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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0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%
115.058769848775968775928754448763058767840.11
215.088787348788068787700.01
单位质量响应值RSD%判断
58258.0758273.870.02数据可信
供试品溶液-FHG0459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%
5min1176764-17676418.20214.7729.2318.2014.7729.22
2202791-20279120.88320.88
3149157-14915715.36015.36
4114760-11476011.81811.82
5129540-12954013.34013.34
687718-877189.0339.03
10min1690259-69025971.08063.3713.8571.2863.5313.87
2690816-69081671.13871.37
3654662-65466267.41567.59
4634770-63477065.36665.50
5535183-53518355.11155.26
6486388-48638850.08650.19
15min1830033-83003385.47484.733.2286.4785.603.34
2860805-86080588.64289.66
3834142-83414285.89786.82
4824280-82428084.88185.74
5802926-80292682.68283.44
6784510-78451080.78681.44
20min1854587-85458788.00290.072.1289.9491.882.15
2890558-89055891.70693.71
3873676-87367689.96891.84
4891001-89100191.75293.55
5888130-88813091.45693.14
6850003-85000387.53089.08
30min1890709-89070991.72293.441.7394.6496.251.74
2921299-92129994.87297.90
3899339-89933992.61095.48
4921464-92146494.88997.71
5921393-92139394.88197.58
6890258-89025891.67594.20
45min1878604-87860490.47592.751.7694.4196.601.75
2916837-91683794.41298.49
3895875-89587592.25496.16
4921239-92123994.86698.74
5896861-89686192.35596.10
6894846-89484692.14895.69
60min1869584-86958489.54691.861.8394.4996.741.86
2910685-91068593.77998.91
3904528-90452893.14598.07
4894238-89423892.08597.01
5898259-89825992.49997.28
6875291-87529190.13494.70
90min1868446-86844689.42990.271.2995.3796.171.37
2891851-89185191.83998.01
3869699-86969989.55895.52
4887375-88737591.37897.33
5878517-87851790.46696.27
6863627-86362788.93394.50
120min1865932-86593289.17087.702.2496.1094.602.19
2845474-84547487.06494.26
3854432-85443287.98694.94
4855817-85581788.12995.10
5870954-87095489.68796.50
6817390-81739084.17290.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1888090-88809091.45287.313.5399.3895.193.24
2804823-80482382.87791.04
3850544-85054487.58695.52
4864115-86411588.98396.93
5856927-85692788.24396.05
6822652-82265284.71392.21
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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0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%
115.058768078785288779558768688780808776480.09
215.088811368814948813150.03
单位质量响应值RSD%判断
58315.4858442.640.16数据可信
供试品溶液-FHG0459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%
5min18907-89070.9150.9213.890.920.9213.80
27265-72650.7470.75
37903-79030.8120.81
48868-88680.9110.91
59964-99641.0241.02
610595-105951.0891.09
10min128949-289492.9752.943.092.992.953.10
226938-269382.7692.78
328643-286432.9442.95
429370-293703.0193.03
529251-292513.0063.02
628587-285872.9382.95
15min138305-383053.9373.962.333.984.002.37
237112-371123.8143.85
339400-394004.0494.09
439167-391674.0254.07
539254-392544.0344.08
638011-380113.9073.95
20min143079-430794.4284.502.164.514.582.21
243132-431324.4334.51
343540-435404.4754.56
444786-447864.6034.69
545131-451314.6384.73
642956-429564.4154.50
30min150312-503125.1715.282.115.315.422.07
252816-528165.4285.56
352443-524435.3905.53
450739-507395.2155.35
551721-517215.3165.46
650372-503725.1775.31
45min154715-547155.6235.711.675.825.901.63
254557-545575.6075.80
356607-566075.8186.01
456262-562625.7825.98
556272-562725.7835.98
654869-548695.6395.83
60min156361-563615.7936.032.336.056.292.27
258148-581485.9766.23
359904-599046.1576.42
458454-584546.0086.27
559912-599126.1586.42
659464-594646.1126.37
90min160851-608516.2546.432.316.576.752.26
262425-624256.4166.74
362608-626086.4356.76
461548-615486.3266.65
565081-650816.6897.02
662730-627306.4476.77
120min162326-623266.4066.622.286.807.012.17
263210-632106.4976.89
365673-656736.7507.15
465075-650756.6887.09
563848-638486.5626.97
666040-660406.7877.18
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限161767-617676.3486.542.016.817.021.97
263016-630166.4776.94
363656-636566.5427.02
465306-653066.7127.19
564816-648166.6627.14
663402-634026.5166.99
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