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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.251748471746971746351743591740481745170.19
215.331734771732621733700.09
单位质量响应值RSD%判断
11443.7411309.200.84数据可信
供试品溶液-2025081321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%
30min126351-2635113.82614.182.6313.8314.182.62
226644-2664413.98013.98
327962-2796214.67114.67
427884-2788414.63014.63
526648-2664813.98213.98
626634-2663413.97413.97
60min146349-4634924.31825.082.3824.3425.112.38
246498-4649824.39724.42
348351-4835125.36925.39
448047-4804725.20925.23
549160-4916025.79325.82
648437-4843725.41425.44
120min174856-7485639.27539.751.4439.3439.821.44
274229-7422938.94639.01
377189-7718940.50040.57
476375-7637540.07240.14
576317-7631740.04240.11
675592-7559239.66239.73
240min1112476-11247659.01459.711.3159.1459.841.32
2111694-11169458.60458.73
3115860-11586060.78960.92
4114158-11415859.89660.03
5114101-11410159.86760.00
6114476-11447660.06360.20
360min1137668-13766872.23272.860.9972.4673.090.98
2137343-13734372.06172.29
3141087-14108774.02674.26
4138490-13849072.66372.90
5139106-13910672.98673.22
6139479-13947973.18273.41
480min1152894-15289480.22081.461.1580.5781.811.15
2154178-15417880.89481.24
3157899-15789982.84683.21
4154488-15448881.05781.41
5155720-15572081.70382.06
6156327-15632782.02282.38
600min1164065-16406586.08286.941.2986.5687.431.29
2163232-16323285.64586.13
3168947-16894788.64389.14
4164698-16469886.41486.90
5166055-16605587.12687.62
6167196-16719687.72488.21
720min1170875-17087589.65590.481.1990.2891.111.19
2170214-17021489.30889.93
3175358-17535892.00792.65
4171111-17111189.77990.41
5172933-17293390.73591.37
6174209-17420991.40492.04
960min1180649-18064994.78395.371.4395.5696.151.43
2178392-17839293.59994.37
3185904-18590497.54098.34
4180815-18081594.87095.65
5181360-18136095.15695.94
6183458-18345896.25797.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1185869-18586997.52298.241.3498.4599.191.34
2184239-18423996.66797.60
3190720-190720100.067101.03
4186243-18624397.71898.66
5186576-18657697.89398.84
6189829-18982999.600100.55
1440min1189393-18939399.37199.961.29100.47101.071.29
2186780-18678098.00099.09
3193766-193766101.665102.79
4190312-19031299.853100.96
5190314-19031499.854100.96
6192538-192538101.021102.14
极限1190074-19007499.72899.861.39100.99101.131.39
2186210-18621097.70198.95
3193637-193637101.598102.89
4189488-18948899.421100.69
5189768-18976899.568100.84
6192757-192757101.136102.42
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.251732941737791739121740261738721737770.17
215.331734161736191735180.09
单位质量响应值RSD%判断
11395.2111318.850.48数据可信
供试品溶液-2025081321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%
30min126837-2683714.10515.5411.5914.1015.5411.59
232601-3260117.13417.13
327044-2704414.21314.21
435054-3505418.42318.42
527715-2771514.56614.57
628123-2812314.78014.78
60min143646-4364622.93925.055.0122.9625.075.01
247590-4759025.01225.04
346662-4666224.52424.55
448945-4894525.72425.75
548429-4842925.45325.48
650670-5067026.63026.66
120min171889-7188937.78239.782.8437.8439.852.85
277091-7709140.51640.59
374373-7437339.08839.15
477317-7731740.63540.71
576755-7675540.34040.41
676730-7673040.32740.40
240min1109607-10960757.60659.872.6357.7360.002.64
2118119-11811962.07962.22
3111629-11162958.66858.80
4114596-11459660.22860.37
5115620-11562060.76660.90
6113899-11389959.86160.00
360min1134746-13474670.81872.521.5771.0472.751.57
2137027-13702772.01772.26
3136743-13674371.86772.09
4139827-13982773.48873.73
5140263-14026373.71773.95
6139271-13927173.19673.43
480min1151504-15150479.62581.051.2179.9681.411.21
2153259-15325980.54880.91
3153118-15311880.47480.82
4155971-15597181.97382.34
5155794-15579481.88082.24
6155663-15566381.81182.17
600min1162347-16234785.32486.671.2285.8087.161.22
2163359-16335985.85686.35
3163722-16372286.04786.53
4166628-16662887.57488.07
5166872-16687287.70288.20
6166572-16657287.54588.04
720min1169835-16983589.25990.491.0789.8791.131.07
2170850-17085089.79390.43
3171051-17105189.89990.52
4173642-17364291.26091.91
5174273-17427391.59292.23
6173452-17345291.16091.80
960min1179053-17905394.10495.321.0394.8796.101.03
2179676-17967694.43295.22
3180515-18051594.87395.65
4182523-18252395.92896.73
5183570-18357096.47897.27
6182816-18281696.08296.87
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184014-18401496.71198.321.3297.6399.261.32
2185504-18550497.49598.44
3185363-18536397.42098.35
4188888-18888899.273100.23
5190320-190320100.026100.98
6188382-18838299.00799.96
1440min1187684-18768498.640100.121.1799.72101.231.17
2189000-18900099.332100.44
3189096-18909699.382100.48
4192028-192028100.923102.05
5193447-193447101.669102.79
6191721-191721100.762101.88
极限1190907-190907100.334100.230.93101.58101.500.93
2188499-18849999.069100.34
3188905-18890599.282100.54
4191717-191717100.760102.05
5193211-193211101.545102.84
6190958-190958100.361101.65
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