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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
110.671457289145680214559771456831145597314565740.04
210.751454849145476314548060.01
单位质量响应值RSD%判断
136511.15135330.790.62数据可信
长期24月-供试品溶液-2024041821批-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%
60min148914-489143.3243.505.473.323.505.52
250061-500613.4023.40
355211-552113.7523.75
454978-549783.7363.74
550981-509813.4653.46
649288-492883.3493.35
120min1100729-1007296.8457.736.696.857.746.68
2114692-1146927.7947.80
3124153-1241538.4378.44
4116490-1164907.9167.92
5114497-1144977.7817.79
6112262-1122627.6297.63
240min1210289-21028914.29114.954.9514.3114.974.92
2222120-22212015.09515.11
3238468-23846816.20616.22
4217700-21770014.79414.81
5223114-22311415.16215.18
6208348-20834814.15914.18
360min1295363-29536320.07220.995.5120.1121.035.51
2301242-30124220.47220.51
3335055-33505522.77022.81
4320347-32034721.77021.81
5311925-31192521.19821.24
6289396-28939619.66719.70
480min1373223-37322325.36325.805.0525.4325.865.05
2368491-36849125.04225.11
3410888-41088827.92328.00
4392594-39259426.68026.75
5375052-37505225.48825.56
6357195-35719524.27424.34
600min1429904-42990429.21530.114.3829.3230.224.39
2434737-43473729.54429.65
3474104-47410432.21932.34
4458509-45850931.15931.27
5438668-43866829.81129.92
6422590-42259028.71828.82
720min1496679-49667933.75334.041.6933.9034.191.70
2488830-48883033.22033.37
3513941-51394134.92635.09
4498319-49831933.86534.02
5502810-50281034.17034.32
6504693-50469334.29834.44
840min1526258-52625835.76336.462.0235.9636.662.03
2525801-52580135.73235.93
3552236-55223637.52937.75
4546715-54671537.15337.36
5534146-53414636.29936.50
6534042-53404236.29236.49
960min1569957-56995738.73339.652.5038.9939.912.50
2566002-56600238.46438.72
3605385-60538541.14141.42
4583170-58317039.63139.90
5582844-58284439.60939.87
6592950-59295040.29540.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1612980-61298041.65742.423.0541.9742.743.03
2642357-64235743.65343.97
3647826-64782644.02544.36
4597363-59736340.59540.92
5616726-61672641.91142.23
6628243-62824342.69443.01
1200min1663553-66355345.09345.663.2245.4746.053.19
2635201-63520143.16743.55
3672018-67201845.66946.07
4698203-69820347.44847.83
5676371-67637145.96546.35
6686194-68619446.63247.01
1320min1695849-69584947.28848.963.9147.7349.413.88
2683104-68310446.42246.87
3736354-73635450.04150.51
4749485-74948550.93351.39
5709997-70999748.25048.70
6747828-74782850.82151.27
1440min1744144-74414450.57052.504.8151.0853.024.77
2720514-72051448.96449.48
3779795-77979552.99353.54
4814990-81499055.38555.92
5764886-76488651.98052.50
6810661-81066155.09155.61
1560min1790124-79012453.69555.973.5254.2856.573.50
2805582-80558254.74555.33
3824462-82446256.02856.65
4868460-86846059.01859.64
5807512-80751254.87755.48
6845135-84513557.43358.04
1680min1811648-81164855.15856.146.2955.8356.836.23
2738365-73836550.17850.85
3825444-82544456.09556.81
4879504-87950459.76960.47
5823556-82355655.96756.65
6878117-87811759.67560.37
1800min1853675-85367558.01459.643.9258.7660.413.90
2821837-82183755.85056.59
3895594-89559460.86261.66
4892613-89261360.66061.45
5883784-88378460.06060.83
6917908-91790862.37963.16
1920min1897860-89786061.01662.634.9761.8563.504.93
2854926-85492658.09958.93
3916936-91693662.31363.20
4974885-97488566.25167.14
5913624-91362462.08862.95
6971815-97181566.04266.92
2040min1939200-93920063.82663.974.0664.7664.924.03
2881190-88119059.88460.80
3928163-92816363.07664.06
4986026-98602667.00867.99
5933720-93372063.45364.40
6979248-97924866.54767.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1938226-93822663.76064.704.0164.7965.753.99
2899000-89900061.09462.10
3944185-94418564.16565.24
41009383-100938368.59569.68
5941304-94130463.96965.02
6980299-98029966.61967.69
极限1957705-95770565.08365.073.2266.2066.223.21
2896663-89666360.93562.03
3966546-96654665.68466.85
4978035-97803566.46567.65
5978612-97861266.50467.65
6967419-96741965.74366.92
