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%
110.981462258146126614628551463305146302614625420.06
211.051474375147376414740700.03
单位质量响应值RSD%判断
133200.55133400.000.11数据可信
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%
60min18036-80360.5570.5857.480.560.5857.53
2-0.0000.00
311568-115680.8020.80
46226-62260.4310.43
511206-112060.7760.78
613080-130800.9060.91
120min111553-115530.8012.1935.530.802.1935.53
234136-341362.3652.37
346079-460793.1933.19
434307-343072.3772.38
530332-303322.1022.10
632953-329532.2832.28
240min169546-695464.8195.8816.204.825.8816.19
2104881-1048817.2677.27
397209-972096.7366.74
473082-730825.0645.07
581429-814295.6425.65
682669-826695.7285.73
360min1152436-15243610.56310.285.0510.5710.295.02
2144150-1441509.98810.00
3139480-1394809.6659.68
4160508-16050811.12211.13
5144158-1441589.98910.00
6149398-14939810.35210.37
480min1199103-19910313.79613.825.2713.8213.855.28
2185798-18579812.87412.90
3204136-20413614.14514.18
4189421-18942113.12513.15
5204163-20416314.14714.17
6214295-21429514.84914.88
600min1248362-24836217.21016.223.4617.2616.273.45
2237860-23786016.48216.53
3230077-23007715.94315.99
4226330-22633015.68315.73
5233618-23361816.18816.24
6228441-22844115.82915.88
720min1258494-25849417.91218.823.4117.9818.893.40
2287339-28733919.91019.98
3271409-27140918.80718.88
4268652-26865218.61618.69
5271656-27165618.82418.90
6271731-27173118.82918.90
840min1286703-28670319.86621.363.8719.9621.463.87
2317486-31748621.99922.10
3306748-30674821.25521.36
4312678-31267821.66621.77
5305990-30599021.20321.30
6319848-31984822.16322.27
960min1318241-31824122.05223.304.5222.1823.444.50
2359982-35998224.94425.08
3332232-33223223.02123.16
4323114-32311422.38922.52
5343935-34393523.83223.97
6340119-34011923.56823.70
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1349731-34973124.23424.634.1024.4024.804.07
2362400-36240025.11225.29
3328413-32841322.75722.93
4366036-36603625.36425.53
5360332-36033224.96825.14
6366100-36610025.36825.54
1200min1363146-36314625.16325.561.9425.3625.771.94
2369662-36966225.61525.83
3363744-36374425.20525.41
4364929-36492925.28725.49
5382293-38229326.49026.70
6369380-36938025.59525.81
1320min1360916-36091625.00927.144.5625.2427.384.53
2380226-38022626.34726.60
3405083-40508328.06928.31
4395274-39527427.38927.63
5402813-40281327.91228.16
6405742-40574228.11528.36
1440min1399877-39987727.70828.522.0027.9828.801.99
2406240-40624028.14928.44
3423384-42338429.33729.62
4410174-41017428.42228.70
5412999-41299928.61828.91
6416815-41681528.88229.17
极限1394710-39471027.35028.354.6727.6628.684.62
2428145-42814529.66730.00
3382983-38298326.53826.87
4417896-41789628.95729.28
5429870-42987029.78730.12
6401476-40147627.81928.15
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%
110.981481724148084814811411480204147887514805580.08
211.051468111146675514674330.07
单位质量响应值RSD%判断
134841.35132799.371.08数据可信
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%
60min113280-132800.9170.6870.070.920.6870.31
220949-209491.4461.45
39881-98810.6820.68
47309-73090.5050.50
5-0.0000.00
68079-80790.5580.56
120min123447-234471.6181.6829.321.621.6829.25
237376-373762.5802.58
319505-195051.3461.35
426025-260251.7961.80
522068-220681.5231.52
617204-172041.1881.19
240min1100475-1004756.9355.8216.726.945.8216.72
289902-899026.2066.21
384568-845685.8375.84
461350-613504.2354.24
575488-754885.2115.21
694059-940596.4936.50
360min1150418-15041810.3839.899.2110.409.909.21
2153533-15353310.59810.61
3146509-14650910.11310.12
4117770-1177708.1298.14
5150299-15029910.37510.38
6141287-1412879.7539.76
480min1219692-21969215.16513.3410.0315.1913.3610.01
2198426-19842613.69713.73
3205439-20543914.18114.21
4163184-16318411.26411.29
5185863-18586312.83012.86
6186679-18667912.88612.91
600min1253115-25311517.47216.254.4017.5216.294.40
2236295-23629516.31116.36
3237661-23766116.40516.45
4233333-23333316.10616.15
5221921-22192115.31915.36
6229941-22994115.87215.92
720min1302074-30207420.85118.329.7020.9318.409.69
2285915-28591519.73619.81
3249747-24974717.23917.31
4243942-24394216.83916.90
5273592-27359218.88518.95
6237569-23756916.39916.47
840min1339153-33915323.41120.926.5423.5221.026.54
2306458-30645821.15421.26
3294256-29425620.31220.41
4280221-28022119.34319.43
5296575-29657520.47220.57
6301445-30144520.80820.90
960min1379218-37921826.17623.147.9126.3223.277.91
2352698-35269824.34624.48
3319392-31939222.04722.18
4305059-30505921.05721.17
5327878-32787822.63222.76
6327524-32752422.60822.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1410139-41013928.31125.187.5428.5025.357.54
2376612-37661225.99626.17
3345529-34552923.85124.01
4330116-33011622.78722.94
5361541-36154124.95625.12
6365208-36520825.20925.37
1200min1424966-42496629.33425.976.8929.5626.186.89
2370209-37020925.55425.77
3362928-36292825.05225.25
4348520-34852024.05724.24
5374574-37457425.85626.05
6376336-37633625.97726.18
1320min1455895-45589531.46927.847.6731.7428.087.66
2417279-41727928.80429.05
3391009-39100926.99027.23
4364759-36475925.17825.40
5400351-40035127.63527.87
6390336-39033626.94427.18
1440min1477827-47782732.98328.668.5733.3028.958.55
2430618-43061829.72430.02
3396606-39660627.37727.65
4380457-38045726.26226.52
5390538-39053826.95827.24
6415354-41535428.67128.95
极限1463644-46364432.00429.396.5332.3729.726.52
2430847-43084729.74030.08
3389873-38987326.91227.23
4403394-40339427.84528.14
5417839-41783928.84229.16
6449269-44926931.01231.33
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