玛巴洛沙韦干混悬剂项目信息
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对照品来源原料药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 11.3799802310038121000843997881100012310001360.25
2 11.441001904100121310015580.05
单位质量响应值RSD%判断
87962.7187548.780.34数据可信
供试品溶液-24112901批-pH6.8(内含0.16%CTAB)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1507879-50787952.40046.1710.4952.4046.1710.50
2428718-42871844.23244.23
3503196-50319651.91651.92
4392930-39293040.54040.54
5422980-42298043.64043.64
6429145-42914544.27644.28
10min1585651-58565160.42454.218.5860.5154.288.58
2508937-50893752.50952.58
3577287-57728759.56159.65
4475417-47541749.05049.12
5503735-50373551.97252.04
6501333-50133351.72451.80
15min1625801-62580164.56658.567.4364.7558.737.43
2559015-55901557.67557.84
3613350-61335063.28163.47
4522352-52235253.89354.04
5545748-54574856.30756.47
6539342-53934255.64655.81
20min1648288-64828866.88661.436.7567.1861.696.76
2588638-58863860.73260.99
3641486-64148666.18466.48
4553469-55346957.10357.34
5575947-57594759.42259.68
6564469-56446958.23858.49
30min1678289-67828969.98165.675.3370.3966.045.35
2625075-62507564.49164.85
3679745-67974570.13270.53
4602144-60214462.12562.46
5621722-62172264.14564.50
6611997-61199763.14263.49
45min1705589-70558972.79869.924.0173.3270.394.03
2661324-66132468.23168.70
3717882-71788274.06674.58
4654474-65447467.52467.96
5669177-66917769.04169.50
6657629-65762967.85068.30
60min1715880-71588073.86072.293.0074.5072.883.02
2680465-68046570.20670.79
3734650-73465075.79676.44
4685666-68566670.74271.29
5699932-69993272.21472.79
6687351-68735170.91671.48
极限1921289-92128995.05294.671.1995.8295.381.20
2910092-91009293.89794.59
3926908-92690895.63296.40
4925909-92590995.52996.20
5922129-92212995.13995.83
6899041-89904192.75793.44
玛巴洛沙韦干混悬剂项目信息
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对照品来源原料药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 11.37100299610011971001816100381599961610018880.17
2 11.449998389986029992200.09
单位质量响应值RSD%判断
88116.8087344.410.63数据可信
供试品溶液-24112902批-pH6.8(内含0.16%CTAB)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1733821-73382175.73365.148.3375.7365.148.32
2604980-60498062.43762.44
3623455-62345564.34364.34
4626930-62693064.70264.70
5584481-58448160.32160.32
6613427-61342763.30863.31
10min1795242-79524282.07272.886.4982.2072.986.50
2683466-68346670.53770.64
3697159-69715971.95072.06
4704012-70401272.65772.76
5663745-66374568.50168.60
6693262-69326271.54871.65
15min1814676-81467684.07875.895.5484.3476.125.55
2715437-71543773.83674.06
3731622-73162275.50775.73
4730061-73006175.34575.57
5698077-69807772.04572.26
6722204-72220474.53574.76
20min1822641-82264184.90077.474.9285.3077.834.92
2731445-73144575.48875.83
3747504-74750477.14677.50
4742250-74225076.60376.96
5717343-71734374.03374.37
6742808-74280876.66177.01
30min1829132-82913285.57079.513.9186.1179.993.92
2755041-75504177.92378.39
3768722-76872279.33579.82
4762498-76249878.69379.18
5743640-74364076.74777.21
6763273-76327378.77379.25
45min1831116-83111685.77580.523.3386.4681.143.34
2767166-76716679.17579.78
3781456-78145680.65081.26
4770057-77005779.47380.09
5759968-75996878.43279.02
6771267-77126779.59880.21
60min1830577-83057785.71980.673.1886.5581.423.20
2770264-77026479.49580.23
3782962-78296280.80581.55
4768516-76851679.31480.06
5763262-76326278.77279.49
6774370-77437079.91880.66
极限1958509-95850998.92298.221.1199.9099.111.11
2956887-95688798.75599.62
3956803-95680398.74699.63
4931320-93132096.11696.99
5949392-94939297.98198.83
6957300-95730098.79799.67
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