替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.692701727035264342645626436266761.20
213.792652926596265620.18
单位质量响应值RSD%判断
1948.581926.180.82数据可信
中间24月-供试品溶液-20220104批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125382-2538294.38295.431.2794.3895.421.27
225180-2518093.63093.63
325794-2579495.91495.91
425857-2585796.14896.15
525699-2569995.56095.56
626066-2606696.92596.92
10min127227-27227101.24299.181.64102.19100.141.62
226507-2650798.56599.50
327227-27227101.242102.20
426357-2635798.00798.97
526279-2627997.71798.67
626445-2644598.33499.30
15min127249-27249101.32498.411.69103.28100.351.66
226431-2643198.282100.20
326633-2663399.033101.00
426326-2632697.89299.83
525967-2596796.55798.49
626180-2618097.34999.30
20min126773-2677399.55497.642.42102.52100.572.36
227134-27134100.896103.80
326031-2603196.79599.76
426125-2612597.144100.06
525308-2530894.10697.00
626179-2617997.345100.27
30min126680-2668099.20895.752.42103.1799.652.35
224807-2480792.24396.16
325743-2574395.72499.65
425899-2589996.304100.20
525410-2541094.48698.33
625954-2595496.509100.41
替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.692653526527265502656526528265410.07
213.792639426428264110.10
单位质量响应值RSD%判断
1938.711915.230.87数据可信
中间24月-供试品溶液-20220105批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124810-2481092.75394.711.9992.7594.711.99
225678-2567895.99896.00
325881-2588196.75796.76
425639-2563995.85295.85
525351-2535194.77694.78
624644-2464492.13392.13
10min126966-26966100.81399.882.24101.74100.832.23
227306-27306102.085103.04
327110-27110101.352102.32
426995-26995100.922101.88
525981-2598197.13198.08
625939-2593996.97497.90
15min127248-27248101.86899.852.36103.80101.802.34
227438-27438102.578104.56
326565-2656599.314101.30
427020-27020101.015102.98
525917-2591796.89298.81
626066-2606697.44999.34
20min125875-2587596.73598.812.7699.69101.762.71
227029-27029101.049104.06
325927-2592796.92999.90
427534-27534102.937105.91
526498-2649899.064101.95
625723-2572396.16699.03
30min126128-2612897.68197.391.38101.60101.331.35
225957-2595797.041101.06
325600-2560095.70799.65
426558-2655899.288103.30
526320-2632098.398102.28
625745-2574596.249100.08
替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.692661826622265792653126523265750.18
213.792656926563265660.02
单位质量响应值RSD%判断
1941.201926.470.54数据可信
中间24月-供试品溶液-20220107批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125235-2523594.00595.802.1594.0195.802.14
225919-2591996.55396.55
325689-2568995.69695.70
426189-2618997.55997.56
526345-2634598.14098.14
624927-2492792.85892.86
10min127916-27916103.992100.973.29104.93101.933.27
226700-2670099.463100.43
327435-27435102.201103.16
427500-27500102.443103.42
527592-27592102.785103.77
625483-2548394.92995.86
15min126679-2667999.38498.121.30101.36100.091.29
226346-2634698.144100.10
325870-2587096.37198.35
426281-2628197.90299.90
526767-2676799.712101.72
626102-2610297.23599.11
20min126616-2661699.15097.671.63102.12100.621.57
225671-2567195.62998.57
326166-2616697.473100.42
426664-2666499.328102.31
525770-2577095.99899.00
626431-2643198.460101.31
30min126671-2667199.35594.994.80103.3298.924.61
227207-27207101.351105.25
324132-2413289.89693.81
425286-2528694.19598.17
524388-2438890.85094.82
625310-2531094.28598.12
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