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%
114.851729841725381727901727691725061727170.12
215.031732251724461728360.32
单位质量响应值RSD%判断
11630.7711499.400.81数据可信
供试品溶液-25010601-1-cq4M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%
30min128830-2883014.88015.014.2914.8815.014.29
228079-2807914.49214.49
327575-2757514.23214.23
429286-2928615.11515.12
529619-2961915.28715.29
631105-3110516.05416.05
60min152910-5291027.30826.930.7327.3326.960.72
252221-5222126.95226.98
352019-5201926.84826.87
452035-5203526.85626.88
551860-5186026.76626.79
652022-5202226.85026.88
120min186190-8619044.48543.232.2044.5543.302.20
283043-8304342.86042.93
380836-8083641.72141.79
483526-8352643.11043.18
583868-8386843.28643.36
685149-8514943.94744.02
240min1129712-12971266.94764.852.1467.0965.002.13
2125230-12523064.63464.77
3121582-12158262.75162.89
4125058-12505864.54564.69
5125257-12525764.64864.79
6127106-12710665.60265.75
360min1156141-15614180.58878.231.8380.8478.481.83
2151082-15108277.97778.22
3148114-14811476.44576.69
4150491-15049177.67277.92
5150366-15036677.60777.86
6153203-15320379.07179.33
480min1171109-17110988.31386.231.5588.7086.611.54
2166738-16673886.05786.44
3163544-16354484.40984.78
4165964-16596485.65886.04
5166408-16640885.88786.27
6168696-16869687.06887.45
600min1180095-18009592.95191.111.4093.4991.641.40
2177051-17705191.38091.90
3173293-17329389.44089.95
4175153-17515390.40090.92
5175286-17528690.46990.99
6178321-17832192.03592.57
720min1181415-18141593.63294.312.1594.3294.982.14
2179175-17917592.47693.15
3180502-18050293.16193.82
4181510-18151093.68194.35
5183559-18355994.73995.41
6190157-19015798.14498.83
960min1187546-18754696.79796.971.7397.6597.801.73
2184448-18444895.19896.03
3186195-18619596.09996.91
4186588-18658896.30297.13
5188600-18860097.34198.17
6193864-193864100.057100.91
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190547-19054798.34598.411.2599.3699.401.25
2187236-18723696.63797.62
3189273-18927397.68898.66
4190760-19076098.45599.44
5191949-19194999.069100.06
6194264-194264100.264101.28
1440min1190288-19028898.21298.751.3399.3999.911.32
2186916-18691696.47197.62
3191141-19114198.65299.79
4192429-19242999.317100.47
5193851-193851100.051101.21
6193334-19333499.784100.97
极限1190552-19055298.34882.4949.0399.6983.8248.24
2186191-18619196.09797.41
3194061-194061100.159101.46
4194530-194530100.401101.72
5193618-19361899.930101.26
6-0.0001.35
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%
114.851729041733771731381730231730681731020.11
215.031727111722511724810.19
单位质量响应值RSD%判断
11656.7011475.781.11数据可信
供试品溶液-25010601-2-cq4M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%
30min129407-2940715.17715.653.9915.1815.653.99
229401-2940115.17315.17
329994-2999415.47915.48
431830-3183016.42716.43
531895-3189516.46116.46
629461-2946115.20415.20
60min152013-5201326.84327.543.2526.8727.573.24
253305-5330527.51027.54
352590-5259027.14127.17
455348-5534828.56428.59
555561-5556128.67428.70
651411-5141126.53226.56
120min182384-8238442.51744.133.6642.5944.203.66
284936-8493643.83443.91
382936-8293642.80242.87
489211-8921146.04046.12
589523-8952346.20146.28
684016-8401643.35943.43
240min1121148-12114862.52364.823.8962.6664.973.89
2124198-12419864.09764.24
3122111-12211163.02063.16
4131867-13186768.05568.21
5131698-13169867.96768.12
6122627-12262763.28663.43
360min1144777-14477774.71777.363.7974.9677.623.79
2149272-14927277.03777.29
3145444-14544475.06175.31
4158538-15853881.81982.08
5155112-15511280.05180.32
6146284-14628475.49575.74
480min1159459-15945982.29484.703.0082.6685.093.01
2163919-16391984.59684.98
3159959-15995982.55282.92
4170725-17072588.10988.51
5169561-16956187.50887.91
6161147-16114783.16683.54
600min1168542-16854286.98289.352.9087.4989.882.90
2173096-17309689.33289.85
3168296-16829686.85587.37
4180000-18000092.89593.44
5178358-17835892.04892.59
6170520-17052088.00388.51
720min1174363-17436389.98692.302.6890.6492.972.69
2179187-17918792.47693.15
3174055-17405589.82790.48
4185311-18531195.63696.34
5183738-18373894.82495.52
6176422-17642291.04991.71
960min1180111-18011192.95395.573.0293.7596.393.02
2185405-18540595.68596.51
3180396-18039693.10093.90
4194526-194526100.392101.25
5188502-18850297.28398.14
6182142-18214294.00194.81
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184334-18433495.13297.372.3796.0998.362.38
2190151-19015198.13499.12
3183861-18386194.88895.85
4194591-194591100.426101.46
5192636-19263699.417100.43
6186505-18650596.25297.22
1440min1186541-18654196.27198.332.4597.3999.482.45
2192406-19240699.298100.44
3184785-18478595.36596.48
4196721-196721101.525102.72
5194201-194201100.224101.41
6188498-18849897.28198.41
极限1186372-18637296.18498.232.2797.4699.542.28
2192085-19208599.132100.44
3185091-18509195.52396.80
4196133-196133101.221102.59
5193612-19361299.920101.27
6188754-18875497.41398.70
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