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%
1 14.941705181697931694221705691707591702120.34
2 14.851695561695991695780.02
单位质量响应值RSD%判断
11393.0411419.390.17数据可信
影响因素30天-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%
30min142502-4250222.24126.1123.3322.2426.1123.32
266224-6622434.65534.65
348174-4817425.20925.21
461744-6174432.31032.31
536460-3646019.07919.08
644262-4426223.16223.16
60min168237-6823735.70844.4423.6035.7544.4823.59
2106179-10617955.56355.62
3100880-10088052.79052.83
4101665-10166553.20153.25
561512-6151232.18932.22
671025-7102537.16737.21
120min1114349-11434959.83867.1318.1459.9367.2518.15
2155665-15566581.45981.61
3143903-14390375.30475.43
4145086-14508675.92376.07
595708-9570850.08350.17
6115038-11503860.19960.30
240min1167848-16784887.83486.359.7288.0386.589.74
2178591-17859193.45693.74
3170766-17076689.36189.62
4177098-17709892.67492.94
5135111-13511170.70370.87
6160640-16064084.06284.26
360min1180245-18024594.32192.465.4994.6692.835.51
2181276-18127694.86195.30
3178634-17863493.47893.88
4183260-18326095.89996.32
5157184-15718482.25382.54
6179490-17949093.92694.27
480min1188536-18853698.66096.692.7499.1697.222.78
2185462-18546297.05197.65
3186524-18652497.60798.17
4187286-18728698.00698.59
5174664-17466491.40191.82
6186126-18612697.39997.90
600min1189533-18953399.18297.081.4599.8597.771.47
2184848-18484896.73097.49
3185368-18536897.00297.72
4186628-18662897.66198.41
5181290-18129094.86895.44
6185475-18547597.05897.72
720min1188460-18846098.62096.850.9999.4597.700.99
2183970-18397096.27097.19
3184661-18466196.63297.52
4185745-18574597.19998.11
5183479-18347996.01496.75
6184201-18420196.39197.21
960min1187882-18788298.31896.341.1299.3197.361.08
2182289-18228995.39196.47
3183315-18331595.92896.97
4183884-18388496.22597.30
5184704-18470496.65597.55
6182582-18258295.54496.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186167-18616797.42095.691.0298.5896.860.97
2181089-18108994.76396.01
3182010-18201095.24596.45
4182275-18227595.38396.62
5183828-18382896.19697.25
6181787-18178795.12896.27
1440min1185347-18534796.99195.221.0798.3196.561.02
2180100-18010094.24595.65
3181395-18139594.92396.29
4180985-18098594.70896.10
5183096-18309695.81397.03
6180890-18089094.65995.96
极限1184307-18430796.44794.920.9597.9396.410.90
2179983-17998394.18495.74
3180508-18050894.45995.98
4180044-18004494.21695.76
5182540-18254095.52296.90
6180922-18092294.67596.13
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%
1 14.941690781694681693901694561693481693480.10
2 14.851692841689351691100.15
单位质量响应值RSD%判断
11335.2111387.880.33数据可信
影响因素30天-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%
30min125526-2552613.41013.652.0813.4113.652.09
225349-2534913.31713.32
325815-2581513.56213.56
426201-2620113.76513.76
526107-2610713.71513.72
626849-2684914.10514.11
60min145363-4536323.83224.161.6623.8524.181.67
245242-4524223.76823.79
345808-4580824.06524.09
446028-4602824.18124.20
546160-4616024.25024.27
647362-4736224.88224.91
120min172864-7286438.27938.921.1738.3438.981.17
273482-7348238.60438.67
374666-7466639.22639.29
474240-7424039.00239.07
573929-7392938.83938.90
675308-7530839.56339.63
240min1109619-10961957.58958.551.0357.7158.681.03
2110663-11066358.13758.26
3112356-11235659.02759.15
4111452-11145258.55258.68
5111909-11190958.79258.92
6112691-11269159.20359.33
360min1134228-13422870.51771.320.7470.7471.550.74
2135046-13504670.94771.17
3136836-13683671.88772.11
4135581-13558171.22871.45
5136502-13650271.71271.94
6136358-13635871.63671.87
480min1153037-15303780.39981.320.7880.7481.670.78
2154265-15426581.04481.39
3156062-15606281.98882.33
4154268-15426881.04581.39
5156164-15616482.04182.39
6154995-15499581.42781.78
600min1163317-16331785.79986.741.1986.2787.221.19
2163892-16389286.10186.58
3165701-16570187.05287.53
4163482-16348285.88686.37
5165858-16585887.13487.62
6168421-16842188.48188.97
720min1169653-16965389.12889.780.5189.7490.400.51
2170216-17021689.42490.04
3171570-17157090.13590.76
4170601-17060189.62690.25
5171696-17169690.20190.83
6171619-17161990.16190.79
960min1176509-17650992.73093.600.6593.4994.370.65
2177738-17773893.37594.14
3178342-17834293.69394.47
4177683-17768393.34694.12
5179879-17987994.50095.28
6178808-17880893.93794.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1179613-17961394.36095.010.5095.2895.940.51
2180561-18056194.85895.78
3182056-18205695.64496.58
4180152-18015294.64495.57
5181326-18132695.26096.20
6181397-18139795.29896.24
1440min1180795-18079594.98195.990.6296.0697.080.62
2182161-18216195.69996.78
3183616-18361696.46397.56
4182587-18258795.92397.01
5183686-18368696.50097.59
6183445-18344596.37497.47
极限1180915-18091595.04495.940.5896.2897.190.58
2182105-18210595.67096.91
3183698-18369896.50697.76
4182698-18269895.98197.23
5183700-18370096.50897.76
6182631-18263195.94697.20
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