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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.066182461926617766177961695618000.14
210.016175361868618100.14
单位质量响应值RSD%判断
6143.146174.830.37数据可信
供试品溶液-2026051421批-厄贝沙坦-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%
5min111181-1118116.32614.799.5716.3314.799.59
210366-1036615.13615.14
310910-1091015.93015.93
410434-1043415.23515.23
59035-903513.19213.19
68851-885112.92412.92
10min139052-3905257.02156.922.9657.2057.082.96
240218-4021858.72358.89
339892-3989258.24758.42
437109-3710954.18454.35
539416-3941657.55257.70
638219-3821955.80455.95
15min148277-4827770.49071.492.2271.3172.292.22
250599-5059973.88174.70
349874-4987472.82273.65
447955-4795570.02070.79
549045-4904571.61272.40
648023-4802370.11970.88
20min152774-5277477.05678.611.5378.6580.201.53
255149-5514980.52482.17
354313-5431379.30480.94
453784-5378478.53180.08
553688-5368878.39179.97
653333-5333377.87379.42
30min156554-5655482.57683.851.1185.0386.321.13
258205-5820584.98687.52
358123-5812384.86787.38
457161-5716183.46285.88
557401-5740183.81286.27
657124-5712483.40885.82
45min160538-6053888.39388.961.1791.7692.351.17
262175-6217590.78394.26
361002-6100289.07092.53
460277-6027788.01291.36
560371-6037188.14991.53
661186-6118689.33992.67
60min161544-6154489.86290.821.5394.2295.201.52
263764-6376493.10397.59
362321-6232190.99695.44
461407-6140789.66293.99
562768-6276891.64996.01
661395-6139589.64493.97
90min162128-6212890.71493.431.6696.0798.821.60
264933-6493394.810100.33
364171-6417193.69799.16
464039-6403993.50598.83
563619-6361992.89198.27
665042-6504294.969100.29
120min161114-6111489.23492.601.8695.5999.031.78
264222-6422293.772100.35
363720-6372093.03999.54
464308-6430893.897100.26
563510-6351092.73299.15
663630-6363092.90799.29
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162833-6283391.74493.191.5199.10100.651.42
264540-6454094.236101.86
362725-6272591.58699.12
463608-6360892.875100.28
564066-6406693.544100.99
665171-6517195.158102.57
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%
114.96471076473746476906472636473496473570.04
214.96476956467386472160.11
单位质量响应值RSD%判断
43446.7843437.320.02数据可信
供试品溶液-2026051421批-非奈利酮-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%
5min1109861-10986115.17311.3830.1815.1711.3830.17
277830-7783010.74910.75
3108109-10810914.93114.93
442999-429995.9395.94
583362-8336211.51411.51
672287-722879.9849.98
10min1328331-32833145.34742.517.0645.5242.647.12
2310549-31054942.89143.01
3321724-32172444.43544.60
4267249-26724936.91136.98
5315910-31591043.63243.76
6303008-30300841.85041.96
15min1437906-43790660.48159.422.9261.1560.023.00
2437622-43762260.44261.04
3440788-44078860.87961.54
4407650-40765056.30356.78
5433496-43349659.87260.49
6423905-42390558.54859.12
20min1500425-50042569.11668.851.1870.4670.101.27
2502882-50288269.45670.72
3503383-50338369.52570.86
4487720-48772067.36168.46
5500131-50013169.07670.35
6496380-49638068.55869.78
30min1564298-56429877.93877.880.8680.0579.910.94
2567141-56714178.33180.37
3566788-56678878.28280.39
4555516-55551676.72578.58
5568285-56828578.48980.53
6561371-56137177.53479.52
45min1625833-62583386.43785.800.8789.4288.690.93
2626048-62604886.46789.38
3619741-61974185.59688.57
4611470-61147084.45387.16
5621214-62121485.79988.72
6622882-62288286.02988.88
60min1646779-64677989.33089.041.4393.2792.881.45
2652905-65290590.17694.05
3644476-64447689.01292.94
4635142-63514287.72391.36
5655731-65573190.56694.44
6632978-63297887.42491.23
90min1662539-66253991.50792.910.8396.4497.740.76
2675600-67560093.31198.18
3673009-67300992.95397.87
4671842-67184292.79197.41
5674339-67433993.13698.01
6678983-67898393.77898.55
120min1654143-65414390.34792.561.4196.3098.431.27
2670603-67060392.62098.53
3671541-67154192.75098.70
4680004-68000493.91999.57
5678685-67868593.73799.65
6666222-66622292.01597.83
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1672245-67224592.84793.191.2299.80100.081.13
2675657-67565793.318100.26
3661468-66146891.35998.34
4672224-67222492.84499.53
5684423-68442394.529101.48
6682183-68218394.220101.06
