替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202668826989268432695827217269390.73
214.102683326816268240.05
单位质量响应值RSD%判断
1897.111902.410.20数据可信
供试品溶液-8145822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%
5min113593-1359350.19650.076.8650.2050.076.86
212518-1251846.22646.23
314507-1450753.57153.57
414764-1476454.52054.52
512649-1264946.71046.71
613325-1332549.20649.21
10min119690-1969072.71071.245.4573.2171.745.44
217525-1752564.71565.18
320593-2059376.04576.58
419526-1952672.10572.65
518723-1872369.13969.61
619688-1968872.70373.19
15min122339-2233982.49280.925.6283.7282.145.62
219876-1987673.39774.51
323234-2323485.79787.09
422541-2254183.23884.50
521023-2102377.63378.79
622473-2247382.98784.21
20min123744-2374487.68186.016.4289.7388.036.39
220550-2055075.88677.73
324218-2421889.43191.59
424461-2446190.32892.43
522615-2261583.51285.45
624158-2415889.20991.26
30min124686-2468691.15991.753.5594.0994.643.60
223284-2328485.98288.58
325503-2550394.17697.22
425327-2532793.52696.53
524605-2460590.86093.63
625677-2567794.81997.76
45min123584-2358487.09092.183.2190.9395.983.14
224960-2496092.17195.63
325120-2512092.76296.75
425563-2556394.39898.33
524674-2467491.11594.79
625879-2587995.56599.45
60min124893-2489391.92492.291.4196.6497.011.42
225012-2501292.36396.75
324723-2472391.29696.21
425323-2532393.51198.39
524539-2453990.61695.21
625460-2546094.01798.86
90min124548-2454890.65092.151.1396.2897.791.16
224879-2487991.87297.18
324925-2492592.04297.87
425013-2501392.36798.18
524931-2493192.06497.56
625425-2542593.88899.67
120min1-0.0000.00-6.546.573.22
2-0.0006.23
3-0.0006.75
4-0.0006.74
5-0.0006.42
6-0.0006.72
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1-0.0000.00-6.546.573.22
2-0.0006.23
3-0.0006.75
4-0.0006.74
5-0.0006.42
6-0.0006.72
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202710427048270212684026921269870.40
214.102705727160271080.27
单位质量响应值RSD%判断
1900.491922.550.82数据可信
供试品溶液-8145822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%
5min16431-643123.60326.9810.7423.6026.9810.74
27122-712226.13926.14
38216-821630.15430.15
46472-647223.75323.75
57834-783428.75228.75
68030-803029.47129.47
10min110111-1011137.10943.6111.1737.3443.8811.16
210963-1096340.23640.50
312809-1280947.01147.31
411119-1111940.80841.05
512830-1283047.08847.38
613457-1345749.38949.68
15min112122-1212244.48950.939.0645.1051.639.07
212946-1294647.51448.18
314567-1456753.46354.23
413424-1342449.26849.91
514724-1472454.03954.80
615472-1547256.78457.57
20min113403-1340349.19156.118.4150.2457.328.44
214262-1426252.34453.48
316171-1617159.35060.66
414966-1496654.92756.07
516387-1638760.14361.44
616539-1653960.70062.06
30min115309-1530956.18663.237.2057.7365.007.26
216375-1637560.09961.76
318055-1805566.26468.16
416935-1693562.15463.84
518267-1826767.04368.94
618425-1842567.62269.59
45min117396-1739663.84669.725.8765.9572.135.97
218160-1816066.65068.91
320033-2003373.52476.09
418578-1857868.18470.49
520045-2004573.56876.14
619774-1977472.57375.21
60min118812-1881269.04373.464.6571.7976.564.77
219019-1901969.80272.73
321071-2107177.33480.63
419934-1993473.16176.15
520710-2071076.00979.31
620544-2054475.39978.76
90min119285-1928570.77976.785.1474.2180.625.18
220232-2023274.25477.88
322044-2204480.90584.98
421342-2134278.32882.05
521975-2197580.65184.72
620643-2064375.76379.88
120min121302-2130278.18180.632.2282.3285.232.42
221403-2140378.55282.92
322417-2241782.27487.15
422314-2231481.89686.40
522227-2222781.57686.45
622145-2214581.27586.15
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124205-2420588.83690.321.9693.7695.742.01
224212-2421288.86294.02
325007-2500791.77997.48
425159-2515992.33797.66
524967-2496791.63297.32
624113-2411388.49894.19
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