乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.003405653403363393913406623402143402340.15
215.103395473389023392240.14
单位质量响应值RSD%判断
22682.2722465.170.69数据可信
供试品溶液-1224287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%
30min167283-6728317.42617.313.2017.4317.303.20
270124-7012418.16218.16
366998-6699817.35217.35
463444-6344416.43216.43
566571-6657117.24217.24
666478-6647817.21817.22
60min1114578-11457829.67529.252.7629.7029.282.75
2117266-11726630.37230.40
3112026-11202629.01429.04
4107843-10784327.93127.96
5113221-11322129.32429.35
6112789-11278929.21229.24
120min1180397-18039746.72246.212.4446.8046.292.44
2184120-18412047.68747.77
3177056-17705645.85745.93
4171043-17104344.30044.37
5179654-17965446.53046.61
6178334-17833446.18846.27
240min1273451-27345170.82370.171.9470.9870.331.94
2279057-27905772.27572.44
3268620-26862069.57269.73
4263432-26343268.22868.38
5271761-27176170.38570.54
6269349-26934969.76169.92
360min1327084-32708484.71484.371.4284.9984.641.43
2332607-33260786.14486.43
3323163-32316383.69883.97
4319731-31973182.81083.07
5328668-32866885.12485.40
6323273-32327383.72784.00
480min1371040-37104096.09896.071.5696.5196.481.56
2380560-38056098.56498.99
3366974-36697495.04595.45
4366317-36631794.87595.27
5374554-37455497.00997.42
6366159-36615994.83495.24
600min1385325-38532599.79899.981.48100.37100.551.48
2395338-395338102.392102.98
3382253-38225399.00399.57
4381223-38122398.73699.29
5390331-390331101.095101.67
6381649-38164998.84699.41
720min1392386-392386101.627101.521.40102.37102.261.40
2400368-400368103.694104.45
3388821-388821100.704101.44
4387719-387719100.418101.14
5396323-396323102.647103.39
6386243-386243100.036100.77
960min1389107-389107100.778101.441.63101.69102.341.63
2401671-401671104.032104.96
3387862-387862100.455101.36
4386694-386694100.153101.04
5397532-397532102.960103.88
6387030-387030100.240101.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1385733-38573399.904100.461.70100.98101.541.70
2398210-398210103.135104.24
3384832-38483299.671100.74
4383359-38335999.289100.35
5393714-393714101.971103.06
6381481-38148198.80399.87
1440min1388903-388903100.725100.201.55101.97101.441.55
2395192-395192102.354103.63
3383940-38394099.439100.67
4381662-38166298.849100.07
5391559-391559101.413102.67
6379914-37991498.39799.63
极限1383363-38336399.29099.791.59100.70101.201.59
2394884-394884102.274103.72
3382909-38290999.172100.57
4380728-38072898.60899.99
5390564-390564101.155102.58
6379257-37925798.22799.62
乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.003398143395103391843395313393063394690.08
215.103392253398933395590.14
单位质量响应值RSD%判断
22631.2722487.350.46数据可信
供试品溶液-1224287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%
30min143354-4335411.23611.744.6611.2411.744.65
246733-4673312.11112.11
344948-4494811.64911.65
443587-4358711.29611.30
548846-4884612.65912.66
644417-4441711.51111.51
60min174493-7449319.30620.154.1419.3220.174.14
279803-7980320.68220.70
377125-7712519.98820.01
474697-7469719.35819.38
582962-8296221.50021.52
677449-7744920.07220.09
120min1118792-11879230.78632.183.7330.8432.243.74
2126837-12683732.87132.93
3123011-12301131.87931.93
4120554-12055431.24331.29
5131702-13170234.13234.19
6124214-12421432.19132.24
240min1181943-18194347.15249.573.3247.2549.683.32
2193140-19314050.05450.16
3188174-18817448.76748.87
4189098-18909849.00749.11
5200331-20033151.91852.03
6194944-19494450.52250.63
360min1222023-22202357.53961.044.0457.7261.234.04
2234444-23444460.75860.95
3228665-22866559.26159.45
4236500-23650061.29161.48
5248057-24805764.28664.49
6243473-24347363.09863.29
480min1257663-25766366.77671.124.5867.0571.414.58
2269425-26942569.82470.12
3265094-26509468.70268.99
4278383-27838372.14672.43
5290637-29063775.32175.63
6285240-28524073.92374.22
600min1277110-27711071.81676.244.5972.2076.654.59
2288518-28851874.77275.18
3283018-28301873.34773.75
4298798-29879877.43677.84
5311302-31130280.67781.11
6306340-30634079.39179.81
720min1288812-28881274.84879.594.6675.3680.134.65
2300769-30076977.94778.48
3295494-29549476.58077.10
4312743-31274381.05081.59
5324809-32480984.17784.74
6320074-32007482.95083.50
960min1309612-30961280.23984.624.2580.8785.294.25
2319817-31981782.88483.55
3314725-31472581.56482.21
4331860-33186086.00586.68
5343574-34357489.04089.75
6339544-33954487.99688.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1324267-32426784.03787.813.6684.8088.623.67
2333727-33372786.48987.29
3326666-32666684.65985.44
4343979-34397989.14589.96
5352993-35299391.48192.34
6351268-35126891.03491.87
1440min1335683-33568386.99590.103.2787.9091.053.27
2342806-34280688.84189.79
3335763-33576387.01687.94
4350964-35096490.95691.92
5361299-36129993.63494.64
6359362-35936293.13294.12
极限1335979-33597987.07290.003.0788.1291.113.08
2342695-34269588.81389.91
3335932-33593287.06088.13
4351147-35114791.00392.12
5359706-35970693.22194.39
6358194-35819492.82993.97
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