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%
113.821547391548351545191542801543951545540.15
213.881546201548651547420.12
单位质量响应值RSD%判断
11183.3611148.560.23数据可信
供试品溶液-123852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%
5min149581-4958131.02433.084.3631.0233.084.36
256720-5672035.49235.49
352273-5227332.70932.71
453427-5342733.43133.43
552426-5242632.80532.80
652772-5277233.02133.02
10min180274-8027450.23053.144.5950.5753.504.57
285289-8528953.36853.76
383423-8342352.20052.56
492052-9205257.60057.97
584406-8440652.81653.18
684080-8408052.61252.98
15min199038-9903861.97165.265.7462.8766.225.71
2105812-10581266.21067.20
399850-9985062.47963.42
4115466-11546672.25173.26
5103136-10313664.53565.49
6102482-10248264.12665.08
20min1110732-11073269.28973.795.0870.8875.475.07
2118093-11809373.89575.62
3115003-11500371.96173.60
4128762-12876280.57082.38
5118203-11820373.96375.63
6116732-11673273.04374.71
30min1127733-12773379.92784.405.0182.2986.914.97
2134727-13472784.30386.85
3126783-12678379.33281.77
4142228-14222888.99791.71
5135411-13541184.73187.22
6142442-14244289.13191.61
45min1144179-14417990.21794.353.0193.4797.792.96
2154037-15403796.38699.87
3150705-15070594.30197.62
4149158-14915893.33397.03
5149219-14921993.37196.80
6157384-15738498.480101.95
60min1143610-14361089.86192.432.1794.1196.922.10
2144940-14494090.69495.25
3152212-15221295.24499.61
4149115-14911593.30698.04
5149576-14957693.59498.06
6146857-14685791.89396.45
90min1144550-14455090.45090.263.3095.7095.783.11
2148043-14804392.63598.19
3144965-14496590.70996.13
4146259-14625991.51997.29
5146805-14680591.86197.37
6134908-13490884.41690.00
极限1141250-14125088.38589.601.0094.6496.121.06
2142712-14271289.29995.89
3142590-14259089.22395.66
4144417-14441790.36697.16
5142984-14298489.47096.00
6145243-14524390.88397.40
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%
113.821538691547381536941545131543521542330.29
213.881538071537181537620.05
单位质量响应值RSD%判断
11160.1311077.950.53数据可信
供试品溶液-123852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%
5min149696-4969631.22831.611.3631.2331.611.36
249411-4941131.04931.05
350705-5070531.86231.86
450844-5084431.94931.95
550058-5005831.45531.46
651116-5111632.12032.12
10min181017-8101750.90952.112.1851.2652.462.16
286311-8631154.23654.58
383106-8310652.22252.58
482288-8228851.70852.06
582763-8276352.00752.36
682108-8210851.59551.95
15min1101652-10165263.87664.431.6464.7965.361.62
2103773-10377365.20966.16
399808-9980862.71763.65
4104041-10404165.37766.31
5103888-10388865.28166.21
6102058-10205864.13165.06
20min1116456-11645673.17972.291.4274.8073.941.39
2116589-11658973.26274.93
3114951-11495172.23373.86
4113031-11303171.02672.68
5113120-11312071.08272.73
6116115-11611572.96474.61
30min1130857-13085782.22881.801.9484.6684.251.89
2133447-13344783.85586.34
3127120-12712079.88082.31
4131775-13177582.80585.25
5130609-13060982.07284.51
6127283-12728379.98282.44
45min1141289-14128988.78389.851.5192.1393.211.48
2146443-14644392.02295.44
3142120-14212089.30592.63
4141077-14107788.65092.02
5144796-14479690.98794.34
6142170-14217089.33792.68
60min1144451-14445190.77092.592.2395.1196.952.15
2151397-15139795.13599.58
3151562-15156295.23899.55
4144620-14462090.87695.23
5146353-14635391.96596.33
6145678-14567891.54195.88
90min1147738-14773892.83592.621.5398.1898.011.48
2150300-15030094.44599.94
3145474-14547491.41396.78
4147756-14775692.84798.21
5144160-14416090.58795.97
6148980-14898093.61698.97
极限1142000-14200089.23090.502.0595.6196.921.97
2148620-14862093.39099.94
3146859-14685992.28398.67
4141955-14195589.20295.59
5141993-14199389.22595.62
6142742-14274289.69696.09
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%
113.821459741456141453731452941451721454850.22
213.881456331454881455600.08
单位质量响应值RSD%判断
10527.1310487.030.27数据可信
供试品溶液-123852批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159557-5955739.60439.351.6439.6039.351.64
257362-5736238.14438.14
359768-5976839.74439.74
459688-5968839.69139.69
559874-5987439.81439.81
658795-5879539.09739.10
10min187289-8728958.04558.873.2958.4859.313.26
289528-8952859.53459.96
391567-9156760.88961.33
490711-9071160.32060.76
588654-8865458.95259.39
683466-8346655.50255.94
15min1105362-10536270.06370.941.9871.1572.031.98
2107115-10711571.22872.31
3108612-10861272.22473.34
4106238-10623870.64571.76
5109213-10921372.62373.72
6103525-10352568.84169.89
20min1118623-11862378.88178.391.8880.7480.261.88
2116333-11633377.35879.23
3119699-11969979.59681.52
4117501-11750178.13580.03
5120550-12055080.16282.07
6114572-11457276.18778.00
30min1139244-13924492.59388.482.5395.3391.232.46
2132110-13211087.84990.59
3132430-13243088.06290.87
4131702-13170287.57890.34
5133591-13359188.83491.63
6129243-12924385.94388.61
45min1151819-151819100.95598.054.04104.72101.783.91
2142801-14280194.95998.67
3145034-14503496.443100.23
4141340-14134093.98797.72
5157056-157056104.438108.22
6146615-14661597.495101.11
60min1148898-14889899.01397.740.81103.90102.560.83
2147111-14711197.825102.59
3146576-14657697.469102.32
4145593-14559396.815101.60
5147637-14763798.174103.12
6146081-14608197.140101.84
90min1152015-152015101.08698.992.16107.08104.902.04
2149154-14915499.183105.04
3146188-14618897.211103.15
4144070-14407095.802101.66
5149606-14960699.484105.52
6152122-152122101.157106.94
极限1145740-14574096.913104.4117.53104.03111.4216.40
2213080-213080141.692148.65
3147506-14750698.087105.11
4143092-14309295.152102.07
5145277-14527796.605103.74
6147390-14739098.010104.91
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