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%
113.921553541554401555401557611558231555840.14
213.901552561555141553850.12
单位质量响应值RSD%判断
11177.0111178.780.02数据可信
供试品溶液-2025051921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%
5min174293-7429346.84946.763.0346.8546.763.03
273374-7337446.27046.27
378117-7811749.26149.26
473193-7319346.15646.16
571377-7137745.01045.01
674522-7452246.99446.99
10min1101606-10160664.07363.502.8164.5964.022.77
2102220-10222064.46064.97
398136-9813661.88562.43
4105140-10514066.30166.81
599242-9924262.58263.08
697826-9782661.68962.21
15min1119062-11906275.08172.483.4076.3173.703.35
2115120-11512072.59573.83
3108905-10890568.67669.91
4119176-11917675.15376.40
5114527-11452772.22173.42
6112805-11280571.13572.34
20min1127760-12776080.56678.772.7682.6380.792.72
2124495-12449578.50780.54
3118231-11823174.55776.55
4126577-12657779.82081.90
5125818-12581879.34181.34
6126555-12655579.80681.80
30min1142167-14216789.65186.752.7192.6189.662.67
2138608-13860887.40690.32
3131483-13148382.91385.74
4139990-13999088.27891.25
5137548-13754886.73889.62
6135587-13558785.50188.39
45min1150253-15025394.75091.382.6598.7195.252.61
2142937-14293790.13694.02
3138953-13895387.62491.37
4145113-14511391.50995.46
5147274-14727492.87196.71
6144959-14495991.41195.25
60min1153857-15385797.02294.221.77102.0399.101.75
2147349-14734992.91997.80
3147891-14789193.26097.98
4148814-14881493.84298.81
5151277-15127795.396100.27
6147263-14726392.86497.71
90min1152227-15222795.99593.753.14102.0899.683.05
2147669-14766993.12099.03
3140697-14069788.72494.48
4149785-14978594.455100.47
5154081-15408197.164103.10
6147572-14757293.05998.94
极限1151137-15113795.30792.273.43102.4699.243.33
2145381-14538191.67898.63
3137615-13761586.78093.52
4148306-14830693.522100.58
5150720-15072095.044102.06
6144745-14474591.27698.19
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%
113.921530321533651529041546061554301538670.72
213.901549141546301547720.13
单位质量响应值RSD%判断
11053.6611134.680.52数据可信
供试品溶液-2025051921批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min170972-7097245.09345.285.7945.0945.285.79
277495-7749549.23849.24
367879-6787943.12843.13
471832-7183245.64045.64
573512-7351246.70746.71
665864-6586441.84841.85
10min199878-9987863.45964.514.3863.9665.024.38
2110267-11026770.06070.61
3101401-10140164.42764.91
497731-9773162.09562.60
5100461-10046163.83064.35
699489-9948963.21263.68
15min1115211-11521173.20274.943.0074.4176.163.01
2123123-12312378.22979.55
3119531-11953175.94677.14
4116312-11631273.90175.10
5119952-11995276.21477.44
6113585-11358572.16873.34
20min1123626-12362678.54880.132.9780.5782.182.97
2130855-13085583.14185.34
3130597-13059782.97785.02
4122474-12247477.81679.83
5125842-12584279.95682.03
6123304-12330478.34480.31
30min1135709-13570986.22588.432.7389.1291.382.75
2145493-14549392.44295.56
3141090-14109089.64492.61
4137134-13713487.13190.01
5139907-13990788.89391.86
6135785-13578586.27489.11
45min1149066-14906694.71294.212.6798.5698.132.67
2155002-15500298.483102.63
3147895-14789593.96897.92
4142739-14273990.69294.54
5147755-14775593.87997.83
6147180-14718093.51497.31
60min1145487-14548792.43895.072.7897.34100.042.78
2156577-15657799.484104.72
3150609-15060995.692100.69
4145615-14561592.51997.38
5151074-15107495.988100.98
6148411-14841194.29699.13
90min1147606-14760693.78496.313.4999.71102.343.45
2160022-160022101.673108.02
3152518-15251896.905102.97
4145134-14513492.21498.10
5154289-15428998.030104.09
6149903-14990395.244101.13
极限1142699-14269990.66793.783.2097.64100.883.17
2154958-15495898.456105.93
3149396-14939694.922102.06
4142699-14269990.66797.58
5149584-14958495.041102.19
6146255-14625592.92699.87
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