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%
113.573168431697315993163831451316140.32
213.593152631687316060.37
单位质量响应值RSD%判断
2329.702325.680.13数据可信
中间条件6月-供试品溶液-24032001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%
5min117150-1715046.51951.087.4646.5251.087.46
221249-2124957.63757.64
318088-1808849.06349.06
419234-1923452.17252.17
519074-1907451.73851.74
618190-1819049.34049.34
10min128727-2872777.92182.283.6578.1882.563.66
231764-3176486.15986.48
329874-2987481.03381.31
430710-3071083.30083.59
531206-3120684.64684.93
629713-2971380.59680.87
15min132488-3248888.12392.202.5288.8192.942.53
234331-3433193.12293.92
333682-3368291.36292.08
434176-3417692.70293.45
535029-3502995.01595.77
634243-3424392.88393.61
20min134175-3417592.69994.502.2393.8895.762.24
235331-3533195.83497.15
334644-3464493.97195.20
435273-3527395.67796.94
535832-3583297.19398.48
633787-3378791.64692.88
30min132992-3299289.49092.583.6191.1994.363.57
233333-3333390.41592.26
334579-3457993.79595.55
434323-3432393.10094.90
536292-3629298.441100.27
633273-3327390.25292.00
45min134031-3403192.30894.691.6294.5096.981.63
235791-3579197.08299.43
334743-3474394.24096.51
434955-3495594.81597.13
534986-3498694.89997.27
634938-3493894.76897.02
60min135710-3571096.86397.991.2199.57100.811.17
235545-3554596.41599.31
336455-3645598.883101.68
436043-3604397.766100.61
536367-3636798.645101.54
636637-3663799.377102.15
90min133668-3366891.32497.583.6294.57100.943.57
236972-36972100.286103.71
335507-3550796.31299.66
436686-3668699.510102.90
537160-37160100.796104.24
635855-3585597.256100.58
120min135306-3530695.76798.641.9099.52102.551.91
236980-36980100.307104.29
336115-3611597.961101.84
436167-3616798.102102.04
537244-37244101.023105.03
636387-3638798.699102.57
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136311-3631198.49398.961.59102.78103.411.59
236847-3684799.947104.49
336347-3634798.590103.02
436004-3600497.660102.14
537459-37459101.607106.18
635922-3592297.438101.85
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%
115.152045731204661020461992047494204645520464980.04
215.202044057204581120449340.07
单位质量响应值RSD%判断
135082.38134535.130.29数据可信
中间条件6月-供试品溶液-24032001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%
5min1460950-46095020.51621.645.2520.5221.645.25
2533511-53351123.74523.75
3479252-47925221.33021.33
4493544-49354421.96621.97
5476968-47696821.22921.23
6472463-47246321.02821.03
10min1974973-97497343.39445.212.6843.5145.332.68
21051972-105197246.82146.95
3997097-99709744.37844.50
41020689-102068945.42845.55
51034497-103449746.04346.16
61015849-101584945.21345.33
15min11272370-127237056.63058.502.0456.9958.882.05
21347721-134772159.98460.38
31294991-129499157.63758.00
41320017-132001758.75159.13
51330211-133021159.20559.58
61321545-132154558.81959.19
20min11501123-150112366.81267.131.4767.4867.831.47
21538608-153860868.48069.21
31494756-149475666.52867.21
41523213-152321367.79568.50
51515424-151542467.44868.15
61476683-147668365.72466.42
30min11666730-166673074.18275.542.2375.2276.602.19
21669277-166927774.29675.40
31760830-176083078.37079.43
41702560-170256075.77776.85
51716939-171693976.41777.49
61666653-166665374.17975.24
45min11852029-185202982.43083.901.5483.8885.381.53
21934107-193410786.08387.60
31879010-187901083.63085.12
41879571-187957183.65585.15
51864694-186469482.99384.50
61900346-190034684.58086.05
60min11993770-199377088.73889.951.6490.6591.911.61
22022898-202289890.03492.03
32036287-203628790.63092.59
42045850-204585091.05693.02
51970352-197035287.69689.66
62057070-205707091.55593.50
90min12068302-206830292.05595.051.8394.4697.511.81
22131357-213135794.86297.36
32123815-212381594.52696.98
42176393-217639396.86699.34
52170302-217030296.59599.05
62143755-214375595.41497.86
120min12184973-218497397.24897.701.04100.16100.681.02
22226993-222699399.118102.14
32159990-215999096.13699.12
42189412-218941297.446100.45
52206748-220674898.217101.20
62202214-220221498.015101.00
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12201425-220142597.98098.420.78101.44101.940.75
22185286-218528697.262100.84
32229565-222956599.233102.75
42205109-220510998.144101.69
52228050-222805099.165102.70
62217857-221785798.712102.24
