06
单位质量响应值RSD%判断
67193.0167004.080.20数据可信
供试品溶液-24102201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%
5min1176092-17609223.61925.777.1223.6225.777.11
2175537-17553723.54523.55
3193173-19317325.91125.91
4197541-19754126.49626.50
5208883-20888328.01828.02
6201621-20162127.04427.04
10min1330865-33086544.37946.856.3344.5147.006.33
2321906-32190643.17843.31
3362224-36222448.58648.73
4353417-35341747.40447.55
5383096-38309651.38551.54
6344393-34439346.19446.34
15min1501242-50124267.23266.506.3867.6166.906.37
2468000-46800062.77363.14
3507870-50787068.12168.54
4483819-48381964.89565.31
5549653-54965373.72674.17
6464133-46413362.25562.66
20min1630306-63030684.54481.965.3885.3082.745.38
2564379-56437975.70176.42
3605463-60546381.21282.00
4607646-60764681.50482.28
5662033-66203388.79989.65
6596515-59651580.01180.76
30min1695337-69533793.26695.682.0894.4996.912.10
2699614-69961493.84094.98
3711816-71181695.47796.72
4713776-71377695.74096.96
5734358-73435898.50099.84
6725200-72520097.27298.47
45min1707932-70793294.95696.941.5296.6998.701.53
2711636-71163695.45397.11
3724844-72484497.22499.00
4725262-72526297.28099.04
5730429-73042997.97399.86
6736337-73633798.766100.50
60min1704938-70493894.55495.690.8596.8297.990.84
2711557-71155795.44297.63
3712720-71272095.59897.91
4722357-72235796.89199.19
5710992-71099295.36697.80
6718073-71807396.31698.60
极限1681033-68103391.34894.591.7194.1497.421.68
2708746-70874695.06597.79
3708329-70832995.00997.85
4712088-71208895.51398.35
5707888-70788894.95097.92
6713020-71302095.63898.46
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