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500
标示量(mg)30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%
114.943420823417863409383414333418003416080.13
215.033420503424593422540.09
单位质量响应值RSD%判断
22865.3322771.390.30数据可信
供试品溶液-24091201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%
30min163660-6366016.31116.774.7216.3116.774.72
268134-6813417.45717.46
362705-6270516.06616.07
469907-6990717.91117.91
565896-6589616.88416.88
662337-6233715.97215.97
60min1110588-11058828.33428.312.8528.3628.342.86
2114819-11481929.41829.45
3107653-10765327.58227.61
4111856-11185628.65928.69
5111852-11185228.65828.69
6106141-10614127.19527.22
120min1179983-17998346.11445.272.4746.1945.342.47
2180833-18083346.33246.41
3173484-17348444.44944.52
4177746-17774645.54145.62
5178494-17849445.73345.81
6169484-16948443.42443.50
240min1267875-26787568.63468.351.5468.7968.501.54
2272619-27261969.84970.00
3263248-26324867.44867.60
4267185-26718568.45768.61
5268576-26857668.81368.97
6261047-26104766.88467.03
360min1325797-32579783.47482.811.1983.7483.071.19
2328616-32861684.19784.47
3320233-32023382.04982.31
4321956-32195682.49082.76
5324419-32441983.12183.39
6318159-31815981.51781.77
480min1359928-35992892.21991.131.2092.6291.541.20
2361758-36175892.68893.10
3354052-35405290.71491.11
4353547-35354790.58490.99
5354287-35428790.77491.18
6350574-35057489.82390.21
600min1374310-37431095.90495.301.1196.4695.861.11
2379019-37901997.11197.68
3371231-37123195.11595.66
4368870-36887094.51095.07
5370470-37047094.92095.48
6367841-36784194.24794.79
720min1380858-38085897.58297.101.2798.3097.811.27
2387853-38785399.374100.10
3377506-37750696.72397.43
4375777-37577796.28096.99
5376855-37685596.55697.27
6374966-37496696.07296.77
960min1390605-390605100.07999.611.04100.96100.481.04
2395939-395939101.446102.34
3388465-38846599.531100.40
4385554-38555498.78599.66
5386468-38646899.01999.89
6385583-38558398.79299.65
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1388449-38844999.52798.911.00100.5799.951.00
2392349-392349100.526101.59
3386507-38650799.029100.06
4383389-38338998.23099.27
5382761-38276198.06999.11
6382857-38285798.09499.12
1440min1384115-38411598.41697.791.0999.6399.001.09
2388663-38866399.582100.81
3381798-38179897.82399.02
4378861-37886197.07098.27
5378525-37852596.98498.19
6378133-37813396.88498.07
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500
标示量(mg)30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%
114.943412903414113413863416483413633414200.04
215.033425583422733424160.06
单位质量响应值RSD%判断
22852.7422782.170.22数据可信
供试品溶液-24091201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%
30min140721-4072110.43410.404.4710.4310.404.46
242493-4249310.88810.89
337371-373719.5759.58
439992-3999210.24710.25
541053-4105310.51910.52
641958-4195810.75110.75
60min173926-7392618.94218.694.5118.9618.704.52
275099-7509919.24219.26
367275-6727517.23817.25
471608-7160818.34818.36
572979-7297918.69918.72
676734-7673419.66119.68
120min1120221-12022130.80430.364.0230.8530.414.03
2120036-12003630.75630.81
3110793-11079328.38828.43
4116116-11611629.75229.80
5118769-11876930.43230.48
6125037-12503732.03832.09
240min1182268-18226846.70246.352.7246.8046.452.73
2180659-18065946.28946.39
3173833-17383344.54044.63
4177359-17735945.44445.54
5183218-18321846.94547.04
6188051-18805148.18348.29
360min1222464-22246457.00157.171.9857.1857.351.98
2221655-22165556.79456.97
3218639-21863956.02156.19
4219255-21925556.17956.35
5227048-22704858.17558.35
6229733-22973358.86359.05
