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%
115.268303418300168303668302128305088302890.03
215.238314568312598313580.02
单位质量响应值RSD%判断
54409.5054586.870.24数据可信
供试品溶液-5122601批-厄贝沙坦-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%
5min19510-95101.0470.938.051.050.938.02
28511-85110.9370.94
38259-82590.9090.91
47701-77010.8480.85
57795-77950.8580.86
68834-88340.9730.97
10min127748-277483.0553.014.403.073.024.40
226648-266482.9342.94
325305-253052.7862.80
428762-287623.1673.18
527662-276623.0453.06
627883-278833.0703.08
15min137840-378404.1664.212.454.214.252.42
238839-388394.2764.32
337549-375494.1344.18
439755-397554.3774.42
537229-372294.0994.14
638027-380274.1874.23
20min142924-429244.7264.811.854.824.901.82
244853-448534.9385.03
343933-439334.8374.92
444394-443944.8884.98
542894-428944.7224.81
643327-433274.7704.86
30min149222-492225.4195.450.745.565.590.75
250080-500805.5145.66
349562-495625.4575.60
449581-495815.4595.61
549460-494605.4455.59
649017-490175.3975.54
45min154162-541625.9635.961.476.176.171.41
254729-547296.0256.23
354268-542685.9756.18
454757-547576.0296.24
554286-542865.9776.18
652597-525975.7916.00
60min156267-562676.1956.241.976.476.511.91
257760-577606.3596.63
356629-566296.2356.50
458073-580736.3946.67
555938-559386.1596.43
655143-551436.0716.34
90min158916-589166.4866.621.366.836.961.29
261472-614726.7687.11
360045-600456.6116.95
460016-600166.6086.95
560269-602696.6356.97
660118-601186.6196.95
120min160271-602716.6366.882.567.057.292.46
263111-631116.9487.37
364724-647247.1267.54
463280-632806.9677.39
562213-622136.8497.26
661175-611756.7357.14
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162332-623326.8626.901.617.357.401.55
263427-634276.9837.48
363280-632806.9677.46
463730-637307.0167.51
562551-625516.8877.37
660973-609736.7137.20
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2500
标示量(mg)20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%
110.276226962239621906223662299622470.07
210.346203862219621280.21
单位质量响应值RSD%判断
6061.056008.510.62数据可信
供试品溶液-5122601批-非奈利酮-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%
5min18048-804811.9936.2258.9811.996.2258.99
23244-32444.8344.83
35973-59738.9018.90
43780-37805.6335.63
52906-29064.3304.33
61101-11011.6411.64
10min143457-4345764.75956.0611.2264.8956.1311.27
236057-3605753.73253.79
341818-4181862.31762.42
433605-3360550.07850.14
537475-3747555.84555.89
633295-3329549.61649.63
15min152812-5281278.70077.852.6979.5578.542.74
253545-5354579.79280.44
353356-5335679.51180.30
452772-5277278.64079.26
550762-5076275.64576.31
650211-5021174.82475.39
20min156117-5611783.62584.811.8985.3586.371.89
258750-5875087.54989.09
357486-5748685.66587.34
456733-5673384.54386.04
556615-5661584.36785.88
655772-5577283.11184.51
30min159689-5968988.94889.901.1691.6092.391.15
261148-6114891.12293.63
360225-6022589.74792.37
460456-6045690.09192.52
561028-6102890.94393.39
659406-5940688.52690.85
45min161662-6166291.88892.561.8995.5396.061.85
262710-6271093.45096.97
361672-6167291.90395.53
462926-6292693.77297.20
563475-6347594.59098.05
660228-6022889.75193.06
60min161394-6139491.48993.091.9896.1597.611.88
263773-6377395.03499.59
361425-6142591.53596.18
463863-6386395.16899.64
563049-6304993.95598.46
661299-6129991.34795.65
90min160899-6089990.75193.612.1496.4399.171.95
264354-6435495.900101.52
361491-6149191.63397.30
462982-6298293.85599.39
563551-6355194.703100.26
663613-6361394.795100.12
120min160264-6026489.80594.252.5496.50100.852.37
263567-6356794.727101.41
364072-6407295.479102.16
464362-6436295.912102.49
564525-6452596.155102.76
662680-6268093.40599.78
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161700-6170091.94593.801.7999.63101.451.70
263320-6332094.359102.09
362546-6254693.205100.95
464421-6442196.000103.64
563907-6390795.234102.91
661772-6177292.05299.46
