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%
115.111734351732891733221732181730061732540.10
215.171726101730271728180.18
单位质量响应值RSD%判断
11466.1811392.090.46数据可信
供试品溶液-25030702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%
30min134009-3400917.76117.153.5417.7617.153.55
233909-3390917.70917.71
332633-3263317.04317.04
433514-3351417.50317.50
531424-3142416.41116.41
631526-3152616.46416.46
60min159393-5939331.01830.172.6731.0530.202.68
258662-5866230.63630.67
358855-5885530.73730.77
457924-5792430.25130.28
556021-5602129.25729.28
655732-5573229.10629.13
120min192719-9271948.42247.761.7348.5047.841.73
292804-9280448.46748.55
392174-9217448.13848.22
492116-9211648.10848.19
589234-8923446.60246.68
689704-8970446.84846.92
240min1138164-13816472.15671.570.8572.3271.730.86
2138040-13804072.09172.25
3137298-13729871.70471.86
4137573-13757371.84772.01
5135857-13585770.95171.11
6135376-13537670.70070.85
360min1165260-16526086.30785.510.8886.5985.790.88
2163563-16356385.42185.70
3164282-16428285.79686.08
4163754-16375485.52085.80
5164504-16450485.91286.18
6161079-16107984.12384.40
480min1184744-18474496.48395.751.1796.9196.181.17
2183807-18380795.99396.42
3183705-18370595.94096.36
4182294-18229495.20395.63
5185832-18583297.05197.47
6179697-17969793.84794.26
600min1191811-191811100.17399.591.16100.76100.171.16
2190932-19093299.714100.30
3190405-19040599.439100.02
4189005-18900598.70899.29
5194162-194162101.401101.98
6187867-18786798.11398.68
720min1194088-194088101.362100.961.37102.12101.711.37
2193594-193594101.104101.85
3193456-193456101.032101.78
4191251-19125199.881100.63
5197616-197616103.205103.95
6189925-18992599.18899.92
960min1194324-194324101.486101.450.91102.41102.360.90
2194208-194208101.425102.34
3193985-193985101.309102.22
4191526-191526100.024100.94
5197038-197038102.903103.82
6194407-194407101.529102.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1194651-194651101.656101.681.02102.75102.771.02
2193941-193941101.286102.37
3196792-196792102.775103.86
4191757-191757100.145101.22
5197058-197058102.913104.00
6194025-194025101.330102.40
1440min1192820-192820100.700100.401.11101.96101.651.11
2192950-192950100.768102.02
3192927-192927100.756102.01
4190500-19050099.489100.73
5195160-195160101.922103.18
6189103-18910398.75999.99
极限1192286-192286100.42199.851.09101.85101.271.09
2190617-19061799.550100.97
3191844-191844100.190101.61
4189149-18914998.783100.19
5194379-194379101.514102.95
6188911-18891198.659100.06
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%
115.111729551732361733151727401735281731550.18
215.171732741734471733600.08
单位质量响应值RSD%判断
11459.6311427.820.20数据可信
供试品溶液-25030702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%
30min126121-2612113.62413.354.7413.6213.354.74
225320-2532013.20613.21
327703-2770314.44914.45
424792-2479212.93112.93
524213-2421312.62912.63
625470-2547013.28513.28
60min147775-4777524.91824.414.6924.9424.434.68
245686-4568623.82923.85
350730-5073026.46026.48
446437-4643724.22124.24
544661-4466123.29423.32
645487-4548723.72523.75
120min179210-7921041.31440.052.8341.3840.122.83
276039-7603939.66039.72
379103-7910341.25941.33
477503-7750340.42440.49
574103-7410338.65138.71
674799-7479939.01439.08
240min1120482-12048262.84161.412.9362.9761.542.93
2116526-11652660.77860.91
3121808-12180863.53363.67
4119649-11964962.40662.54
5113048-11304858.96459.09
6114904-11490459.93260.06
360min1145502-14550275.89174.272.2776.1374.502.27
2141083-14108373.58673.82
3144651-14465175.44775.69
4145494-14549475.88776.12
5138261-13826172.11472.34
6139382-13938272.69972.93
480min1166836-16683687.01885.072.2787.3885.432.28
2161313-16131384.13884.49
3165239-16523986.18586.55
4166956-16695687.08187.44
