乌帕替尼缓释片片项目信息
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
215.051732251724461728360.32
单位质量响应值RSD%判断
11630.7711484.120.90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%
30min128830-2883014.89015.024.2914.8915.024.29
228079-2807914.50214.50
327575-2757514.24214.24
429286-2928615.12515.13
529619-2961915.29715.30
631105-3110516.06516.06
60min152910-5291027.32626.950.7327.3526.970.72
252221-5222126.97026.99
352019-5201926.86626.89
452035-5203526.87426.90
551860-5186026.78426.81
652022-5202226.86826.89
120min186190-8619044.51443.262.2044.5843.342.20
283043-8304342.88942.96
380836-8083641.74941.82
483526-8352643.13843.21
583868-8386843.31543.39
685149-8514943.97744.05
240min1129712-12971266.99264.902.1467.1465.042.14
2125230-12523064.67764.82
3121582-12158262.79362.93
4125058-12505864.58864.73
5125257-12525764.69164.83
6127106-12710665.64665.79
360min1156141-15614180.64278.281.8380.9078.531.83
2151082-15108278.02978.28
3148114-14811476.49676.74
4150491-15049177.72477.97
5150366-15036677.65977.91
6153203-15320379.12479.38
480min1171109-17110988.37286.291.5588.7686.671.55
2166738-16673886.11586.49
3163544-16354484.46584.84
4165964-16596485.71586.09
5166408-16640885.94486.32
6168696-16869687.12687.51
600min1180095-18009593.01391.171.4093.5591.701.40
2177051-17705191.44191.96
3173293-17329389.50090.01
4175153-17515390.46190.98
5175286-17528690.52991.05
6178321-17832192.09792.63
720min1184177-18417795.12193.851.0395.8194.531.04
2181415-18141593.69594.37
3179175-17917592.53893.20
4180502-18050293.22393.90
5181510-18151093.74494.42
6183559-18355994.80295.49
960min1190157-19015798.21096.711.0799.0697.541.07
2187546-18754696.86197.69
3184448-18444895.26196.08
4186195-18619596.16496.99
5186588-18658896.36797.20
6188600-18860097.40698.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193864-193864100.12498.441.19101.1499.431.20
2190547-19054798.41199.40
3187236-18723696.70197.67
4189273-18927397.75398.74
5190760-19076098.52199.51
6191949-19194999.135100.14
1440min1194264-194264100.33198.891.42101.51100.051.42
2190288-19028898.27799.43
3186916-18691696.53697.67
4191141-19114198.71899.87
5192429-19242999.383100.54
6193851-193851100.118101.29
极限1193334-19333499.85199.191.67101.20100.511.66
2190552-19055298.41499.73
3186191-18619196.16297.46
4194061-194061100.226101.54
5194530-194530100.468101.79
6193618-19361899.997101.33
乌帕替尼缓释片片项目信息
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
215.051727111722511724810.19
单位质量响应值RSD%判断
11656.7011460.531.21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%
30min129407-2940715.18715.663.9815.1915.663.99
229401-2940115.18415.18
329994-2999415.49015.49
431830-3183016.43816.44
531895-3189516.47216.47
629461-2946115.21515.21
60min152013-5201326.86127.563.2526.8927.593.25
253305-5330527.52827.55
352590-5259027.15927.18
455348-5534828.58328.61
555561-5556128.69328.72
651411-5141126.55026.58
120min182384-8238442.54644.163.6642.6244.233.66
284936-8493643.86443.93
382936-8293642.83142.90
489211-8921146.07146.15
589523-8952346.23246.31
684016-8401643.38843.46
240min1121148-12114862.56564.873.8962.7165.013.89
2124198-12419864.14064.28
3122111-12211163.06263.20
4131867-13186768.10068.25
5131698-13169868.01368.17
6122627-12262763.32863.47
360min1144777-14477774.76777.423.7975.0177.673.80
2149272-14927277.08977.34
3145444-14544475.11275.36
4158538-15853881.87482.14
5155112-15511280.10580.37
6146284-14628475.54675.79
480min1159459-15945982.35084.763.0082.7285.143.01
2163919-16391984.65385.03
3159959-15995982.60882.98
4170725-17072588.16888.57
5169561-16956187.56787.97
6161147-16114783.22183.59
600min1168542-16854287.04089.412.9087.5589.942.91
2173096-17309689.39289.91
3168296-16829686.91387.42
4180000-18000092.95893.51
5178358-17835892.11092.65
6170520-17052088.06288.57
720min1174363-17436390.04692.362.6890.7093.042.69
2179187-17918792.53893.21
3174055-17405589.88790.54
4185311-18531195.70096.40
5183738-18373894.88895.59
6176422-17642291.11091.77
960min1180111-18011193.01595.633.0293.8296.463.02
2185405-18540595.74996.57
3180396-18039693.16293.97
4194526-194526100.459101.32
5188502-18850297.34898.21
6182142-18214294.06494.87
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184334-18433495.19697.442.3796.1598.422.38
2190151-19015198.20099.18
3183861-18386194.95295.91
4194591-194591100.493101.52
5192636-19263699.483100.50
6186505-18650596.31797.28
1440min1186541-18654196.33698.392.4597.4599.542.45
2192406-19240699.364100.51
3184785-18478595.42996.55
4196721-196721101.593102.79
5194201-194201100.291101.48
6188498-18849897.34698.47
极限1186372-18637296.24898.302.2797.5299.612.28
2192085-19208599.199100.51
3185091-18509195.58796.86
4196133-196133101.289102.66
5193612-19361299.987101.34
6188754-18875497.47898.77
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