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%
115.268308138303708311108304388304398306340.04
215.238311208304238307720.06
单位质量响应值RSD%判断
54432.1154548.390.16数据可信
供试品溶液-5122901批-厄贝沙坦-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%
5min15509-55090.6070.7824.850.610.7824.58
27493-74930.8250.83
34599-45990.5060.51
47054-70540.7770.78
59017-90170.9930.99
68785-87850.9670.97
10min124424-244242.6892.664.472.702.674.58
224554-245542.7042.71
322042-220422.4272.43
424871-248712.7392.75
524136-241362.6582.67
624935-249352.7462.76
15min136360-363604.0043.962.284.043.992.33
236669-366694.0384.08
334602-346023.8103.84
436707-367074.0424.08
535730-357303.9343.97
635478-354783.9073.95
20min141232-412324.5404.511.204.624.601.23
241745-417454.5974.68
340497-404974.4594.53
440727-407274.4854.57
541246-412464.5424.63
640552-405524.4654.55
30min147024-470245.1785.231.325.315.371.27
248272-482725.3155.45
348191-481915.3065.43
447029-470295.1785.31
547809-478095.2645.40
646897-468975.1645.30
45min152165-521655.7445.741.995.935.921.93
253383-533835.8786.07
352318-523185.7615.94
452499-524995.7815.97
551998-519985.7265.92
650227-502275.5315.72
60min154997-549976.0566.021.446.316.271.43
255359-553596.0966.36
354914-549146.0476.29
455227-552276.0816.34
554117-541175.9596.22
653321-533215.8716.12
90min158611-586116.4546.492.376.776.812.30
260458-604586.6576.98
359478-594786.5496.86
460091-600916.6176.94
558303-583036.4206.74
656637-566376.2366.55
120min161483-614836.7706.661.877.167.051.77
260961-609616.7137.11
360309-603096.6417.03
461432-614326.7647.16
560150-601506.6237.02
658463-584636.4376.83
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161794-617946.8046.811.657.277.271.61
261536-615366.7767.25
361741-617416.7987.26
463168-631686.9567.43
562510-625106.8837.35
660154-601546.6247.08
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2500
标示量(mg)20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%
110.276208462064620386207462212620940.11
210.346211462119621160.01
单位质量响应值RSD%判断
6046.156007.350.46数据可信
供试品溶液-5122901批-非奈利酮-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%
5min11257-12571.8763.1129.871.883.1129.75
21820-18202.7162.72
32556-25563.8143.81
41607-16072.3982.40
52369-23693.5353.53
62891-28914.3144.31
10min118954-1895428.28237.0121.3328.3037.0521.33
226257-2625739.18039.21
327050-2705040.36340.41
424708-2470836.86836.89
519005-1900528.35928.40
632858-3285849.02949.08
15min147047-4704770.20273.763.0070.5474.213.09
250719-5071975.68176.15
349830-4983074.35474.85
448927-4892773.00773.44
548934-4893473.01773.37
651144-5114476.31576.91
20min152979-5297979.05381.083.4980.1782.343.49
256137-5613783.76685.07
353302-5330279.53580.85
451745-5174577.21278.46
555861-5586183.35484.52
655994-5599483.55284.99
30min156697-5669784.60189.314.0386.5991.484.03
260826-6082690.76293.00
361629-6162991.96094.16
456856-5685684.83886.94
561806-6180692.22594.32
661305-6130591.47793.85
45min159376-5937688.59992.002.7691.5395.152.78
263082-6308294.12997.37
362619-6261993.43896.66
459763-5976389.17692.22
563273-6327394.41497.53
661801-6180192.21795.60
60min159851-5985189.30792.512.6393.2396.692.68
262881-6288193.82998.12
363371-6337194.56098.82
459963-5996389.47593.51
562951-6295193.93398.10
662957-6295793.94298.35
90min160310-6031089.99294.273.1294.9099.483.15
264742-6474296.606101.94
364638-6463896.450101.76
461035-6103591.07496.11
564080-6408095.618100.83
664263-6426395.891101.34
120min161203-6120391.32593.572.3297.2399.832.36
263163-6316394.249100.66
363533-6353394.802101.18
460646-6064690.49496.54
564360-6436096.036102.31
663349-6334994.527101.05
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161458-6145891.70594.823.1498.63102.123.05
263360-6336094.543102.00
362568-6256893.362100.80
462291-6229192.948100.00
566973-6697399.935107.27
664625-6462596.431104.00
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%
