玛巴洛沙韦片项目信息
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
1 11.21101034510136261006932100733210095590.31
2 11.171010574100627410084240.31
单位质量响应值RSD%判断
90058.7990279.680.18数据可信
供试品溶液-24102901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%
5min1166035-16603516.67215.707.5616.6715.707.55
2167555-16755516.82416.82
3154319-15431915.49515.50
4154032-15403215.46715.47
5161093-16109316.17616.18
6135215-13521513.57713.58
10min1290497-29049729.16929.192.9629.2029.222.97
2300840-30084030.20830.24
3288563-28856328.97529.00
4292214-29221429.34229.37
5296506-29650629.77329.80
6275676-27567627.68127.70
15min1357717-35771735.91936.261.7836.0036.341.78
2367569-36756936.90836.99
3358577-35857736.00536.08
4364191-36419136.56936.64
5367321-36732136.88336.96
6351244-35124435.26935.34
20min1397413-39741339.90540.201.1740.0440.331.18
2403131-40313140.47940.62
3398083-39808339.97240.11
4404720-40472040.63840.77
5405049-40504940.67240.81
6393541-39354139.51639.64
30min1440334-44033444.21544.360.6844.4244.560.68
2443022-44302244.48444.69
3442431-44243144.42544.63
4445013-44501344.68444.89
5443255-44325544.50844.71
6436526-43652643.83244.03
45min1467051-46705146.89747.431.5447.1747.711.53
2469068-46906847.10047.38
3472411-47241147.43547.71
4470802-47080247.27447.55
5468307-46830747.02347.30
6486698-48669848.87049.14
极限1488161-48816149.01740.8349.0049.3741.1848.58
2484943-48494348.69449.05
3491892-49189249.39249.75
4488067-48806749.00749.36
5486719-48671948.87249.23
6-0.0000.35
玛巴洛沙韦片项目信息
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
1 11.211006383100664810085351006137100612410067650.11
2 11.171008583100932210089520.06
单位质量响应值RSD%判断
89809.5590326.950.41数据可信
供试品溶液-24102901批-pH6.8(内含%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269701-26970127.11224.8921.9127.1124.8921.91
2183659-18365918.46218.46
3299320-29932030.08930.09
4241241-24124124.25124.25
5306564-30656430.81730.82
6184924-18492418.58918.59
10min1497896-49789650.05147.509.3250.1047.549.33
2427751-42775142.99943.03
3510404-51040451.30851.36
4464043-46404346.64846.69
5519749-51974952.24852.30
6415074-41507441.72541.76
15min1624875-62487562.81560.136.4262.9460.256.43
2564732-56473256.76956.87
3629656-62965663.29663.43
4590582-59058259.36859.49
5635979-63597963.93264.07
6543027-54302754.58854.69
20min1702442-70244270.61367.684.9470.8567.904.96
2647146-64714665.05465.25
3698974-69897470.26470.51
4665994-66599466.94967.17
5701553-70155370.52370.77
6623483-62348362.67562.87
30min1780682-78068278.47876.003.6278.8376.343.64
2753870-75387075.78276.09
3777373-77737378.14578.50
4750297-75029775.42375.75
5768012-76801277.20477.57
6706038-70603870.97471.27
45min1846833-84683385.12881.763.8285.6182.223.82
2834949-83494983.93384.36
3825673-82567383.00083.49
4799515-79951580.37180.83
5813262-81326281.75382.24
6759696-75969676.36876.78
极限1914965-91496591.97691.631.1592.6092.221.13
2926554-92655493.14193.71
3907452-90745291.22191.85
4917225-91722592.20492.79
5896204-89620490.09190.72
6906490-90649091.12591.67
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