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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.151709911712081708051709901711411710270.10
215.211709361711181710270.08
单位质量响应值RSD%判断
11288.9111244.380.28数据可信
供试品溶液-24090201-1批-15mg规格-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%
30min121830-2183011.61412.092.3611.6112.092.38
222700-2270012.07712.08
323211-2321112.34912.35
423044-2304412.26012.26
522392-2239211.91311.91
623153-2315312.31812.32
60min139189-3918920.84921.722.6620.8721.742.65
240661-4066121.63221.65
341942-4194222.31422.33
441905-4190522.29422.31
540035-4003521.29921.32
641193-4119321.91521.94
120min164963-6496334.56135.602.0234.6235.662.01
266703-6670335.48735.54
367360-6736035.83735.89
468205-6820536.28636.34
565852-6585235.03435.09
668411-6841136.39636.45
240min1102894-10289454.74155.420.7954.8555.540.80
2103883-10388355.26755.38
3104607-10460755.65255.77
4105379-10537956.06356.18
5104136-10413655.40255.52
6104151-10415155.41055.53
360min1127403-12740367.78068.710.8767.9868.920.87
2130204-13020469.27069.48
3129064-12906468.66468.87
4130525-13052569.44169.65
5128888-12888868.57068.78
6128792-12879268.51968.73
480min1144535-14453576.89577.490.5277.2177.810.52
2146412-14641277.89378.22
3145070-14507077.17977.50
4146408-14640877.89178.22
5145604-14560477.46477.78
6145879-14587977.61077.93
600min1155645-15564582.80583.160.2583.2583.620.25
2156130-15613083.06383.52
3156449-15644983.23383.69
4156441-15644183.22983.69
5156736-15673683.38683.84
6156498-15649883.25983.71
720min1161652-16165286.00186.410.3386.5887.000.33
2162429-16242986.41587.01
3162503-16250386.45487.05
4162052-16205286.21486.81
5163218-16321886.83487.42
6162634-16263486.52487.12
960min1168752-16875289.77990.220.3490.5090.950.34
2169000-16900089.91190.65
3170133-17013390.51391.25
4169794-16979490.33391.07
5169735-16973590.30291.03
6170018-17001890.45291.19
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1172399-17239991.71991.990.2892.5992.880.27
2172533-17253391.79092.68
3173465-17346592.28693.17
4172758-17275891.91092.80
5173507-17350792.30893.19
6172836-17283691.95192.84
1440min1173464-17346492.28592.730.4393.3193.760.43
2173504-17350492.30793.34
3174140-17414092.64593.69
4174911-17491193.05594.10
5174471-17447192.82193.86
6175268-17526893.24594.29
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.151707341707511708511709931707621708180.07
215.211715731715451715590.02
单位质量响应值RSD%判断
11275.1211279.360.03数据可信
供试品溶液-24090201-2-1批-15mg规格-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%
30min125423-2542313.51313.196.2913.5113.196.27
226744-2674414.21514.21
325031-2503113.30413.30
425362-2536213.48013.48
522102-2210211.74811.75
624216-2421612.87112.87
60min142748-4274822.72123.062.8722.7423.082.87
244569-4456923.68923.71
343756-4375623.25723.28
444972-4497223.90323.93
542372-4237222.52122.54
641895-4189522.26822.29
120min169128-6912836.74237.453.0436.8037.513.04
273299-7329938.95939.02
370844-7084437.65537.72
472639-7263938.60938.67
568319-6831936.31236.37
668566-6856636.44436.50
240min1107608-10760857.19558.152.9457.3258.282.94
2114718-11471860.97461.10
3108668-10866857.75857.88
4111862-11186259.45659.58
5107014-10701456.87957.00
6106606-10660656.66356.78
360min1133103-13310370.74671.651.8970.9671.861.89
2139157-13915773.96474.19
3133470-13347070.94171.16
4136434-13643472.51672.74
5134128-13412871.29171.50
6132479-13247970.41470.63