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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
110.671441311143961214398311440146144039014402580.05
210.751452500145097214517360.08
单位质量响应值RSD%判断
134982.01135045.210.04数据可信
长期24月-供试品溶液-2024041821批-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%
60min151210-512103.5032.4726.023.502.4726.02
222843-228431.5631.56
331263-312632.1392.14
435600-356002.4362.44
539874-398742.7282.73
636002-360022.4632.46
120min1105544-1055447.2217.294.147.237.294.12
2103015-1030157.0487.05
3103484-1034847.0807.08
4109603-1096037.4987.50
5114013-1140137.8007.80
6103527-1035277.0837.09
240min1201508-20150813.78614.194.3613.8014.204.36
2194346-19434613.29613.31
3216226-21622614.79314.81
4211799-21179914.49014.50
5217019-21701914.84714.86
6203751-20375113.93913.95
360min1304691-30469120.84520.144.1920.8820.184.18
2280549-28054919.19319.23
3290546-29054619.87719.91
4286515-28651519.60119.64
5313554-31355421.45121.49
6290424-29042419.86919.90
480min1344254-34425423.55124.685.7123.6224.755.70
2358468-35846824.52424.59
3349818-34981823.93224.00
4349560-34956023.91423.98
5400658-40065827.41027.48
6362115-36211524.77324.84
600min1411637-41163728.16129.095.4328.2629.205.42
2412911-41291128.24828.35
3414551-41455128.36128.46
4410148-41014828.05928.16
5468964-46896432.08332.19
6433357-43335729.64729.75
720min1479812-47981232.82532.764.5432.9732.914.54
2469324-46932432.10832.25
3466887-46688731.94132.09
4462970-46297031.67331.82
5521654-52165435.68835.85
6472333-47233332.31432.46
840min1482483-48248333.00835.365.2333.2035.555.22
2526442-52644236.01536.20
3514305-51430535.18535.38
4494775-49477533.84934.04
5559652-55965238.28738.50
6523362-52336235.80536.00
960min1566124-56612438.73038.926.2938.9739.176.27
2596090-59609040.78041.02
3566765-56676538.77439.02
4523138-52313835.78936.03
5621068-62106842.48942.76
6540123-54012336.95137.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1601085-60108541.12241.094.5041.4241.394.50
2582298-58229839.83740.14
3619224-61922442.36342.67
4561280-56128038.39938.69
5638277-63827743.66644.00
6601331-60133141.13941.44
1200min1644568-64456844.09744.984.2544.4645.354.23
2705070-70507048.23648.60
3656518-65651844.91445.28
4623260-62326042.63942.99
5670012-67001245.83846.24
6645567-64556744.16544.53
1320min1650077-65007744.47448.326.1844.9048.766.14
2773586-77358652.92353.36
3722543-72254349.43149.87
4681773-68177346.64247.06
5726622-72662249.71050.18
6683142-68314246.73647.17
1440min1729944-72994449.93851.555.9250.4352.065.88
2831916-83191656.91457.43
3772055-77205552.81953.33
4724808-72480849.58650.07
5754370-75437051.60952.15
6708179-70817948.44948.95
1560min1758501-75850151.89155.135.8252.4655.725.79
2882367-88236760.36560.97
3836792-83679257.24757.83
4776877-77687753.14953.71
5807654-80765455.25455.87
6772913-77291352.87753.45
1680min1771811-77181152.80256.635.6453.4557.305.61
2904566-90456661.88462.58
3853923-85392358.41959.09
4799290-79929054.68255.32
5828233-82823356.66257.37
6808942-80894255.34256.00
1800min1840730-84073057.51759.967.2058.2560.717.14
2991428-99142867.82768.61
3904429-90442961.87562.64
4837066-83706657.26657.99
5861346-86134658.92759.72
6823384-82338456.33057.07
1920min1875029-87502959.86361.226.1860.6862.066.13
2999200-99920068.35869.24
3907317-90731762.07262.93
4846679-84667957.92458.73
5882571-88257160.37961.26
6858125-85812558.70759.53
2040min1904704-90470461.89462.663.8762.8063.603.86
2976469-97646966.80367.79
3940003-94000364.30865.26
4899718-89971861.55262.45
5887460-88746060.71461.68
6887019-88701960.68461.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1914440-91444062.56062.242.8863.5663.282.87
2959839-95983965.66566.75
3890213-89021360.90261.95
4902940-90294061.77362.76
5902063-90206361.71362.77
6889551-88955160.85761.86
极限1912008-91200862.39363.423.2963.4864.543.28
2956534-95653465.43966.63
3973438-97343866.59667.73
4901946-90194661.70562.79
5916901-91690162.72863.88
6901301-90130161.66162.75
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