厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053271432875328013286733002328520.33
214.153284232848328450.02
单位质量响应值RSD%判断
2338.222321.200.52数据可信
供试品溶液-2024042411批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114916-1491640.42538.914.6140.4238.914.60
213358-1335836.20236.20
314879-1487940.32440.32
414726-1472639.91039.91
514561-1456139.46339.46
613707-1370737.14837.15
10min124977-2497767.69266.841.6767.9267.061.67
224667-2466766.85167.05
325306-2530668.58368.81
424428-2442866.20466.43
524232-2423265.67365.89
624364-2436466.03066.24
15min126783-2678372.58671.831.5673.1972.421.56
226561-2656171.98472.56
327034-2703473.26673.87
426433-2643371.63872.23
526388-2638871.51672.10
625819-2581969.97470.55
20min128020-2802075.93976.570.8376.9477.550.83
228109-2810976.18077.15
328543-2854377.35678.37
428552-2855277.38078.37
528139-2813976.26177.24
628146-2814676.28077.24
30min130780-3078083.41983.901.1884.8485.311.15
231085-3108584.24585.64
330312-3031282.15083.59
431353-3135384.97286.39
531112-3111284.31885.72
631099-3109984.28385.67
45min133012-3301289.46890.251.6591.3692.131.63
233028-3302889.51191.37
334399-3439993.22795.12
433245-3324590.09991.99
532958-3295889.32191.19
633168-3316889.89091.74
60min133306-3330690.26491.030.4792.6593.410.47
233697-3369791.32493.69
333737-3373791.43393.85
433677-3367791.27093.66
533579-3357991.00493.37
633539-3353990.89693.25
90min132889-3288989.13491.021.3292.0293.901.29
233812-3381291.63694.50
334157-3415792.57195.49
433795-3379591.59094.49
533511-3351190.82093.70
633340-3334090.35793.21
120min1-0.0000.00-3.383.390.85
2-0.0003.38
3-0.0003.44
4-0.0003.41
5-0.0003.38
6-0.0003.36
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1-0.0000.00-3.383.390.85
2-0.0003.38
3-0.0003.44
4-0.0003.41
5-0.0003.38
6-0.0003.36
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.222135017213610521341182140084213601321362670.11
215.252129565213679321331790.24
单位质量响应值RSD%判断
140359.20139880.590.25数据可信
供试品溶液-2024042411批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188574-885743.7933.588.053.793.578.12
278334-783343.3543.35
389416-894163.8293.83
488254-882543.7793.78
583627-836273.5813.58
672743-727433.1153.11
10min1152204-1522046.5176.443.636.546.463.61
2146346-1463466.2676.29
3155552-1555526.6616.68
4154996-1549966.6376.66
5151756-1517566.4986.52
6141494-1414946.0596.08
15min1188014-1880148.0517.822.768.117.872.79
2178789-1787897.6567.71
3185868-1858687.9598.02
4184889-1848897.9177.97
5183442-1834427.8557.91
6174476-1744767.4717.52
20min1204332-2043328.7508.671.798.858.771.82
2199782-1997828.5558.65
3204443-2044438.7548.86
4207183-2071838.8728.97
5202229-2022298.6608.76
6197101-1971018.4408.53
30min1228271-2282719.7759.721.609.939.871.63
2222878-2228789.5449.69
3228383-2283839.7799.93
4231412-2314129.90910.06
5228607-2286079.7899.94
6222166-2221669.5139.65
45min1246559-24655910.55810.601.9710.7610.801.96
2243110-24311010.41010.61
3255156-25515610.92611.13
4250780-25078010.73910.94
5247486-24748610.59710.80
6242113-24211310.36710.56
60min1256533-25653310.98510.901.3211.2511.161.35
2250099-25009910.70910.96
3254435-25443510.89511.16
4259082-25908211.09411.36
5256214-25621410.97111.23
6251511-25151110.77011.02
90min1258517-25851711.07011.041.0511.3911.361.07
2254968-25496810.91811.23
3258479-25847911.06811.39
4261403-26140311.19311.52
5259632-25963211.11811.44
6254450-25445010.89611.21
120min1-0.0000.00-0.390.382.58
2-0.0000.37
3-0.0000.39
4-0.0000.39
5-0.0000.38
6-0.0000.37
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1-0.0000.00-0.390.382.58
2-0.0000.37
3-0.0000.39
4-0.0000.39
5-0.0000.38
6-0.0000.37
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053280933031328183296732832328910.31
214.153288832690327890.43
单位质量响应值RSD%判断
2341.002317.240.73数据可信
供试品溶液-2024042411批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128663-2866377.70271.0012.9477.7071.0012.94
230593-3059382.93482.93
326425-2642571.63571.63
421826-2182659.16859.17