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.066156461542615716154761691615830.10
210.016198361952619680.04
单位质量响应值RSD%判断
6121.576190.610.80数据可信
供试品溶液-2026051421批-厄贝沙坦-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%
5min14927-49277.19811.4143.337.2011.4143.34
27410-741010.82510.82
37599-759911.10111.10
410277-1027715.01315.01
512910-1291018.85918.86
63733-37335.4535.45
10min132951-3295148.13654.588.5948.2254.718.64
240377-4037758.98459.10
337493-3749354.77154.89
440352-4035258.94859.11
539002-3900256.97657.19
634007-3400749.67949.74
15min145346-4534666.24368.873.0166.8669.603.11
247224-4722468.98769.76
347741-4774169.74270.47
448869-4886971.39072.21
548113-4811370.28671.13
645564-4556466.56267.17
20min152448-5244876.61875.781.5077.9777.281.55
251409-5140975.10076.64
351690-5169075.51177.02
452547-5254776.76378.38
552531-5253176.74078.36
650639-5063973.97675.33
30min156120-5612081.98381.872.3884.1884.212.36
253603-5360378.30680.68
356878-5687883.09085.44
457104-5710483.42085.89
556965-5696583.21785.69
655587-5558781.20483.38
45min159232-5923286.52987.220.8889.6490.470.97
259467-5946786.87290.12
360340-6034088.14791.42
460267-6026788.04191.44
559816-5981687.38290.78
659115-5911586.35889.43
60min161407-6140789.70690.372.1393.7894.592.16
261491-6149189.82994.04
361747-6174790.20394.45
464277-6427793.89998.27
561953-6195390.50494.88
660291-6029188.07692.11
90min163486-6348692.74392.451.1297.8197.671.17
262508-6250891.31496.52
363732-6373293.10298.35
464103-6410393.64499.06
563546-6354692.83198.21
662342-6234291.07296.09
120min161836-6183690.33392.331.7896.4398.581.78
262080-6208090.68996.91
363040-6304092.09298.38
464819-6481994.690101.15
563809-6380993.21599.62
663621-6362192.94098.97
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163443-6344392.68092.971.0999.79100.251.17
263005-6300592.04099.27
363810-6381093.216100.52
464208-6420893.798101.31
564586-6458694.350101.79
662803-6280391.74598.80
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%
114.96484296488596489246493986493196489860.07
214.96489586493966491770.05
单位质量响应值RSD%判断
43556.1143568.930.03数据可信
供试品溶液-2026051421批-非奈利酮-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%
5min157135-571357.86910.5040.807.8710.5040.80
2112039-11203915.43115.43
343630-436306.0096.01
4115438-11543815.90015.90
577338-7733810.65210.65
651930-519307.1527.15
10min1278482-27848238.35640.997.9538.4441.108.04
2312725-31272543.07343.24
3279072-27907238.43738.50
4337147-33714746.43646.61
5297488-29748840.97441.09
6280506-28050638.63538.71
15min1406237-40623755.95257.822.9256.4758.403.02
2431354-43135459.41260.06
3413731-41373156.98457.48
4437760-43776060.29460.99
5418245-41824557.60658.18
6411520-41152056.68057.19
20min1486824-48682467.05266.991.1468.1968.201.25
2492087-49208767.77769.09
3477772-47777265.80566.93
4492456-49245667.82769.19
5485688-48568866.89568.11
6483336-48333666.57167.71
30min1552418-55241876.08676.391.7877.9778.351.71
2536035-53603573.83075.89
3560845-56084577.24779.11
4560836-56083677.24679.36
5562221-56222177.43679.39
6555505-55550576.51178.39
45min1604997-60499783.32884.240.8186.0587.050.81
2614025-61402584.57287.46
3619646-61964685.34688.06
4611755-61175584.25987.23
5610477-61047784.08386.90
6608953-60895383.87386.60
60min1636250-63625087.63388.781.7391.2892.521.77
2646260-64626089.01192.83
3645453-64545388.90092.56
4663932-66393291.44595.36
5644205-64420588.72892.48
6631389-63138986.96390.62
90min1674272-67427292.87092.210.9097.4996.940.85
2665140-66514091.61296.42
3676675-67667593.20197.85
4668818-66881892.11897.05
5671623-67162392.50597.24
6660393-66039390.95895.58
120min1653704-65370490.03792.411.5595.6998.161.50
2662954-66295491.31197.14
3673991-67399192.83198.52
4678431-67843193.44299.39
5679894-67989493.64499.41
6676714-67671493.20698.84
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1671328-67132892.46493.180.9499.1299.970.90
2673447-67344792.75699.60
3681526-68152693.869100.59
4674658-67465892.92399.91
5686921-68692194.612101.42
6671463-67146392.48399.16
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