辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.112705882704082705052707412705152705510.05
210.142712012710312711160.05
单位质量响应值RSD%判断
26760.7326737.280.07数据可信
供试品溶液-25010401批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1121379-12137945.15045.641.7845.1545.641.78
2126104-12610446.90846.91
3122116-12211645.42445.42
4124243-12424346.21546.22
5122458-12245845.55245.55
6119956-11995644.62144.62
10min1153676-15367657.16456.931.7957.3057.071.79
2156467-15646758.20258.34
3151282-15128256.27356.41
4155121-15512157.70157.84
5152960-15296056.89857.03
6148824-14882455.35955.49
15min1171790-17179063.90264.032.1564.2164.342.14
2174674-17467464.97565.29
3169125-16912562.91163.22
4173841-17384164.66564.98
5176609-17660965.69466.00
6166694-16669462.00662.31
20min1183840-18384068.38468.122.3968.8868.622.38
2184852-18485268.76169.27
3180571-18057167.16867.66
4190642-19064270.91471.42
5180456-18045667.12567.63
6178457-17845766.38266.87
30min1202812-20281275.44173.921.9076.1574.621.90
2199823-19982374.32975.05
3198142-19814273.70474.40
4202451-20245175.30776.03
5195870-19587072.85973.56
6193203-19320371.86772.55
45min1210604-21060478.34077.641.2179.2778.571.22
2209362-20936277.87878.82
3206875-20687576.95377.87
4212516-21251679.05180.00
5206150-20615076.68377.61
6206859-20685976.94777.85
60min1215919-21591980.31779.551.4381.4880.711.43
2214568-21456879.81480.99
3212646-21264679.09980.25
4218293-21829381.20082.38
5211948-21194878.84079.99
6209769-20976978.02979.16
极限1245903-24590391.47090.391.5892.8891.791.57
2243080-24308090.42091.83
3240745-24074589.55190.94
4247334-24733492.00293.43
5244181-24418190.83092.22
6236737-23673788.06189.43
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.112703412704132701912700232696722701280.11
210.142710502710722710610.01
单位质量响应值RSD%判断
26718.8926731.850.04数据可信
供试品溶液-25010402批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1129058-12905848.04946.574.3048.0546.574.30
2131900-13190049.10749.11
3122471-12247145.59745.60
4128102-12810247.69347.69
5120696-12069644.93644.94
6118246-11824644.02444.02
10min1151191-15119156.28955.685.2256.4355.825.22
2153875-15387557.28857.44
3148694-14869455.36055.50
4160864-16086459.89160.03
5144578-14457853.82753.96
6138163-13816351.43951.57
15min1169792-16979263.21461.885.8463.5362.195.83
2172466-17246664.21064.53
3168456-16845662.71763.02
4177572-17757266.11166.43
5156563-15656358.28958.59
6152409-15240956.74357.03
20min1176867-17686765.84965.338.5066.3565.828.47
2185486-18548669.05769.57
3179930-17993066.98967.48
4194056-19405672.24872.77
5163192-16319260.75761.23
6153281-15328157.06757.52
30min1198044-19804473.73372.892.5074.4373.582.51
2193931-19393172.20272.92
3202568-20256875.41776.11
4198946-19894674.06974.81
5191447-19144771.27771.93
6189786-18978670.65871.29
45min1192730-19273071.75476.376.3072.6877.276.27
2210790-21079078.47879.41
3215819-21581980.35181.27
4222413-22241382.80683.77
5192369-19236971.62072.49
6196572-19657273.18574.02
60min1215677-21567780.29879.633.3381.4380.773.36
2215268-21526880.14581.32
3218361-21836181.29782.46
4222958-22295883.00884.22
5207449-20744977.23478.32
6203662-20366275.82476.88
极限1239292-23929289.09090.875.4990.4792.255.44
2243478-24347890.64892.06
3259987-25998796.79598.20
4242562-24256290.30791.76
5256580-25658095.52696.84
6222575-22257582.86684.15
辅酶Q10片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.112707732709022710772708362709492709070.05
210.142769162768802768980.01
单位质量响应值RSD%判断
26795.9427307.501.34数据可信
供试品溶液-25010403批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1107006-10700639.36239.861.9739.3639.861.97
2108050-10805039.74639.75
3109213-10921340.17440.17
4105094-10509438.65838.66
5109506-10950640.28140.28
6111213-11121340.90940.91
10min1127720-12772046.98149.934.7747.1050.054.77
2139223-13922351.21351.33
3140909-14090951.83351.95
4127954-12795447.06747.18
5136131-13613150.07550.20
6142486-14248652.41352.54
15min1155921-15592157.35557.043.2557.6157.313.24
2152006-15200655.91556.19
3146946-14694654.05454.33
4156177-15617757.44957.71
5157800-15780058.04658.32
6161567-16156759.43259.71
20min1133375-13337549.06259.008.8949.4959.448.83
2163035-16303559.97260.41
3168633-16863362.03162.47
4156825-15682557.68858.12
5168892-16889262.12662.57
6171561-17156163.10863.57
30min1167340-16734061.55565.835.3262.1366.455.30
2182790-18279067.23967.86
3185261-18526168.14868.77
4174443-17444364.16864.77
5171392-17139263.04663.68
6192563-19256370.83471.48
45min1200429-20042973.72770.496.0574.4971.315.98
2177078-17707865.13865.96
3198462-19846273.00473.83
4177400-17740065.25666.05
5202995-20299574.67175.49
6193445-19344571.15872.02
60min1210187-21018777.31775.024.8178.3076.054.77
2206751-20675176.05377.07
3200459-20045973.73874.79
4188011-18801169.15970.15
5201610-20161074.16275.21
6216675-21667579.70380.78
极限1231660-23166085.21581.426.0586.4382.675.98
2203577-20357774.88576.13
3230272-23027284.70585.97
4207795-20779576.43777.64
5219077-21907780.58781.85
6235664-23566486.68888.00
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