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%
110.921421960142124814209561420419142033614209840.05
211.251467150146700714670780.01
单位质量响应值RSD%判断
130126.74130406.930.16数据可信
加速6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%
240min1204998-20499813.95312.5813.1513.9512.5813.15
2203219-20321913.83213.83
3194749-19474913.25513.26
4153963-15396310.47910.48
5153587-15358710.45410.45
6198121-19812113.48513.48
480min1357966-35796624.36523.388.0824.3923.408.08
2370495-37049525.21725.24
3350285-35028523.84223.86
4309350-30935021.05621.07
5308253-30825320.98121.00
6364766-36476624.82724.85
720min1495158-49515833.70231.845.6633.7631.905.67
2486609-48660933.12133.18
3469656-46965631.96732.02
4430254-43025429.28529.33
5441048-44104830.01930.07
6484254-48425432.96033.02
1440min1824529-82452956.12151.225.5256.2351.325.52
2758197-75819751.60651.71
3763163-76316351.94452.05
4734394-73439449.98650.08
5701749-70174947.76447.86
6733195-73319549.90450.01
极限1856046-85604658.26653.655.1058.4653.835.11
2795835-79583554.16854.35
3799237-79923754.39954.58
4770848-77084852.46752.63
5736027-73602750.09750.26
6771766-77176652.52952.71
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%
110.921417316141677714162061416602141736614168530.04
211.251468867146853114686990.02
单位质量响应值RSD%判断
129748.44130551.020.44数据可信
加速6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%
240min1210854-21085414.36513.4813.0714.3613.4813.07
2204302-20430213.91813.92
3152690-15269010.40210.40
4185620-18562012.64512.65
5227239-22723915.48115.48
6206895-20689514.09514.09
480min1425121-42512128.96225.2512.8428.9825.2612.83
2353951-35395124.11324.13
3298969-29896920.36720.38
4345949-34594923.56823.59
5382243-38224326.04126.06
6417330-41733028.43128.45
720min1575074-57507439.17734.8316.7939.2434.8816.78
2474654-47465432.33632.39
3405750-40575027.64227.69
4459525-45952531.30531.36
5508473-50847334.64034.70
6643860-64386043.86343.93
1440min1812770-81277055.37154.0113.5355.4954.1213.52
2749059-74905951.03051.14
3645643-64564343.98544.07
4740517-74051750.44850.55
5850811-85081157.96258.08
6958292-95829265.28465.41
极限1847895-84789557.76356.1312.8357.9756.3212.83
2784838-78483853.46853.65
3674922-67492245.98046.13
4769564-76956452.42752.60
5884107-88410760.23060.43
6981786-98178666.88567.11
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%
110.921416747141641014167381416914141653514166690.02
211.251469660146807414688670.08
单位质量响应值RSD%判断
129731.59130565.960.46数据可信
加速6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%
240min1180938-18093812.32712.429.1912.3312.429.17
2169032-16903211.51611.52
3198021-19802113.49013.49
4157600-15760010.73710.74
5187786-18778612.79312.79
6200683-20068313.67213.67
480min1336071-33607122.89523.3911.3822.9123.4011.37
2326348-32634822.23322.25
3353823-35382324.10524.12
4295108-29510820.10520.12
5335787-33578722.87622.90
6412526-41252628.10428.12
720min1440768-44076830.02831.5414.8530.0831.6014.84
2422907-42290728.81128.86
3473098-47309832.23032.29
4401008-40100827.31927.37
5445582-44558230.35630.41
6594446-59444640.49740.56
1440min1564602-56460238.46444.1013.4938.5644.2013.49
2582861-58286139.70839.80
3665109-66510945.31145.42
4609627-60962741.53241.62
5655225-65522544.63844.74
6806457-80645754.94155.06
极限1593106-59310640.40646.1213.8540.5646.2813.84
2607950-60795041.41741.57
3691945-69194547.14047.31
4632718-63271843.10543.25
5686343-68634346.75846.92
6849673-84967357.88558.09
