他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.021536901538021536261535121534641536190.09
214.091527801526861527330.05
单位质量响应值RSD%判断
10957.1310839.820.77数据可信
供试品溶液-023431批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159650-5965038.54239.562.4538.5439.562.45
260232-6023238.91838.92
360587-6058739.14739.15
461106-6110639.48239.48
561967-6196740.03940.04
663823-6382341.23841.24
10min187309-8730956.41357.863.6456.8458.303.63
285301-8530155.11555.55
391735-9173559.27359.71
487479-8747956.52356.96
592359-9235959.67660.12
693151-9315160.18760.65
15min1102574-10257466.27667.873.2967.3368.963.28
299980-9998064.60065.64
3103920-10392067.14668.24
4107411-10741169.40170.47
5108938-10893870.38871.50
6107449-10744969.42670.55
20min1112301-11230172.56175.593.4174.3577.433.40
2112445-11244572.65474.42
3116015-11601574.96076.80
4119549-11954977.24479.08
5120796-12079678.05079.94
6120841-12084178.07979.98
30min1129848-12984883.89885.892.7786.5088.572.76
2128001-12800182.70585.27
3131468-13146884.94587.62
4136886-13688688.44691.14
5136219-13621988.01590.77
6135166-13516687.33490.10
45min1141462-14146291.40293.172.2594.9396.802.27
2139086-13908689.86793.36
3144806-14480693.56397.18
4147310-14731095.18198.86
5145916-14591694.28098.02
6146606-14660694.72698.46
60min1144960-14496093.66395.092.4698.2199.762.47
2141664-14166491.53396.02
3146027-14602794.35299.01
4148753-14875396.113100.85
5150698-15069897.370102.15
6150915-15091597.510102.30
90min1145253-14525393.85294.692.1499.44100.422.16
2142057-14205791.78797.29
3144554-14455493.40099.10
4147872-14787295.544101.35
5149594-14959496.657102.52
6149998-14999896.918102.79
极限1145736-14573694.16493.622.13100.79100.402.13
2140718-14071890.92297.45
3142077-14207791.80098.54
4144671-14467193.476100.34
5147429-14742995.258102.20
6148770-14877096.124103.07
他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.021530391530541530811531801528291530370.09
214.091523981523511523740.03
单位质量响应值RSD%判断
10915.6210814.340.66数据可信
供试品溶液-023431批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163575-6357541.20439.165.1141.2039.165.10
262382-6238240.43140.43
361546-6154639.88939.89
460892-6089239.46539.47
554860-5486035.55635.56
659248-5924838.40038.40
10min190912-9091258.92157.422.9759.3857.852.97
292357-9235759.85860.31
387874-8787456.95257.40
485456-8545655.38555.82
586458-8645856.03556.43
688494-8849457.35457.78
15min1105396-10539668.30967.691.1169.4268.761.13
2106103-10610368.76769.88
3103427-10342767.03368.11
4103227-10322766.90367.96
5103793-10379367.27068.29
6104657-10465767.83068.89
20min1119380-11938077.37275.782.7279.2477.602.70
2121190-12119078.54580.42
3116197-11619775.30977.13
4112729-11272973.06174.86
5114227-11422774.03275.80
6117787-11778776.33978.16
30min1130598-13059884.64284.652.3587.3787.322.32
2132282-13228285.73488.49
3128596-12859683.34586.00
4127646-12764682.72985.34
5128648-12864883.37985.97
6135864-13586488.05590.72
45min1141455-14145591.67991.932.3195.3595.542.28
2143853-14385393.23396.94
3141573-14157391.75695.34
4137944-13794489.40492.93
5139212-13921290.22593.74
6147058-14705895.31098.95
60min1147505-14750595.60094.202.27100.2998.832.22
2143334-14333492.89797.64
3145803-14580394.49799.10
4143938-14393893.28897.81
5141121-14112191.46395.98
6150397-15039797.475102.18
90min1146199-14619994.75494.771.88100.51100.451.85
2145275-14527594.15599.93
3147076-14707695.322100.98
4144864-14486493.88899.45
5142912-14291292.62398.16
6151019-15101997.878103.66
极限1145707-14570794.43592.692.23101.2499.422.19
2143336-14333692.89899.72
3143789-14378993.19299.90
4137716-13771689.25695.86
5141163-14116391.49098.05
6146386-14638694.875101.75
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