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%
113.813223632342323793233932348323290.17
213.863208132066320740.04
单位质量响应值RSD%判断
2340.982314.140.82数据可信
中间条件3月-供试品溶液-24032502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%
5min121721-2172158.92361.515.9058.9261.515.90
223996-2399665.09465.09
323309-2330963.23163.23
423035-2303562.48762.49
520440-2044055.44855.45
623542-2354263.86363.86
10min130279-3027982.13883.841.9382.4784.181.93
231332-3133284.99585.36
330742-3074283.39483.75
430721-3072183.33783.68
530485-3048582.69783.01
631882-3188286.48786.84
15min132228-3222887.42589.863.1088.2190.663.09
233291-3329190.30991.14
332949-3294989.38190.20
432743-3274388.82289.63
532463-3246388.06388.83
635074-3507495.14695.98
20min133701-3370191.42193.521.9992.6994.821.99
234368-3436893.23094.57
334030-3403092.31493.62
435120-3512095.27096.57
534148-3414892.63493.89
635476-3547696.23697.60
30min133436-3343690.70292.722.7892.4894.552.75
232917-3291789.29491.15
334542-3454293.70295.53
434571-3457193.78195.61
534015-3401592.27394.04
635604-3560496.58398.48
45min134861-3486194.56894.811.9896.8597.161.96
234504-3450493.59995.95
333920-3392092.01594.36
435298-3529895.75398.11
535212-3521295.52097.80
635913-3591397.42299.86
60min134077-3407792.44194.612.2795.2597.482.26
235003-3500394.95397.82
334407-3440793.33696.19
434588-3458893.82796.71
534836-3483694.50097.31
636349-3634998.604101.58
90min134465-3446593.49494.962.0696.8198.352.04
234185-3418592.73496.13
334789-3478994.37397.75
435215-3521595.52898.94
535146-3514695.34198.68
636230-3623098.282101.81
120min132917-3291789.29490.541.7693.1394.461.73
232443-3244388.00891.92
333543-3354390.99294.89
433860-3386091.85295.79
533548-3354891.00694.88
633954-3395492.10796.18
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134135-3413592.59893.812.5096.9398.242.44
234752-3475294.27298.67
335555-3555596.450100.85
433902-3390291.96696.41
533553-3355391.02095.39
635602-3560296.578101.16
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100607-202305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%
115.272098078209863720988202098699209999720988460.04
215.252088450208907720887640.03
单位质量响应值RSD%判断
137448.98136968.130.25数据可信
中间条件3月-供试品溶液-24032502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%
5min1511717-51171722.37722.967.9122.3822.967.91
2589560-58956025.78125.78
3541646-54164623.68623.69
4534029-53402923.35323.35
5464545-46454520.31420.31
6509228-50922822.26822.27
10min11006389-100638944.00945.422.7544.1345.542.77
21080837-108083747.26447.41
31057381-105738146.23846.37
41038962-103896245.43345.56
51008680-100868044.10944.22
61039418-103941845.45345.58
15min11292422-129242256.51758.171.9556.8958.551.96
21351882-135188259.11759.52
31338088-133808858.51358.90
41326973-132697358.02758.41
51310168-131016857.29357.65
61361719-136171959.54759.92
20min11490680-149068065.18667.231.7465.8767.941.74
21550919-155091967.82068.55
31542370-154237067.44768.16
41568257-156825768.57969.28
51526216-152621666.74067.42
61546719-154671967.63768.34
30min11721919-172191975.29877.231.4976.3478.311.49
21750816-175081676.56277.67
31792738-179273878.39579.48
41787077-178707778.14779.23
51767478-176747877.29078.34
61776955-177695577.70578.79
45min11910931-191093183.56385.411.6685.0386.921.64
21914394-191439483.71585.25
31967783-196778386.05087.57
41968537-196853786.08387.60
51969804-196980486.13887.61
61988137-198813786.94088.45
60min11990786-199078687.05590.141.8188.9892.121.80
22064457-206445790.27792.28
32069853-206985390.51392.51
42072515-207251590.62992.63
52068164-206816490.43992.39
62102723-210272391.95093.95
90min12110882-211088292.30794.511.3694.7296.991.34
22152635-215263594.13396.64
32161383-216138394.51697.02
42166680-216668094.74797.25
52197555-219755596.09798.55
62178537-217853795.26697.77
120min12073844-207384490.68893.661.9293.6196.671.89
22116466-211646692.55195.58
32189402-218940295.74198.77
42151434-215143494.08097.11
52167143-216714394.76797.76
62152753-215275394.13897.18
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12055423-205542389.88294.292.3593.3197.822.31
22191384-219138495.82799.37
32186244-218624495.60399.16
42167227-216722794.77198.32
52165502-216550294.69698.21
62171775-217177594.97098.53
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%
