氨氯地平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070220417对照品来源原料药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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.703743437541374183749037432374630.14
215.703747637453374640.05
单位质量响应值RSD%判断
2386.182386.240.01数据可信
供试品溶液-24102401批-氨氯地平-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%
5min129474-2947480.00282.522.4080.0082.522.40
231148-3114884.54584.55
331102-3110284.42184.42
429878-2987881.09881.10
530891-3089183.84883.85
629928-2992881.23481.23
10min133460-3346090.82192.222.2690.9592.362.26
234453-3445393.51693.66
334351-3435193.23993.38
432674-3267488.68788.82
534723-3472394.24994.39
634190-3419092.80292.94
15min133961-3396192.18193.911.8892.4794.211.88
234172-3417292.75393.05
335040-3504095.11095.41
434017-3401792.33392.62
535560-3556096.52196.82
634847-3484794.58694.88
20min135061-3506195.16794.721.2995.6095.161.29
234873-3487394.65695.11
334758-3475894.34494.80
434158-3415892.71593.15
535527-3552796.43196.89
634995-3499594.98795.44
30min135199-3519995.54195.841.4596.1496.451.45
235163-3516395.44396.05
335834-3583497.26597.88
434652-3465294.05694.65
535994-3599497.69998.32
635011-3501195.03195.64
45min135179-3517995.48795.240.5496.2496.010.54
235333-3533395.90596.67
335186-3518695.50696.28
435025-3502595.06995.82
535027-3502795.07495.86
634786-3478694.42095.18
60min135089-3508995.24395.920.7996.1696.850.79
235485-3548596.31797.25
335413-3541396.12297.06
435065-3506595.17796.08
535786-3578697.13498.07
635197-3519795.53696.46
极限136484-3648499.02997.881.75100.1098.961.74
236052-3605297.85698.94
336635-3663599.439100.53
434975-3497594.93396.00
536489-3648999.043100.14
635723-3572396.96398.04
氨氯地平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OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.332323812323052320602321482323302322450.06
211.382353362354762354060.05
单位质量响应值RSD%判断
20498.2320685.940.65数据可信
供试品溶液-24102401批-奥美沙坦酯-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%
5min1108806-10880647.50847.152.5547.5147.152.55
2109431-10943147.78147.78
3110510-11051048.25248.25
4103049-10304944.99544.99
5106585-10658546.53946.54
6109487-10948747.80647.81
10min1151261-15126166.04666.082.3666.1266.162.36
2153845-15384567.17467.25
3150809-15080965.84865.93
4144835-14483563.24063.31
5152316-15231666.50666.58
6155034-15503467.69367.77
15min1170748-17074874.55473.901.9974.7474.081.99
2172332-17233275.24675.44
3169320-16932073.93174.12
4162767-16276771.06971.25
5169438-16943873.98274.17
6170829-17082974.59074.78
20min1178280-17828077.84376.982.3078.1677.292.29
2179354-17935478.31278.63
3176939-17693977.25777.57
4168236-16823673.45773.76
5177217-17721777.37977.69
6177761-17776177.61677.93
30min1183849-18384980.27579.720.9380.7280.160.93
2184521-18452180.56881.02
3182738-18273879.78980.23
4179688-17968878.45878.88
5182003-18200379.46979.91
6182724-18272479.78380.23
45min1184983-18498380.77080.430.7481.3581.000.74
2186054-18605481.23781.82
3183828-18382880.26580.84
4182977-18297779.89480.45
5184869-18486980.72081.29
6182477-18247779.67580.25
60min1184092-18409280.38180.210.8681.0980.920.86
2186028-18602881.22681.94
3182863-18286379.84480.55
4184089-18408980.37981.06
5183891-18389180.29381.00
6181256-18125679.14279.85
极限1192457-19245784.03382.921.7884.8883.771.78
2193030-19303084.28385.14
3191679-19167983.69384.54
4184003-18400380.34281.16
5190054-19005482.98483.83
6188284-18828482.21183.05
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