氟伐他汀钠片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741411344141108114117451411756141786614127580.21
211.231481535148125814813960.02
单位质量响应值RSD%判断
131541.71131914.160.20数据可信
供试品溶液-X0731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%
240min1309590-30959020.83825.1115.7120.8425.1115.70
2456150-45615030.70330.70
3326107-32610721.95021.95
4344924-34492423.21723.22
5429904-42990428.93628.94
6371924-37192425.03425.03
480min1685530-68553046.14253.1511.2146.1753.1811.22
2908347-90834761.14061.19
3731263-73126349.22149.25
4732403-73240349.29749.33
5875017-87501758.89758.94
6805145-80514554.19454.23
720min11018105-101810568.52876.807.9868.6376.927.99
21254022-125402284.40784.54
31092516-109251673.53673.64
41099645-109964574.01674.12
51143676-114367676.98077.11
61238425-123842583.35783.48
960min11267420-126742085.30994.095.8285.5194.325.83
21486584-1486584100.061100.32
31363839-136383991.79992.02
41390097-139009793.56693.79
51397866-139786694.08994.34
61481160-148116099.69599.94
1200min11433232-143323296.46999.791.7296.80100.161.74
21500783-1500783101.016101.43
31489854-1489854100.281100.64
41493082-1493082100.498100.86
51478384-147838499.50999.90
61499825-1499825100.952101.35
1440min11477052-147705299.419100.231.0199.89100.761.01
21481844-148184499.741100.31
31507407-1507407101.462101.97
41487849-1487849100.146100.66
51473370-147337099.17199.71
61507452-1507452101.465102.01
极限11509665-1509665101.614100.270.93102.24100.950.90
21476618-147661899.390100.11
31504339-1504339101.256101.91
41482041-148204199.755100.42
51479504-147950499.584100.27
61486349-1486349100.045100.74
氟伐他汀钠片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741407186140489014060201405884140599514059950.06
211.231461077146004014605580.06
单位质量响应值RSD%判断
130912.01130058.590.47数据可信
供试品溶液-X0731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%
240min1306252-30625220.81024.9328.6320.8124.9328.63
2477288-47728832.43232.43
3460516-46051631.29231.29
4439475-43947529.86329.86
5290485-29048519.73919.74
6227493-22749315.45815.46
480min1616371-61637141.88353.3620.3941.9153.3920.40
2973572-97357266.15566.20
3921438-92143862.61262.66
4888551-88855160.37860.42
5629940-62994042.80542.83
6681492-68149246.30846.33
720min1866176-86617658.85773.3816.8758.9573.4916.88
21289498-128949887.62287.77
31276260-127626086.72386.86
41142113-114211377.60777.74
5926398-92639862.94963.04
6978678-97867866.50266.59
960min11099919-109991974.74090.0412.1574.9290.2712.17
21483667-1483667100.816101.10
31489739-1489739101.229101.50
41412271-141227195.96596.22
51202044-120204481.68081.87
61263095-126309585.82886.02
1200min11352109-135210991.87799.054.1792.1799.414.21
21491147-1491147101.324101.75
31506477-1506477102.366102.79
41514167-1514167102.889103.28
51445752-144575298.24098.55
61436386-143638697.60397.92
1440min11473924-1473924100.154101.620.99100.59102.131.02
21485765-1485765100.959101.54
31511059-1511059102.677103.25
41512270-1512270102.760103.31
51496372-1496372101.679102.14
61493257-1493257101.468101.94
极限11474996-1474996100.227101.500.92100.81102.160.93
21480433-1480433100.596101.33
31497772-1497772101.775102.50
41512172-1512172102.753103.46
51496153-1496153101.665102.28
61500505-1500505101.960102.58
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