依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67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%
110.221726551722091720261720491719811721840.17
210.151730071735461732760.22
单位质量响应值RSD%判断
16847.7517071.530.94数据可信
供试品溶液-2023121421批-依折麦布-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%
5min111931-119316.3116.092.226.316.092.19
211617-116176.1456.14
311228-112285.9395.94
411335-113355.9966.00
511606-116066.1396.14
611380-113806.0196.02
10min118623-186239.8519.663.159.899.703.15
217972-179729.5069.54
319219-1921910.16610.20
417629-176299.3259.36
517914-179149.4759.51
618235-182359.6459.68
15min119227-1922710.17010.102.2310.2610.192.21
219556-1955610.34410.43
318884-188849.98910.08
418401-184019.7339.82
519055-1905510.07910.17
619472-1947210.30010.39
20min119648-1964810.39310.241.2210.5410.381.19
219273-1927310.19410.34
318983-1898310.04110.19
419265-1926510.19010.33
519544-1954410.33810.48
619396-1939610.25910.40
30min119173-1917310.14110.052.0110.3510.251.99
218813-188139.95110.15
318595-185959.83610.04
418929-1892910.01210.21
519671-1967110.40510.61
618799-187999.94410.14
45min118588-185889.8329.882.2310.0910.142.19
218766-187669.92610.18
319234-1923410.17410.43
417955-179559.4979.75
518716-187169.90010.16
618806-188069.94710.20
60min117792-177929.4119.631.719.739.951.66
218053-180539.5499.86
318647-186479.86310.18
418143-181439.5979.90
518498-184989.78410.10
618152-181529.6019.91
极限118219-182199.63710.0710.7210.0010.4310.31
218085-180859.5669.93
318239-182399.64710.01
423192-2319212.26712.62
518243-182439.65010.02
618201-182019.6279.99
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.403122143113143112353111873110983114100.15
210.403126423134753130580.19
单位质量响应值RSD%判断
29943.2730101.730.38数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-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%
5min1123831-12383134.06939.9614.1934.0739.9614.19
2155258-15525842.71642.72
3181240-18124049.86449.86
4131275-13127536.11836.12
5137128-13712837.72837.73
6142666-14266639.25239.25
10min1240379-24037966.13568.448.9866.3268.668.96
2210375-21037557.88058.12
3277292-27729276.29176.57
4257823-25782370.93571.14
5255411-25541170.27170.48
6251167-25116769.10369.32
15min1280945-28094577.29678.696.0277.8579.296.02
2255216-25521670.21770.78
3305169-30516983.96184.66
4291406-29140680.17480.77
5296521-29652181.58282.18
6286798-28679878.90679.51
20min1308426-30842684.85784.675.0485.8485.715.04
2277872-27787276.45177.40
3319620-31962087.93789.10
4316645-31664587.11888.16
5317045-31704587.22888.28
6306876-30687684.43085.47
30min1326279-32627989.76988.574.5591.2390.084.55
2295778-29577881.37782.75
3327453-32745390.09291.75
4331124-33112491.10292.63
5336092-33609292.46994.01
6314775-31477586.60488.11
45min1333036-33303691.62891.462.9793.5893.463.02
2315839-31583986.89688.72
3346904-34690495.44397.60
4333106-33310691.64793.68
5333167-33316791.66493.72
6332467-33246791.47193.46
60min1333240-33324091.68491.382.4194.1593.892.46
2317952-31795287.47889.79
3338906-33890693.24395.93
4337214-33721492.77795.32
5337361-33736192.81895.38
6328070-32807090.26292.76
极限1336873-33687392.68492.991.6995.6696.011.70
2333022-33302291.62494.42
3338013-33801392.99796.20
4349058-34905896.03699.09
5336418-33641892.55895.63
6334584-33458492.05495.05
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