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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.266242262654625486251962502625290.14
210.296254062609625740.08
单位质量响应值RSD%判断
6094.446081.050.16数据可信
供试品溶液-5122601批-非奈利酮-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%
5min110299-1029915.21417.0328.8915.2117.0328.89
26403-64039.4599.46
312010-1201017.74117.74
416005-1600523.64323.64
510429-1042915.40615.41
614015-1401520.70320.70
10min148551-4855171.71972.667.8271.8972.857.87
241918-4191861.92162.03
350038-5003873.91674.11
452759-5275977.93678.20
550173-5017374.11574.29
651689-5168976.35576.58
15min158819-5881986.88787.292.3087.8588.282.39
256906-5690684.06184.85
358305-5830586.12887.15
460408-6040889.23590.36
560328-6032889.11690.11
659779-5977988.30589.38
20min162215-6221591.90491.601.8393.8493.571.89
261037-6103790.16491.89
360315-6031589.09791.07
462863-6286392.86194.98
562316-6231692.05394.04
663330-6333093.55195.61
30min162418-6241892.20492.801.9895.1695.781.98
262501-6250192.32695.06
361215-6121590.42793.39
462586-6258692.45295.60
563216-6321693.38396.39
664973-6497395.97899.08
45min162846-6284692.83694.972.6396.8198.992.62
263437-6343793.70997.46
362690-6269092.60696.58
464203-6420394.84199.02
565624-6562496.940100.98
666960-6696098.913103.08
60min163287-6328793.48795.591.8798.50100.661.85
264751-6475195.650100.45
363393-6339393.64498.64
465025-6502596.055101.29
566414-6641498.107103.23
665403-6540396.613101.88
90min164063-6406394.63495.561.96100.68101.691.95
264185-6418594.814100.67
363277-6327793.47399.51
464169-6416994.790101.09
566682-6668298.503104.71
665763-6576397.145103.48
120min163781-6378194.21796.062.62101.32103.262.53
265147-6514796.235103.15
362920-6292092.945100.02
464399-6439995.130102.48
567462-6746299.655106.96
666471-6647198.191105.61
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163200-6320093.35995.172.96101.50103.432.80
264053-6405394.619102.60
363339-6333993.564101.68
465050-6505096.092104.50
567992-67992100.438108.85
662931-6293192.962101.47
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%
115.226413006417546420136411096410476414450.07
215.286421586422966422270.02
单位质量响应值RSD%判断
42144.8842030.560.20数据可信
供试品溶液-5122601批-厄贝沙坦-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%
5min122064-220643.1453.0815.523.153.0815.58
214831-148312.1142.11
323099-230993.2933.29
423553-235533.3583.36
523206-232063.3083.31
622765-227653.2453.25
10min133189-331894.7314.525.204.774.565.27
228670-286704.0874.11
331422-314224.4804.52
432708-327084.6634.70
532732-327324.6664.70
631578-315784.5024.54
15min137703-377035.3755.182.465.465.272.53
235255-352555.0265.09
335787-357875.1025.19
437042-370425.2815.37
536398-363985.1895.28
635961-359615.1275.21
20min139994-399945.7025.512.165.855.652.15
238511-385115.4905.61
337488-374885.3445.49
439007-390075.5615.71
538410-384105.4765.62
638331-383315.4645.61
30min141492-414925.9155.861.566.136.071.52
241603-416035.9316.12
339990-399905.7015.90
440729-407295.8066.02
541462-414625.9116.12
641469-414695.9126.12
45min144073-440736.2836.231.316.566.501.29
243937-439376.2646.52
342612-426126.0756.34
443525-435256.2056.48
543764-437646.2396.51
644168-441686.2976.57
60min145705-457056.5166.471.146.866.811.10
245923-459236.5476.87
344672-446726.3686.70
445661-456616.5096.85
545648-456486.5086.85
644860-448606.3956.73
90min147949-479496.8366.741.217.257.151.18
247649-476496.7937.19
346439-464396.6207.02
446967-469676.6967.11
547641-476416.7927.21
646966-469666.6957.11
120min149026-490266.9896.971.557.487.461.46
249872-498727.1107.58
347738-477386.8067.28
448461-484616.9097.40
549496-494967.0567.55
648893-488936.9707.46
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148342-483426.8926.962.817.467.522.63
249613-496137.0737.62
348602-486026.9297.48
449140-491407.0057.57
550576-505767.2107.78
646515-465156.6317.19
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