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%
114.111556271568441572171558461555751562220.49
214.171560451555851558150.21
单位质量响应值RSD%判断
11071.7210996.120.49数据可信
供试品溶液-24111101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%
5min145369-4536928.72927.852.5528.7327.852.55
243350-4335027.45027.45
343053-4305327.26227.26
445087-4508728.55028.55
542667-4266727.01827.02
644338-4433828.07628.08
10min169710-6971044.14245.121.5644.4645.431.55
271417-7141745.22345.53
371961-7196145.56845.87
472794-7279446.09546.41
571364-7136445.19045.49
670317-7031744.52744.84
15min184457-8445753.48056.092.5354.2956.902.50
288981-8898156.34557.15
390855-9085557.53258.34
488438-8843856.00156.83
588484-8848456.03056.83
690220-9022057.13057.94
20min196939-9693961.38462.841.8162.7964.281.79
298160-9816062.15763.59
3101688-10168864.39165.84
4100428-10042863.59465.05
598088-9808862.11263.54
6100132-10013263.40664.85
30min1110831-11083170.18172.052.3072.2774.182.27
2111318-11131870.48972.61
3115992-11599273.44975.61
4116711-11671173.90476.06
5112186-11218671.03973.15
6115615-11561573.21075.36
45min1122369-12236977.48780.393.2380.3583.333.15
2121412-12141276.88179.79
3127625-12762580.81583.80
4129943-12994382.28385.26
5131128-13112883.03485.94
6129288-12928881.86884.83
60min1124788-12478879.01983.633.3582.7587.463.27
2129164-12916481.79085.55
3135028-13502885.50389.38
4136713-13671386.57090.46
5134471-13447185.15088.98
6132300-13230083.77687.64
90min1131142-13114283.04286.894.0787.6591.643.95
2129722-12972282.14386.81
3142937-14293790.51195.34
4142251-14225190.07794.93
5138838-13883887.91692.69
6138405-13840587.64292.44
极限1128950-12895081.65486.103.2387.1891.823.17
2132547-13254783.93289.52
3139577-13957788.38494.22
4140218-14021888.79094.65
5137823-13782387.27393.02
6136711-13671186.56992.34
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%
114.111542661545401538041555861550311546450.45
214.171560781555761558270.23
单位质量响应值RSD%判断
10959.9610996.970.24数据可信
供试品溶液-24111102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%
5min147012-4701229.91928.036.0029.9228.036.01
245023-4502328.65328.65
346714-4671429.73029.73
441143-4114326.18426.18
543333-4333327.57827.58
641029-4102926.11226.11
10min173461-7346146.75245.373.5347.0845.683.54
273853-7385347.00147.32
373348-7334846.68047.01
469673-6967344.34144.63
568718-6871843.73344.04
668676-6867643.70744.00
15min194997-9499760.45857.103.3561.3157.913.34
287286-8728655.55056.39
391112-9111257.98558.83
489359-8935956.87057.65
588701-8870156.45157.24
686871-8687155.28656.06
20min1109458-10945869.66164.184.4571.1865.634.40
297727-9772762.19563.65
399110-9911063.07564.57
4102009-10200964.92066.34
598715-9871562.82464.24
698087-9808762.42463.81
30min1121283-12128377.18773.762.3579.4875.932.37
2114117-11411772.62674.78
3116017-11601773.83576.03
4114968-11496873.16875.30
5114518-11451872.88175.00
6114536-11453672.89374.98
45min1132259-13225984.17281.212.2987.3384.202.30
2124785-12478579.41682.37
3129535-12953582.43985.45
4125284-12528479.73382.68
5125712-12571280.00582.93
6128096-12809681.52384.42
60min1138044-13804487.85484.192.6191.9488.072.60
2129445-12944582.38186.22
3133864-13386485.19489.12
4129423-12942382.36786.20
5129727-12972782.56186.38
6133214-13321484.78088.58
90min1142399-14239990.62588.202.7095.6993.022.67
2136033-13603386.57491.33
3143921-14392191.59496.47
4134519-13451985.61090.36
5136990-13699087.18391.92
6137634-13763487.59392.33
极限1137844-13784487.72786.162.6993.8091.972.64
2132696-13269684.45090.17
3141328-14132889.94495.84
4131618-13161883.76489.47
5133552-13355284.99590.70
6135299-13529986.10791.82
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