113.813227032242322693225632200322470.09
213.863225432197322260.13
单位质量响应值RSD%判断
2335.052325.110.31数据可信
中间条件3月-供试品溶液-24032502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%
5min117060-1706046.22857.3510.5746.2357.3410.57
221592-2159258.50858.51
323527-2352763.75163.75
421420-2142058.04258.04
520753-2075356.23556.23
622627-2262761.31361.31
10min126501-2650171.81081.686.5072.0782.006.51
230636-3063683.01583.34
332119-3211987.03387.39
429890-2989080.99381.32
530278-3027882.04482.36
631436-3143685.18285.52
15min127805-2780575.34385.906.1276.0086.686.13
232983-3298389.37490.16
332052-3205286.85287.69
432654-3265488.48389.26
532195-3219587.23988.01
632526-3252688.13688.95
20min130074-3007481.49290.214.9182.5791.464.94
234134-3413492.49393.78
334460-3446093.37694.70
433685-3368591.27692.54
533246-3324690.08791.34
634149-3414992.53493.84
30min130805-3080583.47291.525.0685.0093.275.08
234944-3494494.68896.48
335646-3564696.59098.43
433678-3367891.25793.03
533130-3313089.77391.53
634447-3444793.34195.16
45min131377-3137785.02293.694.9787.0195.954.99
235430-3543096.00598.33
336350-3635098.498100.87
434478-3447893.42595.70
534489-3448993.45595.71
635338-3533895.75698.09
60min131065-3106584.17793.565.3286.6496.345.33
236117-3611797.866100.72
336021-3602197.606100.53
434767-3476794.20897.01
534504-3450493.49696.27
634690-3469094.00096.87
90min132742-3274288.72195.114.3391.6598.414.36
236234-3623498.183101.58
336312-3631298.395101.86
434830-3483094.37997.70
534003-3400392.13895.43
636488-3648898.872102.26
120min130288-3028882.07289.764.9585.5093.594.96
234634-3463493.84897.79
334652-3465293.89797.91
432569-3256988.25292.10
532872-3287289.07392.88
633741-3374191.42895.37
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130727-3072783.26191.254.4287.1495.584.46
234763-3476394.19898.66
334397-3439793.20697.74
433874-3387491.78996.12
533846-3384691.71396.01
634450-3445093.34997.80
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100607-202305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%
115.272090615209120020901542091409209171820910190.04
215.252091627209257320921000.04
单位质量响应值RSD%判断
136936.41137186.890.13数据可信
中间条件3月-供试品溶液-24032502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%
5min1437923-43792319.17021.517.4819.1721.517.48
2508716-50871622.27022.27
3547985-54798523.98923.99
4495770-49577021.70321.70
5474375-47437520.76620.77
6483256-48325621.15521.15
10min1976467-97646742.74644.692.9042.8544.812.91
21032063-103206345.18045.30
31065409-106540946.63946.77
41011149-101114944.26444.38
51010033-101003344.21544.33
61030098-103009845.09445.21
15min11275960-127596055.85657.381.9056.2057.741.91
21312550-131255057.45857.83
31353109-135310959.23459.63
41305387-130538757.14557.51
51312569-131256957.45957.82
61304687-130468757.11457.48
20min11489408-148940865.20066.331.2565.8567.011.27
21535120-153512067.20167.90
31536853-153685367.27768.00
41501233-150123365.71866.40
51508605-150860566.04166.72
61519683-151968366.52667.21
30min11761279-176127977.10277.230.9178.1278.280.92
21766404-176640477.32678.39
31789615-178961578.34279.44
41740054-174005476.17377.22
51767290-176729077.36578.41
61760030-176003077.04778.10
45min11980301-198030186.69086.091.0388.1387.571.02
21975595-197559586.48487.98
31977323-197732386.55988.09
41928359-192835984.41685.89
51959391-195939185.77487.25
61978549-197854986.61388.10
60min12075556-207555690.85990.340.8092.7992.300.78
22052470-205247089.84991.83
32060968-206096890.22192.23
42053051-205305189.87491.82
52090915-209091591.53293.49
62048672-204867289.68391.65
90min12290299-2290299100.26096.332.12102.6998.792.05
22197207-219720796.18598.66
32179957-217995795.43097.94
42162375-216237594.66097.10
52171255-217125595.04997.51
62201563-220156396.37698.84
120min12191497-219149795.93593.841.4598.9296.841.40
22153322-215332294.26497.27
32124987-212498793.02396.07
42111473-211147392.43295.40
52162789-216278994.67897.67
62118228-211822892.72795.73
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12257596-225759698.82895.152.30102.3598.672.22
22166551-216655194.84398.38
32123209-212320992.94696.51
42128895-212889593.19496.67
52200569-220056996.33299.85
62163997-216399794.73198.24
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%
113.813221832234321583218632162321920.11
