非奈利酮厄贝沙坦片项目信息
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%
110.066185362011618536193861885619080.11
210.016211162010620600.12
单位质量响应值RSD%判断
6153.886199.800.53数据可信
供试品溶液-2026051421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%
5min18348-834812.15420.7749.7612.1520.7849.75
25768-57688.3988.40
314609-1460921.26921.27
422145-2214532.24132.24
511749-1174917.10517.11
622995-2299533.47933.48
10min150695-5069573.80775.485.9373.9475.716.01
250984-5098474.22874.32
349453-4945371.99972.24
451855-5185575.49675.85
550184-5018473.06373.25
657901-5790184.29984.67
15min162903-6290391.58188.802.4992.5489.872.45
260504-6050488.08889.01
361436-6143689.44590.48
458739-5873985.51986.72
560132-6013287.54788.55
662238-6223890.61391.92
20min163842-6384292.94891.991.7894.9294.041.66
263605-6360592.60394.50
364880-6488094.45996.49
461914-6191490.14192.29
562443-6244390.91192.89
662402-6240290.85293.17
30min165968-6596896.04492.722.5199.0595.802.39
264208-6420893.48196.41
363699-6369992.74095.82
461050-6105088.88392.03
563224-6322492.04895.03
663968-6396893.13296.46
45min164849-6484994.41493.711.8498.4997.821.80
264208-6420893.48197.45
365463-6546395.30899.42
462151-6215190.48694.62
564356-6435693.69797.70
665147-6514794.84899.21
60min165021-6502194.66591.941.8899.7997.091.79
263183-6318391.98996.99
363745-6374592.80797.98
461578-6157889.65294.79
562357-6235790.78695.83
663000-6300091.72297.14
90min164051-6405193.25391.461.9699.4397.631.87
263343-6334392.22298.25
363598-6359892.59398.79
460684-6068488.35094.49
562120-6212090.44196.50
663114-6311491.88898.32
120min162527-6252791.03490.191.6298.2497.381.48
262990-6299091.70898.76
362799-6279991.43098.66
460415-6041587.95995.08
561650-6165089.75796.82
661318-6131889.27496.73
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163308-6330892.17191.381.24100.3999.571.24
262410-6241090.86398.93
363589-6358992.580100.82
461528-6152889.57997.68
562471-6247190.95299.01
663298-6329892.156100.60
非奈利酮厄贝沙坦片项目信息
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%
114.906435876442666441446444116437276440270.06
214.906459946461946460940.03
单位质量响应值RSD%判断
43223.2943362.010.23数据可信
供试品溶液-2026051421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%
5min110858-108581.5051.4726.311.501.4726.35
28761-87611.2141.21
315939-159392.2092.21
49463-94631.3111.31
58268-82681.1461.15
610268-102681.4231.42
10min125116-251163.4813.5511.103.503.5711.15
223066-230663.1973.21
330692-306924.2544.28
425629-256293.5523.57
522894-228943.1733.19
626262-262623.6403.66
15min133117-331174.5904.565.364.654.625.48
231068-310684.3064.35
335799-357994.9615.03
433234-332344.6064.66
531030-310304.3014.35
633339-333394.6214.68
20min136760-367605.0955.154.055.205.264.16
236062-360624.9985.09
339728-397285.5065.63
438056-380565.2745.38
535583-355834.9325.03
636913-369135.1165.22
30min142302-423025.8635.761.916.035.932.02
241130-411305.7005.85
342331-423315.8676.05
441381-413815.7355.90
540318-403185.5885.74
642038-420385.8265.99
45min144976-449766.2336.341.996.466.572.14
245165-451656.2606.48
347064-470646.5236.78
445673-456736.3306.56
544968-449686.2326.44
646669-466696.4686.70
60min147778-477786.6226.581.456.926.871.60
247233-472336.5466.83
348277-482776.6917.02
447524-475246.5866.88
546244-462446.4096.69
647643-476436.6036.90
90min150234-502346.9626.941.347.337.311.46
250064-500646.9387.30
350807-508077.0417.44
449742-497426.8947.26
548968-489686.7877.14
650660-506607.0217.40
120min151177-511777.0937.130.947.547.571.03
251965-519657.2027.64
351992-519927.2067.68
451240-512407.1017.55
550753-507537.0347.46
651364-513647.1197.57
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151620-516207.1547.263.087.687.782.94
251879-518797.1907.71
352610-526107.2917.85
451304-513047.1107.64
551267-512677.1057.61
655490-554907.6908.22
非奈利酮厄贝沙坦片项目信息
