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%
114.598267738270318270548268858270068269500.02
214.608263938262968263440.01
单位质量响应值RSD%判断
56679.2356598.900.11数据可信
供试品溶液-25101502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%
5min11037391-10373918.7718.6919.838.778.6919.82
21368782-136878211.57311.57
3811065-8110656.8586.86
41113255-11132559.4139.41
5837636-8376367.0827.08
6998185-9981858.4408.44
10min12088861-208886117.66217.701.2617.7617.801.30
22095329-209532917.71617.85
32108820-210882017.83017.91
42129007-212900718.00118.11
52049303-204930317.32717.41
62091671-209167117.68517.78
15min12262056-226205619.12619.050.9419.4219.340.93
22228943-222894318.84619.17
32256399-225639919.07819.35
42285741-228574119.32619.63
52231297-223129718.86619.14
62253634-225363419.05519.35
20min12292036-229203619.38019.330.9319.8919.830.96
22279334-227933419.27219.81
32269848-226984819.19219.68
42318270-231827019.60120.12
52258798-225879819.09919.58
62295713-229571319.41119.91
30min12255904-225590419.07419.401.0319.8020.120.99
22295706-229570619.41120.16
32310934-231093419.53920.24
42321884-232188419.63220.37
52301638-230163819.46120.15
62280374-228037419.28120.00
45min12257246-225724619.08519.210.7720.0220.140.80
22277209-227720919.25420.22
32252308-225230819.04419.96
42298957-229895719.43820.39
52264868-226486819.15020.06
62281314-228131419.28920.22
60min12233558-223355818.88519.120.9220.0320.270.92
22256263-225626319.07720.26
32249036-224903619.01620.14
42290750-229075019.36920.54
52259201-225920119.10220.22
62279806-227980619.27620.42
极限12186675-218667518.48918.981.3519.8420.341.31
22252657-225265719.04720.44
32256206-225620619.07720.42
42273010-227301019.21920.61
52244156-224415618.97520.31
62257465-225746519.08720.45
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%
114.598249948238898229558233078230238236340.11
214.608272328279188275750.06
单位质量响应值RSD%判断
56451.9556683.220.29数据可信
供试品溶液-25101502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%
5min133990-339900.2880.3318.930.290.3319.31
234705-347050.2940.29
351435-514350.4350.44
444028-440280.3730.37
534200-342000.2900.29
634024-340240.2880.29
10min180719-807190.6830.696.760.690.706.62
277446-774460.6560.66
390837-908370.7690.77
486873-868730.7350.74
578882-788820.6680.67
677528-775280.6560.66
15min1100156-1001560.8480.863.330.860.873.41
297952-979520.8290.84
3106974-1069740.9060.92
4104172-1041720.8820.89
599588-995880.8430.85
6100349-1003490.8500.86
20min1121523-1215231.0290.976.181.051.006.03
2109760-1097600.9290.95
3115180-1151800.9751.00
4113968-1139680.9650.99
5123543-1235431.0461.07
6104656-1046560.8860.91
30min1123345-1233451.0441.041.761.081.082.02
2119512-1195121.0121.04
3125567-1255671.0631.10
4124665-1246651.0551.09
5123759-1237591.0481.08
6121830-1218301.0311.06
45min1141222-1412221.1961.142.711.241.182.76
2130273-1302731.1031.14
3135253-1352531.1451.19
4134586-1345861.1391.18
5133040-1330401.1261.17
6134010-1340101.1351.18
60min1138861-1388611.1761.181.021.231.231.11
2136564-1365641.1561.21
3139787-1397871.1831.24
4139399-1393991.1801.24
5139156-1391561.1781.23
6140772-1407721.1921.25
极限1142815-1428151.2091.201.261.281.281.47
2138865-1388651.1761.24
3143424-1434241.2141.29
4142640-1426401.2081.28
5141677-1416771.1991.27
6143901-1439011.2181.29
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%
114.598246538236728242498244738240528242200.05
214.608234458235318234880.01
单位质量响应值RSD%判断
56492.1256403.290.12数据可信
供试品溶液-25101502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%
5min1372569-3725693.1613.2926.813.163.2926.80
2354708-3547083.0093.01
3230794-2307941.9581.96
4548984-5489844.6584.66
5431549-4315493.6613.66
6385550-3855503.2713.27
10min11038911-10389118.8149.334.518.859.374.54
21046833-10468338.8818.91
31134376-11343769.6249.65
41155739-11557399.8059.86
51135371-11353719.6329.67
61086798-10867989.2209.26
15min11337889-133788911.35011.893.2911.4812.033.30
21362230-136223011.55711.69
31437392-143739212.19512.32
41428784-142878412.12212.28
51454923-145492312.34312.49
61391129-139112911.80211.94
20min11491963-149196312.65813.222.5012.9213.502.50
21545512-154551213.11213.37
31600966-160096613.58213.85
41568929-156892913.31113.61
51590468-159046813.49313.78
61554135-155413513.18513.45
30min11723530-172353014.62215.122.6015.0215.542.58
21754348-175434814.88415.29
31829196-182919615.51915.93
41761510-176151014.94415.39
51844273-184427315.64716.08
61782482-178248215.12215.54
45min11867961-186796115.84816.291.7116.4116.881.70
21922461-192246116.31016.88
31946468-194646816.51417.10
41894618-189461816.07416.68
51946506-194650616.51417.12
61944497-194449716.49717.08
60min11955463-195546316.59016.991.5417.3317.761.55
21990737-199073716.88917.64
32042418-204241817.32818.10
41991949-199194916.89917.69
52027279-202727917.19917.99
62010612-201061217.05817.83
极限11999013-199901316.95917.401.6517.8818.351.65
22038461-203846117.29418.23
32074634-207463417.60118.56
42030319-203031917.22518.20
52082571-208257117.66818.65
62080037-208003717.64718.60
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