522698-2269861.53261.53
626942-2694273.03673.04
10min135524-3552496.30199.241.7296.7399.631.71
237148-37148100.704101.16
336517-3651798.99399.39
436409-3640998.70099.03
536788-3678899.728100.07
637254-37254100.991101.40
15min135792-3579297.02898.971.0797.9999.921.06
236620-3662099.272100.29
336391-3639198.65299.60
436580-3658099.164100.04
536800-3680099.760100.66
636867-3686799.942100.91
20min135560-3556096.39998.251.5997.9099.741.58
236651-3665199.356100.93
335683-3568396.73298.23
436406-3640698.692100.12
536093-3609397.84499.29
637054-37054100.449101.97
30min135686-3568696.74098.221.0998.78100.261.09
236463-3646398.847100.97
335830-3583097.13199.16
436260-3626098.296100.27
536472-3647298.871100.86
636688-3668899.457101.54
45min135276-3527695.62997.421.3198.21100.011.30
236242-3624298.248100.92
335475-3547596.16898.74
435916-3591697.36499.89
536352-3635298.546101.09
636367-3636798.587101.22
60min134889-3488994.58096.741.5297.6999.871.51
236064-3606497.765100.98
335507-3550796.25599.36
435356-3535695.84698.91
535925-3592597.388100.48
636379-3637998.619101.80
90min134572-3457293.72095.981.4097.3699.651.40
235733-3573396.868100.63
335419-3541996.01799.66
435369-3536995.88199.48
535291-3529195.67099.30
636047-3604797.719101.45
120min1-0.0000.00-4.164.201.63
2-0.0004.30
3-0.0004.18
4-0.0004.13
5-0.0004.16
6-0.0004.27
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1-0.0000.00-4.164.201.63
2-0.0004.30
3-0.0004.18
4-0.0004.13
5-0.0004.16
6-0.0004.27
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.222128375212359221280042123081211964321245390.18
215.252115609212755021215800.40
单位质量响应值RSD%判断
139588.63139120.000.24数据可信
供试品溶液-2024042411批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1214253-2142539.2258.769.799.228.769.77
2233993-23399310.07510.07
3199774-1997748.6018.60
4179762-1797627.7407.74
5185096-1850967.9697.97
6207976-2079768.9558.95
10min1540100-54010023.25423.002.0223.3123.052.03
2548021-54802123.59623.65
3532839-53283922.94222.99
4517601-51760122.28622.33
5527023-52702322.69122.74
6539265-53926523.21923.27
15min1732385-73238531.53331.430.4031.7131.600.38
2727000-72700031.30231.49
3727190-72719031.31031.49
4730387-73038731.44731.61
5734151-73415131.60931.78
6728533-72853331.36831.55
20min1863296-86329637.17037.241.0237.5337.591.00
2857304-85730436.91237.27
3852153-85215336.69037.04
4872852-87285237.58137.92
5871741-87174137.53437.88
6872189-87218937.55337.91
30min11047484-104748445.10045.311.1945.6645.871.17
21037111-103711144.65445.22
31042003-104200344.86445.42
41069228-106922846.03746.59
51063248-106324845.77946.33
61055717-105571745.45546.02
45min11213821-121382152.26252.971.8753.0753.781.83
21208753-120875352.04452.86
31211099-121109952.14552.95
41253395-125339553.96654.77
51261513-126151354.31655.12
61232669-123266953.07453.89
60min11312339-131233956.50457.491.8557.6158.601.82
21306624-130662456.25857.36
31324826-132482657.04158.13
41354941-135494158.33859.44
51368181-136818158.90860.02
61345165-134516557.91759.03
90min11396551-139655160.13061.181.9461.5562.601.90
21382253-138225359.51460.93
31421217-142121761.19262.60
41456337-145633762.70464.13
51439400-143940061.97563.41
61430301-143030161.58363.01
120min1-0.0000.00-1.751.760.86
2-0.0001.75
3-0.0001.75
4-0.0001.78
5-0.0001.78
6-0.0001.77
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1-0.0000.00-1.751.760.86
2-0.0001.75
3-0.0001.75
4-0.0001.78
5-0.0001.78
6-0.0001.77
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053193031786317843166131789317900.30
214.153165131474315620.40
单位质量响应值RSD%判断
2262.632230.531.02数据可信
供试品溶液-2024042411批-左氨氯地平-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%
5min115051-1505142.30245.458.2142.3045.458.21
217752-1775249.89349.89
316117-1611745.29845.30
416894-1689447.48147.48
517000-1700047.77947.78
614211-1421139.94139.94
10min130585-3058585.96185.401.9586.2085.651.96
230601-3060186.00586.28
329879-2987983.97684.23
430763-3076386.46186.72
