他克莫司缓释颗粒项目信息
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%
114.291567651566651568231561121558341564400.29
214.201559781555941557860.18
单位质量响应值RSD%判断
10947.5210970.850.16数据可信
供试品溶液-123852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%
5min162058-6205839.91538.893.5339.9138.883.52
257807-5780737.18137.18
361249-6124939.39539.39
459786-5978638.45438.45
558524-5852437.64237.64
663331-6333140.73440.73
10min185560-8556055.03155.722.6055.4756.162.59
288655-8865557.02257.43
385798-8579855.18455.62
485841-8584155.21255.64
583944-8394453.99254.41
690027-9002757.90458.36
15min1104594-10459467.27466.981.8268.3368.031.82
2103387-10338766.49767.54
3106044-10604468.20669.26
4102959-10295966.22267.26
5101481-10148165.27166.29
6106359-10635968.40969.50
20min1114925-11492573.91873.981.5975.7275.771.60
2114662-11466273.74975.53
3115882-11588274.53476.34
4115039-11503973.99275.77
5111996-11199672.03473.78
6117577-11757775.62477.48
30min1130325-13032583.82383.571.8886.4586.181.88
2129905-12990583.55386.16
3130955-13095584.22986.87
4128990-12899082.96585.56
5125984-12598481.03183.58
6133390-13339085.79588.49
45min1140883-14088390.61491.141.4394.1794.691.44
2141231-14123190.83894.37
3142880-14288091.89995.47
4140348-14034890.27093.79
5139700-13970089.85393.30
6145188-14518893.38397.03
60min1142635-14263591.74192.640.9996.3097.191.01
2144299-14429992.81197.35
3143979-14397992.60597.20
4143441-14344192.25996.78
5143153-14315392.07496.52
6146645-14664594.32099.01
90min1144312-14431292.82093.610.6698.4099.190.69
2146124-14612493.98599.56
3145394-14539493.51699.14
4145311-14531193.46299.01
5145003-14500393.26498.73
6147061-14706194.588100.32
极限1143173-14317392.08792.310.6998.7098.940.72
2143626-14362692.37899.00
3144996-14499693.26099.92
4142477-14247791.63998.23
5142576-14257691.70398.20
6144285-14428592.80299.59
他克莫司缓释颗粒项目信息
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%
114.291559961561741563421566051567391563710.20
214.201565911564271565090.08
单位质量响应值RSD%判断
10942.6911021.760.51数据可信
供试品溶液-123852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%
5min170649-7064945.34646.573.8445.3546.583.84
274143-7414347.58847.59
370681-7068145.36645.37
477478-7747849.72949.73
571985-7198546.20346.20
670448-7044845.21745.22
10min1101652-10165265.24564.413.7165.7564.933.70
2105364-10536467.62768.16
396405-9640561.87762.38
4103358-10335866.34066.89
598954-9895463.51364.03
696399-9639961.87362.38
15min1117927-11792775.69176.113.6576.9277.343.64
2125739-12573980.70581.99
3115926-11592674.40775.60
4121313-12131377.86479.15
5116940-11694075.05776.28
6113625-11362572.93074.12
20min1129907-12990783.38083.052.8685.4585.132.87
2134661-13466186.43288.61
3126756-12675681.35883.38
4132611-13261185.11687.27
5127414-12741481.78083.83
6125028-12502880.24982.25
30min1139426-13942689.49090.202.7092.4993.202.70
2146254-14625493.87297.01
3135507-13550786.97589.90
4141748-14174890.98094.08
5142464-14246491.44094.40
6137796-13779688.44491.34
45min1145545-14554593.41795.002.8497.4199.012.84
2154821-15482199.371103.55
3143393-14339392.03695.92
4149534-14953495.978100.09
5149770-14977096.129100.11
6145036-14503693.09196.97
60min1146435-14643593.98994.402.3299.0299.462.34
2152637-15263797.969103.25
3143370-14337092.02196.93
4148236-14823695.145100.32
5147925-14792594.94599.99
6143819-14381992.31097.22
90min1144062-14406292.46693.152.3398.5499.262.35
2150708-15070896.731103.10
3140740-14074090.33396.27
4146142-14614293.801100.04
5145937-14593793.66999.77
6143186-14318691.90397.84
极限1141382-14138290.74591.842.7197.8598.982.70
2149326-14932695.844103.29
3138364-13836488.80895.75
4144456-14445692.718100.00
5144540-14454092.77299.91
6140465-14046590.15797.11
他克莫司缓释颗粒项目信息
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%
114.291572621572951570961561111559861567500.42
214.201572181571091571640.05
单位质量响应值RSD%判断
10969.2111067.890.64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%
5min172151-7215146.15747.035.0046.1647.035.00
278589-7858950.27650.28
372816-7281646.58346.58
475005-7500547.98347.98
567605-6760543.24943.25
674955-7495547.95147.95
10min199400-9940063.59062.686.3664.1063.206.34
2104146-10414666.62667.18
398643-9864363.10563.62
499918-9991863.92164.45
585898-8589854.95255.43
699845-9984563.87464.41
15min1119908-11990876.70974.325.0777.9375.545.07
2121562-12156277.76779.07
3120287-12028776.95278.17
4114470-11447073.23074.47
5105727-10572767.63768.73
6115092-11509273.62874.87
20min1127311-12731181.44581.595.7183.5283.635.69
2136744-13674487.48089.64
3127159-12715981.34883.42
4128947-12894782.49284.55
5114544-11454473.27875.12
6130504-13050483.48885.55
30min1136448-13644887.29088.523.8190.2791.473.84
2148141-14814194.77197.91
3136492-13649287.31990.30
4138110-13811088.35491.33
5132373-13237384.68487.34
6138610-13861088.67491.66
45min1142718-14271891.30292.923.0895.2596.863.10
2153906-15390698.459102.65
3142592-14259291.22195.17
4144420-14442092.39096.35
5142075-14207590.89094.49
6145755-14575593.24497.22
60min1149001-14900195.32195.473.12100.28100.443.15
2157650-157650100.854106.14
3150708-15070896.413101.37
4146887-14688793.96998.95
5144322-14432292.32896.94
6146879-14687993.96498.97
90min1149696-14969695.76696.542.16101.79102.572.23
2156477-156477100.104106.51
3152733-15273397.709103.74
4150539-15053996.305102.33
5148026-14802694.697100.33
6147967-14796794.660100.71
极限1149522-14952295.65495.662.56102.74102.762.55
2156537-156537100.142107.66
3149739-14973995.793102.91
4145993-14599393.397100.49
5149163-14916395.425102.11
6146203-14620393.531100.64
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