盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.912400752394202397352398692401092398420.12
29.992402732403392403060.02
单位质量响应值RSD%判断
24202.0224054.650.44数据可信
供试品溶液-2095120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%
5min1110262-11026281.84680.187.9281.8580.187.91
2118850-11885088.22188.22
3112989-11298983.87083.87
495780-9578071.09671.10
5110173-11017381.78081.78
6100038-10003874.25774.26
10min1120540-12054089.47589.954.4889.6190.084.48
2128777-12877795.59095.74
3123909-12390991.97692.12
4112477-11247783.49083.61
5122261-12226190.75390.89
6119074-11907488.38788.51
15min1122388-12238890.84791.414.1091.1391.704.11
2130825-13082597.11097.42
3124701-12470192.56492.86
4115390-11539085.65385.91
5124329-12432992.28892.58
6121278-12127890.02390.29
20min1123460-12346091.64392.403.9092.0892.843.90
2132371-13237198.25798.73
3125265-12526592.98393.43
4117499-11749987.21887.62
5125642-12564293.26393.70
6122629-12262991.02691.45
30min1124235-12423592.21893.163.8592.8193.763.86
2133326-13332698.96699.60
3125888-12588893.44594.05
4118852-11885288.22288.77
5127553-12755394.68195.28
6123191-12319191.44392.02
45min1124475-12447592.39693.663.8393.1494.403.83
2134298-13429899.688100.48
3126055-12605593.56994.33
4120672-12067289.57390.27
5128699-12869995.53296.29
6122850-12285091.19091.92
60min1125245-12524592.96894.033.7593.8794.933.76
2134828-134828100.081101.04
3126217-12621793.68994.60
4121431-12143190.13790.98
5128996-12899695.75296.67
6123332-12333291.54892.43
极限1125403-12540393.08594.733.6994.1495.793.69
2135416-135416100.518101.65
3126529-12652993.92194.99
4123474-12347491.65392.65
5131077-13107797.29798.37
6123819-12381991.90992.94
盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.912399602404512403772399652400992401700.10
29.992372302375802374050.11
单位质量响应值RSD%判断
24235.1223764.261.39数据可信
供试品溶液-2185663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%
5min1104141-10414177.72478.869.4277.7278.869.42
2109667-10966781.84881.85
3106466-10646679.45979.46
4117721-11772187.85987.86
5108283-10828380.81580.82
687668-8766865.42965.43
10min1111062-11106282.88987.196.2783.0287.326.27
2123280-12328092.00892.14
3118147-11814788.17788.31
4125086-12508693.35693.50
5117635-11763587.79587.93
6105752-10575278.92679.04
15min1114475-11447585.43690.704.7285.7090.984.73
2125680-12568093.79994.09
3125346-12534693.55093.83
4128206-12820695.68495.99
5119894-11989489.48189.76
6115566-11556686.25186.49
20min1117746-11774687.87892.653.9488.2993.083.95
2126463-12646394.38394.83
3128754-12875496.09396.53
4129789-12978996.86697.33
5121619-12161990.76891.20
6120469-12046989.91090.29
30min1121823-12182390.92094.403.0791.4894.983.08
2126662-12666294.53295.14
3130478-13047897.38097.98
4131546-13154698.17798.80
5123371-12337192.07692.66
6125006-12500693.29693.83
45min1124485-12448592.90795.332.4293.6296.062.42
2126490-12649094.40395.16
3131197-13119797.91698.67
4131893-13189398.43699.22
5125453-12545393.63094.36
6126834-12683494.66095.35
60min1126588-12658894.47795.732.0595.3496.632.07
2126568-12656894.46295.38
3131278-13127897.97798.90
4132019-13201998.53099.48
5126466-12646694.38695.28
6126692-12669294.55495.40
极限1129348-12934896.53696.271.6697.5697.331.66
2126807-12680794.64095.72
3131131-13113197.86798.95
4131845-13184598.40099.51
5127644-12764495.26596.31
6127182-12718294.92095.92
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