氟伐他汀钠缓释片项目信息
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%
110.991487111148749014877691486547148459214867020.09
210.801458437145885914586480.03
单位质量响应值RSD%判断
135277.71135060.000.12数据可信
长期12月-供试品溶液-2024041821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%
240min1476977-47697731.28829.677.0831.2929.677.09
2471549-47154930.93130.93
3467339-46733930.65530.66
4461888-46188830.29830.30
5390784-39078425.63425.63
6445599-44559929.22929.23
480min1925740-92574060.72458.953.8760.7758.993.88
2935990-93599061.39761.44
3904468-90446859.32959.38
4904725-90472559.34659.39
5839020-83902055.03655.07
6881880-88188057.84757.89
720min11285294-128529484.30983.072.2784.4583.212.28
21308999-130899985.86486.00
31265371-126537183.00383.14
41263846-126384682.90383.04
51225557-122555780.39180.51
61249624-124962481.97082.10
960min11535430-1535430100.71799.490.89100.9899.750.90
21529952-1529952100.358100.63
31517412-151741299.53599.79
41505379-150537998.74699.00
51510215-151021599.06399.30
61502339-150233998.54798.80
1200min11535014-1535014100.69098.950.95101.1199.360.95
21507042-150704298.85599.27
31510232-151023299.06499.47
41495821-149582198.11998.53
51505923-150592398.78299.17
61496832-149683298.18598.59
1440min11532242-1532242100.50898.701.00101.0799.251.00
21506981-150698198.85199.42
31502115-150211598.53299.09
41491666-149166697.84798.40
51503390-150339098.61699.15
61491209-149120997.81798.37
极限11533173-1533173100.56998.821.09101.2999.531.09
21498603-149860398.30299.02
31501309-150130998.47999.18
41489547-148954797.70898.41
51497366-149736698.22098.91
61519220-151922099.654100.35
氟伐他汀钠缓释片项目信息
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%
110.991483672148274214836881483255148423814835190.04
210.801463300146315314632260.01
单位质量响应值RSD%判断
134988.08135483.890.26数据可信
长期12月-供试品溶液-2024041821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%
240min1452016-45201629.63629.503.3129.6429.503.32
2460962-46096230.22230.22
3445747-44574729.22529.22
4456247-45624729.91329.91
5422262-42226227.68527.68
6462383-46238330.31530.32
480min1902435-90243559.16657.514.5359.2157.564.53
2866364-86636456.80256.85
3900097-90009759.01359.06
4918367-91836760.21160.26
5807734-80773452.95853.00
6867944-86794456.90556.95
720min11251821-125182182.07380.292.9082.2180.422.90
21217803-121780379.84379.97
31207278-120727879.15379.29
41280776-128077683.97284.11
51207295-120729579.15479.27
61182943-118294377.55777.69
960min11495821-149582198.07197.930.5898.3398.180.59
21480253-148025397.05097.30
31500295-150029598.36498.62
41504612-150461298.64798.91
51488917-148891797.61897.86
61492201-149220197.83398.08
1200min11486202-148620297.44098.060.7997.8498.460.79
21480957-148095797.09697.49
31494528-149452897.98698.38
41499915-149991598.33998.75
51514731-151473199.31099.70
61497697-149769798.19498.59
1440min11479816-147981697.02197.670.7897.5798.220.78
21475780-147578096.75797.30
31489095-148909597.63098.18
41494613-149461397.99198.55
51508478-150847898.90199.44
61490241-149024197.70598.25
极限11478805-147880596.95597.480.6097.6598.170.60
21479917-147991797.02897.71
31484563-148456397.33398.02
41488090-148809097.56498.27
51503456-150345698.57199.25
61485966-148596697.42598.11
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