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%
19.912408662402392406022410122406992406840.13
29.992412462413702413080.04
单位质量响应值RSD%判断
24286.9824154.950.39数据可信
供试品溶液-24091101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%
5min1136401-13640156.03461.5213.4356.0361.5213.43
2127076-12707652.20352.20
3137329-13732956.41556.42
4162482-16248266.74866.75
5153943-15394363.24063.24
6181275-18127574.46974.47
10min1192693-19269379.15983.086.6079.3383.266.62
2183136-18313675.23375.39
3201361-20136182.72082.89
4205313-20531384.34384.54
5209264-20926485.96786.16
6221602-22160291.03591.26
15min1202968-20296883.38086.904.0283.7987.344.04
2203831-20383183.73584.12
3209953-20995386.25086.67
4210884-21088486.63287.09
5215666-21566688.59689.04
6225956-22595692.82493.32
20min1206319-20631984.75788.263.3285.4188.963.35
2211132-21113286.73487.37
3213553-21355387.72888.40
4212643-21264387.35588.07
5218407-21840789.72290.44
6227041-22704193.26994.04
30min1209462-20946286.04889.362.6386.9690.322.65
2216721-21672189.03089.92
3216232-21623288.82989.77
4215781-21578188.64489.62
5220117-22011790.42591.41
6226796-22679693.16994.22
45min1212276-21227687.20490.222.2188.3791.452.24
2220247-22024790.47891.64
3218364-21836489.70590.91
4218360-21836089.70390.94
5221336-22133690.92692.18
6227165-22716593.32094.65
60min1214565-21456588.14490.731.9289.5792.231.94
2222504-22250491.40692.84
3219864-21986490.32191.80
4219373-21937390.11991.63
5221421-22142190.96192.49
6227431-22743193.43095.04
极限1224895-22489592.38892.511.2294.0894.281.19
2229095-22909594.11395.82
3224764-22476492.33494.08
4222495-22249591.40293.18
5222268-22226891.30993.11
6227602-22760293.50095.39
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%
19.912399632398762399132403142402082400550.09
29.992402122403102402610.03
单位质量响应值RSD%判断
24223.5124050.150.51数据可信
供试品溶液-24091102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%
5min1171491-17149170.69556.4822.1570.7056.4822.16
2133779-13377955.14955.15
3111126-11112645.81045.81
496162-9616239.64239.64
5169528-16952869.88669.89
6139920-13992057.68057.68
10min1199228-19922882.12972.1214.3082.3472.2914.31
2162480-16248066.98067.15
3152874-15287463.02163.16
4144159-14415959.42859.55
5188187-18818777.57877.79
6202713-20271383.56683.74
15min1206636-20663685.18376.2111.4785.6476.5911.50
2173823-17382371.65772.02
3164449-16444967.79268.12
4160817-16081766.29566.59
5195049-19504980.40780.85
6208376-20837685.90186.32
20min1211380-21138087.13979.239.0887.8579.849.12
2183905-18390575.81376.39
3174630-17463071.98972.52
4173088-17308871.35471.85
5198728-19872881.92382.61
6211410-21141087.15187.83
30min1217959-21795989.85183.676.4090.8384.526.47
2202947-20294783.66384.47
3187410-18741077.25878.00
4188016-18801677.50778.22
5206721-20672185.21886.15
6214749-21474988.52889.47
45min1223651-22365192.19886.964.6293.4488.064.70
2213400-21340087.97289.03
3199739-19973982.34083.32
4199332-19933282.17283.11
5211880-21188087.34588.53
6217640-21764089.72090.93
60min1224467-22446792.53489.103.3094.0690.473.38
2220308-22030890.81992.14
3207665-20766585.60786.83
4207307-20730785.46086.65
5217025-21702589.46690.91
6220103-22010390.73592.21
极限1231755-23175595.53894.840.7697.3496.480.71
2229893-22989394.77196.37
3230093-23009394.85396.33
4231817-23181795.56497.01
5229828-22982894.74496.46
6227047-22704793.59795.35
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%
19.912389642388372385592385802387222387320.08
29.992383052382172382610.03
单位质量响应值RSD%判断
24090.0123849.950.71数据可信
供试品溶液-24091103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%
5min1120414-12041449.98566.7120.1849.9966.7220.18
2131850-13185054.73354.73
3149786-14978662.17862.18
4175125-17512572.69772.70
5180962-18096275.12075.12
6206148-20614885.57585.57
10min1146140-14614060.66585.0515.4660.8185.2415.46
2192527-19252779.92080.08
3213445-21344588.60488.79
4223644-22364492.83893.06
5223177-22317792.64492.87
6230309-23030995.60495.86
15min1156643-15664365.02588.1713.9265.3688.6313.93
2203275-20327584.38284.79
3219902-21990291.28491.74
4229183-22918395.13795.63
5230355-23035595.62396.13
6235095-23509597.59198.13
20min1164287-16428768.19889.8512.5968.7290.5712.61
2209175-20917586.83187.49
3225559-22555993.63294.36
4231730-23173096.19496.98
5232632-23263296.56997.36
6235298-23529897.67598.51
30min1174782-17478272.55491.4610.6173.2992.4510.64
2216405-21640589.83390.75
3228649-22864994.91595.92
4232523-23252396.52397.59
5233793-23379397.05198.13
6235797-23579797.88299.01
45min1184792-18479276.71092.678.6977.6693.948.75
2222237-22223792.25393.44
3230606-23060695.72897.02
4232972-23297296.71098.07
5233863-23386397.08098.45
6235004-23500497.55398.98
60min1193806-19380680.45193.657.0981.6395.197.18
2225812-22581293.73795.20
3230840-23084095.82597.40
4232135-23213596.36298.01
5235972-23597297.95599.62
6234991-23499197.54899.26
极限1230597-23059795.72496.700.9597.1498.521.06
2234889-23488997.50599.25
3229870-22987095.42297.29
4233479-23347996.92098.86
5234983-23498397.54499.50
6233924-23392497.10599.11
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