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%
111.149860649864929866259861499864689863600.03
211.279925889926289926080.01
单位质量响应值RSD%判断
88542.1988075.240.38数据可信
供试品溶液-24121001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%
5min1903350-90335092.61883.8214.9292.6283.8214.92
2916034-91603493.91993.92
3875910-87591089.80589.80
4887536-88753690.99791.00
5654025-65402567.05567.06
6668289-66828968.51868.52
10min1938787-93878796.25188.8712.1896.4189.0212.19
2955965-95596598.01398.17
3919125-91912594.23594.39
4923136-92313694.64794.80
5719131-71913173.73173.84
6744832-74483276.36676.48
15min1943561-94356196.74190.3010.3897.0690.5910.40
2959940-95994098.42098.74
3926279-92627994.96995.28
4926134-92613494.95495.26
5752151-75215177.11677.35
6776399-77639979.60279.84
20min1942019-94201996.58390.879.2197.0691.319.23
2958266-95826698.24998.73
3928107-92810795.15695.62
4924484-92448494.78595.25
5771301-77130179.07979.44
6793692-79369281.37581.75
30min1947097-94709797.10391.957.9897.7492.548.00
2961836-96183698.61599.26
3930287-93028795.38096.00
4929406-92940695.29095.92
5797110-79711081.72682.22
6815081-81508183.56884.08
45min1942058-94205896.58792.147.1297.3992.887.15
2959043-95904398.32899.14
3929478-92947895.29796.08
4926298-92629894.97195.76
5811568-81156883.20883.84
6823699-82369984.45285.10
60min1937860-93786096.15691.966.7997.1292.866.82
2954892-95489297.90398.88
3927456-92745695.09096.03
4921688-92168894.49895.44
5814479-81447983.50684.28
6825166-82516684.60285.39
极限1958545-95854598.27797.072.4199.4098.122.48
2971273-97127399.582100.72
3967730-96773099.219100.32
4941805-94180596.56197.66
5918321-91832194.15395.06
6922874-92287494.62095.55
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%
111.149879209873519878299873019873959875590.03
211.279886509878839882660.06
单位质量响应值RSD%判断
88649.8287689.970.77数据可信
供试品溶液-24121002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%
5min1721438-72143874.08583.9510.0274.0983.9510.02
2907943-90794393.23893.24
3887534-88753491.14291.14
4718955-71895573.83073.83
5813178-81317883.50683.51
6855974-85597487.90187.90
10min1798451-79845181.99489.637.2782.1289.777.28
2941775-94177596.71296.87
3925241-92524195.01495.17
4793952-79395281.53281.65
5875172-87517289.87290.01
6902266-90226692.65592.80
15min1827820-82782085.01091.186.0685.2791.476.06
2949282-94928297.48397.80
3931500-93150095.65795.97
4820104-82010484.21784.48
5887303-88730391.11891.41
6911515-91151593.60593.91
20min1843848-84384886.65691.905.1087.0692.345.12
2950379-95037997.59698.07
3932118-93211895.72096.19
4840230-84023086.28486.68
5889761-88976191.37191.81
6913025-91302593.76094.22
30min1863778-86377888.70292.804.2989.2593.404.31
2951456-95145697.70698.35
3936589-93658996.17996.81
4855169-85516987.81888.36
5898215-89821592.23992.83
6916847-91684794.15294.77
45min1870412-87041289.38492.943.8390.0893.683.85
2948534-94853497.40698.21
3932672-93267295.77796.57
4861634-86163488.48289.17
5897566-89756692.17292.92
6919174-91917494.39195.16
60min1872459-87245989.59492.693.5990.4493.603.62
2945960-94596097.14298.11
3928198-92819895.31896.27
4862157-86215788.53689.37
5894336-89433691.84092.74
6912556-91255693.71194.64
极限1996427-996427102.32498.772.03103.3299.831.96
2954093-95409397.97799.11
3940192-94019296.54997.66
4969468-96946899.556100.54
5951602-95160297.72198.77
6959179-95917998.49999.58
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