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%
115.001704481703181704691695241698401701200.25
215.101695811703021699420.30
单位质量响应值RSD%判断
11341.3311254.440.55数据可信
供试品溶液-24092301-1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%
30min123985-2398512.41212.603.1112.4112.603.10
225300-2530013.09213.09
323501-2350112.16112.16
425281-2528113.08313.08
524012-2401212.42612.43
623994-2399412.41712.42
60min144380-4438022.96623.362.2222.9923.382.20
246185-4618523.90023.92
343703-4370322.61622.64
446171-4617123.89323.91
545492-4549223.54123.56
644902-4490223.23623.26
120min174724-7472438.66938.791.3538.7338.851.35
276107-7610739.38439.45
374225-7422538.41038.47
475903-7590339.27939.34
575312-7531238.97339.03
673485-7348538.02738.09
240min1114758-11475859.38659.721.2059.5159.841.20
2115785-11578559.91760.04
3113739-11373958.85858.98
4117793-11779360.95661.08
5115559-11555959.80059.92
6114755-11475559.38459.51
360min1140011-14001172.45473.261.2172.6873.491.21
2142856-14285673.92674.15
3139375-13937572.12472.34
4143637-14363774.33074.56
5142552-14255273.76973.99
6141022-14102272.97773.20
480min1156382-15638280.92581.811.3581.2782.161.35
2158547-15854782.04682.40
3155135-15513580.28080.62
4161299-16129983.47083.82
5158520-15852082.03282.38
6158666-15866682.10782.45
600min1167631-16763186.74787.461.4387.2287.941.43
2170521-17052188.24288.73
3165113-16511385.44485.92
4171980-17198088.99789.49
5169907-16990787.92488.41
6168862-16886287.38487.86
720min1174463-17446390.28291.241.4090.9091.861.40
2176741-17674191.46192.10
3172457-17245789.24489.86
4179155-17915592.71093.35
5178091-17809192.15992.79
6176926-17692691.55792.18
960min1182460-18246094.42095.731.5795.1996.511.57
2186174-18617496.34297.13
3180607-18060793.46194.23
4188360-18836097.47398.27
5186737-18673796.63497.42
6185600-18560096.04596.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1186320-18632096.41898.001.7097.3598.941.69
2190222-19022298.43799.38
3184892-18489295.67996.60
4193469-193469100.117101.07
5191400-19140099.04799.99
6189985-18998598.31499.25
1440min1187889-18788997.23098.571.4898.3299.671.48
2190755-19075598.71399.82
3186394-18639496.45697.54
4193553-193553100.161101.28
5192875-19287599.810100.92
6191375-19137599.034100.14
极限1187370-18737096.96198.381.5198.2199.651.51
2191030-19103098.855100.13
3185979-18597996.24197.48
4193673-193673100.223101.51
5191307-19130798.999100.28
6191359-19135999.025100.29
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%
115.001663121663641661631662091661641662420.06
215.101661371665461663420.18
单位质量响应值RSD%判断
11082.8011016.030.43数据可信
供试品溶液-24092301-2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%
30min122047-2204711.66512.554.2411.6712.554.22
223746-2374612.56412.56
323880-2388012.63512.64
423295-2329512.32612.33
525000-2500013.22813.23
624348-2434812.88312.88
60min141451-4145121.93323.103.0521.9523.123.05
243462-4346222.99723.02
343838-4383823.19623.22
443184-4318422.84922.87
545169-4516923.90023.92
644827-4482723.71923.74
120min169920-6992036.99638.632.8037.0538.692.81
272102-7210238.15138.21
372773-7277338.50638.57
472710-7271038.47238.53
575418-7541839.90539.97
675139-7513939.75739.82
240min1109099-10909957.72659.061.2357.8459.181.23
2111258-11125858.86958.99
3111703-11170359.10459.23
4112304-11230459.42259.54
5112414-11241459.48059.61
6112936-11293659.75759.88
360min1135173-13517371.52372.800.9971.7473.020.99
2136814-13681472.39172.61
3138108-13810873.07673.30
4138649-13864973.36273.58
5138604-13860473.33873.57
6138168-13816873.10773.33
480min1153910-15391081.43781.930.8081.7782.270.80
2152842-15284280.87281.21
3155178-15517882.10882.45
4156138-15613882.61682.96
