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%
113.821413041410561400321395671398541403630.55
213.881438431439951439190.08
单位质量响应值RSD%判断
10156.5110368.801.47数据可信
供试品溶液-123852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%
5min150163-5016334.15534.242.4734.1534.242.47
249468-4946833.68233.68
350034-5003434.06734.07
452713-5271335.89135.89
550052-5005234.07934.08
649278-4927833.55233.55
10min181574-8157455.54254.473.0755.9254.853.04
283276-8327656.70157.08
379785-7978554.32454.70
477698-7769852.90353.30
580906-8090655.08755.47
676735-7673552.24752.62
15min198768-9876867.24965.232.4268.2566.222.40
297553-9755366.42267.43
396823-9682365.92566.91
492575-9257563.03264.02
594155-9415564.10865.10
694911-9491164.62365.58
20min1106063-10606372.21672.442.0473.9674.152.00
2107254-10725473.02774.77
3108497-10849773.87375.59
4102711-10271169.93471.62
5105501-10550171.83373.54
6108336-10833673.76475.44
30min1117666-11766680.11681.382.3682.6683.892.32
2122134-12213483.15885.71
3123663-12366384.20086.73
4116200-11620079.11881.58
5118709-11870980.82683.33
6118721-11872180.83583.33
45min1126669-12666986.24688.431.7389.6891.851.69
2130825-13082589.07692.55
3133021-13302190.57194.04
4128084-12808487.21090.55
5129902-12990288.44891.85
6130742-13074289.01992.41
60min1134358-13435891.48291.401.3795.8895.801.35
2136275-13627592.78797.25
3134517-13451791.59096.07
4131607-13160789.60893.92
5136000-13600092.60096.98
6132638-13263890.31094.69
90min1136583-13658392.99693.351.7398.4198.761.69
2139916-13991695.266100.76
3139677-13967795.103100.60
4135503-13550392.26197.57
5137048-13704893.31398.72
6133872-13387291.15196.53
极限1134910-13491091.85790.101.6098.3096.551.56
2134306-13430691.44698.00
3133236-13323690.71897.27
4130051-13005188.54994.88
5131223-13122389.34795.79
6130233-13023388.67395.07
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%
113.821439481435631436571433371435201436050.16
213.881437411434381435900.15
单位质量响应值RSD%判断
10391.1010345.100.32数据可信
供试品溶液-123852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%
5min146064-4606431.04230.312.9531.0430.312.96
245130-4513030.41230.41
345654-4565430.76630.77
444263-4426329.82829.83
546070-4607031.04631.05
642651-4265128.74228.74
10min173096-7309649.25848.631.2149.6048.971.21
270802-7080247.71248.05
372183-7218348.64348.98
472522-7252248.87249.20
572881-7288149.11349.46
671526-7152648.20048.52
15min190964-9096461.29961.452.4162.1962.332.37
290889-9088961.24962.12
390695-9069561.11862.00
495475-9547564.33965.21
589467-8946760.29161.18
689677-8967760.43261.29
20min1103586-10358669.80568.861.3371.3870.421.30
299660-9966067.15968.71
3102331-10233168.95970.52
4102259-10225968.91170.50
5102153-10215368.83970.40
6103085-10308569.46870.99
30min1115560-11556077.87479.253.7580.2281.583.64
2110628-11062874.55176.85
3118247-11824779.68582.01
4116746-11674678.67381.03
5122528-12252882.57084.90
6121907-12190782.15184.45
45min1127082-12708285.63986.882.9088.8590.082.82
2124550-12455083.93287.06
3129723-12972387.41890.63
4132321-13232189.16992.40
5125879-12587984.82888.07
6133982-13398290.28993.50
60min1130392-13039287.86989.674.0392.0493.843.86
2130385-13038587.86591.92
3133709-13370990.10594.29
4130944-13094488.24192.46
5143568-14356896.748100.93
6129363-12936387.17691.39
90min1130982-13098288.26789.681.5393.4194.851.43
2135773-13577391.49596.53
3132068-13206888.99994.18
4131870-13187088.86594.07
5135485-13548591.30196.56
6132330-13233089.17594.36
极限1128750-12875086.76386.660.8692.8992.820.79
2129553-12955387.30493.35
3129480-12948087.25593.43
4127361-12736185.82792.01
5129314-12931487.14393.42
6127097-12709785.64991.82
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%
113.821460711459411461791459121457641459730.11
213.881458511459181458840.04
单位质量响应值RSD%判断
10562.4510510.370.35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%
5min161279-6127940.63539.993.1240.6439.993.13
259932-5993239.74239.74
360041-6004139.81439.81
462681-6268141.56541.57
557054-5705437.83437.83
660811-6081140.32540.33
10min186734-8673457.51558.493.6957.9758.933.66
289913-8991359.62360.06
393898-9389862.26662.71
484900-8490056.29956.76
586233-8623357.18357.60
687531-8753158.04458.49
15min1104862-10486269.53670.183.9270.6371.273.88
2103928-10392868.91770.02
3107676-10767671.40272.54
4103587-10358768.69169.78
5101635-10163567.39668.45
6113268-11326875.11076.20
20min1118125-11812578.33178.162.6980.1980.032.65
2117602-11760277.98479.85
3123960-12396082.20184.13
4116162-11616277.03078.88
5115782-11578276.77878.58
6115543-11554376.61978.55
30min1135055-13505589.55888.132.9292.2990.882.90
2130690-13069086.66389.40
3139260-13926092.34695.19
4131774-13177487.38290.09
5128002-12800284.88187.54
6132661-13266187.97090.75
45min1141746-14174693.99596.163.8297.7299.883.74
2141932-14193294.11897.82
3155811-155811103.322107.19
4146028-14602896.834100.51
5142150-14215094.26397.86
6142436-14243694.45298.21
60min1149686-14968699.26096.322.36104.03101.112.33
2144396-14439695.752100.50
3148144-14814498.238103.25
4144438-14443895.780100.53
5139864-13986492.74797.40
6144980-14498096.139100.95
90min1144658-14465895.92695.661.76101.80101.521.79
2144776-14477696.004101.81
3147639-14763997.903104.01
4142911-14291194.767100.58
5140149-14014992.93698.61
6145450-14545096.451102.33
极限1140417-14041793.11494.181.76100.06101.111.78
2142470-14247094.475101.35
3145720-14572096.630103.82
4141181-14118193.620100.49
5138679-13867991.96198.67
6143722-14372295.305102.25
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