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%
110.921415664141524314153211415134141530214153330.02
211.251466990146687214669310.01
单位质量响应值RSD%判断
129609.25130393.870.43数据可信
加速6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%
240min1214194-21419414.60913.0112.8214.6113.0112.81
2163263-16326311.13511.14
3191214-19121413.04113.04
4183473-18347312.51312.51
5224288-22428815.29715.30
6168292-16829211.47811.48
480min1369430-36943025.19622.7113.3025.2222.7313.30
2278539-27853918.99719.01
3325493-32549322.20022.22
4324796-32479622.15222.17
5398826-39882627.20127.22
6300654-30065420.50620.52
720min1480588-48058832.77830.8712.2132.8430.9212.21
2378837-37883725.83825.88
3437119-43711929.81329.87
4422229-42222928.79728.85
5541311-54131136.91936.98
6455284-45528431.05231.10
1440min1708495-70849548.32243.6516.1748.4343.7516.16
2578790-57879039.47539.56
3605844-60584441.32141.42
4543637-54363737.07837.17
5817910-81791055.78455.90
6585448-58544839.93040.02
极限1750340-75034051.17645.5315.6951.3645.6915.68
2617183-61718342.09442.24
3625784-62578442.68142.84
4563030-56303038.40138.55
5839070-83907057.22757.43
6609706-60970641.58441.74
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%
110.921414626141514314148781415501141512914150550.03
211.251462901146342714631640.03
单位质量响应值RSD%判断
129583.79130059.020.26数据可信
加速6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%
240min1199209-19920913.60513.313.9813.6113.313.97
2203407-20340713.89213.89
3197083-19708313.46013.46
4180808-18080812.34912.35
5195980-19598013.38513.38
6192856-19285613.17213.17
480min1363581-36358124.83224.105.1124.8524.125.11
2355697-35569724.29324.31
3377886-37788625.80925.83
4324254-32425422.14622.16
5350049-35004923.90823.93
6346030-34603023.63323.65
720min1475654-47565432.48632.514.9732.5432.564.96
2494934-49493433.80333.86
3509870-50987034.82334.88
4443310-44331030.27730.33
5469012-46901232.03232.09
6463215-46321531.63631.69
1440min1743854-74385450.80352.333.6350.9152.433.62
2817780-81778055.85255.96
3757846-75784651.75951.87
4751605-75160551.33351.43
5776832-77683253.05653.16
6749041-74904151.15851.26
极限1777341-77734153.09154.623.1853.2754.803.18
2846066-84606657.78457.98
3798361-79836154.52654.71
4787596-78759653.79153.97
5808097-80809755.19155.37
6780954-78095453.33753.52
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%
110.921410797141183614114961411252141137214113510.03
211.251462094146256114623280.03
单位质量响应值RSD%判断
129244.60129984.710.41数据可信
加速6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%
240min1194424-19442413.30013.429.8313.3013.429.84
2194013-19401313.27213.27
3205257-20525714.04114.04
4223306-22330615.27615.28
5196154-19615413.41813.42
6164063-16406311.22311.22
480min1361669-36166924.74124.589.5124.7624.609.51
2337749-33774923.10423.12
3413989-41398928.32028.34
4379754-37975425.97826.00
5345592-34559223.64123.66
6317322-31732221.70721.72
720min1479505-47950532.80134.0714.3432.8634.1314.32
2463722-46372231.72231.78
3636918-63691843.57043.63
4505698-50569834.59334.66
5461659-46165931.58131.64
6440728-44072830.14930.20
1440min1723898-72389849.52053.2712.5349.6353.3812.53
2744209-74420950.90951.01
3946189-94618964.72664.85
4844656-84465657.78057.89
5725365-72536549.62049.72
6688320-68832047.08647.18
极限1754002-75400251.57955.2411.1951.7655.4311.19
2780794-78079453.41253.59
3962294-96229465.82866.05
4868338-86833859.40059.60
5754217-75421751.59451.77
6725533-72553349.63149.80
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