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%
111.161416985141746414173301418789141709814175330.06
211.211438482143816414383230.02
单位质量响应值RSD%判断
127019.09128307.140.72数据可信
长期6月-供试品溶液-X0734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%
240min1230680-23068016.02216.379.6216.0216.379.63
2273681-27368119.00819.01
3229428-22942815.93515.93
4203755-20375514.15214.15
5234920-23492016.31616.32
6242094-24209416.81416.81
480min1418638-41863829.07629.048.0029.1029.078.00
2477353-47735333.15433.18
3389539-38953927.05527.08
4382927-38292726.59626.62
5423168-42316829.39129.42
6417431-41743128.99229.02
720min1579569-57956940.25340.8211.4640.3240.8911.45
2715277-71527749.67949.76
3519346-51934636.07136.14
4547904-54790438.05438.12
5584324-58432440.58440.65
6580109-58010940.29140.36
1440min11022503-102250371.01770.455.1771.1470.585.17
21104258-110425876.69576.85
3979241-97924168.01268.13
4973909-97390967.64267.76
51037687-103768772.07172.20
6968161-96816167.24267.37
极限11056085-105608573.34972.365.0073.5872.595.01
21125184-112518478.14878.42
31003782-100378269.71669.94
4977549-97754967.89468.11
51063993-106399373.89874.14
61024129-102412971.13071.36
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%
111.161426908142565214273001423698142396914255050.12
211.211441724144325614424900.08
单位质量响应值RSD%判断
127733.42128678.860.53数据可信
长期6月-供试品溶液-X0734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%
240min1165161-16516111.42214.7512.2211.4214.7512.23
2201425-20142513.93013.93
3223067-22306715.42715.43
4232481-23248116.07816.08
5229449-22944915.86815.87
6227794-22779415.75415.75
480min1267397-26739718.49325.6014.7218.5125.6214.72
2350676-35067624.25224.27
3394546-39454627.28627.31
4408276-40827628.23628.26
5405910-40591028.07228.10
6393977-39397727.24727.27
720min1440818-44081830.48635.599.4530.5335.659.46
2472700-47270032.69132.75
3536754-53675437.12137.19
4570211-57021139.43539.50
5546205-54620537.77537.84
6521160-52116036.04336.11
1440min1860549-86054959.51563.8011.0159.6163.9211.00
2807601-80760155.85355.96
3926214-92621464.05664.18
41099835-109983576.06376.19
5959030-95903066.32566.45
6881748-88174860.98161.10
极限1922403-92240363.79266.578.6263.9766.788.62
2872014-87201460.30760.50
3957304-95730466.20666.42
41110229-111022976.78277.02
5993149-99314968.68568.91
6920018-92001863.62763.84
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%
111.161422681142090314216471419685141919014208210.11
211.211430549143104014307940.03
单位质量响应值RSD%判断
127313.71127635.500.18数据可信
加速6月-供试品溶液-X0734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%
240min1186288-18628812.95715.2710.4612.9615.2710.46
2235729-23572916.39616.40
3240773-24077316.74716.75
4236850-23685016.47416.47
5220885-22088515.36415.36
6196809-19680913.68913.69
480min1383368-38336826.66527.247.7926.6827.267.79
2419479-41947929.17729.20
3421809-42180929.33929.36
4412110-41211028.66428.69
5360437-36043725.07025.09
6352948-35294824.54924.57
720min1623529-62352943.36938.6310.4643.4338.6910.45
2589516-58951641.00441.07
3580643-58064340.38740.46
4570224-57022439.66239.73
5479790-47979033.37233.43
6488537-48853733.98034.04
1440min1920258-92025864.00863.7711.3964.1363.8911.38
21032617-103261771.82471.95
3928334-92833464.57064.70
41020933-102093371.01171.14
5763802-76380253.12653.24
6835154-83515458.08958.20
极限1996252-99625269.29467.3111.2069.5167.5211.19
21073847-107384774.69174.93
3986547-98654768.61968.85
41066664-106666474.19274.43
5793732-79373255.20855.40
6889023-88902361.83662.03
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%
111.161428861142791814264651425778142365814265360.15
211.211442555144211214423340.03
单位质量响应值RSD%判断
127825.81128664.940.47数据可信
加速6月-供试品溶液-X0734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%
240min1252860-25286017.48216.147.9917.4816.147.98
2247062-24706217.08117.08
3205799-20579914.22814.23
4247019-24701917.07817.08
5218950-21895015.13815.14
6229421-22942115.86215.86
480min1408601-40860128.25027.294.3228.2827.324.32
2395698-39569827.35827.38
3379084-37908426.20926.23
4417805-41780528.88628.91
5394665-39466527.28627.31
6372768-37276825.77225.80
720min1574717-57471739.73437.735.3539.8037.805.34
2524459-52445936.26036.33
3566357-56635739.15639.22
4571032-57103239.48039.55
5533829-53382936.90836.97
6503834-50383434.83434.90
1440min1956911-95691166.15865.128.0066.2965.247.98
2971940-97194067.19767.32
31060216-106021673.30173.42
4939853-93985364.97965.11
5869704-86970460.12960.25
6852612-85261258.94759.06
极限11010843-101084369.88767.128.3770.1167.348.35
2992447-99244768.61568.84
31098152-109815275.92376.15
4948653-94865365.58765.81
5898121-89812162.09462.30
6876483-87648360.59860.80
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