依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606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(%)99.75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%
111.411930421937101938801936181944431937390.27
211.391938251947081942660.33
单位质量响应值RSD%判断
16979.7517055.840.32数据可信
供试品溶液-X024017批-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min177310-7731040.78422.97100.7840.7822.97100.78
275328-7532839.73839.74
396453-9645350.88350.88
43831-38312.0212.02
54004-40042.1122.11
64339-43392.2892.29
10min1137052-13705272.30037.6197.9472.3737.6597.95
2126832-12683266.90966.98
3140817-14081774.28674.37
47918-79184.1774.18
57391-73913.8993.90
67771-77714.1004.10
15min1156263-15626382.43544.3096.8082.6244.4096.80
2156388-15638882.50182.68
3161833-16183385.37385.58
49792-97925.1665.18
59607-96075.0685.08
69987-99875.2695.28
20min1170807-17080790.10747.9096.8390.4348.0796.83
2173238-17323891.39091.70
3169071-16907189.19189.54
410756-107565.6745.69
510614-106145.5995.62
610290-102905.4285.45
30min1168697-16869788.99449.0995.2189.4749.3495.23
2177169-17716993.46393.93
3175777-17577792.72993.23
412234-122346.4546.48
512315-123156.4976.52
612123-121236.3956.42
45min1173473-17347391.51450.1694.5392.1450.5094.55
2179097-17909794.48195.10
3178783-17878394.31594.97
413369-133697.0537.09
512804-128046.7556.79
612994-129946.8556.89
60min1173235-17323591.38850.2093.3592.1750.6293.37
2178467-17846794.14894.93
3177024-17702493.38794.20
414055-140557.4157.47
514211-142117.4977.55
613994-139947.3827.43
极限1171421-17142190.43148.5992.7191.3649.1092.74
2169074-16907489.19390.13
3169701-16970189.52490.49
413750-137507.2547.32
513826-138267.2947.36
614921-149217.8717.93
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606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(%)99.75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%
111.411947611952321951131961611955001953530.27
211.391949741959881954810.37
单位质量响应值RSD%判断
17121.2117162.510.18数据可信
供试品溶液-X024017批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14560-45602.3882.2412.542.392.2412.50
24679-46792.4502.45
34679-46792.4502.45
43317-33171.7371.74
54469-44692.3402.34
63993-39932.0912.09
10min18707-87074.5604.318.284.564.318.27
28230-82304.3104.31
39205-92054.8214.82
47274-72743.8103.81
58237-82374.3144.32
67748-77484.0584.06
15min111166-111665.8485.438.865.865.448.88
210996-109965.7595.77
311365-113655.9525.96
49909-99095.1905.20
59516-95164.9844.99
69249-92494.8444.85
20min112289-122896.4365.839.696.465.859.68
211684-116846.1196.14
312291-122916.4376.46
410102-101025.2915.31
510210-102105.3475.37
610181-101815.3325.35
30min113198-131986.9126.586.276.946.616.28
213446-134467.0427.07
313180-131806.9036.94
411826-118266.1936.22
511773-117736.1666.19
611956-119566.2626.29
45min113323-133236.9786.847.157.026.887.13
213732-137327.1927.23
314307-143077.4937.54
412935-129356.7746.81
511739-117396.1486.19
612343-123436.4646.50
60min115308-153088.0177.397.628.077.447.61
214939-149397.8247.88
314678-146787.6877.74
412716-127166.6606.71
514038-140387.3527.40
612934-129346.7746.82
极限114865-148657.7857.228.137.857.288.11
214821-148217.7627.83
314552-145527.6217.69
413445-134457.0417.10
512542-125426.5686.63
612453-124536.5226.58
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