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%
110.066204061885620206193862168620100.18
210.016245262479624660.04
单位质量响应值RSD%判断
6164.026240.360.88数据可信
供试品溶液-2026051421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%
5min115405-1540522.33723.9310.9222.3423.9310.91
217917-1791725.98025.98
318975-1897527.51427.51
415289-1528922.16922.17
517172-1717224.89924.90
614270-1427020.69120.69
10min146376-4637667.24570.176.1167.4970.436.12
251701-5170174.96675.25
350834-5083473.70974.01
443800-4380063.51063.76
549601-4960171.92172.20
648040-4804069.65869.89
15min160598-6059887.86788.440.6488.8689.480.69
261555-6155589.25490.38
360796-6079688.15489.28
460693-6069388.00588.96
561386-6138689.00990.09
660921-6092188.33589.34
20min163321-6332191.81591.461.0493.7993.490.98
262565-6256590.71992.83
362050-6205089.97292.08
463273-6327391.74693.68
563885-6388592.63394.70
663355-6335591.86493.85
30min165037-6503794.30392.870.9997.3095.920.98
264166-6416693.04096.16
364018-6401892.82695.93
463416-6341691.95394.90
564338-6433893.29096.38
663328-6332891.82594.83
45min164270-6427093.19193.291.0297.2397.371.03
264649-6464993.74197.90
364492-6449293.51397.65
464125-6412592.98196.95
565240-6524094.59898.73
663267-6326791.73795.76
60min164155-6415593.02491.571.1398.1096.681.10
263870-6387092.61197.81
362581-6258190.74295.92
462575-6257590.73395.74
563162-6316291.58596.77
662555-6255590.70495.75
90min163425-6342591.96691.930.5398.0798.060.42
262889-6288991.18997.41
363190-6319091.62597.81
463848-6384892.57998.59
563395-6339591.92298.12
663637-6363792.27398.33
120min162840-6284091.11891.260.6798.2598.420.62
262477-6247790.59197.83
363030-6303091.39398.59
463309-6330991.79898.84
563496-6349692.06999.29
662495-6249590.61797.70
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162164-6216490.13791.901.4898.28100.061.36
263437-6343791.983100.23
362509-6250990.63898.85
463365-6336591.87999.94
564525-6452593.561101.80
664279-6427993.204101.29
非奈利酮厄贝沙坦片项目信息
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%
114.906446726454666453766453696457876453340.07
214.906503036508756505890.07
单位质量响应值RSD%判断
43311.0143663.690.58数据可信
供试品溶液-2026051421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%
5min115501-155012.1392.146.912.142.146.83
216380-163802.2602.26
316339-163392.2542.25
413521-135211.8661.87
515324-153242.1142.11
616092-160922.2202.22
10min129021-290214.0044.083.014.034.103.07
230295-302954.1804.21
330539-305394.2144.24
428131-281313.8813.90
529538-295384.0754.10
629875-298754.1224.15
15min135322-353224.8734.891.224.944.961.21
236032-360324.9715.04
335824-358244.9435.01
434947-349474.8224.89
535016-350164.8314.90
635444-354444.8904.96
20min138910-389105.3695.340.765.495.460.76
238944-389445.3735.50
338216-382165.2735.40
438527-385275.3165.43
538722-387225.3435.47
638953-389535.3745.50
30min143167-431675.9565.891.476.146.081.49
243489-434896.0006.19
343190-431905.9596.14
442139-421395.8145.99
542331-423315.8416.02
642030-420305.7995.98
45min146084-460846.3586.401.256.616.641.22
247041-470416.4906.74
347035-470356.4906.74
445918-459186.3356.58
546364-463646.3976.64
645675-456756.3026.55
60min147571-475716.5646.560.796.886.880.84
248128-481286.6406.97
347820-478206.5986.92
447415-474156.5426.85
547077-470776.4956.81
647323-473236.5296.85
90min150264-502646.9357.052.317.337.442.23
253273-532737.3507.75
350889-508897.0217.42
451371-513717.0887.47
549965-499656.8947.28
650801-508017.0097.40
120min152238-522387.2077.210.537.687.680.42
252017-520177.1777.66
352382-523827.2277.70
452695-526957.2717.73
552178-521787.1997.67
651938-519387.1667.64
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151449-514497.0997.362.687.657.912.52
255830-558307.7038.26
353532-535327.3867.94
452850-528507.2927.84
553007-530077.3147.86
653375-533757.3647.91
非奈利酮厄贝沙坦片项目信息