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%
113.573149331416316103133131435314570.33
213.593145531466314600.03
单位质量响应值RSD%判断
2318.132314.940.10数据可信
中间条件6月-供试品溶液-24032501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%
5min122752-2275262.01160.146.2062.0160.146.20
223909-2390965.16565.16
321056-2105657.38957.39
423001-2300162.69062.69
521380-2138058.27258.27
620302-2030255.33455.33
10min131213-3121385.07286.593.4485.4286.923.44
233545-3354591.42891.79
330708-3070883.69684.01
431083-3108384.71885.07
532644-3264488.97289.30
631418-3141885.63185.94
15min136494-3649499.46693.643.64100.2894.453.62
234930-3493095.20396.07
333612-3361291.61192.39
433156-3315690.36891.19
534531-3453194.11694.93
633416-3341691.07791.86
20min133966-3396692.57694.534.0593.9595.874.02
236854-36854100.447101.85
333088-3308890.18391.48
433889-3388992.36693.69
535858-3585897.73299.07
634440-3444093.86895.16
30min134951-3495195.26097.303.6397.1499.163.61
238103-38103103.851105.81
335256-3525696.09297.89
434501-3450194.03495.87
536143-3614398.509100.39
635252-3525296.08197.89
45min133873-3387392.32295.192.9894.7497.592.96
236081-3608198.340100.87
334351-3435193.62595.95
434056-3405692.82195.18
536294-3629498.921101.35
634895-3489595.10897.45
60min134591-3459194.27997.503.1797.21100.433.14
237456-37456102.088105.17
335589-3558996.99999.85
434675-3467594.50897.38
536720-36720100.082103.06
635603-3560397.03799.91
90min133996-3399692.65795.103.3896.1198.573.36
236319-3631998.989102.64
333974-3397492.59795.98
433946-3394692.52195.92
536418-3641899.259102.80
634693-3469394.55797.97
120min134723-3472394.63998.884.2498.60102.884.17
238076-38076103.778107.97
335297-3529796.203100.10
435153-3515395.81199.72
538252-38252104.257108.35
636167-3616798.575102.51
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136054-3605498.267100.733.41102.76105.283.37
238167-38167104.026108.80
336506-3650699.499103.93
435494-3549496.740101.18
538756-38756105.631110.30
636769-36769100.215104.70
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%
115.152036954203753120376572038034203813620376620.03
215.202036339203692920366340.03
单位质量响应值RSD%判断
134499.14133989.080.27数据可信
中间条件6月-供试品溶液-24032501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%
5min1565227-56522725.26323.318.7225.2623.318.72
2558865-55886524.97824.98
3503993-50399322.52622.53
4560137-56013725.03525.04
5467780-46778020.90720.91
6473242-47324221.15121.15
10min11059019-105901947.33346.292.5547.4746.422.57
21063867-106386747.54947.69
31029765-102976546.02546.15
41050242-105024246.94047.08
51000020-100002044.69644.81
61010714-101071445.17445.29
15min11343490-134349060.04758.532.1460.4558.922.16
21322225-132222559.09759.50
31303117-130311758.24358.62
41332539-133253959.55859.96
51273264-127326456.90857.27
61283034-128303457.34557.71
20min11500259-150025967.05466.591.3067.7967.301.32
21506879-150687967.35068.08
31477827-147782766.05166.76
41512799-151279967.61468.35
51465757-146575765.51266.19
61475668-147566865.95566.64
30min11766324-176632478.94677.351.2880.0678.431.30
21734732-173473277.53478.64
31722786-172278677.00078.07
41737869-173786977.67478.78
51699647-169964775.96577.01
61721802-172180276.95678.01
45min11917345-191734585.69585.280.7787.2486.790.75
21882844-188284484.15385.69
31912116-191211685.46286.96
41917805-191780585.71687.25
51919706-191970685.80187.27
61898903-189890384.87186.35
60min11993152-199315289.08489.760.7891.1191.750.74
21994769-199476989.15691.16
32031207-203120790.78592.76
42008115-200811589.75291.77
52000411-200041189.40891.35
62022363-202236390.38992.34
90min12073387-207338792.67093.830.9995.1996.310.96
22102033-210203393.95096.45
32123832-212383294.92497.40
42121094-212109494.80297.31
52094966-209496693.63496.07
62080644-208064492.99495.45
120min12143314-214331495.79597.250.9098.83100.260.87
22171869-217186997.071100.09
32185974-218597497.702100.71
42200931-220093198.370101.41
52183881-218388197.608100.57
62169423-216942396.96299.93
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12158026-215802696.45397.991.25100.02101.531.19
22159628-215962896.524100.08
32224288-222428899.414102.96
42199074-219907498.287101.87
52205954-220595498.595102.10
