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%
114.511507061504521504501499191498881502830.25
214.551494921493771494340.06
单位质量响应值RSD%判断
10357.2010270.380.60数据可信
供试品溶液-2025052021批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154476-5447637.23139.286.2837.2339.286.28
255289-5528937.78737.79
361652-6165242.13642.14
459520-5952040.67940.68
553118-5311836.30336.30
660742-6074241.51441.51
10min177839-7783953.19956.083.9053.6156.523.90
281250-8125055.53055.95
383850-8385057.30757.78
480529-8052955.03755.49
581650-8165055.80356.21
687254-8725459.63360.09
15min188454-8845460.45467.176.7461.4668.236.69
297755-9775566.81067.85
399522-9952268.01869.12
495131-9513165.01766.08
5100185-10018568.47169.49
6108637-10863774.24875.37
20min1106603-10660372.85774.925.0974.5376.725.04
2105004-10500471.76573.54
3106780-10678072.97874.84
4106050-10605072.48074.27
5114959-11495978.56880.35
6118321-11832180.86682.81
30min1114568-11456878.30184.876.2080.7987.516.14
2121200-12120082.83485.41
3125811-12581185.98588.66
4118583-11858381.04583.64
5129018-12901888.17790.83
6135877-13587792.86595.71
45min1130382-13038289.10992.024.1592.4795.604.17
2132244-13224490.38293.88
3133024-13302490.91594.54
4130668-13066889.30592.80
5136399-13639993.22196.86
6145152-14515299.204103.08
60min1136405-13640593.22695.873.8597.57100.483.85
2140462-14046295.998100.50
3144862-14486299.005103.64
4133345-13334591.13495.62
5138670-13867094.77499.45
6147940-147940101.109106.09
90min1138068-13806894.36296.705.2699.74102.375.18
2138461-13846194.631100.20
3147214-147214100.613106.35
4130639-13063989.28594.78
5142939-14293997.691103.42
6151643-151643103.640109.74
极限1135477-13547792.59195.193.8399.02101.933.85
2136490-13649093.28499.90
3144450-14445098.724105.58
4132980-13298090.88597.37
5139736-13973695.502102.31
6146538-146538100.151107.41
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%
114.511471791457371469191479821481381471910.66
214.551477851478881478360.05
单位质量响应值RSD%判断
10144.1110160.550.12数据可信
供试品溶液-2025052021批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min151331-5133135.63935.945.6135.6435.945.62
253942-5394237.45237.45
346352-4635232.18232.18
453186-5318636.92736.93
554181-5418137.61837.62
651575-5157535.80935.81
10min174952-7495252.03954.124.2152.4454.524.21
282191-8219157.06657.48
373729-7372951.19051.55
478152-7815254.26154.67
577741-7774153.97654.39
680931-8093156.19156.59
15min191607-9160763.60366.035.5964.5867.045.57
2103853-10385372.10673.16
388696-8869661.58262.51
494737-9473765.77666.79
593639-9363965.01466.03
698122-9812268.12769.15
20min1102712-10271271.31373.943.5272.9975.673.53
2112547-11254778.14279.99
3104692-10469272.68874.30
4105724-10572473.40575.15
5103856-10385672.10873.85
6109404-10940475.96077.74
30min1113523-11352378.81982.934.3581.2985.484.30
2127263-12726388.35991.08
3120602-12060283.73486.15
4119041-11904182.65185.21
5114019-11401979.16481.71
6122175-12217584.82787.45
45min1124327-12432786.32190.443.0389.6793.923.04
2135425-13542594.02697.73
3131186-13118691.08394.43
4131201-13120191.09394.57
5127127-12712788.26591.69
6132308-13230891.86295.43
60min1125793-12579387.33993.364.1391.6597.844.09
2140922-14092297.843102.59
3134023-13402393.05397.41
4133013-13301392.35196.84
5132872-13287292.25496.66
6140128-14012897.291101.88
90min1129961-12996190.23294.643.7395.51100.153.71
2141883-14188398.510104.34
3134893-13489393.65799.05
4136551-13655194.808100.32
5132086-13208691.70897.13
6142453-14245398.906104.57
极限1129373-12937389.82494.353.9096.11100.923.87
2144583-144583100.385107.31
3134251-13425193.21199.65
4134141-13414193.13599.70
5133737-13373792.85499.30
6139254-13925496.685103.45
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