213.863219332184321880.02
单位质量响应值RSD%判断
2331.062322.370.27数据可信
中间条件3月-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%
5min18286-828622.48539.0020.9522.4939.0020.94
215674-1567442.53342.53
315127-1512741.04941.05
416337-1633744.33244.33
515408-1540841.81141.81
615404-1540441.80141.80
10min128402-2840277.07284.565.0077.2084.785.03
230273-3027382.14982.39
332016-3201686.87987.11
431832-3183286.38086.63
531845-3184586.41586.65
632600-3260088.46488.70
15min132922-3292289.33892.253.3589.8992.943.37
234225-3422592.87493.57
332346-3234687.77588.49
434347-3434793.20593.93
534808-3480894.45695.17
635327-3532795.86496.59
20min134333-3433393.16795.631.6094.2296.831.66
234879-3487994.64895.86
335219-3521995.57196.77
435489-3548996.30497.55
535635-3563596.70097.94
635886-3588697.38198.64
30min135000-3500094.97795.511.5696.5497.241.57
234593-3459393.87295.61
334818-3481894.48396.21
435910-3591097.44699.23
535028-3502895.05396.83
635837-3583797.24899.05
45min134358-3435893.23593.571.2295.3395.831.24
233835-3383591.81594.07
334300-3430093.07795.33
434553-3455393.76496.08
534832-3483294.52196.82
635014-3501495.01597.35
60min133616-3361691.22193.381.5393.8396.161.57
234366-3436693.25696.02
334054-3405492.41095.18
434541-3454193.73196.57
535051-3505195.11597.94
634844-3484494.55397.42
90min134624-3462493.95694.301.5097.0897.601.51
234168-3416892.71996.00
334133-3413392.62495.91
435081-3508195.19698.56
535196-3519695.50998.86
635310-3531095.81899.21
120min135063-3506395.14897.922.7398.79101.742.70
234695-3469594.14997.95
336822-3682299.921103.72
436283-3628398.458102.35
537144-37144100.795104.68
636491-3649199.023102.95
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136006-3600697.707100.932.11101.88105.302.11
236995-36995100.390104.71
337336-37336101.316105.67
436774-3677499.791104.23
538113-38113103.424107.87
637942-37942102.960107.43
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100607-202305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%
115.272094184209274420921582092970209208720928290.05
215.252096850209679420968220.01
单位质量响应值RSD%判断
137054.94137496.520.23数据可信
中间条件3月-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%
5min1190851-1908518.34214.1720.688.3414.1720.68
2371706-37170616.24616.25
3332190-33219014.51914.52
4365017-36501715.95415.95
5343337-34333715.00615.01
6342582-34258214.97314.97
10min1866673-86667337.88042.435.4237.9342.515.44
21004771-100477143.91644.01
3991281-99128143.32743.41
4989629-98962943.25443.34
5969412-96941242.37142.45
61002807-100280743.83043.91
15min11274331-127433155.69857.992.4355.9558.302.46
21371179-137117959.93160.27
31315908-131590857.51557.84
41333998-133399858.30658.64
51321989-132198957.78158.10
61342680-134268058.68659.01
20min11516623-151662366.28867.501.3666.8568.131.39
21573217-157321768.76269.43
31530999-153099966.91767.56
41559694-155969468.17168.82
51533271-153327167.01667.66
61551853-155185367.82868.48
30min11768170-176817077.28378.081.3878.2279.101.40
21819844-181984479.54180.59
31762352-176235277.02878.04
41801556-180155678.74279.77
51764135-176413577.10678.12
61802863-180286378.79979.83
45min11883433-188343382.32184.251.2983.6885.701.32
21953150-195315085.36886.86
31927482-192748284.24685.69
41918194-191819483.84085.31
51940531-194053184.81686.26
61942541-194254184.90486.37
60min11984611-198461186.74388.741.5488.5690.661.56
22073316-207331690.62092.59
32008842-200884287.80289.71
42051191-205119189.65391.59
52031758-203175888.80490.72
62032225-203222588.82490.76
90min12116852-211685292.52392.281.4394.8394.681.41
22132147-213214793.19195.66
32054385-205438589.79392.19
42105263-210526392.01694.45
52120744-212074492.69395.10
62137703-213770393.43495.87
120min12283282-228328299.79799.990.95102.61102.910.93
22289222-2289222100.057103.04
32289616-2289616100.074102.97
42254296-225429698.530101.47
52288197-2288197100.012102.93
62322171-2322171101.497104.45
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12261120-226112098.829100.701.73102.20104.181.71
22370228-2370228103.597107.14
32278435-227843599.585103.04
42279381-227938199.627103.12
52319927-2319927101.399104.87
62315060-2315060101.186104.70
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%
113.813223932245322293223132170322230.10
213.863224632228322370.04
