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%
115.111720191717421715241716821717011717340.11
215.171720731715521718120.22
单位质量响应值RSD%判断
11365.5911325.770.25数据可信
供试品溶液-25031201批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min129011-2901115.26214.721.8815.2614.721.88
227636-2763614.53914.54
327852-2785214.65314.65
427609-2760914.52514.52
527789-2778914.61914.62
628008-2800814.73514.73
60min151904-5190427.30626.591.8227.3326.621.82
249899-4989926.25126.28
349779-4977926.18826.21
449736-4973626.16526.19
550549-5054926.59326.62
651393-5139327.03727.06
120min184018-8401844.20143.540.8844.2743.610.88
282813-8281343.56743.63
382296-8229643.29543.36
481963-8196343.12043.19
582463-8246343.38343.45
683032-8303243.68243.75
240min1126832-12683266.72566.150.8266.8766.290.82
2125955-12595566.26366.40
3126022-12602266.29966.44
4123856-12385665.15965.30
5125467-12546766.00766.15
6126273-12627366.43166.57
360min1152066-15206680.00079.590.7080.2679.850.70
2151529-15152979.71779.97
3151371-15137179.63479.89
4150164-15016478.99979.25
5152645-15264580.30580.56
6149988-14998878.90779.16
480min1170962-17096289.94189.280.8890.3389.660.87
2171414-17141490.17990.56
3169972-16997289.42089.80
4167246-16724687.98688.37
5169167-16916788.99789.38
6169487-16948789.16589.55
600min1179485-17948594.42594.130.8094.9694.660.80
2179577-17957794.47395.01
3179713-17971394.54595.08
4176065-17606592.62693.15
5179070-17907094.20694.74
6179659-17965994.51695.05
720min1185175-18517597.41897.090.9498.1197.780.94
2185162-18516297.41198.10
3185411-18541197.54298.23
4181134-18113495.29295.97
5184586-18458697.10897.80
6185874-18587497.78698.48
960min1190073-19007399.99599.760.81100.85100.610.81
2190149-190149100.035100.89
3190201-190201100.062100.91
4186750-18675098.24799.09
5189325-18932599.601100.45
6191223-191223100.600101.45
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193773-193773101.942101.810.99102.97102.820.99
2194184-194184102.158103.18
3193611-193611101.856102.88
4190080-19008099.999101.00
5193498-193498101.797102.81
6195946-195946103.085104.11
1440min1193688-193688101.897101.851.20103.09103.041.19
2194153-194153102.141103.33
3193323-193323101.705102.89
4189716-18971699.807100.98
5193833-193833101.973103.16
6196919-196919103.597104.79
极限1193327-193327101.707101.751.25103.07103.111.25
2194281-194281102.209103.57
3193088-193088101.581102.94
4189263-18926399.569100.91
5193798-193798101.955103.31
6196722-196722103.493104.86
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%
115.111718781711231717291713091719121715900.21
215.171709521710331709920.04
单位质量响应值RSD%判断
11356.0611271.720.53数据可信
供试品溶液-25031202批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min123913-2391312.61613.175.7612.6213.175.75
224243-2424312.79012.79
324424-2442412.88512.89
424933-2493313.15413.15
527807-2780714.67014.67
624407-2440712.87612.88
60min143978-4397823.20224.123.5623.2224.143.55
244049-4404923.23923.26
345977-4597724.25624.28
445616-4561624.06624.09
548353-4835325.51025.53
646308-4630824.43124.45
120min174393-7439339.24839.891.3539.3139.951.35
274883-7488339.50639.57
376092-7609240.14440.21
476562-7656240.39240.45
576816-7681640.52640.59
674867-7486739.49839.56
240min1115940-11594061.16761.010.9161.2961.140.91
2114974-11497460.65760.78
3116334-11633461.37461.50
4115007-11500760.67460.80
5117225-11722561.84561.98
6114393-11439360.35060.48
360min1141983-14198374.90673.561.2775.1373.791.26
2136888-13688872.21872.45
3140126-14012673.92674.16
4138739-13873973.19573.43
5140309-14030974.02374.26
6138546-13854673.09373.32
480min1160835-16083584.85283.811.1785.2084.161.17
2155623-15562382.10282.45
3158813-15881383.78584.14
4160405-16040584.62584.98
5159118-15911883.94684.31
6158364-15836483.54883.90
600min1169679-16967989.51888.130.9690.0188.620.95
2165638-16563887.38687.87
3167085-16708588.14988.64
4165163-16516387.13587.63
5167392-16739288.31188.81
6167334-16733488.28188.77
720min1174099-17409991.85090.590.9992.4991.220.99
2169726-16972689.54390.17
3171869-17186990.67391.31
4169818-16981889.59190.23
5172647-17264791.08491.73
6172086-17208690.78891.42
960min1179226-17922694.55493.211.0795.3594.001.07
2174123-17412391.86292.64
3176873-17687393.31394.11
4174861-17486192.25293.04
5177700-17770093.74994.55
6177294-17729493.53594.32
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184069-18406997.11095.481.2098.0696.421.19
2178556-17855694.20195.13
3181201-18120195.59696.54
4178439-17843994.13995.08
5181650-18165095.83396.79
6181979-18197996.00796.95
1440min1182828-18282896.45595.241.1897.5796.341.18
2177868-17786893.83894.93
3181257-18125795.62696.73
4177884-17788493.84694.95
5181293-18129395.64596.76
6181981-18198196.00897.11
极限1182983-18298396.53795.041.2797.8196.311.26
2177371-17737193.57694.82
3180424-18042495.18796.45
4177460-17746093.62394.88
5181455-18145595.73097.01
6181215-18121595.60496.87
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