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%
110.066205262074620286190662058620240.11
210.016288962854628720.04
单位质量响应值RSD%判断
6165.416280.921.32数据可信
供试品溶液-2026051421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%
5min120220-2022029.22125.4725.4529.2225.4725.46
218274-1827426.40926.41
320972-2097230.30830.31
419216-1921627.77127.77
58729-872912.61512.61
618321-1832126.47726.48
10min154663-5466378.99876.967.1679.3277.247.23
255407-5540780.07380.37
355870-5587080.74281.08
454365-5436578.56778.88
545647-4564765.96866.11
653555-5355577.39677.69
15min163804-6380492.20890.122.3993.4191.262.50
262961-6296190.99092.17
362905-6290590.90992.14
462602-6260290.47191.65
559481-5948185.96186.83
662409-6240990.19291.35
20min165467-6546794.61193.341.3996.8495.481.51
264420-6442093.09895.29
365356-6535694.45196.69
464866-6486693.74395.93
563008-6300891.05892.89
664404-6440493.07595.23
30min166379-6637995.92994.611.5099.2197.791.50
264069-6406992.59195.82
366486-6648696.08499.38
465876-6587695.20398.43
565414-6541494.53597.37
664578-6457893.32796.52
45min165654-6565494.88295.590.9099.2399.820.97
266128-6612895.56799.82
366566-6656696.200100.56
467094-6709496.963101.25
565521-6552194.68998.58
665902-6590295.24099.47
60min165199-6519994.22493.850.9299.6299.140.76
264123-6412392.66997.99
364663-6466393.45098.88
465071-6507194.03999.40
565875-6587595.201100.14
664726-6472693.54198.83
90min163891-6389192.33493.031.7098.7899.371.58
263598-6359891.91098.26
364191-6419192.76799.24
466345-6634595.880102.29
564835-6483593.69899.70
663397-6339791.62097.94
120min162272-6227289.99491.592.0197.4798.961.76
261838-6183889.36796.74
363422-6342291.65699.16
464160-6416092.723100.20
565343-6534394.432101.47
663242-6324291.39698.74
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163402-6340291.62791.321.47100.1099.701.46
262404-6240490.18598.55
364721-6472193.533102.05
463663-6366392.004100.51
562619-6261990.49698.59
662328-6232890.07598.43
非奈利酮厄贝沙坦片项目信息
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%
114.906466016462676468236464396461606464580.05
214.906553996557806555900.05
单位质量响应值RSD%判断
43386.4443999.331.00数据可信
供试品溶液-2026051421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%
5min118633-186332.5592.3116.672.562.3116.68
212656-126561.7381.74
319282-192822.6482.65
418896-188962.5952.59
514015-140151.9251.92
617508-175082.4042.40
10min131681-316814.3514.177.354.384.197.44
227489-274893.7753.79
332038-320384.4004.43
432404-324044.4504.48
527589-275893.7893.81
630773-307734.2264.25
15min138191-381915.2455.033.255.325.103.34
235195-351954.8334.89
337487-374875.1485.23
437005-370055.0825.16
535332-353324.8524.92
636705-367055.0415.11
20min141117-411175.6475.512.405.785.642.52
239289-392895.3965.51
341069-410695.6405.78
440508-405085.5635.70
538767-387675.3245.44
639884-398845.4775.61
30min145029-450296.1846.061.976.386.252.03
243333-433335.9516.13
345164-451646.2026.40
444423-444236.1016.30
543952-439526.0366.21
643055-430555.9136.10
45min147948-479486.5856.642.286.856.902.15
250390-503906.9207.16
348597-485976.6746.94
448243-482436.6256.89
547341-473416.5016.74
647544-475446.5296.79
60min150181-501816.8916.801.007.237.130.98
249119-491196.7457.06
349239-492396.7627.10
449550-495506.8057.14
550071-500716.8767.19
649046-490466.7357.06
90min152565-525657.2197.171.587.637.571.53
252198-521987.1687.56
351810-518107.1157.53
453373-533737.3307.74
552251-522517.1767.57
650894-508946.9897.39
120min152259-522597.1777.341.997.677.821.81
252420-524207.1997.67
353035-530357.2837.78
453610-536107.3627.86
554757-547577.5207.99
654560-545607.4937.97
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153877-538777.3997.351.757.987.921.67
254018-540187.4187.97
354816-548167.5288.10
453450-534507.3407.92
553000-530007.2787.83
652095-520957.1547.72
非奈利酮厄贝沙坦片项目信息
