奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132316652318012315692313742308272314470.17
211.112313752315452314600.06
单位质量响应值RSD%判断
20794.8820833.480.14数据可信
供试品溶液-SD901YA批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134196-13419657.91044.8625.0557.9144.8625.05
281652-8165235.23635.24
3129116-12911655.71855.72
496206-9620641.51641.52
5113241-11324148.86748.87
669335-6933529.92029.92
10min1200104-20010486.35179.008.7886.4579.088.79
2180200-18020077.76277.82
3204292-20429288.15988.25
4166602-16660271.89471.96
5180419-18041977.85777.94
6166860-16686072.00672.06
15min1219600-21960094.76591.184.7095.0191.394.71
2214887-21488792.73192.92
3222975-22297596.22196.46
4196577-19657784.82985.02
5209808-20980890.53990.75
6203932-20393288.00388.17
20min1225797-22579797.43995.932.7997.8496.292.80
2225711-22571197.40297.74
3227754-22775498.28398.68
4210777-21077790.95791.29
5223395-22339596.40296.76
6220365-22036595.09595.41
30min1230504-23050499.47099.291.68100.0399.801.68
2232353-232353100.268100.77
3230579-23057999.502100.07
4222476-22247696.00696.49
5231507-23150799.903100.43
6233038-233038100.564101.04
45min1231902-231902100.073100.341.41100.80101.021.40
2234070-234070101.009101.68
3231677-23167799.976100.71
4226783-22678397.86498.51
5234632-234632101.251101.94
6236039-236039101.859102.50
60min1232204-232204100.204100.361.39101.10101.221.38
2233468-233468100.749101.59
3231277-23127799.804100.70
4227168-22716898.03198.84
5234968-234968101.396102.25
6236359-236359101.997102.81
极限1231561-23156199.926100.281.41100.99101.301.40
2233179-233179100.624101.63
3230361-23036199.408100.47
4227508-22750898.17799.15
5235597-235597101.668102.69
6236143-236143101.904102.89
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.132318222319112319122319472318012318790.03
211.112310102309652309880.02
单位质量响应值RSD%判断
20833.6920791.000.15数据可信
供试品溶液-SD901YA批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146114-4611419.90141.9237.8519.9041.9237.86
2117548-11754850.73050.73
3115297-11529749.75949.76
454752-5475223.62923.63
5131949-13194956.94556.95
6117110-11711050.54150.54
10min1150941-15094165.14280.6417.0365.1780.7117.04
2209878-20987890.57790.66
3208714-20871490.07590.16
4141181-14118160.93060.97
5205644-20564488.75088.84
6204764-20476488.37088.45
15min1202342-20234287.32592.508.0887.4792.708.11
2226636-22663697.81098.05
3226500-22650097.75197.98
4184301-18430179.53979.68
5222512-22251296.03096.27
6223636-22363696.51596.75
20min1219281-21928194.63596.973.5594.9297.333.60
2230627-23062799.53299.93
3230247-23024799.36899.76
4210930-21093091.03191.30
5227167-22716798.03998.44
6229888-22988899.21399.61
30min1232885-232885100.506100.081.26100.95100.601.30
2233621-233621100.824101.39
3233493-233493100.769101.33
4226179-22617997.61298.04
5231458-23145899.891100.46
6233700-233700100.858101.42
45min1237115-237115102.332101.150.75102.94101.840.74
2234685-234685101.283102.02
3234118-234118101.039101.77
4232506-232506100.343100.93
5232603-232603100.385101.12
6235277-235277101.539102.26
60min1237705-237705102.587101.230.79103.37102.080.77
2234979-234979101.410102.31
3233910-233910100.949101.85
4233129-233129100.612101.37
5232509-232509100.344101.24
6235100-235100101.462102.36
极限1237097-237097102.324100.950.87103.28101.970.84
2234607-234607101.250102.32
3233111-233111100.604101.67
4232686-232686100.421101.34
5231279-23127999.813100.88
6234662-234662101.273102.34
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