坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231864161870401873501880381882781874240.41
216.231907611911421909520.15
单位质量响应值RSD%判断
11548.0011765.371.32数据可信
供试品溶液-24112902批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121907-2190710.61010.735.8010.6110.735.82
221794-2179410.55610.56
322542-2254210.91810.92
423160-2316011.21711.22
519933-199339.6549.65
623551-2355111.40611.41
10min167117-6711732.50731.925.3632.6232.045.35
262722-6272230.37830.50
368139-6813933.00233.12
464624-6462431.29931.42
561754-6175429.90930.02
671072-7107234.42234.55
15min1106085-10608551.38049.624.0051.8650.094.00
299673-9967348.27548.73
3105511-10551151.10251.59
498356-9835647.63748.11
598242-9824247.58248.02
6106806-10680651.73052.24
20min1131592-13159263.73460.663.0764.7861.693.07
2122569-12256959.36460.36
3124658-12465860.37661.43
4124001-12400160.05861.06
5120963-12096358.58659.55
6127723-12772361.86062.94
30min1150587-15058772.93472.081.4274.6973.781.46
2148884-14888472.10973.76
3149887-14988772.59574.32
4146057-14605770.74072.41
5146509-14650970.95972.58
6151042-15104273.15474.93
45min1160628-16062877.79778.151.1980.3780.641.22
2161026-16102677.99080.44
3162329-16232978.62181.15
4161516-16151678.22780.68
5158415-15841576.72579.13
6164169-16416979.51282.10
60min1164529-16452979.68779.230.7283.1282.600.76
2164477-16447779.66182.98
3163109-16310978.99982.41
4162649-16264978.77682.10
5162000-16200078.46281.72
6164804-16480479.82083.29
极限1166037-16603780.41780.360.9284.7484.610.91
2164609-16460979.72583.93
3164140-16414079.49883.78
4165768-16576880.28784.49
5166513-16651380.64884.78
6168435-16843581.57885.93
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231929471927581927491927931924531927400.10
216.231925131925431925280.02
单位质量响应值RSD%判断
11875.5411862.480.08数据可信
供试品溶液-24112902批-pH6.8(内含0.35%Tween20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147858-4785822.76322.064.4322.7622.064.43
246606-4660622.16722.17
343084-4308420.49220.49
448277-4827722.96222.96
544773-4477321.29521.30
647721-4772122.69722.70
10min1105256-10525650.06350.264.1550.3250.514.15
2111539-11153953.05153.30
399439-9943947.29647.52
4108922-10892251.80652.06
5102345-10234548.67848.91
6106564-10656450.68550.94
15min1136501-13650164.92366.461.8565.7367.261.86
2142079-14207967.57768.41
3136779-13677965.05665.81
4140799-14079966.96867.80
5139703-13970366.44667.22
6142469-14246967.76268.58
20min1151121-15112171.87773.852.5473.4175.392.53
2157401-15740174.86476.45
3149823-14982371.26072.74
4156521-15652174.44676.02
5156684-15668474.52376.04
6160036-16003676.11777.69
30min1160848-16084876.50476.512.2278.8378.882.13
2154512-15451273.49075.91
3161781-16178176.94779.22
4159853-15985376.03078.43
5163630-16363077.82780.17
6164574-16457478.27680.69
45min1163987-16398777.99778.461.0481.1881.681.03
2167305-16730579.57582.81
3164507-16450778.24481.37
4162585-16258577.33080.58
5164926-16492678.44381.65
6166500-16650079.19282.48
60min1163260-16326077.65178.042.0181.7082.121.90
2167701-16770179.76383.88
3167674-16767479.75083.74
4160710-16071076.43880.54
5160155-16015576.17480.25
6164923-16492378.44282.61
极限1161570-16157076.84777.621.6881.7682.581.57
2160592-16059276.38281.39
3167004-16700479.43184.31
4164017-16401778.01182.97
5160506-16050676.34181.27
6165515-16551578.72383.76
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231921771926941923411913521918551920840.27
216.231919701916691918200.12
单位质量响应值RSD%判断
11835.1211818.850.10数据可信
供试品溶液-24112902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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12169-21691.0351.0750.751.041.0750.69
22838-28381.3551.35
33001-30011.4321.43
42860-28601.3651.37
52557-25571.2201.22
6-0.0000.00
15min15654-56542.6992.783.172.712.793.17
26159-61592.9402.95
35881-58812.8072.82
45834-58342.7852.80
55690-56902.7162.73
65739-57392.7392.74
20min17295-72953.4823.583.393.523.623.26
27378-73783.5223.57
37631-76313.6423.69
47261-72613.4663.51
57520-75203.5893.63
67938-79383.7893.82
30min18899-88994.2484.372.184.334.452.15
29236-92364.4084.50
38953-89534.2734.36
49157-91574.3714.46
59438-94384.5054.59
69227-92274.4044.48
45min19527-95274.5474.814.164.674.944.01
210514-105145.0195.15
39819-98194.6874.82
410200-102004.8695.00
59832-98324.6934.83
610565-105655.0435.16
60min110777-107775.1445.120.985.325.310.86
210548-105485.0355.23
310772-107725.1425.33
410845-108455.1765.36
510669-106695.0925.28
610769-107695.1405.32
极限111628-116285.5505.243.235.795.483.03
210622-106225.0705.32
310902-109025.2045.45
410762-107625.1375.38
510848-108485.1785.42
611060-110605.2795.51
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