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%
110.671455227145323314524321452816145186814531150.09
210.751438810143971814392640.05
单位质量响应值RSD%判断
136186.97133885.021.21数据可信
长期24月-供试品溶液-2024041521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%
60min156292-562923.8513.3411.813.853.3411.81
250051-500513.4243.42
352948-529483.6223.62
444291-442913.0303.03
540383-403832.7622.76
649082-490823.3583.36
120min1111703-1117037.6417.239.317.657.249.34
2114063-1140637.8037.81
3117103-1171038.0118.02
499363-993636.7976.80
593104-931046.3696.37
698742-987426.7556.76
240min1208022-20802214.23014.225.6614.2514.245.66
2208734-20873414.27914.30
3219762-21976215.03315.05
4212627-21262714.54514.56
5212787-21278714.55614.57
6185449-18544912.68612.70
360min1297532-29753220.35320.126.8620.3920.156.85
2305308-30530820.88520.92
3306565-30656520.97121.01
4294205-29420520.12620.16
5306506-30650620.96721.00
6254274-25427417.39417.43
480min1353984-35398424.21525.012.8224.2825.082.82
2383126-38312626.20826.28
3365024-36502424.97025.04
4356958-35695824.41824.49
5368962-36896225.23925.31
6365414-36541424.99725.06
600min1452420-45242030.94928.7910.6131.0528.8910.58
2451820-45182030.90731.02
3418032-41803228.59628.71
4433017-43301729.62129.72
5435963-43596329.82329.93
6333617-33361722.82222.92
720min1506643-50664334.65832.846.7334.8132.996.73
2496660-49666033.97534.13
3492611-49261133.69833.85
4473912-47391232.41932.57
5492705-49270533.70433.85
6417822-41782228.58228.71
840min1537891-53789136.79535.566.3737.0035.766.37
2550216-55021637.63837.84
3510369-51036934.91335.11
4527214-52721436.06536.26
5535695-53569536.64536.85
6457873-45787331.32231.50
960min1593802-59380240.62039.353.7140.8839.603.72
2598594-59859440.94841.21
3561218-56121838.39138.65
4581839-58183939.80240.05
5574508-57450839.30039.56
6541412-54141237.03637.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1647162-64716244.27042.483.8744.5942.793.86
2654261-65426144.75645.08
3597507-59750740.87341.19
4602917-60291741.24441.55
5617562-61756242.24542.56
6606812-60681241.51041.79
1200min1696970-69697047.67746.345.6748.0646.725.64
2745576-74557651.00251.39
3643298-64329844.00644.38
4671567-67156745.94046.31
5651188-65118844.54644.92
6656333-65633344.89845.24
1320min1730628-73062849.98049.377.3550.4449.817.31
2809155-80915555.35255.82
3649128-64912844.40544.84
4736611-73661150.38950.83
5708727-70872748.48248.93
6695826-69582647.59948.01
1440min1788539-78853953.94151.637.3454.4752.147.31
2851155-85115558.22558.78
3708607-70860748.47348.98
4725047-72504749.59850.11
5741140-74114050.69951.22
6713747-71374748.82549.30
1560min1832473-83247356.94755.137.4357.5655.727.40
2913371-91337162.48163.12
3749623-74962351.27951.86
4776323-77632353.10653.70
5797168-79716854.53255.12
6766631-76663152.44352.99
1680min1835827-83582757.17656.477.2057.8857.157.17
2938451-93845164.19664.93
3784300-78430053.65154.31
4801607-80160754.83555.51
5816947-81694755.88556.56
6776146-77614653.09453.72
1800min1907786-90778662.09958.116.6062.8858.876.57
2929545-92954563.58764.42
3787146-78714653.84654.58
4821514-82151456.19756.95
5821259-82125956.18056.94
6829504-82950456.74457.45
1920min1934298-93429863.91260.745.2564.7961.595.25
2956013-95601365.39866.32
3838526-83852657.36158.18
4856796-85679658.61159.45
5876892-87689259.98560.83
6864801-86480159.15859.95
2040min1962402-96240265.83562.087.2966.8163.027.23
2999328-99932868.36169.38
3838738-83873857.37558.28
4834424-83442457.08058.01
5892902-89290261.08062.01
6917117-91711762.73763.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1953831-95383165.24863.694.2966.3264.724.28
2991105-99110567.79868.92
3936595-93659564.06965.06
4879379-87937960.15561.17
5897404-89740461.38862.41
6927790-92779063.46764.44
极限1971488-97148866.45663.804.4467.6364.934.43
2986405-98640567.47768.70
3880356-88035660.22261.31
4902402-90240261.73062.83
5912858-91285862.44663.56
6942480-94248064.47265.55
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%
