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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.411639681639571638161648731646851642600.30
214.451632481631931632200.03
单位质量响应值RSD%判断
11399.0311295.500.65数据可信
供试品溶液-24041201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%
5min187978-8797856.15959.613.0356.1659.613.03
295210-9521060.77660.78
395669-9566961.06961.07
494297-9429760.19360.19
594361-9436160.23460.23
692757-9275759.21059.21
10min197844-9784462.45766.085.1363.0866.755.09
2100198-10019863.96064.64
3100965-10096564.44965.13
4106056-10605667.69968.37
5103359-10335965.97866.65
6112728-11272871.95872.62
15min1137277-13727787.62990.062.5188.9591.462.50
2136268-13626886.98588.37
3143876-14387691.84193.24
4143452-14345291.57092.99
5144471-14447192.22193.62
6141145-14114590.09891.56
20min1140614-14061489.75992.162.6592.0594.562.64
2139230-13923088.87591.23
3145465-14546592.85595.27
4144438-14443892.20094.64
5148927-14892795.06597.49
6147593-14759394.21496.67
30min1140452-14045289.65592.902.2292.9496.322.23
2142660-14266091.06594.40
3147169-14716993.94397.39
4146899-14689993.77197.23
5147317-14731794.03897.52
6148717-14871794.93198.44
45min1143409-14340991.54393.731.6795.8398.191.70
2144100-14410091.98496.34
3149103-14910395.17899.67
4147660-14766094.25698.76
5148515-14851594.80299.33
6148271-14827194.64699.21
60min1139859-13985989.27793.142.8694.5898.642.83
2141592-14159290.38395.76
3149577-14957795.480101.03
4146803-14680393.70999.26
5148475-14847594.777100.36
6149194-14919495.236100.85
90min1135096-13509686.23691.213.0392.5397.742.98
2140426-14042689.63996.02
3145285-14528592.74099.35
4145287-14528792.74299.34
5145392-14539292.80999.44
6145842-14584293.09699.77
极限1135800-13580086.68690.852.9893.9498.402.94
2139132-13913288.81396.19
3145333-14533392.771100.41
4141696-14169690.44998.07
5145379-14537992.800100.47
6146604-14660493.582101.29
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.411641091639211641951630331631591636830.34
214.451651121651401651260.02
单位质量响应值RSD%判断
11358.9911427.400.43数据可信
供试品溶液-24041201-1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119367-1936712.31313.6215.4512.3113.6215.46
223408-2340814.88214.88
327085-2708517.21917.22
420759-2075913.19813.20
519873-1987312.63412.63
618011-1801111.45111.45
10min119829-1982912.60614.4210.3612.7414.5710.27
223359-2335914.85115.02
321850-2185013.89114.08
426829-2682917.05717.20
522567-2256714.34714.49
621646-2164613.76213.89
15min129172-2917218.54618.465.0618.8218.785.10
230729-3072919.53619.87
330093-3009319.13219.48
429379-2937918.67819.01
528332-2833218.01218.31
626553-2655316.88117.16
20min128889-2888918.36619.327.3918.8519.847.27
230112-3011219.14419.69
329882-2988218.99819.56
432666-3266620.76821.31
533346-3334621.20021.70
627450-2745017.45117.92
30min128738-2873818.27019.064.1618.9619.794.19
231740-3174020.17920.94
329966-2996619.05119.82
430274-3027419.24720.02
530716-3071619.52820.26
628405-2840518.05918.72
45min130929-3092919.66319.184.0220.5520.123.92
232035-3203520.36621.35
329039-2903918.46219.44
429995-2999519.06920.06
530200-3020019.20020.15
628770-2877018.29119.15
60min129615-2961518.82818.794.0119.9419.953.96
231010-3101019.71520.93
329089-2908918.49319.68
429042-2904218.46419.66
530772-3077219.56320.73
627842-2784217.70118.77
90min130218-3021819.21118.993.6120.5320.363.53
231902-3190220.28221.71
329284-2928418.61720.01
429329-2932918.64620.05
529551-2955118.78720.17
628970-2897018.41819.68
极限129071-2907118.48218.685.4620.0120.265.31
230944-3094419.67321.33
331280-3128019.88621.48
428873-2887318.35619.97
529280-2928018.61520.21
626843-2684317.06618.53
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