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%
114.941716141715961715651714711715491715590.04
214.951714061716861715460.12
单位质量响应值RSD%判断
11483.2011474.650.06数据可信
加速6月-供试品溶液-2025081321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%
30min127137-2713714.11113.922.1714.1113.922.17
226398-2639813.72613.73
326318-2631813.68513.68
426845-2684513.95913.96
527730-2773014.41914.42
626244-2624413.64613.65
60min148183-4818325.05425.102.7725.0825.122.77
249079-4907925.52025.54
347616-4761624.75924.78
448864-4886425.40825.43
549833-4983325.91225.94
646029-4602923.93423.96
120min180122-8012241.66241.322.4041.7341.382.40
281573-8157342.41642.48
378928-7892841.04141.10
479715-7971541.45041.52
580424-8042441.81941.89
676013-7601339.52539.59
240min1119414-11941462.09361.702.2462.2361.842.23
2121905-12190563.38863.52
3117718-11771861.21161.34
4120366-12036662.58862.72
5118427-11842761.58061.72
6114173-11417359.36859.50
360min1142641-14264174.17074.071.7874.4174.311.79
2146233-14623376.03876.28
3141766-14176673.71573.95
4143681-14368174.71174.95
5141887-14188773.77874.02
6138516-13851672.02572.25
480min1158852-15885282.60082.461.5782.9682.821.57
2162317-16231784.40184.77
3156956-15695681.61481.97
4159974-15997483.18383.55
5158303-15830382.31482.68
6155111-15511180.65481.00
600min1172020-17202089.44789.401.7089.9589.901.70
2176663-17666391.86192.37
3169920-16992088.35588.85
4173479-17347990.20590.71
5171248-17124889.04589.55
6168301-16830187.51387.99
720min1178922-17892293.03692.621.4993.6893.261.49
2182056-18205694.66595.33
3176055-17605591.54592.19
4179199-17919993.18093.83
5177982-17798292.54793.20
6174476-17447690.72491.35
960min1185418-18541896.41396.401.3897.2297.201.38
2189286-18928698.42599.24
3183093-18309395.20596.00
4186986-18698697.22998.04
5185181-18518196.29097.09
6182337-18233794.81195.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1188858-18885898.20298.061.3199.1799.021.32
2192106-19210699.891100.88
3187306-18730697.39598.35
4190197-19019798.89899.87
5188135-18813597.82698.79
6184910-18491096.14997.09
1440min1189826-18982698.70698.791.2299.8399.921.22
2193199-193199100.459101.61
3188513-18851398.02399.14
4191827-19182799.746100.88
5189879-18987998.73399.86
6186703-18670397.08298.18
极限1189643-18964398.61098.761.1499.90100.051.15
2193048-193048100.381101.70
3188220-18822097.87099.15
4191250-19125099.446100.75
5190421-19042199.015100.31
6186999-18699997.23698.49
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%
114.941715221713591707411716061715051713470.21
214.951719111719591719350.02
单位质量响应值RSD%判断
11469.0111500.670.20数据可信
加速6月-供试品溶液-2025081321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%
30min127883-2788314.49113.484.9114.4913.484.91
224542-2454212.75512.75
326395-2639513.71813.72
425965-2596513.49413.49
524529-2452912.74812.75
626329-2632913.68413.68
60min149543-4954325.74824.404.2825.7724.434.28
246354-4635424.09124.11
347492-4749224.68224.71
445586-4558623.69223.71
544117-4411722.92822.95
648647-4864725.28225.31
120min180604-8060441.89140.873.9841.9640.933.99
277673-7767340.36840.43
381853-8185342.54042.60
476736-7673639.88139.94
573773-7377338.34138.40
681200-8120042.20142.27
240min1120521-12052162.63661.032.2062.7761.162.20
2117001-11700160.80760.94
3118247-11824761.45461.59
4115491-11549160.02260.15
5113675-11367559.07859.20
6119650-11965062.18462.32
360min1145535-14553575.63673.881.7975.8874.121.80
2141921-14192173.75873.99
3142725-14272574.17674.41
4138689-13868972.07872.31
5139987-13998772.75372.97
6144108-14410874.89575.13
480min1160474-16047483.40082.311.6883.7782.671.68
2160536-16053683.43383.79
3159036-15903682.65383.01
4154603-15460380.34980.70
5155492-15549280.81181.15
6160166-16016683.24083.60
600min1172374-17237489.58588.471.2190.0988.961.21
2171867-17186789.32189.81
3169934-16993488.31788.82
4166995-16699586.78987.27
5171350-17135089.05389.53
6168840-16884087.74888.25
720min1179032-17903293.04592.070.9793.7092.710.98
2177741-17774192.37493.02
3177370-17737092.18192.83
4173993-17399390.42691.05
5177989-17798992.50393.13
6176802-17680291.88692.53
960min1184965-18496596.12996.001.0696.9496.801.06
2186603-18660396.98097.77
3186255-18625596.79997.60
4182012-18201294.59495.37
5182651-18265194.92695.71
6185871-18587196.59997.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1187787-18778797.59597.600.9898.5798.550.99
2189340-18934098.40299.36
3189949-18994998.71999.68
4185845-18584596.58697.52
5185411-18541196.36097.30
6188411-18841197.92098.88
1440min1189187-18918798.32398.710.8499.4699.830.84
2191553-19155399.552100.67
3191979-19197999.774100.90
4188129-18812997.77398.87
5188570-18857098.00299.10
6190203-19020398.85199.98
极限1188952-18895298.20198.460.7199.5099.740.72
2190874-19087499.200100.49
3190974-19097499.252100.54
4187667-18766797.53398.79
5188410-18841097.91999.18
6189820-18982098.65299.94
