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D230603FK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%
114.061578601573151559221557111561891565990.60
213.721522111503961513040.85
单位质量响应值RSD%判断
11137.9111027.990.71数据可信
供试品溶液-2025032622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%
5min150975-5097532.13633.187.9632.1433.187.96
259137-5913737.28237.28
348533-4853330.59730.60
449243-4924331.04431.04
551586-5158632.52132.52
656264-5626435.47135.47
10min179038-7903849.82849.506.7250.1949.876.70
281624-8162451.45851.87
380391-8039150.68151.02
468259-6825943.03343.38
578794-7879449.67450.04
683009-8300952.33252.73
15min191605-9160557.75158.872.9258.6659.792.96
294723-9472359.71660.70
394999-9499959.89060.79
488593-8859355.85256.67
595416-9541660.15361.07
694951-9495159.86060.84
20min1105733-10573366.65864.654.6068.2166.224.56
2103004-10300464.93766.59
399741-9974162.88064.45
495117-9511759.96561.41
5108678-10867868.51470.10
6103004-10300464.93766.58
30min1113258-11325871.40272.956.1373.6975.246.05
2114934-11493472.45874.83
3115558-11555872.85275.12
4104309-10430965.76067.87
5124605-12460578.55580.90
6121651-12165176.69379.05
45min1130626-13062682.35179.474.1285.4482.574.09
2127209-12720980.19783.37
3120649-12064976.06179.14
4118966-11896675.00077.84
5127254-12725480.22583.44
6131639-13163982.99086.20
60min1127757-12775780.54281.435.5384.5485.425.44
2136944-13694486.33490.40
3122792-12279277.41281.33
4120404-12040475.90779.58
5129327-12932781.53285.64
6137802-13780286.87591.01
90min1133935-13393584.43783.654.4189.3388.544.39
2136196-13619685.86290.89
3126373-12637379.67084.45
4125114-12511478.87683.39
5134231-13423184.62489.64
6140249-14024988.41893.52
极限1137929-13792986.95584.725.0292.7990.544.93
2141770-14177089.37695.36
3127361-12736180.29385.96
4124918-12491878.75284.15
5138801-13880187.50593.46
6135524-13552485.43991.52
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D230603FK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%
114.061595771596511593371594211593251594620.10
213.721539681550581545130.50
单位质量响应值RSD%判断
11341.5411261.880.50数据可信
供试品溶液-2025032622批-pH4.5(内含0.005%羟丙基纤维素)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183895-8389551.86649.319.7651.8749.319.76
278284-7828448.39748.40
369379-6937942.89242.89
479497-7949749.14749.15
592219-9221957.01257.01
675258-7525846.52646.53
10min1100446-10044662.09863.173.8062.6763.723.80
2105969-10596965.51266.05
3101203-10120362.56663.04
495982-9598259.33859.88
5106395-10639565.77666.41
6103072-10307263.72164.24
15min1116214-11621471.84672.053.4773.1173.303.44
2113554-11355470.20271.47
3120939-12093974.76775.94
4112843-11284369.76270.97
5122100-12210075.48576.85
6113646-11364670.25871.48
20min1126662-12666278.30576.353.1980.3778.403.15
2126278-12627878.06880.11
3123989-12398976.65378.66
4122813-12281375.92677.91
5125205-12520577.40579.61
6116009-11600971.71973.72
30min1132462-13246281.89182.223.5384.8385.123.50
2135993-13599384.07486.99
3128192-12819279.25182.11
4133077-13307782.27185.10
5140231-14023186.69489.76
6128006-12800679.13681.94
45min1141037-14103787.19288.574.1391.0492.394.09
2146482-14648290.55894.41
3139030-13903085.95189.69
4141055-14105587.20390.94
5153798-15379895.08199.11
6138208-13820885.44389.13
60min1142815-14281588.29190.603.4993.1095.393.47
2148362-14836291.72196.57
3147422-14742291.14095.83
4143794-14379488.89793.60
5155427-15542796.088101.17
6141426-14142687.43392.06
90min1144899-14489989.58092.293.0795.3798.103.07
2151586-15158693.71499.59
3149619-14961992.49898.20
4147710-14771091.31897.01
5156967-15696797.040103.19
6144954-14495489.61495.22
极限1152323-15232394.16991.752.76100.9698.582.76
2148260-14826091.65898.57
3147454-14745491.15997.89
4145086-14508689.69596.40
5153977-15397795.192102.42
6143385-14338588.64495.24
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