厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.138743978706818767388708408777128740740.38
214.998760148703268731700.47
单位质量响应值RSD%判断
57770.9258250.170.59数据可信
供试品溶液-25111101批-厄贝沙坦-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%
5min186918-869188.96910.5468.578.9710.5468.56
2241471-24147124.91824.92
380868-808688.3458.35
491157-911579.4079.41
551857-518575.3515.35
660296-602966.2226.22
10min1498244-49824451.41553.6119.0251.5153.7319.11
2667502-66750268.88269.16
3510129-51012952.64252.73
4590280-59028060.91361.02
5468255-46825548.32148.38
6382648-38264839.48739.56
15min1823168-82316884.94587.092.4185.6287.802.34
2827145-82714585.35686.40
3853902-85390288.11788.79
4856186-85618688.35289.13
5873688-87368890.15890.75
6829481-82948185.59786.10
20min1856302-85630288.36490.822.5389.9892.502.44
2857583-85758388.49790.49
3870737-87073789.85491.51
4907072-90707293.60395.37
5903746-90374693.26094.86
6885157-88515791.34292.80
30min1870397-87039789.81991.191.8892.4293.881.74
2856261-85626188.36091.33
3894788-89478892.33694.99
4895817-89581792.44295.25
5896148-89614892.47695.11
6888595-88859591.69794.17
45min1870288-87028889.80891.401.7293.4095.101.69
2876412-87641290.44094.40
3878623-87862390.66894.35
4903592-90359293.24497.07
5906162-90616293.51097.17
6879337-87933790.74194.23
60min1870104-87010489.78992.132.5694.3896.852.45
2867393-86739389.50994.47
3900282-90028292.90397.59
4913912-91391294.30999.18
5921895-92189595.13399.83
6883337-88333791.15495.66
极限1904364-90436493.32497.033.5298.91102.773.40
2913879-91387994.306100.26
3953790-95379098.424104.15
4996852-996852102.868108.78
5942093-94209397.217102.98
6930568-93056896.028101.54
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901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(%)0.06对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981298291289711297741288981299471294840.40
210.121291601281551286580.56
单位质量响应值RSD%判断
12974.3512713.241.44数据可信
供试品溶液-25111101批-非奈利酮-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%
5min14347-43473.0513.9929.493.053.9929.48
24500-45003.1583.16
38581-85816.0226.02
46684-66844.6914.69
54465-44653.1333.13
65570-55703.9093.91
10min134191-3419123.99526.8025.3224.0326.8525.32
237520-3752026.33126.37
353070-5307037.24337.31
446131-4613132.37432.43
530191-3019121.18721.22
628068-2806819.69819.74
15min170112-7011249.20352.8513.8049.5053.1913.87
277974-7797454.72155.05
391808-9180864.42964.91
480950-8095056.80957.22
563383-6338344.48144.75
667630-6763047.46147.72
20min183308-8330858.46462.9211.6159.3163.8411.67
297379-9737968.33969.27
399783-9978370.02671.22
499268-9926869.66470.71
575723-7572353.14153.91
682450-8245057.86258.65
30min198959-9895969.44773.598.8070.9475.228.91
2113599-11359979.72281.42
3113529-11352979.67281.65
4111995-11199578.59680.41
592775-9277565.10866.46
698342-9834269.01470.45
45min1112324-11232478.82782.205.5281.1084.655.63
2127657-12765789.58792.17
3121638-12163885.36388.22
4117308-11730882.32485.01
5111840-11184078.48780.57
6112022-11202278.61580.81
60min1122442-12244285.92789.754.0689.0793.114.23
2131143-13114392.03495.61
3131395-13139592.21096.02
4134563-13456394.43498.04
5125506-12550688.07891.03
6122285-12228585.81788.89
极限1131977-13197792.61995.543.9696.7299.903.95
2132562-13256293.02997.63
3135996-13599695.439100.27
4146095-146095102.527107.18
5132530-13253093.00796.94
6137698-13769896.634100.66
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