单位质量响应值RSD%判断
2333.312325.900.23数据可信
中间条件3月-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%
5min116721-1672145.31849.548.9445.3249.548.94
219887-1988753.89953.90
318197-1819749.31849.32
417043-1704346.19146.19
520646-2064655.95655.96
617186-1718646.57846.58
10min132718-3271888.67487.062.2888.9387.332.29
231968-3196886.64186.94
331362-3136284.99985.27
431664-3166485.81786.07
533287-3328790.21690.53
631733-3173386.00486.26
15min135626-3562696.55595.141.8197.3095.901.79
234268-3426892.87593.66
335624-3562496.55097.30
434374-3437493.16293.90
535576-3557696.42097.23
635147-3514795.25795.99
20min136975-36975100.21197.562.10101.4998.842.07
235236-3523695.49896.80
336118-3611897.88999.17
435086-3508695.09296.34
535891-3589197.27498.62
636665-3666599.371100.64
30min137082-37082100.50198.083.36102.3499.913.31
234372-3437293.15794.98
336867-3686799.919101.75
435207-3520795.42097.20
536054-3605497.71599.60
637548-37548101.764103.58
45min135694-3569496.74099.432.2799.14101.812.24
236735-3673599.561101.91
337024-37024100.344102.73
435676-3567696.69199.00
537547-37547101.762104.19
637448-37448101.493103.88
60min135010-3501094.88694.352.2497.8297.282.20
234626-3462693.84596.74
334381-3438193.18196.12
433925-3392591.94594.79
534724-3472494.11197.11
636214-3621498.149101.10
90min135412-3541295.97594.952.9999.4498.402.92
233862-3386291.77495.19
335081-3508195.07898.53
434005-3400592.16295.52
535111-3511195.16098.68
636728-3672899.542103.03
120min137326-37326101.163100.311.76105.16104.291.73
236916-36916100.052103.98
338022-38022103.049107.03
436061-3606197.734101.60
537014-37014100.317104.37
636728-3672899.542103.59
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136470-3647098.84398.491.64103.40103.031.61
235862-3586297.195101.68
337258-37258100.978105.54
435794-3579497.011101.42
536765-3676599.642104.25
635890-3589097.271101.87
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100607-202305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%
115.272091855209052120910542091092209033420909710.03
215.252091131209199820915640.03
单位质量响应值RSD%判断
136933.27137151.740.12数据可信
中间条件3月-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%
5min1359848-35984815.75517.479.2915.7517.479.30
2452144-45214419.79619.80
3400247-40024717.52417.52
4369985-36998516.19916.20
5433897-43389718.99719.00
6377899-37789916.54516.55
10min1994545-99454543.54344.872.1043.6344.972.12
21045258-104525845.76445.87
31028482-102848245.02945.13
41007714-100771444.12044.21
51050707-105070746.00246.11
61022859-102285944.78344.87
15min11345609-134560958.91459.761.2359.2460.111.23
21349803-134980359.09759.46
31377558-137755860.31260.66
41355815-135581559.36059.70
51374318-137431860.17060.53
61386549-138654960.70661.05
20min11594194-159419469.79769.391.2270.4570.071.20
21563675-156367568.46169.15
31570377-157037768.75469.44
41577240-157724069.05569.72
51587163-158716369.48970.18
61617142-161714270.80271.48
30min11843080-184308080.69479.901.7981.7480.961.77
21794228-179422878.55579.63
31823254-182325479.82680.89
41808774-180877479.19280.24
51799374-179937478.78079.86
61880959-188095982.35283.42
45min11952344-195234485.47889.732.5886.9791.242.55
22057176-205717690.06791.58
32048456-204845689.68691.19
42050179-205017989.76191.25
52081356-208135691.12692.65
62107924-210792492.28993.82
60min12053164-205316489.89289.261.2291.8691.261.20
22034384-203438489.07091.08
32007576-200757687.89689.90
42029978-202997888.87790.86
52027502-202750288.76890.79
62079621-207962191.05093.09
90min12118481-211848192.75193.493.1395.2295.993.07
22071379-207137990.68993.19
32101062-210106291.98994.48
42119725-211972592.80695.29
52137571-213757193.58796.11
62263396-226339699.096101.64
120min12249980-224998098.50999.741.55101.49102.761.48
22303247-2303247100.841103.85
32306930-2306930101.002104.01
42302424-2302424100.805103.80
52285061-2285061100.045103.08
62220456-222045697.216100.31
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12254903-225490398.72498.601.95102.25102.171.87
22235435-223543597.872101.44
32267063-226706399.257102.82
42276610-227661099.675103.23
52303170-2303170100.838104.43
62175241-217524195.23798.87
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-08-23 13:38:15 完成)
生成报告数据部分下载报告(谢超君 于 2024-08-23 13:38:42 完成)
Current page cost:94 ms