115.268345158337558327898332558322978333220.11
215.238362138355178358650.06
单位质量响应值RSD%判断
54608.2654882.800.36数据可信
供试品溶液-5123001批-厄贝沙坦-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%
5min115874-158741.7401.3819.641.741.3819.64
212175-121751.3341.33
310638-106381.1661.17
414283-142831.5651.57
513554-135541.4861.49
69116-91160.9991.00
10min131418-314183.4432.9910.753.463.0110.74
227266-272662.9883.00
324719-247192.7092.72
429500-295003.2333.25
527475-274753.0113.03
623490-234902.5742.59
15min139631-396314.3444.144.624.404.194.69
237503-375034.1104.16
336473-364733.9974.04
439294-392944.3074.36
538474-384744.2174.27
635097-350973.8473.89
20min143986-439864.8214.712.884.934.813.02
242710-427104.6814.77
342338-423384.6404.73
444165-441654.8404.94
543795-437954.8004.90
640963-409634.4894.57
30min149471-494715.4225.412.065.585.552.12
249264-492645.3995.54
348730-487305.3415.48
450602-506025.5465.70
550128-501285.4945.64
647746-477465.2335.37
45min154133-541335.9335.901.766.156.111.85
253177-531775.8286.03
354017-540175.9206.12
454524-545245.9766.19
554989-549896.0276.24
652394-523945.7425.93
60min155990-559906.1366.211.576.426.481.59
256424-564246.1846.45
356871-568716.2336.50
457643-576436.3186.60
557721-577216.3266.60
655518-555186.0856.34
90min158964-589646.4626.561.406.826.901.40
259822-598226.5566.90
359914-599146.5666.90
460301-603016.6096.96
561075-610756.6947.04
658868-588686.4526.77
120min161060-610606.6926.691.937.127.112.01
260479-604796.6287.04
360643-606436.6467.05
462559-625596.8567.28
562253-622536.8237.25
659405-594056.5116.90
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161203-612036.7086.801.367.217.281.37
261456-614566.7357.22
362152-621526.8127.29
463027-630276.9087.41
563004-630046.9057.40
661268-612686.7157.18
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2500
标示量(mg)20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%
110.276216862395620826224362107621990.21
210.346238762581624840.22
单位质量响应值RSD%判断
6056.386042.940.16数据可信
供试品溶液-5123001批-非奈利酮-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%
5min11666-16662.4776.1240.252.486.1240.22
24941-49417.3457.34
35099-50997.5807.58
44970-49707.3887.39
55643-56438.3888.39
62380-23803.5383.54
10min131715-3171547.14451.4810.7447.1751.5510.76
239940-3994059.37159.45
337492-3749255.73255.82
436001-3600153.51553.60
531754-3175447.20247.30
630881-3088145.90545.94
15min150289-5028974.75577.653.0575.3178.293.13
253967-5396780.22280.96
353177-5317779.04879.75
453398-5339879.37680.05
552256-5225677.67878.30
650322-5032274.80475.35
20min155521-5552182.53284.541.9583.9186.042.04
257941-5794186.12987.76
357666-5766685.72087.30
457667-5766785.72287.28
556950-5695084.65686.14
655502-5550282.50483.88
30min159572-5957288.55490.851.9890.8593.302.03
262293-6229392.59895.19
360568-6056890.03492.57
462486-6248692.88595.40
561683-6168391.69294.11
660111-6011189.35591.65
45min161518-6151891.44693.301.6494.7396.751.71
263716-6371694.71498.33
362809-6280993.36696.90
463608-6360894.55398.10
563446-6344694.31297.75
661501-6150191.42194.71
60min161442-6144291.33394.632.1095.6399.122.16
264939-6493996.532101.20
364002-6400295.13999.71
464846-6484696.394100.99
563944-6394495.05399.54
662791-6279193.33997.64
90min161300-6130091.12294.342.0596.4499.882.09
264982-6498296.596102.34
363264-6326494.04299.67
464264-6426495.528101.19
564120-6412095.314100.86
662870-6287093.45698.80
120min161399-6139991.27093.322.2797.6099.902.29
264082-6408295.258102.07
362254-6225492.54199.21
464431-6443195.777102.50
563457-6345794.329100.93
661026-6102690.71597.10
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161579-6157991.53793.991.6898.88101.621.76
264192-6419295.421103.30
363394-6339494.235101.94
464326-6432695.621103.41
563477-6347794.358102.01
662415-6241592.780100.17
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