5158521-15852182.68183.02
6159790-15979083.34383.69
600min1177009-17700992.32490.502.2692.8391.002.26
2171935-17193589.67890.17
3175832-17583291.71092.22
4177896-17789692.78793.29
5168792-16879288.03888.52
6169611-16961188.46688.95
720min1184184-18418496.06793.922.2496.7394.562.24
2178425-17842593.06393.70
3182203-18220395.03395.70
4184255-18425596.10496.76
5175140-17514091.34991.98
6176165-17616591.88492.52
960min1191679-19167999.97697.922.31100.8098.732.31
2183596-18359695.76096.56
3189347-18934798.76099.58
4192417-192417100.361101.18
5181691-18169194.76695.55
6187742-18774297.92298.71
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1197892-197892103.216101.282.27104.21102.252.27
2195308-195308101.869102.82
3195296-195296101.862102.85
4198670-198670103.622104.61
5187244-18724497.66398.60
6190659-19065999.444100.39
1440min1198304-198304103.431100.542.53104.59101.682.52
2191446-19144699.854100.98
3194626-194626101.513102.67
4197572-197572103.050104.21
5187298-18729897.69198.79
6187358-18735897.72298.84
极限1197787-197787103.162100.362.58104.50101.662.58
2190731-19073199.481100.77
3194250-194250101.317102.64
4197754-197754103.144104.48
5186440-18644097.24398.51
6187529-18752997.81199.09
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%
115.111734661735291732351731591732881733350.10
215.171738261734631736440.15
单位质量响应值RSD%判断
11471.5411446.540.16数据可信
供试品溶液-25030702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%
30min127737-2773714.44814.664.1514.4514.664.13
229931-2993115.59115.59
328101-2810114.63714.64
428998-2899815.10515.10
526663-2666313.88813.89
627434-2743414.29014.29
60min149455-4945525.76026.478.3125.7826.498.30
259299-5929930.88830.91
350014-5001426.05126.08
449188-4918825.62125.65
547811-4781124.90424.93
649119-4911925.58525.61
120min179742-7974241.53642.301.5841.6042.371.59
283239-8323943.35843.44
381172-8117242.28142.35
480886-8088642.13242.20
582049-8204942.73842.80
680143-8014341.74541.81
240min1123322-12332264.23663.761.2164.3763.901.21
2123442-12344264.29964.45
3123905-12390564.54064.68
4120719-12071962.88063.02
5122616-12261663.86864.00
6120439-12043962.73462.87
360min1146996-14699676.56876.971.5976.8177.221.59
2149665-14966577.95878.21
3150515-15051578.40178.65
4146672-14667276.39976.64
5148724-14872477.46877.71
6144067-14406775.04275.28
480min1167371-16737187.18187.421.5487.5587.801.54
2169500-16950088.28988.68
3171177-17117789.16389.54
4166602-16660286.78087.15
5168636-16863687.83988.21
6163723-16372385.28085.65
600min1176248-17624891.80492.351.5092.3292.881.50
2177424-17742492.41792.95
3180751-18075194.15094.68
4178468-17846892.96193.48
5178116-17811692.77793.30
6172820-17282090.01990.53
720min1181251-18125194.41095.091.9795.0895.761.96
2182945-18294595.29395.98
3186158-18615896.96697.65
4180357-18035793.94594.61
5187008-18700897.40998.08
6177595-17759592.50693.16
960min1186512-18651297.15197.391.5997.9898.221.59
2187739-18773997.79098.64
3191054-19105499.517100.36
4185448-18544896.59797.42
5188667-18866798.27399.11
6182364-18236494.99095.80
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191596-19159699.79999.831.65100.79100.821.65
2192341-192341100.187101.20
3195952-195952102.068103.08
4190220-19022099.082100.07
5193260-193260100.666101.66
6186539-18653997.16598.14
1440min1189960-18996098.94799.521.81100.10100.681.81
2191413-19141399.704100.88
3194601-194601101.364102.54
4189517-18951798.71699.87
5195043-195043101.594102.76
6185817-18581796.78997.92
极限1189525-18952598.72099.811.17100.04101.141.16
2191379-19137999.686101.03
3194854-194854101.496102.84
4188799-18879998.34299.66
5192979-192979100.519101.85
6192196-192196100.111101.40
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