531025-3102587.19787.46
629464-2946482.81083.03
15min133510-3351094.18193.541.4694.8994.271.45
232882-3288292.41693.17
332731-3273191.99292.71
433464-3346494.05294.80
534037-3403795.66396.41
633066-3306692.93393.62
20min134336-3433696.50395.081.5197.7496.321.51
233628-3362894.51395.78
333542-3354294.27195.50
433833-3383395.08996.36
534490-3449096.93698.22
633141-3314193.14494.34
30min134717-3471797.57497.932.5399.3599.702.49
233628-3362894.51396.31
335135-3513598.749100.50
434589-3458997.21499.01
536324-36324102.090103.91
634664-3466497.42599.14
45min133706-3370694.73296.503.2597.0598.823.19
232508-3250891.36593.68
334718-3471897.57799.88
435740-35740100.449102.78
534932-3493298.178100.56
634410-3441096.71198.97
60min136065-36065101.36299.391.80104.20102.251.78
234981-3498198.316101.14
334503-3450396.97299.82
435588-35588100.022102.91
536045-36045101.306104.24
635005-3500598.383101.18
90min133805-3380595.01095.902.0798.4199.302.05
233331-3333193.67897.05
333826-3382695.06998.45
435097-3509798.642102.09
534899-3489998.085101.58
633770-3377094.91298.25
120min134861-3486197.97895.251.46101.9199.191.41
233628-3362894.51398.41
333734-3373494.81198.72
433866-3386695.18299.18
533767-3376794.90498.94
633492-3349294.13198.00
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134283-3428396.35495.861.88100.83100.331.86
233533-3353394.24698.66
333560-3356094.32298.76
434456-3445696.840101.37
535139-3513998.760103.33
633673-3367394.63999.03
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.222120467212657021199602121975212959621237140.20
215.252122841211914621209940.13
单位质量响应值RSD%判断
139534.43139081.570.23数据可信
供试品溶液-2024042411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%
5min1442237-44223719.04718.986.6619.0518.986.67
2460727-46072719.84419.84
3463819-46381919.97719.98
4444633-44463319.15019.15
5448752-44875219.32819.33
6383372-38337216.51216.51
10min11115825-111582548.05947.582.0848.1647.682.09
21100277-110027747.38947.50
31121537-112153748.30548.42
41107373-110737347.69547.80
51121896-112189648.32048.43
61061221-106122145.70745.80
15min11456222-145622262.72061.921.1163.0962.291.12
21417021-141702161.03161.40
31444610-144461062.22062.60
41432099-143209961.68162.05
51452768-145276862.57162.95
61423778-142377861.32261.67
20min11645716-164571670.88170.490.5671.6071.210.56
21631705-163170570.27870.99
31639157-163915770.59971.32
41624482-162448269.96770.68
51647636-164763670.96471.69
61631754-163175470.28070.97
30min11885955-188595581.22881.372.0682.3482.482.04
21832619-183261978.93180.03
31919071-191907182.65583.77
41856791-185679179.97281.07
51934547-193454783.32184.44
61907051-190705182.13783.21
45min12067064-206706489.02989.041.1190.6090.601.07
22109575-210957590.86092.40
32057599-205759988.62190.20
42055234-205523488.51990.07
52043852-204385288.02989.61
62070406-207040689.17390.71
60min12199643-219964394.73993.011.6196.8095.061.57
22119963-211996391.30793.35
32149444-214944492.57794.65
42122829-212282991.43193.47
52169948-216994893.46095.53
62194714-219471494.52796.56
90min12192655-219265594.43893.841.1397.0396.421.12
22135622-213562291.98294.54
32191708-219170894.39796.98
42162652-216265293.14695.69
52195568-219556894.56397.15
62195075-219507594.54297.10
120min12233308-223330896.18994.361.4399.3097.451.40
22159265-215926593.00096.06
32212741-221274195.30398.41
42162524-216252493.14096.20
52168429-216842993.39596.51
62208404-220840495.11698.20
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12229862-222986296.04095.162.1999.6998.782.14
22160008-216000893.03296.61
32204355-220435594.94298.58
42157669-215766992.93196.51
52287219-228721998.511102.14
62217614-221761495.51399.12
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053186731958320243193631815319200.26
214.153166031614316370.11
单位质量响应值RSD%判断
2271.892235.831.14数据可信
供试品溶液-2024042411批-左氨氯地平-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%
5min118289-1828951.23748.4512.7951.2448.4512.79