480min1250110-25011064.08564.341.6864.3664.611.68
2248722-24872263.72964.00
3249101-24910163.82664.09
4246247-24624763.09563.36
5255244-25524465.40065.67
6257147-25714765.88866.17
600min1267226-26722668.47068.831.2868.8569.201.29
2266403-26640368.25968.64
3268098-26809868.69469.06
4264426-26442667.75368.12
5272866-27286669.91570.30
6272655-27265569.86170.25
720min1281556-28155672.14272.231.0872.6472.721.08
2279867-27986771.70972.20
3281473-28147372.12172.60
4277798-27779871.17971.66
5286054-28605473.29473.79
6284580-28458072.91773.43
960min1305311-30531178.22878.590.9578.8479.200.95
2304312-30431277.97278.59
3310384-31038479.52880.13
4303131-30313177.67078.27
5309228-30922879.23279.85
6308015-30801578.92179.55
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1317264-31726481.29181.630.7482.0482.370.74
2317276-31727681.29482.04
3321545-32154582.38883.12
4315472-31547280.83281.56
5320927-32092782.23082.98
6318994-31899481.73482.50
1440min1325565-32556583.41883.580.7184.3084.460.71
2325816-32581683.48284.36
3329808-32980884.50585.38
4323024-32302482.76783.63
5327665-32766583.95684.85
6325349-32534983.36384.26
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500
标示量(mg)30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%
114.943413493412183416493414683412833413930.05
215.033412363410493411420.04
单位质量响应值RSD%判断
22850.9422697.410.48数据可信
供试品溶液-24091201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%
30min150282-5028212.90813.046.7712.9113.046.76
246463-4646311.92811.93
356767-5676714.57314.57
451634-5163413.25513.26
548879-4887912.54812.55
650704-5070413.01613.02
60min188031-8803122.59921.983.3422.6222.003.33
280205-8020520.59020.61
385234-8523421.88121.91
486160-8616022.11922.14
586343-8634322.16622.19
687759-8775922.52922.55
120min1140229-14022935.99935.363.6636.0635.423.66
2128509-12850932.99033.04
3135697-13569734.83534.90
4138952-13895235.67135.73
5142142-14214236.49036.55
6140915-14091536.17536.23
240min1212767-21276754.62053.863.5754.7453.973.57
2196164-19616450.35850.47
3207256-20725653.20653.32
4211921-21192154.40354.52
5217832-21783255.92156.04
6212821-21282154.63454.75
360min1263598-26359867.67066.893.2567.8867.093.25
2244672-24467262.81163.00
3258653-25865366.40066.61
4262841-26284167.47567.68
5268978-26897869.05169.26
6264571-26457167.91968.13
480min1294825-29482575.68675.202.5276.0175.522.53
2279116-27911671.65371.95
3290950-29095074.69175.01
4295285-29528575.80476.13
5299363-29936376.85177.18
6298048-29804876.51376.84
600min1312830-31283080.30880.251.9780.7680.691.97
2301841-30184177.48777.90
3310290-31029079.65680.10
4314238-31423880.67081.12
5316955-31695581.36781.82
6319357-31935781.98482.43
720min1324354-32435483.26683.321.7783.8583.901.77
2316174-31617481.16781.71
3322012-32201282.66583.24
4324677-32467783.34983.93
5326533-32653383.82684.42
6333664-33366485.65686.24
960min1336930-33693086.49586.751.3587.2287.461.36
2331962-33196285.22085.90
3335064-33506486.01686.73
4338435-33843586.88187.60
5339808-33980887.23487.96
6345322-34532288.64989.38
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1355416-35541691.24190.521.5192.1191.381.51
2347527-34752789.21590.04
3347785-34778589.28290.14
4349962-34996289.84090.71
5353676-35367690.79491.67
6361264-36126492.74293.62
1440min1351524-35152490.24190.941.7791.2691.951.76
2350795-35079590.05491.03
3346754-34675489.01790.02
4357559-35755991.79192.81
5354191-35419190.92691.95
6364648-36464893.61194.64
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