盐酸司来吉兰片项目信息
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%
110.172444802447942445282448132443752445980.09
210.082451642457302454470.17
单位质量响应值RSD%判断
24050.9324349.900.88数据可信
供试品溶液-24101001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%
5min1143096-14309658.83663.1324.8658.8463.1324.86
2168241-16824169.17569.17
3102099-10209941.98041.98
4187871-18787177.24677.25
5199045-19904581.84081.84
6120920-12092049.71849.72
10min1211354-21135486.90182.9911.4587.0883.1811.47
2214158-21415888.05488.26
3185591-18559176.30976.43
4214136-21413688.04588.28
5223319-22331991.82192.07
6162458-16245866.79766.95
15min1227180-22718093.40988.098.6593.8588.538.67
2222774-22277491.59792.07
3212726-21272687.46687.82
4218725-21872589.93290.43
5226056-22605692.94693.47
6178012-17801273.19273.54
20min1233252-23325295.90589.818.3896.6290.528.37
2227466-22746693.52694.27
3227270-22727093.44694.06
4216718-21671889.10789.87
5223097-22309791.73092.53
6182819-18281975.16975.74
30min1234899-23489996.58291.786.4397.5992.756.43
2227331-22733193.47194.50
3234525-23452596.42997.33
4220830-22083090.79891.83
5225588-22558892.75493.83
6196116-19611680.63681.43
45min1238658-23865898.12894.124.7599.4295.374.77
2231410-23141095.14896.46
3239712-23971298.56199.75
4225087-22508792.54893.85
5228675-22867594.02395.38
6209983-20998386.33887.37
60min1240623-24062398.93695.323.81100.5396.853.81
2233512-23351296.01297.61
3241855-24185599.442100.93
4226350-22635093.06794.65
5229996-22999694.56696.20
6218629-21862989.89391.19
极限1241488-24148899.29296.652.46101.1898.472.40
2234052-23405296.23498.12
3242320-24232099.634101.41
4227683-22768393.61595.48
5231318-23131895.11097.03
6233526-23352696.01897.58
盐酸司来吉兰片项目信息
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%
110.172457432458072452232451182453812454540.13
210.082449182457212453200.24
单位质量响应值RSD%判断
24135.1024337.300.59数据可信
供试品溶液-24101001批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1169889-16988969.74864.0811.2469.7564.0811.25
2139824-13982457.40557.40
3168016-16801668.97968.98
4171541-17154170.42670.43
5129633-12963353.22153.22
6157608-15760864.70664.71
10min1185688-18568876.23479.183.6376.4479.383.63
2189830-18983077.93578.11
3206127-20612784.62584.83
4190395-19039578.16778.38
5191559-19155978.64578.80
6193647-19364779.50279.70
15min1193777-19377779.55583.893.7879.9984.323.76
2201112-20111282.56782.97
3214606-21460688.10688.57
4198933-19893381.67282.12
5208172-20817285.46585.86
6209444-20944485.98786.42
20min1200200-20020082.19286.363.4682.8787.043.44
2207373-20737385.13785.79
3218014-21801489.50690.23
4204740-20474084.05684.75
5215167-21516788.33788.99
6216588-21658888.92089.61
30min1211667-21166786.90090.092.7187.8291.042.70
2217021-21702189.09890.01
3224737-22473792.26693.26
4214497-21449788.06289.00
5222386-22238691.30192.22
6226382-22638292.94193.90
45min1221178-22117890.80593.232.0591.9994.442.04
2228853-22885393.95695.13
3228944-22894493.99395.26
4222211-22221191.22992.44
5227756-22775693.50594.70
6233576-23357695.89597.13
60min1223753-22375391.86294.632.0993.3296.122.08
2235462-23546296.66998.13
3230887-23088794.79196.34
4226667-22666793.05894.54
5230127-23012794.47995.95
6236060-23606096.91498.44
极限1226036-22603692.79996.462.6994.5398.242.65
2244653-244653100.442102.19
3232313-23231395.37697.21
4233578-23357895.89597.66
5234172-23417296.13997.89
6239021-23902198.13099.94
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