他克莫司缓释颗粒项目信息
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%
113.861613281612481612481602031604701608990.33
213.831609451611881610660.11
单位质量响应值RSD%判断
11608.8711646.130.23数据可信
中间条件6月-供试品溶液-2025052121批-pH4.5含0.005%羟丙基千维素
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177507-7750746.98643.625.1346.9943.635.14
273287-7328744.42844.43
368212-6821241.35141.35
467780-6778041.09041.09
573813-7381344.74744.75
671175-7117543.14843.15
10min1102676-10267662.24459.575.9162.7760.065.88
299402-9940260.25960.75
392326-9232655.97056.43
493297-9329756.55857.02
594884-9488457.52158.02
6106988-10698864.85865.34
15min1120833-12083373.25167.595.3474.4668.745.32
2112063-11206367.93569.10
3107189-10718964.98066.06
4108917-10891766.02867.11
5104509-10450963.35564.49
6115447-11544769.98671.19
20min1127636-12763677.37574.923.2479.4076.823.27
2122741-12274174.40876.33
3119525-11952572.45874.26
4121628-12162873.73375.55
5120622-12062273.12374.96
6129376-12937678.43080.41
30min1140019-14001984.88281.412.8687.7784.142.89
2132842-13284280.53183.28
3129787-12978778.67981.29
4131949-13194979.99082.63
5133421-13342180.88283.54
6137731-13773183.49586.34
45min1152593-15259392.50587.623.2296.3491.253.24
2145234-14523488.04491.68
3139150-13915084.35587.84
4142805-14280586.57190.10
5141521-14152185.79389.34
6145864-14586488.42692.20
60min1152075-15207592.19188.622.5997.0593.232.64
2146126-14612688.58493.20
3141122-14112285.55189.97
4145516-14551688.21592.70
5143859-14385987.21091.71
6148442-14844289.98894.75
90min1151091-15109191.59489.862.2297.4895.462.27
2149756-14975690.78596.39
3143224-14322486.82592.20
4148691-14869190.13995.61
5145329-14532988.10193.57
6151335-15133591.74297.50
极限1149243-14924390.47488.192.2597.3794.782.31
2146851-14685189.02495.63
3139833-13983384.76991.10
4145397-14539788.14294.61
5144104-14410487.35993.81
6147397-14739789.35596.13
他克莫司缓释颗粒项目信息
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%
113.861608801607731610441609531609781609260.07
213.831611651604631608140.31
单位质量响应值RSD%判断
11610.8211627.910.11数据可信
中间条件6月-供试品溶液-2025052121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178602-7860247.68344.375.0547.6844.375.05
271097-7109743.13043.13
368792-6879241.73241.73
470314-7031442.65542.66
574818-7481845.38845.39
675257-7525745.65445.65
10min1102586-10258662.23360.402.9962.7660.902.99
298358-9835859.66860.15
395936-9593658.19958.66
4101505-10150561.57762.05
596622-9662258.61559.12
6102417-10241762.13162.64
15min1120280-12028072.96768.533.4074.1969.693.38
2110153-11015366.82467.97
3113296-11329668.73069.84
4110314-11031466.92168.08
5110779-11077967.20368.36
6112928-11292868.50769.70
20min1127854-12785477.56273.913.1479.5975.843.12
2121671-12167173.81175.70
3121369-12136973.62875.50
4119799-11979972.67574.58
5116514-11651470.68272.58
6123832-12383275.12277.08
30min1142154-14215486.23782.043.3389.1384.793.31
2134790-13479081.76984.47
3135030-13503081.91584.61
4130319-13031979.05781.77
5130830-13083079.36782.05
6138335-13833583.92086.71
45min1149022-14902290.40386.632.9894.2690.292.96
2144940-14494087.92791.54
3143695-14369587.17290.77
4137896-13789683.65487.24
5138106-13810683.78187.35
6143161-14316186.84890.57
60min1150467-15046791.28088.482.2296.1493.102.21
2146431-14643188.83193.42
3147950-14795089.75394.32
4141083-14108385.58790.10
5144678-14467887.76892.27
6144505-14450587.66392.35
90min1152312-15231292.39990.052.8498.2795.662.78
2148834-14883490.28995.87
3153742-15374293.26698.83
4142693-14269386.56492.03
5144921-14492187.91593.39
6148170-14817089.88695.55
极限1150011-15001191.00387.493.2597.9094.103.17
2146147-14614788.65995.24
3148214-14821489.91396.52
4138649-13864984.11090.54
5139394-13939484.56291.01
6142906-14290686.69393.36
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