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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
1 14.121560051558021553341553751552221555480.22
2 14.081554131547991551060.28
单位质量响应值RSD%判断
11016.1511016.050.01数据可信
供试品溶液-023431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%
5min149684-4968431.51232.974.2831.5132.964.28
248879-4887931.00131.00
352759-5275933.46233.46
453275-5327533.78933.79
554653-5465334.66334.66
652613-5261333.36933.37
10min180361-8036150.96849.544.2951.3249.914.25
278729-7872949.93350.28
376198-7619848.32848.70
483375-8337552.88053.26
575137-7513747.65548.04
674888-7488847.49747.87
15min1104507-10450766.28359.816.8967.2060.736.80
287806-8780655.69056.59
394695-9469560.06060.97
495364-9536460.48461.45
596706-9670661.33562.25
686747-8674755.01955.92
20min1109355-10935569.35867.382.1171.0168.962.12
2105922-10592267.18068.70
3106953-10695367.83469.41
4107673-10767368.29169.93
5103363-10336365.55767.15
6104163-10416366.06567.57
30min1127458-12745880.83977.823.2183.2680.153.15
2126620-12662080.30882.57
3122410-12241077.63879.97
4120415-12041576.37278.77
5122391-12239177.62679.95
6116883-11688374.13276.38
45min1145699-14569992.40988.182.8495.7391.382.82
2138291-13829187.71090.87
3135214-13521485.75888.95
4140627-14062789.19292.43
5139300-13930088.35091.54
6135071-13507185.66888.74
60min1143606-14360691.08189.471.5895.4393.641.61
2141029-14102989.44793.58
3142539-14253990.40494.55
4141432-14143289.70293.94
5140639-14063989.19993.37
6137108-13710886.96090.98
90min1141536-14153689.76889.651.6195.1394.821.54
2137066-13706686.93392.06
3142734-14273490.52895.68
4141670-14167089.85395.08
5143623-14362391.09296.25
6141437-14143789.70594.69
极限1139423-13942388.42888.292.2694.7994.452.15
2133871-13387184.90791.00
3140252-14025288.95495.11
4139296-13929688.34794.58
5143593-14359391.07397.24
6138761-13876188.00893.99
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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
1 14.121579451571491572301583181576411576570.32
2 14.081575031564001569520.50
单位质量响应值RSD%判断
11165.5111147.160.12数据可信
供试品溶液-023431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%
5min153146-5314633.28433.932.6633.2833.932.66
256878-5687835.62135.62
354050-5405033.85033.85
454222-5422233.95833.96
554026-5402633.83533.83
652775-5277533.05133.05
10min176765-7676548.07650.362.9948.4550.742.98
283908-8390852.54952.94
381050-8105050.75951.14
481506-8150651.04551.42
580047-8004750.13150.51
679176-7917649.58649.95
15min195780-9578059.98460.752.2660.8961.692.24
296546-9654660.46461.44
3100999-10099963.25364.19
496756-9675660.59561.54
597441-9744161.02461.96
694541-9454159.20860.13
20min1102809-10280964.38667.622.8865.9669.232.85
2108615-10861568.02269.67
3111159-11115969.61671.26
4110713-11071369.33670.95
5108403-10840367.89069.50
6106128-10612866.46568.04
30min1117507-11750773.59177.382.8075.8879.742.76
2122487-12248776.71079.12
3127901-12790180.10182.52
4124431-12443177.92780.32
5124144-12414477.74880.11
6124881-12488178.20980.52
45min1146437-14643791.70986.832.9794.8190.052.81
2137604-13760486.17789.44
3139144-13914487.14290.45
4136584-13658485.53988.79
5134495-13449584.23087.46
6137574-13757486.15989.34
60min1139705-13970587.49389.351.2291.6293.541.20
2144568-14456890.53994.76
3143626-14362689.94994.22
4142917-14291789.50593.71
5141688-14168888.73592.90
6143494-14349489.86694.01
90min1140794-14079488.17589.171.3093.2794.351.21
2141763-14176388.78294.01
3140244-14024487.83193.10
4145199-14519990.93496.13
5142794-14279489.42894.58
6143524-14352489.88595.02
极限1137606-13760686.17989.042.1892.2595.212.08
2147080-14708092.11298.32
3141073-14107388.35094.60
4142812-14281289.43995.65
5141401-14140188.55594.70
6143077-14307789.60595.74
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