替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1119.25721295722875741985727625729075728570.15
2118.35785075781165783120.05
单位质量响应值RSD%判断
4805.854888.521.21数据可信
供试品溶液-25082501批-pH6.8(内含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%
5min1473779-47377986.56885.821.0386.5785.821.03
2470945-47094586.05086.05
3464376-46437684.85084.85
10min1470605-47060585.98885.750.3686.1385.900.35
2467466-46746685.41485.56
3469892-46989285.85786.00
15min1498424-49842491.07190.480.6591.3690.760.65
2495047-49504790.45490.74
3492063-49206389.90890.19
20min1499534-49953491.27491.010.3191.7191.440.31
2496487-49648790.71791.15
3498212-49821291.03291.47
30min1506906-50690692.62092.070.6493.2192.660.64
2504298-50429892.14492.73
3500536-50053691.45792.04
45min1505790-50579092.41792.260.3393.1693.000.33
2503008-50300891.90892.65
3505931-50593192.44293.18
60min1510729-51072993.31992.760.6194.2293.660.60
2507700-50770092.76693.66
3504621-50462192.20393.10
极限1507627-50762792.75293.010.4593.8194.060.45
2507804-50780492.78593.83
3511661-51166193.48994.54
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1119.25734535746785750245753535720195741050.24
2118.35764485755845760160.11
单位质量响应值RSD%判断
4816.324869.110.78数据可信
供试品溶液-49G03N批-pH6.8(内含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%
5min1395689-39568972.36372.210.1972.3672.200.19
2394439-39443972.13472.13
3394388-39438872.12572.12
10min1453126-45312682.86782.140.8182.9982.260.82
2445995-44599581.56381.68
3448369-44836981.99782.12
15min1479926-47992687.76886.930.9288.0387.180.92
2471321-47132186.19486.45
3474722-47472286.81687.07
20min1496326-49632690.76790.050.7391.1790.450.73
2489289-48928989.48089.88
3491634-49163489.90990.31
30min1512806-51280693.78192.990.7594.3493.540.75
2505977-50597792.53293.08
3506628-50662892.65193.20
45min1523458-52345895.72995.030.6996.4495.740.69
2516383-51638394.43595.14
3519103-51910394.93395.64
60min1530446-53044697.00795.861.0497.8896.731.04
2520603-52060395.20796.07
3521496-52149695.37096.23
极限1532613-53261397.40396.530.7998.4497.560.80
2524900-52490095.99397.01
3526017-52601796.19797.22
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