阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.071024351030211033071039161035611032480.55
2 10.151029251030361029800.08
单位质量响应值RSD%判断
10253.0310145.810.75数据可信
长期24月-供试品溶液-542916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%
5min131773-3177327.95325.6616.9727.9525.6616.96
223724-2372420.87220.87
335945-3594531.62431.62
430068-3006826.45326.45
530431-3043126.77326.77
623039-2303920.26920.27
10min175458-7545866.38660.247.2166.5460.387.21
264972-6497257.16157.28
371653-7165363.03963.21
463098-6309855.51255.66
571022-7102262.48462.63
664603-6460356.83656.95
15min192355-9235581.25280.553.1181.7881.033.12
286043-8604375.69976.13
392257-9225781.16681.69
492538-9253881.41381.87
594369-9436983.02483.52
691790-9179080.75581.18
20min1106960-10696094.10193.443.7995.0894.363.77
2100353-10035388.28989.14
3104544-10454491.97692.95
4104237-10423791.70692.61
5109923-10992396.70897.67
6111240-11124097.86798.74
30min1110235-11023596.98399.082.5498.48100.532.53
2109965-10996596.74598.09
3113155-11315599.552101.04
4113154-11315499.551100.97
5117727-117727103.574105.07
6111507-11150798.10299.52
45min1109969-10996996.74997.710.8398.7999.710.84
2109933-10993396.71798.60
3111167-11116797.80399.84
4111846-11184698.400100.37
5112031-11203198.563100.63
6111439-11143998.042100.01
60min1111541-11154198.13298.490.56100.71101.030.60
2111283-11128397.905100.32
3112229-11222998.737101.32
4111451-11145198.052100.57
5112860-11286099.292101.91
6112357-11235798.849101.36
极限1112663-11266399.119100.020.84102.24103.100.83
2113218-11321899.607102.57
3114150-114150100.427103.56
4112894-11289499.322102.38
5113971-113971100.269103.44
6115218-115218101.367104.43
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.071030601028801030991029531029511029890.09
2 10.151022081022391022240.03
单位质量响应值RSD%判断
10227.3110071.331.09数据可信
长期24月-供试品溶液-542916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%
5min136654-3665432.40827.6412.7132.4127.6412.71
231659-3165927.99127.99
333741-3374129.83229.83
429833-2983326.37726.38
524835-2483521.95821.96
630839-3083927.26627.27
10min167301-6730159.50459.286.9759.6859.436.97
264737-6473757.23757.39
368204-6820460.30360.47
473151-7315164.67764.82
559371-5937152.49352.61
669499-6949961.44861.60
15min188152-8815277.94082.286.3678.4582.766.34
286126-8612676.14876.62
394480-9448083.53584.04
497380-9738086.09986.60
590474-9047479.99380.41
6101747-10174789.96090.45
20min1109083-10908396.44694.683.9497.3995.623.94
2100412-10041288.77989.68
3105374-10537493.16794.13
4108463-10846395.89896.88
5106217-10621793.91294.77
6112988-11298899.898100.89
30min1110934-11093498.08298.161.2999.5699.631.27
2110346-11034697.56398.95
3109243-10924396.58798.07
4110180-11018097.41698.93
5112780-11278099.715101.09
6112676-11267699.623101.17
45min1108316-10831695.76897.711.8797.7999.721.83
2108657-10865796.06998.00
3111045-11104598.181100.20
4109684-10968496.97799.04
5113839-113839100.651102.58
6111523-11152398.603100.70
60min1112799-11279999.73198.421.17102.29100.971.18
2110192-11019297.42699.89
3109511-10951196.82499.39
4111511-11151198.593101.19
5111260-11126098.371100.86
6112604-11260499.559102.21
极限1108936-10893696.31697.991.2699.43101.091.24
2109727-10972797.015100.02
3110256-11025697.483100.59
4111965-11196598.994102.14
5112493-11249399.461102.50
6111577-11157798.651101.85
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