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%
114.291587441582281579721582621581511582710.19
214.201592281588981590630.15
单位质量响应值RSD%判断
11075.6511201.620.80数据可信
供试品溶液-2025052121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%
5min153189-5318933.66033.896.8433.6633.896.84
254315-5431534.37334.37
350652-5065232.05532.05
459395-5939537.58837.59
548870-4887030.92730.93
654891-5489134.73734.74
10min180892-8089251.19251.004.8251.5751.384.84
282159-8215951.99452.38
378044-7804449.39049.75
486170-8617054.53254.95
574733-7473347.29447.64
681550-8155051.60851.99
15min193858-9385859.39859.844.2160.3460.784.22
295458-9545860.41061.37
394475-9447559.78860.69
499691-9969163.08964.11
587596-8759655.43556.30
696217-9621760.89061.85
20min1106678-10667867.51166.833.2969.1168.443.32
2105275-10527566.62368.25
3102841-10284165.08266.65
4109051-10905169.01270.74
5100495-10049563.59865.08
6109265-10926569.14870.78
30min1121122-12112276.65174.362.6079.0076.712.61
2117990-11799074.66977.04
3117484-11748474.34976.64
4120249-12024976.09978.59
5113006-11300671.51573.71
6115145-11514572.86975.27
45min1127039-12703980.39679.781.5183.6082.961.52
2123665-12366578.26181.46
3128251-12825181.16384.28
4127588-12758880.74384.08
5124004-12400478.47581.46
6125876-12587679.66082.87
60min1135495-13549585.74782.722.0689.8586.782.02
2130454-13045482.55786.63
3129425-12942581.90685.93
4131783-13178383.39887.63
5129324-12932481.84285.70
6127796-12779680.87584.97
90min1137969-13796987.31385.161.4292.3690.141.40
2132492-13249283.84788.83
3134688-13468885.23790.17
4135095-13509585.49490.65
5133744-13374484.63989.41
6133407-13340784.42689.42
极限1135772-13577285.92384.611.6491.9490.541.56
2130313-13031382.46888.39
3134113-13411384.87390.75
4135445-13544585.71691.83
5134745-13474585.27390.98
6131775-13177583.39389.33
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%
114.291582121586281582621580871578831582140.18
214.201581981584301583140.11
单位质量响应值RSD%判断
11071.6611148.870.50数据可信
供试品溶液-2025052121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%
5min172726-7272646.14145.663.1446.1445.663.14
271222-7122245.18745.19
376145-7614548.31048.31
470738-7073844.88044.88
571166-7116645.15145.15
669795-6979544.28144.28
10min197667-9766761.96561.292.1962.4861.792.19
295942-9594260.87061.37
3100366-10036663.67764.21
495068-9506860.31660.81
595829-9582960.79961.30
694731-9473160.10260.59
15min1112654-11265471.47370.331.9372.6771.521.91
2111835-11183570.95372.13
3111364-11136470.65571.90
4109735-10973569.62170.79
5107047-10704767.91669.09
6112453-11245371.34672.51
20min1122995-12299578.03476.891.0480.0378.861.03
2122476-12247677.70579.67
3120944-12094476.73378.76
4120114-12011476.20678.15
5120032-12003276.15478.09
6120591-12059176.50978.46
30min1132624-13262484.14383.151.9287.0185.971.90
2132109-13210983.81686.65
3134414-13441485.27988.16
4129825-12982582.36785.16
5127311-12731180.77283.55
6130030-13003082.49785.30
45min1140799-14079989.33087.591.7593.1391.341.73
2140098-14009888.88592.65
3139028-13902888.20692.04
4135071-13507185.69689.40
5135324-13532485.85689.53
6137989-13798987.54791.27
60min1143060-14306090.76488.531.5895.5593.241.56
2138862-13886288.10192.85
3140963-14096389.43494.24
4138295-13829587.74192.40
5136798-13679886.79191.42
6139209-13920988.32193.01
90min1144015-14401591.37088.721.8897.1794.421.85
2140731-14073189.28695.01
3140755-14075589.30295.10
4136650-13665086.69792.33
5137658-13765887.33792.93
6139183-13918388.30493.98
极限1138928-13892888.14386.692.0894.9693.382.03
2136258-13625886.44993.17
3140095-14009588.88395.68
4133996-13399685.01391.61
5132825-13282584.27190.83
6137709-13770987.36994.02
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