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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.003410423408923405843409963410083409040.06
215.103401203402983402090.04
单位质量响应值RSD%判断
22726.9322530.400.62数据可信
供试品溶液-1224287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%
30min169157-6915717.86818.312.8317.8718.312.84
268520-6852017.70317.70
372321-7232118.68518.69
469913-6991318.06318.06
571495-7149518.47218.47
673717-7371719.04619.05
60min1115490-11549029.83930.732.6529.8730.762.65
2115049-11504929.72529.75
3121100-12110031.28831.32
4121603-12160331.41831.45
5118344-11834430.57630.61
6122162-12216231.56331.59
120min1182837-18283747.23948.212.1047.3248.292.10
2182649-18264947.19147.27
3190018-19001849.09449.18
4184685-18468547.71747.80
5187138-18713848.35048.43
6192195-19219549.65749.74
240min1275664-27566471.22372.471.8171.3872.641.81
2274586-27458670.94471.10
3286663-28666374.06474.23
4279303-27930372.16372.32
5280863-28086372.56672.73
6285954-28595473.88174.05
360min1335322-33532286.63687.421.4386.9187.701.44
2330688-33068885.43985.71
3343965-34396588.86989.16
4338330-33833087.41387.70
5339444-33944487.70187.98
6342368-34236888.45788.75
480min1368951-36895195.32595.771.2295.7596.201.23
2362792-36279293.73494.15
3375023-37502396.89497.33
4371288-37128895.92996.36
5371200-37120095.90696.34
6374842-37484296.84797.28
600min1382893-38289398.92799.881.2299.51100.471.22
2379585-37958598.07298.65
3391882-391882101.250101.85
4388851-388851100.466101.05
5385894-38589499.702100.29
6390344-390344100.852101.45
720min1389856-389856100.726101.491.27101.47102.241.27
2385602-38560299.627100.37
3400194-400194103.397104.16
4393860-393860101.761102.52
5391957-391957101.269102.02
6395341-395341102.143102.91
960min1389703-389703100.687101.281.00101.60102.201.01
2385957-38595799.719100.62
3396943-396943102.557103.50
4393131-393131101.572102.50
5391309-391309101.102102.03
6394874-394874102.023102.96
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1387364-387364100.082100.661.08101.16101.761.08
2383015-38301598.959100.03
3394874-394874102.023103.13
4390965-390965101.013102.11
5388939-388939100.489101.58
6392524-392524101.415102.52
1440min1383284-38328499.02899.660.91100.28100.920.91
2380836-38083698.39699.63
3389917-389917100.742102.02
4386721-38672199.916101.18
5384585-38458599.364100.62
6389085-389085100.527101.80
极限1383534-38353499.09399.431.01100.51100.861.01
2378789-37878997.86799.27
3390507-390507100.894102.34
4385370-38537099.567101.00
5384106-38410699.240100.67
6386689-38668999.908101.35
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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.003397633411083406833404753409493405960.16
215.103400453398973399710.04
单位质量响应值RSD%判断
22706.4022514.640.60数据可信
供试品溶液-1224287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%
30min148716-4871612.59712.802.7112.6012.802.70
251646-5164613.35413.35
349068-4906812.68812.69
447758-4775812.34912.35
549494-4949412.79812.80
650245-5024512.99212.99
60min183042-8304221.47321.722.2421.4921.742.23
282969-8296921.45421.48
384635-8463521.88421.91
487335-8733522.58322.60
581984-8198421.19921.22
684101-8410121.74621.77
120min1132679-13267934.30734.391.0734.3634.451.07
2131488-13148833.99934.06
3135672-13567235.08135.14
4132298-13229834.20934.27
5132782-13278234.33434.39
6133048-13304834.40334.46
240min1200584-20058451.86652.661.2451.9852.781.23
2202099-20209952.25852.37
3205930-20593053.24853.36
4201950-20195052.21952.33
5206929-20692953.50753.62
6204538-20453852.88853.00
360min1246961-24696163.85864.611.1764.0664.821.17
2247713-24771364.05264.25
3252639-25263965.32665.53
4248587-24858764.27864.48
5254285-25428565.75265.95
6249125-24912564.41764.62
480min1278362-27836271.97772.511.1472.2872.821.14
2277874-27787471.85172.16
3281365-28136572.75473.07
4278034-27803471.89372.20
5286161-28616173.99474.31
6280789-28078972.60572.92
600min1296008-29600876.54077.261.2276.9777.691.22
2296457-29645776.65677.08
3300354-30035477.66478.10
4297372-29737276.89377.32
5305545-30554579.00679.44
6297062-29706276.81377.24
720min1310079-31007980.17980.691.2380.7381.241.23
2309297-30929779.97680.53
3313485-31348581.05981.62
4310451-31045180.27580.83
5319234-31923482.54683.11
6309756-30975680.09580.65
960min1328878-32887885.03985.711.1885.7386.401.17
2329184-32918485.11985.81
3333341-33334186.19486.89
4329164-32916485.11385.80
5338621-33862187.55988.26
6329602-32960285.22785.92
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1341052-34105288.18788.671.1089.0289.501.10
2341078-34107888.19489.03
3344415-34441589.05789.90
4341151-34115188.21389.05
5349899-34989990.47591.33
6339806-33980687.86588.70
1440min1348871-34887190.20990.491.0491.1991.481.04
2348403-34840390.08891.07
3352542-35254291.15892.15
4347322-34732289.80990.79
5356073-35607392.07193.07
6346589-34658989.61990.60
极限1348865-34886590.20890.561.0891.3391.701.08
2348272-34827290.05491.18
3351711-35171190.94492.09
4347384-34738489.82590.95
5357295-35729592.38793.54
6347896-34789689.95791.09
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