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%
113.692649626370266022661426415264990.42
213.792670626496266010.56
单位质量响应值RSD%判断
1935.651929.010.25数据可信
长期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%
5min125978-2597896.84795.333.3196.8595.333.31
225409-2540994.72694.73
323996-2399689.45889.46
426315-2631598.10498.10
526152-2615297.49697.50
625575-2557595.34595.34
10min127195-27195101.38499.422.41102.35100.372.40
226710-2671099.576100.52
325783-2578396.12097.01
426115-2611597.35898.34
526706-2670699.561100.54
627498-27498102.514103.47
15min127192-27192101.37398.572.83103.36100.522.81
227079-27079100.952102.89
325158-2515893.79095.65
426439-2643998.566100.52
526678-2667899.457101.43
626098-2609897.29599.27
20min127529-27529102.62997.512.72105.63100.442.68
225655-2565595.64398.60
325562-2556295.29698.09
426054-2605497.131100.07
526053-2605397.127100.09
626081-2608197.231100.18
30min126954-26954100.48698.371.59104.51102.281.59
226803-2680399.923103.83
326009-2600996.963100.71
425907-2590796.583100.49
526303-2630398.059102.00
626341-2634198.201102.12
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%
113.692682226809267962675626858268080.14
213.792676126725267430.10
单位质量响应值RSD%判断
1958.221939.300.69数据可信
长期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%
5min126271-2627197.11696.642.0597.1296.642.05
226455-2645597.79697.80
326017-2601796.17796.18
426708-2670898.73198.73
526250-2625097.03897.04
625158-2515893.00193.00
10min128433-28433105.108102.102.34106.08103.072.33
228412-28412105.030106.01
327036-2703699.944100.91
427532-27532101.777102.76
527066-27066100.055101.02
627244-27244100.713101.64
15min128007-28007103.533101.321.67105.56103.311.65
227747-27747102.572104.60
327494-27494101.637103.60
426811-2681199.112101.12
526959-2695999.659101.63
627440-27440101.437103.37
20min127344-27344101.08299.262.67104.14102.262.62
227969-27969103.393106.45
326088-2608896.43999.42
426720-2672098.775101.77
526174-2617496.75799.72
626811-2681199.112102.06
30min127086-27086100.12898.671.41104.20102.661.41
227132-27132100.299104.39
326494-2649497.940101.88
426552-2655298.154102.14
526152-2615296.676100.61
626731-2673198.816102.76
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%
113.692664626587268982659726660266780.48
213.792664726541265940.29
单位质量响应值RSD%判断
1948.721928.500.74数据可信
长期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%
5min125213-2521393.69397.342.6393.6997.342.63
225975-2597596.52596.52
326514-2651498.52898.53
426536-2653698.60998.61
527165-27165100.947100.95
625764-2576495.74095.74
10min126879-2687999.884102.244.14100.82103.224.12
227300-27300101.448102.41
329075-29075108.044109.03
427194-27194101.054102.04
528624-28624106.368107.38
626010-2601096.65597.61
15min127411-27411101.861100.211.90103.80102.211.90
226938-26938100.103102.08
327217-27217101.140103.21
426586-2658698.795100.79
527485-27485102.136104.21
626170-2617097.24999.17
20min126506-2650698.49898.501.73101.45101.501.74
226817-2681799.653102.63
327023-27023100.419103.50
426386-2638698.052101.04
526614-2661498.899101.99
625693-2569395.47798.37
30min126170-2617097.24998.681.40101.19102.661.41
226750-2675099.405103.38
326633-2663398.970103.05
426619-2661998.918102.88
527071-27071100.597104.68
626087-2608796.941100.79
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