5155716-15571682.39282.74
6155259-15525982.15082.50
600min1165880-16588087.77087.990.7988.2488.470.79
2163903-16390386.72487.20
3166253-16625387.96888.45
4167221-16722188.48088.96
5167315-16731588.53089.02
6167198-16719888.46888.95
720min1173621-17362191.86691.850.9492.4892.480.94
2170379-17037990.15190.77
3174111-17411192.12592.75
4174702-17470292.43893.07
5174700-17470092.43793.07
6174069-17406992.10392.74
960min1181446-18144696.00796.340.7896.7797.120.78
2179590-17959095.02495.80
3182773-18277396.70997.49
4182279-18227996.44797.23
5183573-18357397.13297.92
6182803-18280396.72597.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1184156-18415697.44098.451.0698.3799.391.06
2183270-18327096.97297.90
3186917-18691798.90199.84
4187309-18730999.109100.05
5188419-18841999.696100.65
6186317-18631798.58499.53
1440min1185490-18549098.14699.300.9099.24100.410.90
2185696-18569698.25599.35
3189069-189069100.040101.15
4188337-18833799.653100.76
5189313-189313100.169101.29
6188116-18811699.536100.65
极限1185339-18533998.06699.081.0299.32100.351.02
2184567-18456797.65898.91
3188267-18826799.616100.89
4188564-18856499.773101.05
5189387-189387100.208101.49
6187403-18740399.158100.44
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%
115.001667321665811662651662991664411664640.12
215.101663891662981663440.04
单位质量响应值RSD%判断
11097.6011016.160.53数据可信
供试品溶液-24092301-3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%
30min120941-2094111.07312.086.2211.0712.086.23
223541-2354112.44812.45
322059-2205911.66411.66
422067-2206711.66811.67
524890-2489013.16113.16
623601-2360112.47912.48
60min139464-3946420.86722.364.5820.8922.384.57
243473-4347322.98723.01
341289-4128921.83221.85
441282-4128221.82821.85
544707-4470723.63923.66
643485-4348522.99323.01
120min168238-6823836.08237.492.3936.1437.552.38
272248-7224838.20238.26
370352-7035237.20037.26
469918-6991836.97037.03
572507-7250738.33938.40
672132-7213238.14138.20
240min1108059-10805957.13858.021.0057.2558.141.00
2110868-11086858.62358.75
3109719-10971958.01558.13
4109137-10913757.70857.83
5109598-10959857.95158.08
6110936-11093658.65958.78
360min1132165-13216569.88471.481.2770.0971.701.27
2137162-13716272.52672.75
3135662-13566271.73371.95
4135029-13502971.39871.61
5134812-13481271.28471.51
6136255-13625572.04772.27
480min1150120-15012079.37880.971.1279.7081.311.12
2154253-15425381.56381.90
3153487-15348781.15881.49
4153751-15375181.29881.63
5154895-15489581.90382.24
6152316-15231680.53980.88
600min1161024-16102485.14487.081.6785.6087.551.67
2169342-16934289.54290.02
3164796-16479687.13887.61
4164199-16419986.82387.29
5165376-16537687.44587.92
6163363-16336386.38086.86
720min1168139-16813988.90690.381.0089.5191.001.00
2172929-17292991.43992.07
3172102-17210291.00191.62
4171733-17173390.80691.42
5170178-17017889.98490.61
6170519-17051990.16490.78
960min1177091-17709193.63994.981.0994.3995.741.08
2182102-18210296.28997.07
3181511-18151195.97696.74
4179942-17994295.14795.91
5178905-17890594.59995.37
6178167-17816794.20894.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1182652-18265296.58097.111.0197.4898.031.00
2185668-18566898.17599.11
3185820-18582098.25599.18
4184105-18410597.34898.27
5182286-18228696.38697.32
6181402-18140295.91996.84
1440min1183224-18322496.88297.751.1497.9598.841.14
2187013-18701398.88699.99
3187655-18765599.225100.32
4185150-18515097.90198.99
5182582-18258296.54397.63
6183579-18357997.07098.16
极限1182929-18292996.72697.551.2997.9598.801.28
2187128-18712898.947100.21
3187114-18711498.939100.19
4185427-18542798.04799.30
5182171-18217196.32597.58
6182117-18211796.29797.54
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