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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.051546341545521544441544331547531545630.09
213.991546181544331545260.09
单位质量响应值RSD%判断
11000.9311045.460.29数据可信
供试品溶液-2025052121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%
5min164543-6454341.27241.275.7741.2741.275.77
270083-7008344.81544.81
364475-6447541.22941.23
459018-5901837.73937.74
566569-6656942.56842.57
662570-6257040.01140.01
10min191808-9180858.70757.814.7459.1758.274.72
292212-9221258.96559.46
396524-9652461.72362.18
483722-8372253.53653.96
588511-8851156.59957.07
689675-8967557.34357.79
15min1109411-10941169.96367.832.3671.0768.932.36
2108048-10804869.09270.24
3105737-10573767.61468.76
4103755-10375566.34767.36
5106639-10663968.19169.29
6102865-10286565.77766.86
20min1117468-11746875.11575.262.7977.0077.112.74
2116066-11606674.21976.14
3123192-12319278.77680.67
4114675-11467573.32975.08
5114994-11499473.53375.39
6119740-11974076.56878.38
30min1129189-12918982.61083.452.3085.3386.142.23
2127934-12793481.80884.55
3132482-13248284.71687.49
4129632-12963282.89485.46
5128166-12816681.95684.63
6135628-13562886.72889.39
45min1144591-14459192.45991.751.8996.1095.371.81
2139956-13995689.49593.15
3144945-14494592.68696.40
4145549-14554993.07296.56
5140122-14012289.60293.19
6145736-14573693.19296.82
60min1143498-14349891.76092.651.4096.4397.291.35
2143097-14309791.50496.15
3148434-14843494.91799.66
4146099-14609993.42497.94
5144127-14412792.16396.75
6144120-14412092.15896.82
90min1147685-14768594.43895.761.70100.13101.421.60
2147794-14779494.508100.17
3149899-14989995.854101.65
4152496-15249697.514103.07
5147470-14747094.30099.91
6153136-15313697.923103.61
极限1142151-14215190.89992.441.9397.6499.161.78
2142738-14273891.27497.99
3145657-14565793.141100.00
4149645-14964595.691102.33
5143116-14311691.51698.17
6144012-14401292.08998.86
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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.051558591555421555251567501565291560410.37
213.991550741553161551950.12
单位质量响应值RSD%判断
11106.1211093.280.09数据可信
供试品溶液-2025052121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%
5min162138-6213839.46040.218.6439.4640.218.64
260622-6062238.49838.50
365535-6553541.61841.62
459890-5989038.03338.03
573334-7333446.57046.57
658423-5842337.10137.10
10min194980-9498060.31757.637.7660.7558.087.76
285720-8572054.43654.86
394778-9477860.18860.65
487558-8755855.60356.03
5100181-10018163.61964.14
681313-8131351.63752.05
15min1110922-11092270.44069.196.7671.5570.276.77
2100381-10038163.74664.78
3113701-11370172.20573.34
4105919-10591967.26368.30
5120031-12003176.22577.45
6102730-10273065.23866.22
20min1121362-12136277.07076.413.5078.9678.273.56
2119792-11979276.07377.81
3120478-12047876.50978.44
4115382-11538273.27375.06
5127633-12763381.05383.12
6117318-11731874.50276.21
30min1131480-13148083.49684.653.0086.2487.363.07
2128967-12896781.90084.49
3136193-13619386.48989.27
4131292-13129283.37685.98
5139880-13988088.83091.80
6132009-13200983.83286.37
45min1142079-14207990.22691.563.4593.9095.203.46
2135799-13579986.23889.73
3148910-14891094.56498.31
4144714-14471491.90095.43
5149283-14928394.80198.76
6144274-14427491.62095.09
60min1146273-14627392.89094.243.5797.5798.913.57
2139429-13942988.54493.00
3153853-15385397.703102.50
4150307-15030795.452100.00
5153002-15300297.163102.18
6147565-14756593.71098.20
90min1148831-14883194.51496.364.59100.22102.064.49
2139292-13929288.45793.89
3155909-15590999.009104.89
4157373-15737399.939105.55
5157146-15714699.795105.89
6151828-15182896.418101.95
极限1147062-14706293.39194.043.67100.15100.823.64
2138119-13811987.71294.13
3149934-14993495.215102.20
4152538-15253896.868103.59
5152934-15293497.120104.32
6147929-14792993.941100.54
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