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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.051293381294191290081293421293021292820.13
215.081300791297921299360.16
单位质量响应值RSD%判断
8590.178616.450.22数据可信
供试品溶液-BXK6BP1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%
5min19579-95796.6808.0315.176.688.0315.16
210648-106487.4267.43
314364-1436410.01810.02
412225-122258.5268.53
512080-120808.4258.42
610176-101767.0977.10
10min131863-3186322.22223.296.2822.3023.386.31
231028-3102821.63921.72
336302-3630225.31725.43
433606-3360623.43723.53
535386-3538624.67824.77
632150-3215022.42222.50
15min150003-5000334.87234.323.4435.1934.663.46
247738-4773833.29333.62
351576-5157635.97036.36
447859-4785933.37733.73
550446-5044635.18135.55
647607-4760733.20233.53
20min162852-6285243.83341.403.8944.5442.133.86
256499-5649939.40340.10
361062-6106242.58543.38
459392-5939241.42042.15
558762-5876240.98141.74
657631-5763140.19240.89
30min181073-8107356.54151.964.8657.7453.154.79
272452-7245250.52951.66
375532-7553252.67753.94
473717-7371751.41152.60
573689-7368951.39152.61
670550-7055049.20250.35
45min199679-9967969.51763.705.1571.3465.465.09
286943-8694360.63562.33
392780-9278064.70666.56
491563-9156363.85765.61
589858-8985862.66864.45
687184-8718460.80362.49
60min1110451-11045177.02971.814.1379.6374.284.10
2100899-10089970.36872.73
3103796-10379672.38874.96
4104091-10409172.59475.06
599749-9974969.56672.05
698777-9877768.88871.25
90min1121826-12182684.96281.272.7988.4184.552.82
2115072-11507280.25283.40
3117512-11751281.95485.33
4116865-11686581.50384.78
5116033-11603380.92284.18
6111914-11191478.05081.18
120min1125109-12510987.25285.641.9191.6589.821.97
2121575-12157584.78788.83
3125410-12541087.46291.75
4123747-12374786.30290.48
5121452-12145284.70288.86
6119484-11948483.32987.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1125508-12550887.53086.141.9292.9091.271.93
2123081-12308185.83890.82
3126876-12687688.48493.74
4122661-12266185.54590.68
5120123-12012383.77588.87
6122876-12287685.69590.62
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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058587918569138591588577278585668582310.11
215.088630768637378634060.06
单位质量响应值RSD%判断
57025.3257255.040.29数据可信
供试品溶液-FHG0459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%
5min1195256-19525620.50319.1514.5020.5019.1414.50
2170510-17051017.90417.90
3171645-17164518.02418.02
4163221-16322117.13917.14
5230556-23055624.21024.21
6162809-16280917.09617.10
10min1576068-57606860.49062.799.7160.7263.009.71
2655582-65558268.84069.04
3546896-54689657.42757.63
4551474-55147457.90858.10
5685170-68517071.94772.22
6572462-57246260.11260.30
15min1810491-81049185.10685.392.6586.0186.302.72
2827522-82752286.89487.86
3791133-79113383.07383.91
4804801-80480184.50885.34
5848760-84876089.12490.19
6796618-79661883.64984.51
20min1860103-86010390.31592.092.3892.1693.952.44
2903292-90329294.85096.78
3855609-85560989.84491.60
4871453-87145391.50793.28
5902526-90252694.77096.83
6869307-86930791.28293.07
30min1912312-91231295.79893.361.8498.6596.241.84
2884054-88405492.83095.81
3865857-86585790.92093.68
4895412-89541294.02396.81
5898022-89802294.29797.41
6879015-87901592.30195.10
45min1904518-90451894.97993.881.3098.8997.801.33
2898444-89844494.34198.36
3878570-87857092.25596.02
4903035-90303594.82498.66
5899268-89926894.42898.59
6880297-88029792.43696.26
60min1887299-88729993.17192.190.8598.1497.150.89
2876287-87628792.01597.08
3871863-87186391.55096.35
4867703-86770391.11396.00
5883481-88348192.77097.98
6881025-88102592.51297.37
90min1877997-87799792.19491.551.6698.2097.541.69
2894271-89427193.90399.99
3854680-85468089.74695.56
4865130-86513090.84396.74
5878232-87823292.21998.46
6860674-86067490.37596.26
120min1858653-85865390.16390.132.2397.1997.142.23
2864495-86449590.77797.91
3829548-82954887.10793.92
4853067-85306789.57796.49
5888652-88865293.313100.58
6855471-85547189.82996.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1843689-84368988.59289.492.0196.6297.502.00
2873368-87336891.70899.85
3826941-82694186.83394.61
4860062-86006290.31198.22
5865409-86540990.87399.17
6843899-84389988.61496.50
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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058543648550338539818558658556638549810.10
215.088590878599268595060.07
单位质量响应值RSD%判断
56809.3756996.420.24数据可信
供试品溶液-FHG0459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%
5min112098-120981.2761.1517.991.281.1618.05
210495-104951.1071.11
39751-97511.0281.03
414318-143181.5101.51
58860-88600.9340.93
610138-101381.0691.07
10min127267-272672.8752.823.912.892.833.88
227227-272272.8712.88
326395-263952.7832.79
428051-280512.9582.97
524987-249872.6352.65
626557-265572.8002.81
15min134519-345193.6403.591.823.693.641.87
234915-349153.6823.73
334295-342953.6163.66
433855-338553.5703.62
533304-333043.5123.55
633514-335143.5343.58
20min137846-378463.9914.041.824.084.121.78
237588-375883.9634.05
338849-388494.0964.18
439393-393934.1544.24
538312-383124.0404.12
637837-378373.9904.07
30min143006-430064.5354.521.344.674.651.29
243361-433614.5724.70
343541-435414.5914.72
442038-420384.4334.57
542873-428734.5214.64
642374-423744.4684.59
45min148666-486665.1315.021.785.315.201.72
247300-473004.9875.17
348614-486145.1265.31
446625-466254.9165.10
547355-473554.9935.17
647045-470454.9615.14
60min151483-514835.4295.442.285.675.672.21
250769-507695.3535.59
353885-538855.6825.92
450837-508375.3605.60
551063-510635.3845.61
651288-512885.4085.64
90min155822-558225.8865.801.386.186.101.30
254457-544575.7426.04
356178-561785.9246.22
454528-545285.7506.05
554815-548155.7806.07
654491-544915.7466.04
120min157719-577196.0866.061.356.456.421.30
257471-574716.0606.42
358408-584086.1596.52
456417-564175.9496.31
556719-567195.9816.33
658083-580836.1246.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限158579-585796.1776.131.716.616.561.65
258525-585256.1716.60
359507-595076.2756.71
456634-566345.9726.40
557920-579206.1076.53
657509-575096.0646.49
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