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%
110.066203162155619456217862128620870.16
210.016296062916629380.05
单位质量响应值RSD%判断
6171.676287.511.32数据可信
供试品溶液-2026051421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%
5min119660-1966028.38325.2639.8928.3825.2639.88
221032-2103230.36430.36
323984-2398434.62534.63
422865-2286533.01033.01
59410-941013.58513.59
68013-801311.56811.57
10min157215-5721582.60177.437.9882.9277.718.09
255621-5562180.29980.64
355408-5540879.99280.38
456900-5690082.14682.51
549804-4980471.90172.05
646836-4683667.61767.75
15min162800-6280090.66489.542.1691.9090.682.27
263522-6352291.70692.94
362089-6208989.63790.91
461927-6192789.40390.68
562212-6221289.81590.76
659575-5957586.00886.89
20min164999-6499993.83892.831.2396.0894.971.19
263588-6358891.80194.05
363438-6343891.58593.85
464679-6467993.37695.65
565290-6529094.25896.21
663815-6381592.12993.96
30min166869-6686996.53894.421.5899.8297.591.55
265188-6518894.11197.38
364865-6486593.64596.93
464541-6454193.17796.49
566483-6648395.98198.98
664464-6446493.06695.92
45min165519-6551994.58994.291.6298.9498.511.39
265113-6511394.00398.32
364688-6468893.38997.72
463746-6374692.02996.37
566080-6608095.39999.46
666734-6673496.343100.24
60min167179-6717996.98593.372.28102.3998.642.15
264117-6411792.56597.92
363742-6374292.02397.39
462911-6291190.82496.19
565025-6502593.87699.00
665088-6508893.96798.93
90min164031-6403192.44192.511.2398.9398.811.08
263506-6350691.68398.07
363076-6307691.06297.45
464281-6428192.80299.18
565380-6538094.388100.55
664180-6418092.65698.66
120min163898-6389892.24991.741.3899.7699.071.31
263197-6319791.23798.64
362458-6245890.17097.57
464176-6417692.650100.06
564752-6475293.482100.69
662802-6280290.66697.70
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164915-6491593.71791.952.47102.25100.302.25
262456-6245690.16798.59
363015-6301590.97499.38
462225-6222589.83398.27
566245-6624595.637103.89
663285-6328591.36499.41
非奈利酮厄贝沙坦片项目信息
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%
114.906472526472396463566470956468236469530.06
214.906584076583736583900.01
单位质量响应值RSD%判断
43419.6644187.251.24数据可信
供试品溶液-2026051421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%
5min111751-117511.6102.0829.401.612.0829.36
220569-205692.8182.82
320358-203582.7892.79
49624-96241.3181.32
514353-143531.9661.97
614491-144911.9851.99
10min127098-270983.7123.939.013.733.959.10
231980-319804.3814.41
331781-317814.3544.38
425883-258833.5463.56
527783-277833.8063.83
627388-273883.7523.77
15min134576-345764.7364.884.904.804.955.02
238190-381905.2315.31
337335-373355.1145.19
433692-336924.6154.67
535496-354964.8624.93
634682-346824.7514.81
20min139071-390715.3525.442.245.465.562.44
240571-405715.5585.70
341030-410305.6215.76
438997-389975.3425.45
539280-392805.3815.50
639146-391465.3625.48
30min145735-457356.2656.113.666.446.293.73
247130-471306.4566.66
344904-449046.1516.35
443255-432555.9256.09
543718-437185.9896.17
642879-428795.8746.05
45min146988-469886.4376.521.606.686.761.75
248328-483286.6206.89
348287-482876.6156.88
446533-465336.3746.60
547189-471896.4646.71
648054-480546.5836.82
60min151034-510346.9916.791.747.307.111.72
249519-495196.7837.13
349828-498286.8267.17
448597-485976.6576.96
548864-488646.6947.01
649346-493466.7607.07
90min151510-515107.0567.110.947.457.510.94
252075-520757.1347.55
352253-522537.1587.57
452518-525187.1947.57
551930-519307.1147.50
651196-511967.0137.40
120min154460-544607.4607.341.617.937.821.53
253640-536407.3487.85
353526-535267.3327.83
454468-544687.4617.92
553237-532377.2937.76
652160-521607.1457.61
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154632-546327.4847.421.588.047.981.50
253822-538227.3737.95
354260-542607.4338.01
453655-536557.3507.89
555467-554677.5988.15
652998-529987.2607.81
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