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%
115.061721991724451721521725741712381721220.31
215.101731121726241728680.20
单位质量响应值RSD%判断
11429.0811448.210.12数据可信
供试品溶液-1270307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%
30min125955-2595513.54413.242.5113.5413.242.49
224551-2455112.81112.81
325993-2599313.56313.56
424697-2469712.88712.89
525273-2527313.18813.19
625757-2575713.44013.44
60min144185-4418523.05622.552.3523.0822.582.35
242134-4213421.98622.01
344350-4435023.14223.16
441955-4195521.89321.91
543096-4309622.48822.51
643619-4361922.76122.78
120min170846-7084636.96836.581.0637.0336.641.06
269280-6928036.15136.21
370554-7055436.81636.88
469399-6939936.21336.27
569693-6969336.36736.43
670889-7088936.99137.05
240min1107906-10790656.30656.071.0056.4356.191.00
2105346-10534654.97155.09
3108084-10808456.39956.52
4108027-10802756.37056.49
5107325-10732556.00356.12
6107986-10798656.34856.47
360min1133390-13339069.60469.641.3069.8269.851.30
2130381-13038168.03468.24
3134649-13464970.26170.48
4135082-13508270.48770.70
5132785-13278569.28969.50
6134422-13442270.14370.36
480min1154591-15459180.66781.060.7281.0081.390.72
2153633-15363380.16780.49
3155548-15554881.16781.50
4156835-15683581.83882.17
5155866-15586681.33281.66
6155597-15559781.19281.52
600min1165400-16540086.30786.720.5586.7787.180.55
2165043-16504386.12186.58
3166652-16665286.96187.43
4167562-16756287.43687.90
5166149-16614986.69887.16
6166342-16634286.79987.27
720min1171624-17162489.55590.280.5990.1790.890.58
2171879-17187989.68890.29
3173597-17359790.58591.20
4174023-17402390.80791.42
5173378-17337890.47091.08
6173591-17359190.58291.19
960min1178378-17837893.07993.850.7893.8494.620.78
2178263-17826393.01993.77
3180378-18037894.12394.89
4181862-18186294.89795.66
5179633-17963393.73494.49
6180671-18067194.27695.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1183246-18324695.62096.400.6996.5397.320.70
2183404-18340495.70296.61
3185364-18536496.72597.65
4186305-18630597.21698.14
5184348-18434896.19597.11
6185795-18579596.95097.87
1440min1178339-17833993.05994.260.7694.1395.330.76
2180348-18034894.10795.17
3181038-18103894.46795.55
4182583-18258395.27496.36
5180845-18084594.36795.44
6180664-18066494.27295.35
极限1176715-17671592.21293.040.5993.4494.280.59
2177516-17751692.63093.85
3179111-17911193.46294.70
4179575-17957593.70494.95
5178369-17836993.07594.31
6178568-17856893.17994.42
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%
115.061724811731401729591726391730301728500.17
215.101731581733471732520.08
单位质量响应值RSD%判断
11477.4211473.640.03数据可信
供试品溶液-1270307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%
30min126095-2609513.57312.963.3413.5712.953.34
223825-2382512.39212.39
324132-2413212.55212.55
425341-2534113.18113.18
525168-2516813.09113.09
624885-2488512.94412.94
60min143609-4360922.68222.182.9322.7122.202.94
241214-4121421.43721.46
340918-4091821.28321.30
443500-4350022.62622.65
542995-4299522.36322.38
643631-4363122.69422.72
120min170268-7026836.54935.933.0236.6135.993.02
267054-6705434.87734.93
366037-6603734.34834.40
471470-7147037.17437.23
569935-6993536.37536.43
669761-6976136.28536.34
240min1107760-10776056.05055.141.8456.1755.251.84
2103679-10367953.92754.04
3103598-10359853.88554.00
4107915-10791556.13056.25
5106963-10696355.63555.75
6106116-10611655.19455.31
360min1133583-13358369.48168.401.2869.7068.611.28
2129262-12926267.23367.44
3129874-12987467.55267.76
4132667-13266769.00469.22
5132288-13228868.80769.02
6131301-13130168.29468.51
480min1155005-15500580.62379.741.1980.9580.061.19
2150166-15016678.10678.42
3152333-15233379.23379.55
4153561-15356179.87280.20
5153892-15389280.04480.37
6154844-15484480.53980.87
600min1165199-16519985.92585.201.1786.3985.661.17
2160553-16055383.50983.96
3162889-16288984.72485.17
4163556-16355685.07185.53
5165690-16569086.18186.64
6164986-16498685.81586.27
720min1172873-17287389.91788.621.3090.5389.221.29
2167847-16784787.30387.89
3169609-16960988.21988.81
4167994-16799487.37987.98
5172009-17200989.46890.07
6171990-17199089.45890.06
960min1179843-17984393.54292.721.1094.3093.461.10
2175923-17592391.50392.23
3178157-17815792.66593.40
4180549-18054993.90994.66
5175972-17597291.52992.28
6179112-17911293.16293.91
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186304-18630496.90394.312.6897.8295.222.66
2180900-18090094.09294.98
3182781-18278195.07095.96
4181565-18156594.43895.35
5172240-17224089.58890.49
6184171-18417195.79396.70
1440min1186332-18633296.91795.381.3197.9996.431.30
2181400-18140094.35295.39
3184118-18411895.76696.82
4182677-18267795.01696.08
5180163-18016393.70994.76
6185516-18551696.49397.56
极限1186480-18648096.99495.511.0898.2396.731.08
2180964-18096494.12595.32
3182777-18277795.06896.28
4182425-18242594.88596.11
5184226-18422695.82297.03
6184907-18490796.17697.40
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