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%
110.13 2475922473162470272469252465202470760.17
210.082448502455692452100.21
单位质量响应值RSD%判断
24390.5224326.390.19数据可信
供试品溶液-24082702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%
5min1108522-10852244.32946.3510.3544.3346.3510.35
2135445-13544555.32755.33
3111662-11166245.61245.61
4101563-10156341.48741.49
5115691-11569147.25847.26
6107874-10787444.06544.06
10min1172450-17245070.44370.0911.5970.5870.2311.58
2188164-18816476.86277.03
3187801-18780176.71476.85
4150809-15080961.60361.73
5186618-18661876.23076.37
6143652-14365258.67958.81
15min1187668-18766876.65975.629.1077.0075.979.10
2197973-19797380.86981.27
3199685-19968581.56881.93
4168242-16824268.72469.03
5196771-19677180.37880.75
6160384-16038465.51465.82
20min1195791-19579179.97778.808.0180.5579.378.02
2203178-20317882.99583.63
3207492-20749284.75785.37
4178430-17843072.88673.40
5203091-20309182.95983.57
6169410-16941069.20169.71
30min1207352-20735284.70083.307.0185.5184.127.02
2210330-21033085.91686.80
3220277-22027789.97990.85
4190862-19086277.96478.70
5212268-21226886.70887.57
6182493-18249374.54575.26
45min1216474-21647488.42686.775.7189.4987.835.74
2214090-21409087.45288.60
3227826-22782693.06394.20
4200507-20050781.90482.87
5219903-21990389.82790.95
6195672-19567279.92980.86
60min1223007-22300791.09589.145.0492.4390.465.07
2218702-21870289.33690.74
3233406-23340695.34296.76
4206715-20671584.44085.65
5223139-22313991.14992.54
6204325-20432583.46384.64
极限1234821-23482195.92095.371.3097.5396.961.28
2232746-23274695.07396.75
3237492-23749297.01198.71
4232422-23242294.94096.41
5228525-22852593.34995.01
6234850-23485095.93297.36
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%
110.13 2455212460362471022456002450612458640.32
210.082453202449462451330.11
单位质量响应值RSD%判断
24270.8824318.750.14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%
5min1185002-18500275.76863.1619.5475.7763.1619.54
2132286-13228654.17854.18
3104708-10470842.88342.88
4176090-17609072.11872.12
5164911-16491167.54067.54
6162331-16233166.48366.48
10min1211218-21121886.50578.369.5186.7378.559.53
2172453-17245370.62970.79
3165315-16531567.70567.83
4198468-19846881.28381.50
5202770-20277083.04583.25
6197788-19778881.00581.20
15min1217994-21799489.28082.097.3189.7782.527.34
2184876-18487675.71676.09
3180577-18057773.95674.29
4204755-20475583.85884.32
5209977-20997785.99786.45
6204491-20449183.75084.19
20min1220638-22063890.36384.086.6291.1284.766.65
2189697-18969777.69178.29
3187932-18793276.96877.52
4209433-20943385.77486.49
5216096-21609688.50389.21
6208045-20804585.20585.90
30min1223130-22313091.38486.055.5192.4186.985.56
2197031-19703180.69581.53
3195682-19568280.14280.93
4214691-21469187.92788.90
5220078-22007890.13491.11
6210026-21002686.01786.97
45min1225205-22520592.23387.904.2493.5389.084.30
2205378-20537884.11385.19
3202513-20251382.94083.96
4220005-22000590.10491.34
5220922-22092290.47991.72
6213795-21379587.56088.77
60min1225883-22588392.51189.023.5494.0990.473.61
2210898-21089886.37487.70
3206703-20670384.65685.93
4223830-22383091.67093.17
5221843-22184390.85692.37
6215065-21506588.08089.55
极限1227264-22726493.07792.952.5094.9394.662.52
2228812-22881293.71195.30
3220013-22001390.10791.63
4236520-23652096.86798.65
5226201-22620192.64194.43
6222934-22293491.30393.04
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%
110.13 2456392459032466902460842457552460140.17
210.082460562465402462980.14
单位质量响应值RSD%判断
24285.6924434.330.44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%
5min189738-8973836.65458.2320.4636.6558.2320.47
2159153-15915365.00865.01
3150658-15065861.53861.54
4140225-14022557.27657.28
5139718-13971857.06957.07
6175859-17585971.83171.83
10min1146286-14628659.75273.0413.6459.8673.2113.65
2187902-18790276.75076.95
3172693-17269370.53870.72
4157582-15758264.36664.54
5198924-19892481.25381.42
6209454-20945485.55485.77
15min1176566-17656672.12078.5510.1372.4178.9510.14
2196543-19654380.28080.71
3181949-18194974.31974.72
4169463-16946369.21969.58
5214882-21488287.77188.19
6214486-21448687.60988.08
20min1190589-19058977.84881.378.1978.3582.008.21
2200188-20018881.76982.43
3188998-18899877.19877.82
4178872-17887273.06273.63
5219753-21975389.76090.44
6216940-21694088.61189.35
30min1202589-20258982.75084.985.8583.4985.865.88
2205521-20552183.94784.86
3199489-19948981.48382.33
4194892-19489279.60680.40
5225614-22561492.15493.10
6220253-22025389.96590.97
45min1210820-21082086.11287.273.8587.1088.403.91
2211169-21116986.25487.42
3207839-20783984.89485.99
4204892-20489283.69084.72
5226439-22643992.49193.72
6220724-22072490.15791.43
60min1216012-21601288.23288.352.9889.4889.743.03
2214720-21472087.70589.13
3211276-21127686.29887.65
4208750-20875085.26686.55
5226505-22650592.51894.02
6220516-22051690.07291.61
极限1232573-23257394.99791.682.0596.5193.341.98
2223164-22316491.15492.84
3224275-22427591.60793.22
4219006-21900689.45590.99
5225824-22582492.24094.02
6221925-22192590.64892.46
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