62207060-220706098.644102.15
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%
113.573149631481313613127631441314110.30
213.593157531470315220.24
单位质量响应值RSD%判断
2314.742319.500.15数据可信
中间条件6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%
5min119469-1946953.05055.444.4853.0555.444.48
220387-2038755.55255.55
319911-1991154.25554.25
421256-2125657.91957.92
521603-2160358.86558.86
619461-1946153.02853.03
10min130087-3008781.98383.891.8882.2884.201.89
231654-3165486.25286.56
330759-3075983.81484.12
431148-3114884.87485.20
530830-3083084.00784.33
630244-3024482.41082.70
15min133663-3366391.72793.371.7692.4894.151.73
234168-3416893.10393.89
334735-3473594.64895.41
434067-3406792.82793.62
533752-3375291.96992.76
635221-3522195.97296.72
20min135557-3555796.88895.552.9998.1596.842.95
236422-3642299.245100.55
333680-3368091.77393.07
434057-3405792.80094.11
534940-3494095.20696.51
635734-3573497.37098.66
30min133988-3398892.61294.162.0194.4195.981.98
233929-3392992.45194.31
334212-3421293.22395.03
434419-3441993.78795.61
535116-3511695.68697.52
635671-3567197.19899.02
45min135241-3524196.02695.950.7698.3498.300.74
234996-3499695.35997.73
335137-3513795.74398.06
434911-3491195.12797.47
535362-3536296.35698.72
635640-3564097.11499.48
60min135243-3524396.03296.941.2498.8899.821.21
235805-3580597.563100.46
335617-3561797.05199.90
435673-3567397.204100.08
534929-3492995.17698.08
636185-3618598.599101.50
90min134426-3442693.80695.692.0397.1999.111.98
234608-3460894.30297.74
335471-3547196.653100.04
434684-3468494.50997.92
535189-3518995.88599.31
636336-3633699.010102.46
120min135144-3514495.76296.411.0899.66100.361.04
234807-3480794.84498.81
335687-3568797.242101.17
435793-3579397.531101.47
535242-3524296.02999.99
635618-3561897.054101.06
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135776-3577697.48497.731.45101.92102.221.40
236658-3665899.888104.38
335912-3591297.855102.32
435481-3548196.680101.16
535189-3518995.885100.38
636184-3618498.596103.14
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%
115.152039302203832920381692037941203672720380940.05
215.202034112203341020337610.03
单位质量响应值RSD%判断
134527.66133800.070.39数据可信
中间条件6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%
5min1533805-53380523.87323.484.6823.8723.484.68
2513931-51393122.98422.98
3511221-51122122.86322.86
4555973-55597324.86424.86
5545387-54538724.39124.39
6489747-48974721.90221.90
10min11032894-103289446.19346.461.2446.3346.591.24
21047295-104729546.83746.96
31029516-102951646.04246.17
41056957-105695747.26947.41
51044322-104432246.70446.84
61022487-102248745.72745.85
15min11322206-132220659.13159.210.7959.5259.600.80
21322339-132233959.13759.53
31322265-132226559.13459.52
41342193-134219360.02560.43
51325243-132524359.26759.66
61309827-130982758.57858.95
20min11532484-153248468.53567.570.9969.2568.290.98
21498146-149814667.00067.72
31496702-149670266.93567.65
41502955-150295567.21567.95
51525482-152548268.22268.95
61509847-150984767.52368.22
30min11707924-170792476.38177.621.0677.4878.721.05
21725441-172544177.16578.25
31751582-175158278.33479.42
41746297-174629778.09779.21
51755136-175513678.49379.60
61727782-172778277.26978.35
45min11904846-190484685.18885.860.8286.7187.390.82
21926325-192632586.14987.67
31922784-192278485.99087.51
41939131-193913186.72188.26
51928810-192881086.26087.80
61897544-189754484.86286.37
60min12015921-201592190.15690.360.5992.1592.360.58
22026597-202659790.63392.63
32038098-203809891.14793.14
42009449-200944989.86691.89
52025806-202580690.59892.62
62006895-200689589.75291.73
90min12085108-208510893.25095.361.2195.7597.871.18
22141581-214158195.77598.27
32134371-213437195.45397.96
42133685-213368595.42297.94
52163001-216300196.73399.26
62136692-213669295.55798.03
120min12132210-213221095.35696.491.5898.3799.521.55
22165132-216513296.82999.86
32191525-219152598.009101.04
42181511-218151197.561100.61
52172925-217292597.177100.24
62101746-210174693.99497.00
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12161649-216164996.67397.711.02100.22101.281.00
22199483-219948398.365101.93
32188527-218852797.875101.45
42187131-218713197.812101.41
52215178-221517899.067102.67
62157522-215752296.488100.02
