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%
115.221715801719031719501719811716361718100.11
215.231729401725251727320.17
单位质量响应值RSD%判断
11288.4411341.560.34数据可信
供试品溶液-24082901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%
30min124133-2413312.78412.643.5712.7812.643.58
222925-2292512.14412.14
323057-2305712.21412.21
423738-2373812.57512.58
524114-2411412.77412.77
625253-2525313.37813.38
60min143097-4309722.83022.653.0322.8522.673.02
241264-4126421.85921.88
341972-4197222.23422.25
442157-4215722.33222.35
543119-4311922.84222.86
644968-4496823.82123.84
120min170363-7036337.27437.402.9337.3337.462.93
268049-6804936.04836.11
369804-6980436.97837.04
469272-6927236.69636.75
572959-7295938.64938.71
673205-7320538.78038.84
240min1109152-10915257.82257.752.0057.9457.872.00
2107186-10718656.78156.90
3107768-10776857.08957.21
4107081-10708156.72556.84
5110137-11013758.34458.47
6112724-11272459.71559.84
360min1135834-13583471.95771.651.5772.1771.871.57
2133706-13370670.83071.04
3134055-13405571.01571.23
4132858-13285870.38070.59
5136627-13662772.37772.60
6138502-13850273.37073.60
480min1154180-15418081.67681.161.6082.0181.491.60
2151863-15186380.44880.78
3151523-15152380.26880.60
4150315-15031579.62879.96
5154297-15429781.73882.08
6157031-15703183.18683.53
600min1169029-16902989.54288.831.7090.0289.301.70
2166176-16617688.03088.49
3166143-16614388.01388.48
4164027-16402786.89287.36
5168561-16856189.29489.77
6172127-17212791.18391.67
720min1175938-17593893.20292.501.6193.8293.121.62
2173576-17357691.95192.56
3173424-17342491.87092.48
4170565-17056590.35590.96
5175313-17531392.87193.50
6178899-17889994.77095.41
960min1183341-18334197.12396.391.7697.9097.161.76
2180880-18088095.82096.58
3180187-18018795.45396.22
4177270-17727093.90794.67
5183634-18363497.27998.06
6186415-18641598.75299.55
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186604-18660498.85298.051.6999.7998.981.69
2184392-18439297.68098.60
3183660-18366097.29298.22
4180614-18061495.67996.59
5185297-18529798.16099.10
6189948-189948100.623101.59
1440min1188042-18804299.61498.851.44100.7299.951.44
2185587-18558798.31399.40
3185113-18511398.06299.15
4183299-18329997.10198.18
5186534-18653498.81599.92
6191041-191041101.202102.33
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%
115.221718641722301719631717321717911719160.12
215.231725251724951725100.02
单位质量响应值RSD%判断
11295.4011326.990.20数据可信
供试品溶液-24082902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%
30min124690-2469013.08413.225.2513.0813.225.27
223996-2399612.71612.72
326979-2697914.29714.30
424177-2417712.81212.81
526108-2610813.83513.84
623709-2370912.56412.56
60min143573-4357323.09023.174.6723.1123.204.67
244072-4407223.35523.38
347585-4758525.21625.24
442869-4286922.71722.74
542060-4206022.28822.31
642233-4223322.38022.40
120min171085-7108537.66938.143.4237.7338.203.42
272472-7247238.40438.46
376001-7600140.27440.34
469718-6971836.94537.00
573146-7314638.76138.82
669421-6942136.78736.85
240min1109964-10996458.27258.572.2358.4058.692.24
2110728-11072858.67758.80
3114403-11440360.62460.76
4107756-10775657.10257.22
5112013-11201359.35859.48
6108267-10826757.37357.49
360min1136722-13672272.45272.451.7572.6772.681.75
2137093-13709372.64872.87
3140157-14015774.27274.51
4133717-13371770.85971.08
5138222-13822273.24673.47
6134452-13445271.24971.46
480min1154861-15486182.06481.921.5782.4082.261.57
2154564-15456481.90682.25
3158166-15816683.81584.17
4151263-15126380.15780.49
5155935-15593582.63382.98
6152709-15270980.92381.26
600min1169649-16964989.90089.741.4590.3890.221.45
2169398-16939889.76790.25
3173264-17326491.81692.31
4165846-16584687.88588.35
5169964-16996490.06790.55
6168014-16801489.03489.50
720min1176753-17675393.66593.241.5294.2993.871.52
2175644-17564493.07793.71
3180081-18008195.42896.08
4172093-17209391.19591.81
5176714-17671493.64494.28
6174474-17447492.45793.07
960min1184330-18433097.68097.071.3098.4697.851.30
2183229-18322997.09697.88
3186573-18657398.86999.68
4179468-17946895.10395.87
5183413-18341397.19497.98
6182041-18204196.46797.24
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187851-18785199.54698.721.34100.4999.661.35
2185992-18599298.56199.51
3189847-189847100.603101.58
4182443-18244396.68097.60
5186326-18632698.73899.69
6185268-18526898.17799.11
1440min1188846-188846100.07399.311.35101.19100.421.36
2186621-18662198.894100.00
3191026-191026101.228102.37
4183437-18343797.20798.29
5187682-18768299.456100.57
6186858-18685899.020100.12
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