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%
114.941716711714031713681718441714161715400.13
214.951719131718161718640.04
单位质量响应值RSD%判断
11481.9311495.920.09数据可信
加速6月-供试品溶液-1276525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%
30min125277-2527713.13212.882.8113.1312.882.79
223747-2374712.33712.34
325107-2510713.04413.04
425542-2554213.27013.27
524151-2415112.54712.55
624907-2490712.94012.94
60min143509-4350922.60422.373.8022.6322.393.80
240784-4078421.18821.21
343271-4327122.48022.50
444548-4454823.14423.17
541442-4144221.53021.55
644810-4481023.28023.30
120min172401-7240137.61436.493.1837.6736.553.18
267656-6765635.14935.20
371587-7158737.19137.25
471594-7159437.19537.26
567202-6720234.91334.97
671011-7101136.89236.95
240min1109354-10935456.81256.552.1956.9356.672.20
2106152-10615255.14955.26
3110686-11068657.50457.63
4109591-10959156.93557.06
5105746-10574654.93855.05
6111558-11155857.95758.08
360min1136312-13631270.81870.701.4071.0370.921.40
2133647-13364769.43369.64
3139315-13931572.37872.59
4136495-13649570.91371.13
5134862-13486270.06470.27
6135940-13594070.62470.84
480min1156126-15612681.11280.611.6381.4580.941.63
2151375-15137578.64378.97
3158935-15893582.57182.91
4154616-15461680.32780.66
5153946-15394679.97980.30
6155976-15597681.03481.37
600min1171246-17124688.96788.391.7689.4488.861.76
2165200-16520085.82686.28
3174243-17424390.52491.00
4168822-16882287.70888.18
5170482-17048288.57089.03
6170813-17081388.74289.21
720min1178890-17889092.93892.481.7293.5693.091.72
2172476-17247689.60690.20
3181277-18127794.17894.80
4180070-18007093.55194.17
5177331-17733192.12892.73
6177974-17797492.46293.08
960min1186301-18630196.78896.041.8297.5696.811.81
2179031-17903193.01193.76
3189290-18929098.34199.12
4184312-18431295.75596.53
5185055-18505596.14196.90
6185206-18520696.21996.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1190657-19065799.05198.111.7699.9999.041.76
2182805-18280594.97295.87
3192742-192742100.135101.08
4188637-18863798.00298.93
5189111-18911198.24899.17
6189079-18907998.23299.17
1440min1191983-19198399.74098.881.71100.8499.971.71
2184566-18456695.88796.95
3194414-194414101.003102.12
4189928-18992898.67399.77
5190583-19058399.013100.09
6190504-19050498.972100.07
极限1191815-19181599.65398.941.92100.92100.201.91
2184104-18410495.64796.87
3195158-195158101.390102.67
4189496-18949698.44899.71
5191511-19151199.495100.74
6190584-19058499.013100.28
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%
114.941718781722011717641714201715401717610.18
214.951728861727981728420.04
单位质量响应值RSD%判断
11496.7211561.340.40数据可信
加速6月-供试品溶液-1276525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%
30min125362-2536213.13013.042.5013.1313.042.49
224668-2466812.77112.77
326177-2617713.55213.55
424455-2445512.66112.66
525522-2552213.21313.21
624979-2497912.93212.93
60min145843-4584323.73422.772.9823.7622.802.98
242858-4285822.18922.21
345079-4507923.33823.36
442591-4259122.05022.07
544322-4432222.94722.97
643226-4322622.37922.40
120min171846-7184637.19636.601.6837.2636.661.68
269471-6947135.96736.03
372384-7238437.47537.54
469804-6980436.13936.20
570684-7068436.59536.66
669941-6994136.21036.27
240min1111541-11154157.74756.671.5057.8756.791.50
2108602-10860256.22656.34
3110358-11035857.13557.26
4107220-10722055.51055.63
5110599-11059957.26057.38
6108395-10839556.11956.24
360min1138250-13825071.57570.541.2971.7970.751.29
2135669-13566970.23970.45
3136737-13673770.79271.01
4133610-13361069.17369.38
5137920-13792071.40471.62
6135293-13529370.04470.26
480min1157100-15710081.33480.021.3781.6780.361.37
2154585-15458580.03280.36
3154939-15493980.21680.55
4151281-15128178.32278.65
5156294-15629480.91781.25
6153217-15321779.32479.65
600min1173343-17334389.74488.221.3190.2288.681.31
2171577-17157788.82989.29
3169818-16981887.91988.39
4167113-16711386.51886.97
5171556-17155688.81989.29
6168960-16896087.47587.94
720min1178880-17888092.61091.640.8793.2392.260.87
2177630-17763091.96392.57
3176984-17698491.62992.25
4174370-17437090.27590.88
5177783-17778392.04292.66
6176439-17643991.34791.95
960min1186892-18689296.75895.580.9597.5496.340.95
2184827-18482795.68996.45
3184699-18469995.62396.39
4181558-18155893.99794.75
5185389-18538995.98096.75
6184298-18429895.41596.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1191163-19116398.97097.520.9899.9198.440.98
2189619-18961998.17099.09
3187785-18778597.22198.15
4185771-18577196.17897.09
5188015-18801597.34098.27
6187801-18780197.22998.15
1440min1193348-193348100.10198.611.00101.2199.691.00
2191496-19149699.142100.23
3190157-19015798.44999.54
4187642-18764297.14798.21
5190299-19029998.52299.62
6189815-18981598.27299.35
极限1193227-193227100.03898.521.07101.3199.771.07
2191393-19139399.089100.34
3189858-18985898.29499.55
4187074-18707496.85398.08
5190360-19036098.55499.81
6189849-18984998.28999.53
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