215468-1546843.33443.33
315115-1511542.34542.34
420528-2052857.50957.51
518742-1874252.50652.51
615619-1561943.75743.76
10min131417-3141788.01585.892.1588.3086.162.16
231080-3108087.07187.31
329974-2997483.97284.21
431231-3123187.49487.81
529969-2996983.95884.25
630287-3028784.84985.09
15min133821-3382194.75093.610.8295.5294.360.82
233690-3369094.38395.11
333181-3318192.95793.66
433279-3327993.23194.04
533217-3321793.05893.82
633294-3329493.27393.99
20min134349-3434996.22995.411.6997.5396.671.70
234397-3439796.36397.61
332953-3295392.31893.54
434537-3453796.75698.08
534076-3407695.46496.74
634018-3401895.30296.53
30min135003-3500398.06196.781.1399.9098.571.13
235021-3502198.11299.90
334136-3413695.63297.36
434517-3451796.70098.56
534176-3417695.74497.55
634412-3441296.40598.17
45min135095-3509598.31996.941.33100.7099.271.32
235123-3512398.397100.73
334116-3411695.57697.84
434407-3440796.39198.79
534110-3411095.55997.90
634756-3475697.36999.67
60min134955-3495597.92797.711.22100.85100.581.17
235582-3558299.683102.56
334913-3491397.809100.60
434428-3442896.45099.38
534446-3444696.50199.37
634932-3493297.862100.70
90min135019-3501998.10696.341.38101.5899.751.36
234808-3480897.515100.94
333742-3374294.52897.87
434082-3408295.48198.95
534218-3421895.86299.27
634456-3445696.52999.91
120min134310-3431096.12094.421.53100.1398.371.51
234324-3432496.159100.13
333128-3312892.80896.67
433702-3370294.41698.42
533455-3345593.72497.66
633295-3329593.27697.19
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133842-3384294.80994.270.5999.3698.740.61
233944-3394495.09499.60
333457-3345793.73098.11
433539-3353993.96098.48
533531-3353193.93798.39
633583-3358394.08398.52
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.222118931212028121296962121745212744821236200.23
215.252121842211708221194620.16
单位质量响应值RSD%判断
139528.25138981.110.28数据可信
供试品溶液-2024042411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%
5min1516015-51601522.23320.0812.6222.2320.0812.62
2423811-42381118.26118.26
3413348-41334817.81017.81
4540923-54092323.30723.31
5496770-49677021.40421.40
6405378-40537817.46617.47
10min11151428-115142849.61148.602.1949.7348.712.21
21127448-112744848.57848.68
31107815-110781547.73247.83
41148490-114849049.48549.61
51142927-114292749.24549.36
61090029-109002946.96647.06
15min11472608-147260863.45062.491.0763.8562.881.07
21461363-146136362.96563.34
31454590-145459062.67363.04
41443841-144384162.21062.61
51439097-143909762.00662.40
61430809-143080961.64962.01
20min11639050-163905070.62170.770.7971.3771.500.77
21649622-164962271.07771.80
31664429-166442971.71572.43
41640249-164024970.67371.42
51630385-163038570.24870.98
61631320-163132070.28870.99
30min11897682-189768281.76581.080.7782.9182.200.77
21887761-188776181.33782.45
31897375-189737581.75282.86
41874154-187415480.75181.89
51868825-186882580.52181.65
61864906-186490680.35381.44
45min12045303-204530388.12588.250.6889.7289.820.66
22061829-206182988.83790.41
32064105-206410588.93590.50
42037612-203761287.79489.39
52028438-202843887.39988.97
62052132-205213288.42089.96
60min12116077-211607791.17591.701.2793.2693.771.24
22166339-216633993.34095.40
32118745-211874591.29093.35
42146748-214674892.49694.58
52088591-208859189.99092.05
62133647-213364791.93293.96
90min12178303-217830393.85693.241.0196.4595.810.99
22180793-218079393.96396.54
32182939-218293994.05696.62
42135261-213526192.00194.59
52137810-213781092.11194.67
62168338-216833893.42795.97
120min12177506-217750693.82293.300.9596.9496.390.92
22190473-219047394.38097.48
32158353-215835392.99696.08
42149037-214903792.59595.70
52137281-213728192.08895.16
62179943-217994393.92796.98
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12147468-214746892.52793.121.1696.1696.731.12
22194199-219419994.54198.17
32179490-217949093.90797.51
42133216-213321691.91395.53
52138288-213828892.13295.72
62174643-217464393.69897.28
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