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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
115.161694911695561693341692141689281693050.15
215.141693671692061692860.07
单位质量响应值RSD%判断
11167.8811181.370.09数据可信
供试品溶液-24081901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%
30min123177-2317712.49412.833.6812.4912.833.69
224678-2467813.30313.30
322803-2280312.29312.29
423124-2312412.46612.47
524136-2413613.01113.01
624855-2485513.39913.40
60min141434-4143422.33623.064.0922.3623.084.09
243947-4394723.69123.71
341122-4112222.16822.19
441230-4123022.22622.25
543708-4370823.56223.58
645250-4525024.39324.42
120min168294-6829436.81637.893.8236.8737.953.82
271988-7198838.80738.87
367729-6772936.51136.57
468051-6805136.68536.74
571378-7137838.47838.54
674324-7432440.06640.13
240min1107235-10723557.80859.102.8557.9359.222.85
2112372-11237260.57760.70
3106314-10631457.31257.43
4107841-10784158.13558.25
5109774-10977459.17759.30
6114223-11422361.57561.70
360min1133424-13342471.92673.142.6072.1473.362.60
2138360-13836074.58774.81
3132525-13252571.44171.66
4132945-13294571.66871.88
5135400-13540072.99173.21
6141353-14135376.20076.43
480min1150212-15021280.97682.442.5081.3182.782.50
2155295-15529583.71684.07
3149429-14942980.55480.89
4150480-15048081.12181.46
5152729-15272982.33382.68
6159389-15938985.92386.28
600min1160985-16098586.78488.092.4187.2588.572.41
2166409-16640989.70890.20
3160793-16079386.68087.15
4159943-15994386.22286.69
5162396-16239687.54488.03
6169926-16992691.60392.11
720min1167395-16739590.23991.472.3090.8592.102.30
2172229-17222992.84593.49
3167527-16752790.31090.92
4166387-16638789.69690.31
5168102-16810290.62091.25
6176459-17645995.12595.78
960min1174038-17403893.82094.942.2394.5995.722.23
2177440-17744095.65496.45
3174602-17460294.12494.89
4173299-17329993.42294.19
5173761-17376193.67194.45
6183532-18353298.93899.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1177730-17773095.81096.572.3096.7397.502.30
2178723-17872396.34697.30
3177960-17796095.93496.85
4176135-17613594.95195.87
5176930-17693095.37996.31
6187337-187337100.989101.97
1440min1179261-17926196.63697.402.3297.7298.502.32
2179000-17900096.49597.61
3180291-18029197.19198.27
4177491-17749195.68296.76
5179057-17905796.52697.62
6189024-189024101.899103.05
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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
115.161692101691671689951689561689081690470.08
215.141697471697831697650.02
单位质量响应值RSD%判断
11150.8611213.010.40数据可信
供试品溶液-24081902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%
30min122365-2236512.04912.333.9512.0512.323.96
222634-2263412.19412.19
322255-2225511.98911.99
424409-2440913.15013.15
522097-2209711.90411.90
623517-2351712.66912.67
60min140290-4029021.70522.042.9121.7322.062.91
240497-4049721.81721.84
340029-4002921.56521.58
442500-4250022.89622.92
539797-3979721.44021.46
642306-4230622.79222.81
120min166625-6662535.89336.072.6035.9536.132.61
266054-6605435.58535.64
365809-6580935.45335.51
468727-6872737.02537.09
565090-6509035.06635.12
669464-6946437.42237.48
240min1103995-10399556.02556.492.3556.1456.602.35
2104610-10461056.35756.47
3103154-10315455.57255.69
4106741-10674157.50557.63
5101959-10195954.92855.04
6108664-10866458.54158.66
360min1129332-12933269.67569.901.9569.8870.111.96
2128167-12816769.04769.26
3128777-12877769.37669.58
4131034-13103470.59270.81
5127014-12701468.42668.63
6134130-13413072.26072.48
480min1146417-14641778.87978.882.0279.2079.202.03
2144866-14486678.04478.37
3145557-14555778.41678.74
4145848-14584878.57378.91
5143655-14365577.39177.71
6152129-15212981.95682.30
600min1156959-15695984.55984.591.9185.0285.041.91
2154857-15485783.42683.88
3157830-15783085.02885.48
4155635-15563583.84584.31
5154278-15427883.11483.56
6162505-16250587.54688.02
720min1162992-16299287.80987.712.2088.4188.312.20
2160765-16076586.60987.20
3162287-16228787.42988.02
4161541-16154187.02787.63
5159592-15959285.97786.56
6169707-16970791.42692.05
960min1170990-17099092.11791.492.1092.8692.232.10
2167270-16727090.11390.85
3169892-16989291.52692.27
4167729-16772990.36191.11
5166753-16675389.83590.57
6176268-17626894.96195.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1173917-17391793.69493.092.2194.5993.992.21
2170306-17030691.74992.64
3172617-17261792.99493.89
4170528-17052891.86992.77
5169543-16954391.33892.22
6179838-17983896.88497.82
1440min1175279-17527994.42894.222.4995.4895.272.48
2171606-17160692.44993.49
3174906-17490694.22795.28
4172338-17233892.84493.90
5172022-17202292.67393.71
6183177-18317798.68399.78
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