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%
113.573134831428314333135431276313680.21
213.593155431661316080.24
单位质量响应值RSD%判断
2311.572325.830.44数据可信
中间条件6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%
5min120112-2011254.76546.4013.1854.7746.4013.18
218555-1855550.52650.53
316172-1617244.03744.04
417958-1795848.90048.90
513983-1398338.07638.08
615456-1545642.08742.09
10min131733-3173386.41084.492.2386.7184.752.23
229866-2986681.32681.61
330958-3095884.29984.54
431388-3138885.47085.74
530674-3067483.52683.74
631557-3155785.93086.16
15min134551-3455194.08392.092.1394.8792.822.12
232653-3265388.91589.65
333247-3324790.53291.25
434293-3429393.38094.13
534095-3409592.84193.52
634065-3406592.76093.47
20min135570-3557096.85895.821.2598.1697.061.25
234621-3462194.27495.50
335660-3566097.10398.32
435059-3505995.46696.73
534765-3476594.66695.86
635458-3545896.55397.78
30min135876-3587697.69196.401.1099.5498.171.09
234820-3482094.81596.57
335663-3566397.11198.87
435143-3514395.69597.49
535598-3559896.93498.65
635313-3531396.15897.92
45min134531-3453194.02994.092.6196.4296.402.55
232796-3279689.30491.58
334711-3471194.51996.81
434911-3491195.06397.39
535242-3524295.96598.22
635127-3512795.65197.95
60min137248-37248101.42796.182.86104.3499.022.82
234629-3462994.29597.07
334493-3449393.92596.75
435116-3511695.62198.48
535509-3550996.69299.48
634938-3493895.13797.97
90min136043-3604398.14696.872.23101.62100.242.19
234385-3438593.63196.93
335255-3525596.00099.34
435558-3555896.825100.21
535467-3546796.57799.90
636749-36749100.068103.43
120min134098-3409892.84994.532.2496.8798.432.15
233477-3347791.15894.98
335539-3553996.773100.65
434854-3485494.90898.83
535108-3510895.60099.46
635212-3521295.88399.80
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136023-3602398.09197.371.19102.63101.801.17
235433-3543396.485100.81
335442-3544296.509100.92
436485-3648599.349103.80
535699-3569997.209101.60
635466-3546696.575101.02
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%
115.152039342203872020391992038798203874720389610.02
215.202039305203958120394430.01
单位质量响应值RSD%判断
134584.88134173.880.22数据可信
中间条件6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%
5min1460463-46046320.56017.6811.3920.5617.6811.39
2395827-39582717.67417.67
3404584-40458418.06518.06
4415700-41570018.56118.56
5324459-32445914.48714.49
6375165-37516516.75116.75
10min11012087-101208745.18944.461.9245.3044.561.94
2986175-98617544.03344.13
31014530-101453045.29945.40
4994953-99495344.42444.53
5963308-96330843.01243.09
61003548-100354844.80844.90
15min11317936-131793658.84658.491.3559.2158.831.35
21286029-128602957.42157.76
31315855-131585558.75359.10
41325661-132566159.19159.54
51289504-128950457.57657.90
61324413-132441359.13559.48
20min11495562-149556266.77767.081.4167.4767.751.40
21499452-149945266.95067.61
31537573-153757368.65269.33
41491025-149102566.57467.25
51476550-147655065.92866.57
61513736-151373667.58868.26
30min11708157-170815776.26977.121.0177.3378.160.99
21723999-172399976.97678.01
31745880-174588077.95379.01
41705419-170541976.14777.20
51737640-173764077.58578.59
61741558-174155877.76078.81
45min11848111-184811182.51885.532.1684.0087.002.12
21898250-189825084.75786.22
31962212-196221287.61289.11
41907263-190726385.15986.63
51926199-192619986.00487.44
61951354-195135487.12888.61
60min11966791-196679187.81789.491.7889.7691.441.76
21998658-199865889.24091.17
32069310-206931092.39494.37
41979034-197903488.36390.31
52002204-200220489.39891.31
62009998-200999889.74691.71
90min12043193-204319391.22892.971.5093.6695.411.49
22074063-207406392.60795.03
32131365-213136595.16597.66
42057371-205737191.86194.30
52091760-209176093.39795.81
62094871-209487193.53696.00
120min12016044-201604490.01694.252.7392.9697.222.68
22101508-210150893.83296.77
32181359-218135997.397100.42
42106012-210601294.03396.98
52100804-210080493.80196.73
62160036-216003696.44599.43
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12076556-207655692.71895.152.0196.1698.641.97
22077903-207790392.77896.24
32164207-216420796.631100.19
42146657-214665795.84899.32
52148779-214877995.94399.39
62172360-217236096.995100.51
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