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%
114.031536901538021536261535121534641536190.09
214.021527801526861527330.05
单位质量响应值RSD%判断
10949.3210893.940.36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%
5min159650-5965038.45939.482.4538.4639.482.45
260232-6023238.83438.83
360587-6058739.06339.06
461106-6110639.39839.40
561967-6196739.95339.95
663823-6382341.14941.15
10min187309-8730956.29257.743.6456.7258.183.63
285301-8530154.99755.43
391735-9173559.14659.58
487479-8747956.40156.84
592359-9235959.54859.99
693151-9315160.05860.52
15min1102574-10257466.13467.733.2967.1968.813.27
299980-9998064.46165.50
3103920-10392067.00268.09
4107411-10741169.25270.32
5108938-10893870.23771.34
6107449-10744969.27770.40
20min1112301-11230172.40575.433.4174.1977.263.40
2112445-11244572.49874.26
3116015-11601574.80076.64
4119549-11954977.07878.91
5120796-12079677.88279.77
6120841-12084177.91179.81
30min1129848-12984883.71985.712.7786.3188.382.77
2128001-12800182.52885.09
3131468-13146884.76387.43
4136886-13688688.25690.95
5136219-13621987.82690.58
6135166-13516687.14789.91
45min1141462-14146291.20792.972.2594.7396.602.27
2139086-13908689.67593.16
3144806-14480693.36396.97
4147310-14731094.97798.65
5145916-14591694.07897.81
6146606-14660694.52398.25
60min1144960-14496093.46294.892.4698.0099.542.47
2141664-14166491.33795.81
3146027-14602794.15098.80
4148753-14875395.907100.63
5150698-15069897.161101.93
6150915-15091597.301102.08
90min1145253-14525393.65194.492.1499.23100.202.16
2142057-14205791.59097.08
3144554-14455493.20098.89
4147872-14787295.339101.13
5149594-14959496.450102.30
6149998-14999896.710102.57
极限1145736-14573693.96293.422.13100.58100.182.13
2140718-14071890.72797.24
3142077-14207791.60398.33
4144671-14467193.276100.13
5147429-14742995.054101.98
6148770-14877095.918102.85
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%
114.031530391530541530811531801528291530370.09
214.021523981523511523740.03
单位质量响应值RSD%判断
10907.8410868.330.26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%
5min163575-6357541.11639.075.1141.1239.075.11
262382-6238240.34440.34
361546-6154639.80339.80
460892-6089239.38139.38
554860-5486035.47935.48
659248-5924838.31738.32
10min190912-9091258.79557.292.9759.2557.732.97
292357-9235759.73060.18
387874-8787456.83157.27
485456-8545655.26755.70
586458-8645855.91556.31
688494-8849457.23157.66
15min1105396-10539668.16267.541.1169.2768.611.13
2106103-10610368.62069.73
3103427-10342766.88967.96
4103227-10322766.76067.81
5103793-10379367.12668.14
6104657-10465767.68568.75
20min1119380-11938077.20675.612.7279.0777.442.70
2121190-12119078.37780.25
3116197-11619775.14876.96
4112729-11272972.90574.70
5114227-11422773.87475.64
6117787-11778776.17677.99
30min1130598-13059884.46184.472.3587.1987.132.32
2132282-13228285.55088.30
3128596-12859683.16785.82
4127646-12764682.55285.16
5128648-12864883.20085.78
6135864-13586487.86790.53
45min1141455-14145591.48391.742.3195.1595.342.28
2143853-14385393.03496.73
3141573-14157391.55995.14
4137944-13794489.21292.73
5139212-13921290.03293.54
6147058-14705895.10698.74
60min1147505-14750595.39694.002.27100.0898.622.22
2143334-14333492.69897.43
3145803-14580394.29598.89
4143938-14393893.08997.60
5141121-14112191.26795.77
6150397-15039797.266101.96
90min1146199-14619994.55194.571.88100.29100.231.85
2145275-14527593.95399.71
3147076-14707695.118100.76
4144864-14486493.68899.23
5142912-14291292.42597.95
6151019-15101997.668103.44
极限1145707-14570794.23392.492.23101.0299.202.19
2143336-14333692.69999.50
3143789-14378992.99299.69
4137716-13771689.06595.65
5141163-14116391.29497.84
6146386-14638694.672101.53
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