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%
114.851725741715101716061722511729111721700.36
215.031746641744171745400.11
单位质量响应值RSD%判断
11593.9411612.770.12数据可信
供试品溶液-2025022001-2-2js3M-bc2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%
30min134165-3416517.57517.552.5917.5717.552.59
232541-3254116.73916.74
334504-3450417.74917.75
435225-3522518.12018.12
534010-3401017.49517.49
634243-3424317.61517.61
60min159226-5922630.46630.244.2130.5030.274.22
255184-5518428.38728.41
361484-6148431.62831.66
459431-5943130.57130.60
560924-6092431.34031.37
656523-5652329.07629.10
120min191376-9137647.00447.192.0047.0847.261.99
290715-9071546.66446.74
390374-9037446.48946.57
495242-9524248.99349.07
592054-9205447.35347.43
690619-9061946.61546.69
240min1131073-13107367.42468.091.1467.5868.251.14
2131646-13164667.71967.87
3133728-13372868.79068.95
4134431-13443169.15269.31
5130657-13065767.21067.37
6132699-13269968.26168.42
360min1155478-15547879.97880.901.0480.2581.171.04
2157574-15757481.05781.32
3156181-15618180.34080.61
4159807-15980782.20582.48
5156187-15618780.34380.62
6158378-15837881.47081.74
480min1165343-16534385.05386.841.7585.4687.251.74
2171786-17178688.36788.77
3166629-16662985.71486.12
4172864-17286488.92289.34
5167833-16783386.33486.74
6168439-16843986.64687.05
600min1177177-17717791.14092.931.7791.6993.481.76
2185210-18521095.27395.82
3177304-17730491.20691.76
4183195-18319594.23694.80
5180516-18051692.85893.41
6180562-18056292.88293.43
720min1183745-18374594.51995.271.5395.2295.981.52
2189464-18946497.46198.17
3182111-18211193.67894.38
4187856-18785696.63497.35
5183690-18369094.49195.20
6184350-18435094.83095.53
960min1187005-18700596.19697.891.7197.0598.751.70
2193834-19383499.709100.58
3187238-18723896.31697.18
4193725-19372599.653100.53
5191970-19197098.75099.61
6187970-18797096.69297.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1188416-18841696.92298.421.4397.9499.441.43
2194632-194632100.119101.15
3189298-18929897.37598.40
4194277-19427799.937100.98
5192097-19209798.81599.84
6189196-18919697.32398.35
1440min1190158-19015897.81898.542.0299.0099.732.01
2195208-195208100.416101.62
3187503-18750396.45297.63
4196971-196971101.323102.54
5191567-19156798.54399.73
6187910-18791096.66297.85
极限1187344-18734496.37098.011.8897.7199.361.88
2194262-19426299.929101.30
3187706-18770696.55797.90
4195716-195716100.677102.06
5189746-18974697.60698.96
6188389-18838996.90898.25
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%
114.851715321722181707991698761718381712530.55
215.031752171751921752040.02
单位质量响应值RSD%判断
11532.1911656.950.77数据可信
供试品溶液-12025032321-js2M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%
30min1160805-16080582.78474.289.5882.7874.289.58
2144354-14435474.31574.31
3153116-15311678.82578.83
4147776-14777676.07676.08
5120503-12050362.03662.04
6139156-13915671.63971.64
60min1186489-18648996.00690.754.1296.1490.874.12
2172851-17285188.98589.11
3179397-17939792.35592.49
4175707-17570790.45590.58
5164789-16478984.83584.94
6178398-17839891.84191.96
120min1191829-19182998.75597.901.4099.0598.181.41
2188334-18833496.95697.23
3189979-18997997.80398.09
4192466-19246699.08399.36
5185891-18589195.69895.94
6192552-19255299.12799.40
240min1192437-19243799.06898.430.9499.5398.870.95
2190733-19073398.19198.62
3191062-19106298.36098.81
4191296-19129698.48198.92
5188209-18820996.89197.30
6193473-19347399.601100.04
360min1193044-19304499.38199.371.24100.0199.981.25
2189869-18986997.74698.34
3193103-19310399.411100.02
4195744-195744100.770101.38
5190855-19085598.25498.82
6195566-195566100.679101.28
480min1192318-19231899.00798.981.2599.8099.751.25
2192355-19235599.02699.79
3191174-19117498.41899.20
4194478-194478100.119100.89
5188356-18835696.96797.70
6194969-194969100.372101.14
600min1194325-194325100.040100.420.80101.00101.360.81
2195468-195468100.628101.55
3194991-194991100.383101.32
4196828-196828101.329102.27
5192504-19250499.10399.99
6196319-196319101.067102.01
720min1195090-195090100.434101.071.19101.56102.171.19
2195936-195936100.869101.96
3194350-194350100.053101.16
4198426-198426102.151103.26
5194283-194283100.018101.07
6199921-199921102.921104.03
960min1193358-19335899.54299.190.87100.83100.460.88
2191278-19127898.47199.73
3193062-19306299.390100.67
4193598-19359899.666100.95
5190139-19013997.88599.11
6194665-194665100.215101.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1192183-19218398.93798.330.67100.4099.770.68
2189465-18946597.53898.96
3190387-19038798.01399.45
4192053-19205398.870100.32
5189799-18979997.71099.10
6192166-19216698.929100.37
1440min1189946-18994697.78697.731.1499.4199.331.14
2189387-18938797.49899.09
3189495-18949597.55399.16
4192200-19220098.946100.56
5186202-18620295.85897.41
6191816-19181698.748100.36
极限1189131-18913197.36697.481.0099.1599.241.01
2191273-19127398.469100.22
3188842-18884297.21798.98
4190615-19061598.13099.91
5185979-18597995.74397.45
6190296-19029697.96699.74
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