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%
115.056489464697648426490164867648400.13
215.086483064772648010.07
单位质量响应值RSD%判断
4308.314297.150.19数据可信
供试品溶液-BJ86589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%
5min110816-1081615.08316.1025.0815.0816.1025.07
28044-804411.21711.22
314659-1465920.44120.44
415352-1535221.40821.41
511010-1101015.35315.35
69392-939213.09713.10
10min134187-3418747.67348.444.2447.8448.624.30
232723-3272345.63145.76
336025-3602550.23650.46
436036-3603650.25150.49
535972-3597250.16250.33
633481-3348146.68846.83
15min144556-4455662.13262.181.5162.8362.891.58
243642-4364260.85761.49
344560-4456062.13762.92
445476-4547663.41564.21
545182-4518263.00563.73
644112-4411261.51362.18
20min150318-5031870.16770.841.1671.5572.251.18
250284-5028470.11971.43
350230-5023070.04471.52
451520-5152071.84373.34
551308-5130871.54772.98
651150-5115071.32772.67
30min157708-5770880.47280.190.8082.6482.390.80
256747-5674779.13281.22
357664-5766480.41182.66
457167-5716779.71782.02
557865-5786580.69182.91
657896-5789680.73482.87
45min162322-6232286.90687.071.6689.9790.161.58
261753-6175386.11389.08
361845-6184586.24189.39
461515-6151585.78188.97
562909-6290987.72590.84
664286-6428689.64592.68
60min165545-6554591.40090.372.0695.4394.421.95
264170-6417089.48393.41
363853-6385389.04193.15
463646-6364688.75292.89
564458-6445889.88593.98
667155-6715593.64597.68
90min167240-6724093.76492.723.1598.8197.783.00
264586-6458690.06394.98
365591-6559191.46496.56
464568-6456890.03895.16
566856-6685693.22898.32
670097-7009797.748102.82
120min166663-6666392.95992.323.3399.0498.403.16
265343-6534391.11997.04
364535-6453589.99296.10
464636-6463690.13396.26
565612-6561291.49497.62
670417-7041798.194104.35
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165247-6524790.98591.353.6998.1098.473.50
263945-6394589.16996.10
364644-6464490.14497.26
464249-6424989.59396.72
564626-6462690.11997.26
670356-7035698.109105.36
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%
115.051335091334291333741335071334141334470.05
215.081328331328231328280.01
单位质量响应值RSD%判断
8866.918808.220.47数据可信
供试品溶液-BXK6BP1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%
5min15434-54343.6894.7518.753.694.7518.70
27894-78945.3595.36
39050-90506.1446.14
45988-59884.0654.07
56887-68874.6764.68
66689-66894.5414.54
10min129496-2949620.02620.945.8320.0721.005.85
232472-3247222.04622.11
333112-3311222.48122.55
429303-2930319.89519.94
531701-3170121.52321.57
628994-2899419.68519.74
15min145272-4527230.73631.242.4431.0031.532.48
246866-4686631.81932.12
346857-4685731.81332.13
445606-4560630.96331.23
547158-4715832.01732.31
644337-4433730.10230.37
20min155898-5589837.95138.192.7738.5638.822.77
257005-5700538.70239.36
357192-5719238.82939.50
456721-5672138.50939.12
557422-5742238.98539.63
653269-5326936.16636.77
30min169680-6968047.30847.581.1548.3348.641.15
270111-7011147.60048.69
370356-7035647.76748.87
471351-7135148.44249.48
570051-7005147.56048.64
668917-6891746.79047.80
45min182649-8264956.11356.471.4257.6758.061.33
282750-8275056.18157.80
382040-8204055.69957.33
483870-8387056.94258.52
582503-8250356.01457.62
685237-8523757.87059.40
60min190757-9075761.61761.711.2263.7963.921.15
290511-9051161.45063.69
389290-8929060.62162.87
492625-9262562.88665.09
590668-9066861.55763.79
691484-9148462.11164.28
90min199318-9931867.43068.050.9170.2970.950.89
2101327-10132768.79471.72
399118-9911867.29470.22
4100941-10094168.53271.44
5100741-10074168.39671.31
699968-9996867.87170.73
120min1103804-10380470.47571.341.1774.0974.991.11
2104209-10420970.75074.44
3104580-10458071.00274.68
4106931-10693172.59876.27
5104709-10470971.09074.76
6106205-10620572.10575.72
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1107242-10724272.81072.512.7777.2076.962.62
2103630-10363070.35774.83
3105827-10582771.84976.31
4112355-11235576.28180.76
5105886-10588671.88976.35
6105896-10589671.89676.31
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%
115.058803298793848783918785138781388789510.11
215.088831508836328833910.04
单位质量响应值RSD%判断
58402.0658580.310.22数据可信
供试品溶液-FHG0459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%
5min1159800-15980016.39217.7013.4116.3917.7013.41
2174294-17429417.87917.88
3168317-16831717.26617.27
4195121-19512120.01520.02
5137553-13755314.11014.11
6200037-20003720.52020.52
10min1411648-41164842.22743.073.9742.4143.264.01
2423629-42362943.45643.65
3414281-41428142.49742.69
4438801-43880145.01245.23
5394487-39448740.46640.62
6436290-43629044.75544.98
15min1519579-51957953.29855.802.9553.9556.472.97
2561873-56187357.63758.32
3545058-54505855.91256.58
4558406-55840657.28158.00
5531765-53176554.54855.15
6546854-54685456.09656.82
20min1624794-62479464.09164.542.4065.3365.842.39
2656536-65653667.34768.67
3625479-62547964.16265.45
4635180-63518065.15766.52
5616502-61650263.24164.45
6616649-61664963.25664.60
30min1699312-69931271.73574.131.8873.6976.141.88
2737909-73790975.69577.76
3725599-72559974.43276.43
4732255-73225575.11577.20
5724283-72428374.29776.21
6716338-71633873.48275.53
45min1779880-77988080.00081.411.3082.7584.241.32
2806572-80657282.73885.65
3789168-78916880.95383.78
4803488-80348882.42285.34
5795887-79588781.64284.38
6786506-78650680.68083.55
60min1814946-81494683.59785.271.5987.2489.011.56
2846598-84659886.84490.67
3826271-82627184.75988.48
4838535-83853586.01789.85
5842489-84248986.42290.07
6818503-81850383.96287.73
90min1844431-84443186.62287.611.1491.1992.301.15
2863641-86364188.59293.39
3849388-84938887.13091.80
4863327-86332788.56093.35
5860968-86096888.31892.93
6842530-84253086.42791.12
120min1846010-84601086.78488.531.5492.3294.191.53
2878859-87885990.15395.93
3850572-85057287.25292.89
4873904-87390489.64595.42
5869759-86975989.22094.81
6859016-85901688.11893.78
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1837863-83786385.94888.722.0292.4495.361.98
2878957-87895790.16396.94
3855322-85532287.73994.34
4883044-88304490.58297.35
5875884-87588489.84896.43
6858079-85807988.02294.66
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