厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.317748417750577746977740997741657745720.06
210.117730587723437727000.07
单位质量响应值RSD%判断
75128.2376429.281.22数据可信
供试品溶液-25110301批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1806358-8063585.0963.7439.155.103.7439.15
2582753-5827533.6833.68
3425078-4250782.6872.69
4219742-2197421.3891.39
5774550-7745504.8954.90
6742249-7422494.6914.69
10min11909004-190900412.0659.9629.5812.1210.0029.62
21620306-162030610.24110.28
31518348-15183489.5969.63
4680175-6801754.2994.31
51897278-189727811.99112.05
61827834-182783411.55211.60
15min12275999-227599914.38513.637.4814.5813.787.74
22124402-212440213.42613.58
32136116-213611613.50013.64
41866623-186662311.79711.86
52316912-231691214.64314.83
62222178-222217814.04414.22
20min12353904-235390414.87714.473.3915.2314.783.71
22277188-227718814.39214.70
32264659-226465914.31314.60
42165710-216571013.68813.88
52388926-238892615.09815.45
62286495-228649514.45114.79
30min12356764-235676414.89514.612.4115.4115.082.62
22295317-229531714.50714.97
32250235-225023514.22214.67
42279806-227980614.40914.75
52400849-240084915.17415.69
62291242-229124214.48114.98
45min12346693-234669314.83114.591.9615.5115.212.15
22268894-226889414.34014.96
32280186-228018614.41115.01
42294777-229477714.50315.01
52380381-238038115.04415.73
62276130-227613014.38515.04
60min12299403-229940314.53214.472.1115.3815.262.13
22237044-223704414.13814.92
32255211-225521114.25315.02
42313285-231328514.62015.29
52370053-237005314.97915.83
62266574-226657414.32515.14
极限12293139-229313914.49314.411.8515.5015.361.97
22259668-225966814.28115.22
32235567-223556714.12915.05
42282911-228291114.42815.26
52354528-235452814.88115.90
62253929-225392914.24515.22
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.317815807828947822417827827816017822200.08
210.117818827807817813320.10
单位质量响应值RSD%判断
75870.0377283.091.31数据可信
供试品溶液-25110301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%
5min135196-351960.2200.2053.710.220.2053.54
246281-462810.2890.29
3-0.0000.00
439727-397270.2480.25
526821-268210.1680.17
645074-450740.2820.28
10min174773-747730.4680.4721.500.470.4821.39
291105-911050.5700.57
347428-474280.2970.30
484018-840180.5250.53
568862-688620.4310.43
689192-891920.5580.56
15min1104249-1042490.6520.6411.410.660.6411.37
2109564-1095640.6850.69
380735-807350.5050.51
4109501-1095010.6850.69
596793-967930.6050.61
6110747-1107470.6930.70
20min1118635-1186350.7420.725.670.760.746.38
2119705-1197050.7490.77
3103206-1032060.6450.65
4118654-1186540.7420.76
5113244-1132440.7080.72
6119722-1197220.7490.77
30min1130995-1309950.8190.812.410.840.842.91
2130289-1302890.8150.84
3124403-1244030.7780.79
4133239-1332390.8330.86
5129545-1295450.8100.83
6132593-1325930.8290.85
45min1143086-1430860.8950.891.460.930.931.48
2142846-1428460.8930.93
3139172-1391720.8700.90
4144898-1448980.9060.94
5144605-1446050.9040.93
6143819-1438190.8990.93
60min1148405-1484050.9280.921.000.970.961.27
2145381-1453810.9090.95
3146133-1461330.9140.95
4149103-1491030.9330.98
5148443-1484430.9280.97
6147503-1475030.9230.97
极限1151052-1510520.9450.950.831.001.001.04
2149958-1499580.9380.99
3149967-1499670.9380.98
4151536-1515360.9481.00
5153393-1533930.9591.01
6150960-1509600.9441.00
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.317760237749767766977766477764047761490.10
210.117744317755057749680.10
单位质量响应值RSD%判断
75281.1876653.611.28数据可信
供试品溶液-25110301批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386435-3864352.4362.4716.772.442.4716.65
2444529-4445292.8032.80
3319675-3196752.0152.02
4427854-4278542.6972.70
5308810-3088101.9471.95
6465159-4651592.9332.93
10min11063673-10636736.7066.5710.166.736.6010.20
21141566-11415667.1977.23
3950286-9502865.9916.01
41087695-10876956.8576.89
5877075-8770755.5295.55
61130528-11305287.1277.16
15min11449028-14490289.1358.865.029.248.965.04
21484924-14849249.3629.47
31409383-14093838.8858.97
41440497-14404979.0829.19
51294459-12944598.1618.24
61350572-13505728.5158.63
20min11591619-159161910.03410.053.1710.2410.253.24
21644198-164419810.36610.58
31618335-161833510.20310.39
41593196-159319610.04410.25
51498647-14986479.4489.62
61616775-161677510.19310.40
30min11805097-180509711.38011.533.1511.6911.843.20
21912942-191294212.06012.39
31859812-185981211.72512.03
41838410-183841011.59011.91
51740800-174080010.97511.25
61819207-181920711.46911.79
45min11952264-195226412.30812.441.6912.7512.871.71
21990814-199081412.55113.02
32024375-202437512.76313.19
41977481-197748112.46712.91
51929026-192902612.16112.56
61960588-196058812.36012.81
60min12029817-202981712.79712.941.7713.3713.521.81
22067623-206762313.03513.64
32103173-210317313.25913.83
42059643-205964312.98513.57
51996382-199638212.58613.12
62057867-205786712.97413.56
极限12090818-209081813.18113.261.6513.9013.981.66
22127279-212727913.41114.16
32154397-215439713.58214.30
42113734-211373413.32614.06
52064437-206443713.01513.69
62071483-207148313.06013.79
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