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%
113.921537191538231535151536761535321536530.09
213.901524921526821525870.09
单位质量响应值RSD%判断
11038.2910977.480.40数据可信
供试品溶液-2025052121批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min171656-7165645.88546.353.0845.8846.353.09
274555-7455547.74147.74
375202-7520248.15548.16
469033-6903344.20544.20
572052-7205246.13846.14
671820-7182045.99045.99
10min1100375-10037564.27563.502.6364.7864.022.62
2103415-10341566.22166.75
399634-9963463.80064.34
498530-9853063.09363.58
596517-9651761.80462.32
696564-9656461.83462.35
15min1114051-11405173.03274.641.9274.2675.861.90
2117596-11759675.30276.57
3117965-11796575.53876.78
4119777-11977776.69977.89
5114524-11452473.33574.53
6115494-11549473.95675.15
20min1120205-12020576.97380.243.9379.0182.293.86
2132781-13278185.02687.13
3126051-12605180.71682.80
4128937-12893782.56484.61
5123035-12303578.78580.80
6120835-12083577.37679.40
30min1131183-13118384.00288.283.4386.8991.223.38
2143965-14396592.18795.24
3138244-13824488.52491.50
4141440-14144090.57193.53
5138532-13853288.70891.60
6133850-13385085.71088.59
45min1140415-14041589.91494.092.7693.7498.022.74
2151679-15167997.127101.20
3148879-14887995.33499.30
4148685-14868595.21099.18
5148028-14802894.78998.66
6143947-14394792.17696.01
60min1141359-14135990.51995.203.3295.34100.163.28
2155176-15517699.366104.52
3151044-15104496.720101.74
4150721-15072196.514101.54
5149015-14901595.421100.35
6144668-14466892.63897.49
90min1143513-14351391.89896.913.4197.73102.943.36
2158181-158181101.291107.55
3152572-15257297.699103.80
4152505-15250597.656103.75
5153885-15388598.540104.53
6147384-14738494.377100.26
极限1141257-14125790.45394.393.2197.30101.493.17
2153171-15317198.082105.46
3149304-14930495.606102.79
4149057-14905795.448102.63
5149671-14967195.841102.92
6142000-14200090.92997.86
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%
113.921535691536221533411535511535461535260.08
213.901534801531341533070.16
单位质量响应值RSD%判断
11029.1711029.280.01数据可信
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%
5min173826-7382647.18245.244.3847.1845.244.38
272717-7271746.47446.47
367069-6706942.86442.86
468775-6877543.95443.95
574065-7406547.33547.34
668262-6826243.62643.63
10min1100056-10005663.94663.513.0364.4764.023.03
2101979-10197965.17565.69
394298-9429860.26660.74
497985-9798562.62263.11
5102555-10255565.54366.07
699412-9941263.53464.02
15min1114649-11464973.27273.553.5274.5174.763.51
2119418-11941876.32077.56
3107634-10763468.78969.94
4114821-11482173.38274.57
5116715-11671574.59375.85
6117262-11726274.94276.13
20min1123867-12386779.16480.072.8981.2182.102.89
2130193-13019383.20785.30
3119269-11926976.22578.14
4125365-12536580.12182.12
5126601-12660180.91182.99
6126449-12644980.81482.84
30min1136132-13613287.00288.743.3989.9391.663.37
2145759-14575993.15596.17
3131889-13188984.29187.05
4138051-13805188.22991.12
5140483-14048389.78392.77
6140827-14082790.00392.92
45min1146626-14662693.70994.873.0997.6098.773.09
2154865-15486598.975103.02
3141399-14139990.36894.06
4146921-14692193.89897.77
5151022-15102296.518100.50
6149807-14980795.74299.66
60min1147831-14783194.47996.483.7799.42101.443.73
2158907-158907101.558106.71
3142879-14287991.31496.01
4148442-14844294.87099.78
5153928-15392898.376103.43
6153793-15379398.289103.27
90min1149138-14913895.31496.923.94101.30102.943.90
2160009-160009102.262108.54
3142451-14245191.04196.75
4149757-14975795.710101.68
5154714-15471498.878105.02
6153792-15379298.289104.37
极限1146901-14690193.88595.223.81100.93102.323.77
2155406-15540699.320106.73
3139104-13910488.90295.63
4149109-14910995.296102.33
5152802-15280297.656104.90
6150613-15061396.257103.43
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