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%
110.152501872503672503992499412496172501020.14
210.182499682499612499640.01
单位质量响应值RSD%判断
24640.5924554.420.25数据可信
供试品溶液-24103001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%
5min1149381-14938160.42763.7019.3460.4363.7019.34
2150901-15090161.04261.04
3105223-10522342.56442.56
4168787-16878768.27768.28
5193114-19311478.11778.12
6177432-17743271.77471.77
10min1201007-20100781.31076.987.5181.4977.177.52
2176858-17685871.54271.72
3169559-16955968.58968.72
4192204-19220477.74977.95
5206395-20639583.49083.72
6195835-19583579.21879.43
15min1209948-20994884.92780.445.9185.3580.865.93
2187963-18796376.03476.43
3181916-18191673.58873.92
4199187-19918780.57481.01
5210571-21057185.17985.66
6203594-20359482.35782.81
20min1214973-21497386.96082.954.8287.6483.624.85
2195601-19560179.12379.75
3190799-19079977.18177.74
4205686-20568683.20383.88
5213688-21368886.44087.18
6209639-20963984.80285.50
30min1222033-22203389.81587.832.1590.7688.752.21
2214433-21443386.74187.60
3209290-20929084.66185.45
4217124-21712487.83088.76
5219824-21982488.92289.92
6220099-22009989.03389.99
45min1230568-23056893.26891.800.8194.4892.980.83
2225655-22565591.28192.40
3225955-22595591.40292.44
4226534-22653491.63692.83
5226070-22607091.44892.71
6226908-22690891.78793.01
60min1234336-23433694.79293.650.7596.2895.100.73
2232548-23254894.06995.47
3230784-23078493.35594.67
4231279-23127993.55695.02
5229335-22933592.76994.31
6230821-23082193.37094.87
极限1237175-23717595.94195.241.2097.7296.971.14
2240226-24022697.17598.85
3235319-23531995.19096.78
4233271-23327194.36196.11
5233258-23325894.35696.18
6233428-23342894.42596.20
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%
110.152497452497372499162499132496192497860.06
210.182502012501202501600.03
单位质量响应值RSD%判断
24609.4624573.670.11数据可信
供试品溶液-24103001批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1187921-18792176.03569.8617.0576.0369.8617.05
2159005-15900564.33564.34
3206073-20607383.37983.38
4148812-14881260.21160.21
5199920-19992080.89080.89
6134179-13417954.29054.29
10min1214779-21477986.90280.5011.8187.1380.7111.82
2189588-18958876.70976.90
3225048-22504891.05791.31
4177628-17762871.87072.05
5218064-21806488.23188.47
6168662-16866268.24268.41
15min1221631-22163189.67484.678.4390.1685.128.46
2202096-20209681.77082.19
3229560-22956092.88293.41
4189680-18968076.74777.14
5222655-22265590.08990.60
6189905-18990576.83877.21
20min1226264-22626491.54986.986.8092.3187.696.84
2208680-20868084.43485.10
3231667-23166793.73594.54
4197752-19775280.01380.64
5225314-22531491.16491.94
6200215-20021581.00981.61
30min1230512-23051293.26890.404.4194.3091.374.47
2220264-22026489.12190.04
3235000-23500095.08396.17
4210631-21063185.22486.09
5229920-22992093.02894.08
6214286-21428686.70287.54
45min1232898-23289894.23393.062.2695.5594.302.34
2228657-22865792.51793.71
3235981-23598195.48096.85
4221739-22173989.71890.84
5233542-23354294.49495.82
6227197-22719791.92693.03
60min1234533-23453394.89594.181.1796.4995.701.26
2232549-23254994.09295.56
3236057-23605795.51197.17
4228038-22803892.26793.66
5233277-23327794.38696.00
6232133-23213393.92395.30
极限1232912-23291294.23995.110.9396.1296.910.86
2234389-23438994.83696.59
3235757-23575795.39097.33
4234493-23449394.87896.55
5233794-23379494.59696.49
6239095-23909596.74098.40
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%
110.152503512503582503702503192504342503660.02
210.182496982496712496840.01
单位质量响应值RSD%判断
24666.6024526.920.41数据可信
供试品溶液-24103001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%
5min1122352-12235249.49552.7320.7949.4952.7320.79
2130244-13024452.68752.69
3139376-13937656.38256.38
4177421-17742171.77271.77
5115304-11530446.64446.64
697457-9745739.42439.42
10min1151920-15192061.45667.9211.7161.6068.0811.73
2178130-17813072.05972.22
3172844-17284469.92070.09
4199227-19922780.59380.81
5159648-15964864.58264.72
6145604-14560458.90159.02
15min1167526-16752667.76973.439.1968.1073.799.23
2192010-19201077.67378.05
3184105-18410574.47674.85
4207012-20701283.74284.20
5177266-17726671.70972.04
6161248-16124865.22965.52
20min1185006-18500674.84077.056.9675.3877.647.00
2199344-19934480.64081.25
3192171-19217177.73978.34
4209651-20965184.81085.52
5185556-18555675.06375.61
6171144-17114469.23369.72
30min1201716-20171681.60081.105.1182.3681.915.16
2206635-20663583.59084.44
3203215-20321582.20683.04
4211447-21144785.53686.50
5198100-19810080.13780.91
6181752-18175273.52474.22
45min1214040-21404086.58584.704.0987.5985.764.12
2213363-21336386.31187.41
3212491-21249185.95987.04
4213952-21395286.55087.77
5210304-21030485.07486.09
6192177-19217777.74178.66
60min1216865-21686587.72886.663.8488.9987.973.86
2217236-21723687.87889.24
3218499-21849988.38989.73
4215049-21504986.99388.47
5219890-21989088.95290.22
6197793-19779380.01381.16
极限1220797-22079789.31989.972.6090.8591.542.63
2229983-22998393.03594.66
3223314-22331490.33791.94
4221532-22153289.61691.36
5225939-22593991.39992.94
6212804-21280486.08587.48
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