110.671445763144704214472701447933144805014472120.07
210.751440925144091114409180.01
单位质量响应值RSD%判断
135633.74134038.880.84数据可信
长期24月-供试品溶液-2024041721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%
60min161526-615264.2153.8412.044.213.8412.04
249222-492223.3723.37
354806-548063.7553.75
458557-585574.0114.01
547706-477063.2683.27
664624-646244.4274.43
120min1124830-1248308.5527.926.878.567.936.90
2119654-1196548.1978.20
3111604-1116047.6457.65
4111479-1114797.6377.64
5104039-1040397.1277.13
6122465-1224658.3908.40
240min1232432-23243215.92314.935.4915.9414.945.49
2220439-22043915.10115.12
3212612-21261214.56514.58
4217822-21782214.92214.94
5197862-19786213.55513.57
6226051-22605115.48615.50
360min1315095-31509521.58620.804.5621.6320.844.57
2319527-31952721.88921.93
3288278-28827819.74919.79
4293628-29362820.11520.15
5291626-29162619.97820.01
6313219-31321921.45721.50
480min1369340-36934025.30224.884.6225.3824.964.60
2380779-38077926.08526.16
3370866-37086625.40625.47
4366489-36648925.10625.18
5359942-35994224.65824.72
6331961-33196122.74122.82
600min1418571-41857128.67429.053.1528.7929.163.14
2438064-43806430.01030.12
3419304-41930428.72528.83
4425145-42514529.12529.23
5403893-40389327.66927.77
6439231-43923130.09030.20
720min1494548-49454833.87933.632.0634.0433.792.07
2499248-49924834.20134.36
3503249-50324934.47534.63
4487660-48766033.40733.56
5475589-47558932.58032.72
6485444-48544433.25633.41
840min1529286-52928636.25935.384.2036.4735.584.18
2503175-50317534.47034.68
3552632-55263237.85838.06
4509307-50930734.89035.09
5491295-49129533.65633.85
6512941-51294135.13935.34
960min1571590-57159039.15739.725.5339.4239.975.50
2570238-57023839.06439.32
3640644-64064443.88844.15
4585080-58508040.08140.33
5560490-56049038.39738.64
6550480-55048037.71137.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1610873-61087341.84842.945.3642.1743.265.34
2617005-61700542.26842.59
3684962-68496246.92447.25
4647337-64733744.34644.66
5593652-59365240.66840.97
6607145-60714541.59341.91
1200min1664804-66480445.54346.126.3945.9346.506.35
2664703-66470345.53645.92
3759325-75932552.01852.41
4648104-64810444.39944.78
5657512-65751245.04345.41
6644945-64494544.18244.56
1320min1712718-71271848.82549.856.0549.2850.306.02
2709462-70946248.60249.05
3811144-81114455.56856.04
4740492-74049250.72851.17
5695127-69512747.62048.05
6697175-69717547.76048.20
1440min1755921-75592151.78551.957.2652.3152.487.22
2743843-74384350.95751.48
3864865-86486559.24859.80
4751095-75109551.45451.98
5708998-70899848.57049.07
6725617-72561749.70950.22
1560min1769950-76995052.74654.176.1553.3554.776.12
2771716-77171652.86753.47
3886314-88631460.71761.36
4795745-79574554.51355.11
5761259-76125952.15052.72
6759502-75950252.03052.62
1680min1815467-81546755.86452.663.8456.5553.343.81
2726951-72695149.80050.48
3783694-78369453.68754.42
4762688-76268852.24852.93
5766919-76691952.53853.19
6756484-75648451.82352.49
1800min1845848-84584857.94555.504.5858.7156.264.55
2837262-83726257.35758.11
3844084-84408457.82458.64
4780868-78086853.49454.25
5759643-75964352.04052.77
6792902-79290254.31855.06
1920min1912155-91215562.48857.616.1663.3458.466.11
2871990-87199059.73660.58
3874844-87484459.93260.83
4797480-79748054.63255.47
5799070-79907054.74155.55
6790169-79016954.13154.96
2040min1951039-95103965.15161.397.6866.1062.327.56
2991168-99116867.90068.83
3826070-82607056.59057.58
4814991-81499155.83156.75
5889090-88909060.90761.80
6904039-90403961.93262.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1944205-94420564.68363.124.1665.7364.144.12
2978653-97865367.04368.07
3927020-92702063.50664.58
4872328-87232859.75960.77
5888547-88854760.87061.85
6917390-91739062.84663.85
极限1960405-96040565.79363.254.2166.9364.364.13
2972544-97254466.62467.76
3872431-87243159.76660.94
4895697-89569761.36062.46
5905972-90597262.06463.14
6932334-93233463.87064.96
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