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5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2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%
115.081723561725691726651729111727061726410.12
215.121720971721471721220.03
单位质量响应值RSD%判断
11448.3411383.730.41数据可信
供试品溶液-25022801批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min133625-3362517.70817.233.8717.7117.233.87
233865-3386517.83417.83
330879-3087916.26216.26
433437-3343717.60917.61
531388-3138816.53016.53
633141-3314117.45317.45
60min158300-5830030.70330.152.2730.7330.182.28
257892-5789230.48830.52
355331-5533129.13929.17
457747-5774730.41130.44
555894-5589429.43629.46
658327-5832730.71730.75
120min192860-9286048.90348.171.5348.9848.241.53
292277-9227748.59648.68
389498-8949847.13247.21
491193-9119348.02548.11
590208-9020847.50647.58
692728-9272848.83448.91
240min1137615-13761572.47272.210.6272.6372.370.62
2137652-13765272.49272.65
3136251-13625171.75471.91
4138283-13828372.82472.98
5136239-13623971.74871.90
6136676-13667671.97872.14
360min1167584-16758488.25588.421.3288.5488.701.31
2163978-16397886.35686.64
3167638-16763888.28488.56
4169896-16989689.47389.75
5168279-16827988.62188.90
6170054-17005489.55689.84
480min1184398-18439897.11096.801.4597.5497.231.45
2179000-17900094.26794.69
3182624-18262496.17696.60
4186162-18616298.03998.47
5185662-18566297.77698.20
6185059-18505997.45897.89
600min1190441-190441100.292100.261.54100.88100.851.54
2186237-18623798.07898.66
3187518-18751898.75399.33
4193370-193370101.835102.43
5192963-192963101.620102.21
6191788-191788101.002101.59
720min1194547-194547102.455101.941.81103.21102.701.80
2187586-18758698.78999.54
3191220-191220100.703101.45
4196591-196591103.531104.29
5195468-195468102.940103.70
6195990-195990103.215103.98
960min1194352-194352102.352102.252.13103.28103.182.12
2188165-18816599.094100.01
3190614-190614100.383101.30
4195961-195961103.199104.14
5199437-199437105.030105.96
6196446-196446103.455104.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1195742-195742103.084102.842.12104.18103.942.10
2188270-18827099.149100.23
3192727-192727101.496102.58
4199250-199250104.931106.04
5197899-197899104.220105.32
6197813-197813104.175105.28
1440min1194336-194336102.344101.651.97103.62102.921.96
2187193-18719398.58299.82
3189620-18962099.860101.11
4197017-197017103.755105.04
5194253-194253102.300103.58
6195697-195697103.060104.34
极限1194072-194072102.204101.852.03103.65103.292.02
2187434-18743498.709100.11
3189978-189978100.048101.47
4197145-197145103.823105.28
5194733-194733102.553104.00
6197017-197017103.755105.21
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5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2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%
115.081728201734221726411734451727611730180.23
215.121707461722721715090.63
单位质量响应值RSD%判断
11473.3411343.190.81数据可信
供试品溶液-25022801批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min123789-2378912.53712.906.9912.5412.906.97
224898-2489813.12113.12
323961-2396112.62812.63
423182-2318212.21712.22
527726-2772614.61214.61
623274-2327412.26512.27
60min147632-4763225.10223.766.2625.1223.786.25
244492-4449223.44723.47
343640-4364022.99823.02
442430-4243022.36122.38
549430-4943026.05026.07
642860-4286022.58722.61
120min171846-7184637.86338.684.4837.9338.744.48
273912-7391238.95239.01
372083-7208337.98838.05
471601-7160137.73437.79
579802-7980242.05642.12
671083-7108337.46137.52
240min1111914-11191458.97959.203.1759.1059.333.18
2111633-11163358.83158.96
3112135-11213559.09659.22
4108918-10891857.40057.52
5119165-11916562.80062.94
6110248-11024858.10158.22
360min1142592-14259275.14674.922.3475.3775.152.35
2140822-14082274.21474.44
3141742-14174274.69974.92
4139130-13913073.32273.54
5148488-14848878.25478.50
6140231-14023173.90274.12
480min1158528-15852883.54583.652.2683.8984.002.27
2156034-15603482.23082.58
3157723-15772383.12183.47
4156300-15630082.37182.71
5165764-16576487.35887.73
6157989-15798983.26183.60
600min1171761-17176190.51989.352.2991.0189.842.29
2166122-16612287.54788.03
3168850-16885088.98589.47
4165490-16549087.21487.69
5175956-17595692.72993.25
6169036-16903689.08389.56
720min1177514-17751493.55192.672.1694.1993.312.16
2171164-17116490.20490.83
3175421-17542192.44793.08
4173310-17331091.33591.96
5182198-18219896.01996.69
6175506-17550692.49293.12
960min1184632-18463297.30297.161.8198.1097.961.81
2180968-18096895.37196.15
3184582-18458297.27598.06
4181530-18153095.66796.44
5190319-190319100.299101.13
6184203-18420397.07697.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191731-191731101.043100.272.02102.00101.222.03
2186995-18699598.54799.49
3191241-191241100.785101.73
4186126-18612698.08999.02
5196643-196643103.632104.63
6188813-18881399.505100.45
1440min1189847-189847100.050100.241.31101.18101.361.32
2186394-18639498.23099.33
3191864-191864101.113102.23
4188693-18869399.442100.54
5193468-193468101.958103.13
6191033-191033100.675101.78
极限1189553-18955399.895100.591.49101.19101.881.50
2187560-18756098.845100.11
3190365-190365100.323101.61
4191283-191283100.807102.07
5196065-196065103.327104.67
6190355-190355100.318101.60
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