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%
114.031594241596671605381612211583541598410.69
214.081587371588131587750.04
单位质量响应值RSD%判断
11392.8011276.630.73数据可信
供试品溶液-023200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%
5min155311-5531134.09533.876.8134.1033.876.81
260003-6000336.98836.99
358672-5867236.16736.17
453006-5300632.67532.67
551696-5169631.86731.87
650958-5095831.41231.41
10min186885-8688553.55950.944.8453.9451.324.85
287738-8773854.08454.50
383378-8337851.39751.80
479126-7912648.77649.14
578470-7847048.37148.73
680261-8026149.47549.82
15min1101029-10102962.27761.133.2763.2562.073.28
299857-9985761.55562.57
3104170-10417064.21465.19
495195-9519558.68159.59
596565-9656559.52660.42
698159-9815960.50861.41
20min1114573-11457370.62667.995.8172.2969.615.75
2111904-11190468.98170.68
3119135-11913573.43875.12
4106827-10682765.85167.41
5100768-10076862.11663.67
6108595-10859566.94168.51
30min1133325-13332582.18678.663.0284.6481.043.04
2127545-12754578.62381.08
3130851-13085180.66183.16
4123088-12308875.87578.16
5124830-12483076.94979.19
6126004-12600477.67379.99
45min1142967-14296788.12986.702.5491.4989.962.56
2145536-14553689.71393.05
3141934-14193487.49290.89
4135404-13540483.46786.60
5139056-13905685.71888.82
6139026-13902685.70088.88
60min1143597-14359788.51889.011.7692.8693.231.70
2142071-14207187.57791.91
3146730-14673090.44994.82
4143188-14318888.26592.32
5142475-14247587.82691.88
6148330-14833091.43595.57
90min1147720-14772091.05990.331.5296.3995.531.56
2145461-14546189.66794.97
3150500-15050092.77398.15
4145825-14582589.89194.93
5144835-14483589.28194.31
6144835-14483589.28194.43
极限1143234-14323488.29488.050.5594.6394.260.61
2141947-14194787.50093.80
3143978-14397888.75295.16
4143265-14326588.31394.35
5142155-14215587.62993.65
6142439-14243987.80493.94
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%
114.031586571594951605781601501606431599050.53
214.081581591577401579500.19
单位质量响应值RSD%判断
11397.3611218.041.13数据可信
供试品溶液-023200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%
5min161615-6161538.07335.415.8238.0735.415.82
259321-5932136.65636.66
359027-5902736.47436.47
456956-5695635.19535.19
553174-5317432.85832.86
653728-5372833.20033.20
10min186243-8624353.29251.457.8953.7151.847.86
286913-8691353.70654.11
388082-8808254.42854.83
488581-8858154.73655.13
575370-7537046.57346.94
674350-7435045.94346.31
15min1105410-10541065.13663.017.7666.1563.987.73
2106812-10681266.00267.01
3100121-10012161.86762.88
4112507-11250769.52170.52
596648-9664859.72160.60
690355-9035555.83356.71
20min1113945-11394570.41069.537.6872.1571.207.66
2117782-11778272.78174.52
3113733-11373370.27971.98
4124298-12429876.80778.58
5104912-10491264.82866.37
6100462-10046262.07863.58
30min1132829-13282982.07879.595.2684.6082.035.29
2136263-13626384.20086.75
3125079-12507977.29079.77
4135278-13527883.59286.22
5121960-12196075.36277.63
6121413-12141375.02477.21
45min1146752-14675290.68287.773.7494.1291.093.81
2147333-14733391.04194.52
3140356-14035686.73090.07
4144710-14471089.42092.97
5139686-13968686.31689.42
6133396-13339682.42985.45
60min1149161-14916192.17089.293.7196.6193.593.77
2147874-14787491.37595.87
3148785-14878591.93896.24
4145624-14562489.98594.53
5138325-13832585.47589.54
6137258-13725884.81588.75
90min1144506-14450689.29489.753.3694.7695.043.44
2149308-14930892.26197.77
3144538-14453889.31494.64
4152373-15237394.15599.70
5141551-14155187.46892.48
6139193-13919386.01190.89
极限1145552-14555289.94088.383.1096.4094.663.21
2148165-14816591.55598.09
3143121-14312188.43894.75
4145822-14582290.10796.70
5136800-13680084.53290.52
6138678-13867885.69391.53
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