480min1148584-14858478.97480.432.0279.3180.772.02
2155959-15595982.89483.25
3149549-14954979.48779.83
4154198-15419881.95882.30
5150742-15074280.12180.45
6148921-14892179.15379.48
600min1158926-15892684.47186.011.8284.9486.481.83
2166208-16620888.34288.83
3160129-16012985.11185.58
4164502-16450287.43587.92
5161695-16169585.94386.41
6159445-15944584.74785.21
720min1165384-16538487.90489.411.8488.5190.031.84
2172550-17255091.71392.35
3165808-16580888.12988.74
4171273-17127391.03491.66
5168450-16845089.53390.14
6165860-16586088.15788.76
960min1172142-17214291.49693.241.9792.2594.001.98
2178981-17898195.13195.92
3172800-17280091.84592.60
4180082-18008295.71696.50
5175853-17585393.46894.23
6172683-17268391.78392.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1176340-17634093.72795.031.7094.6395.961.71
2182539-18253997.02297.97
3176108-17610893.60494.52
4182346-18234696.91997.86
5179140-17914095.21596.13
6176316-17631693.71494.62
1440min1179041-17904195.16396.081.8696.2397.161.86
2185811-18581198.76199.87
3177703-17770394.45295.52
4183699-18369997.63898.74
5180651-18065196.01897.09
6177663-17766394.43095.49
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.151708991710351716531711631709841711470.18
215.211707321707091707200.01
单位质量响应值RSD%判断
11296.8311224.190.46数据可信
供试品溶液-24090201-2-2批-15mg规格-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%
30min124505-2450513.04413.132.6413.0413.132.65
225599-2559913.62713.63
325329-2532913.48313.48
424344-2434412.95912.96
524372-2437212.97312.97
623895-2389512.72012.72
60min143316-4331623.05723.291.4323.0823.311.43
244405-4440523.63723.66
344401-4440123.63523.66
444021-4402123.43323.45
543441-4344123.12423.15
642887-4288722.82922.85
120min170303-7030337.42337.711.3537.4837.771.35
271809-7180938.22538.29
372065-7206538.36138.42
470094-7009437.31237.37
571027-7102737.80837.87
669728-6972837.11737.18
240min1109665-10966558.37658.361.1158.5058.481.12
2110820-11082058.99059.12
3110540-11054058.84158.97
4107916-10791657.44557.57
5110458-11045858.79858.92
6108402-10840257.70357.82
360min1134505-13450571.59872.001.3171.8272.221.31
2137046-13704672.95173.17
3135702-13570272.23572.46
4133009-13300970.80271.02
5137409-13740973.14473.37
6133845-13384571.24771.46
480min1151926-15192680.87181.031.2181.2181.371.21
2153908-15390881.92682.27
3152735-15273581.30281.65
4149749-14974979.71380.05
5154401-15440182.18982.53
6150585-15058580.15880.49
600min1162027-16202786.24886.681.4086.7287.161.40
2165314-16531487.99888.48
3163189-16318986.86787.35
4159945-15994585.14085.61
5165523-16552388.10988.59
6161041-16104185.72386.19
720min1173150-17315092.16990.561.5892.7991.181.58
2171992-17199291.55392.18
3169765-16976590.36790.99
4166450-16645088.60389.21
5171835-17183591.46992.10
6167526-16752689.17589.79
960min1175209-17520993.26593.821.3894.0494.591.37
2178537-17853795.03795.82
3176667-17666794.04194.82
4173413-17341392.30993.07
5179481-17948195.53996.32
6174201-17420192.72993.49
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1178134-17813494.82295.871.4195.7596.791.41
2183028-18302897.42798.37
3180347-18034796.00096.93
4178506-17850695.02095.93
5183203-18320397.52098.46
6177349-17734994.40495.32
1440min1181206-18120696.45796.641.3697.5497.731.35
2184418-18441898.16799.27
3181726-18172696.73497.83
4177999-17799994.75095.82
5184071-18407197.98299.08
6179895-17989595.76096.83
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