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%
114.023301533138331413299633169330920.25
214.073288032938329090.13
单位质量响应值RSD%判断
2360.342338.950.65数据可信
长期3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%
5min121218-2121857.01763.238.6357.0263.238.63
224658-2465866.26166.26
325148-2514867.57767.58
421218-2121857.01757.02
525928-2592869.67369.67
623018-2301861.85461.85
10min131078-3107883.51286.813.7383.8387.163.74
232817-3281788.18588.55
334216-3421691.94592.32
431015-3101583.34383.66
532615-3261587.64288.03
632082-3208286.21086.55
15min133968-3396891.27892.122.2092.0692.962.22
234428-3442892.51493.37
335366-3536695.03595.92
433101-3310188.94889.73
534642-3464293.08993.96
634190-3419091.87592.70
20min134308-3430892.19293.873.0493.4895.213.05
235588-3558895.63197.00
335568-3556895.57896.99
433433-3343389.84191.11
536293-3629397.52698.92
634400-3440092.43993.77
30min134834-3483493.60596.403.2295.4198.263.22
235773-3577396.12998.03
336436-3643697.91099.86
434551-3455192.84594.62
537742-37742101.420103.35
635903-3590396.47898.32
45min134462-3446292.60695.392.0194.9397.802.02
235177-3517794.52796.96
335598-3559895.65898.15
435386-3538695.08997.38
536629-3662998.429100.93
635746-3574696.05698.44
60min135573-3557395.59196.201.5498.4399.141.57
236530-3653098.163101.13
336340-3634097.652100.67
435153-3515394.46397.28
535877-3587796.40899.45
635333-3533394.94697.86
90min134031-3403191.44895.893.1494.8199.353.10
235148-3514894.44997.96
335990-3599096.712100.27
435534-3553495.48698.83
537428-37428100.576104.15
635969-3596996.655100.10
120min134844-3484493.63296.261.9397.51100.261.91
235586-3558695.62699.66
335466-3546695.30499.40
435996-3599696.728100.60
536869-3686999.074103.21
636171-3617197.198101.18
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135808-3580896.22397.001.32100.62101.531.32
235615-3561595.704100.27
335828-3582896.276100.91
436052-3605296.878101.29
536918-3691899.205103.89
636356-3635697.695102.22
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%
115.372118945211870021185662116215211775321180360.06
215.322111583211340321124930.07
单位质量响应值RSD%判断
137803.25137891.190.05数据可信
长期3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%
5min1478590-47859020.83124.2412.0420.8324.2412.04
2620721-62072127.01827.02
3601225-60122526.16926.17
4479960-47996020.89120.89
5620730-62073027.01827.02
6540164-54016423.51123.51
10min11002197-100219743.62246.934.8843.7447.064.89
21121937-112193748.83448.98
31124768-112476848.95749.10
41025382-102538244.63144.75
51111849-111184948.39548.54
61082547-108254747.11947.25
15min11332298-133229857.99059.382.4758.3559.782.50
21396989-139698960.80661.23
31372949-137294959.76060.18
41318667-131866757.39757.76
51401638-140163861.00861.43
61363258-136325859.33859.73
20min11515025-151502565.94467.811.9166.6268.541.94
21589180-158918069.17169.93
31556443-155644367.74668.50
41537832-153783266.93667.62
51592271-159227169.30670.06
61556866-155686667.76568.49
30min11751390-175139076.23278.232.1277.2879.342.14
21832616-183261679.76780.91
31792089-179208978.00379.13
41758397-175839776.53777.59
51844957-184495780.30481.45
61804636-180463678.54979.65
45min11927363-192736383.89185.321.7985.3686.861.80
21946654-194665484.73186.32
31942227-194222784.53886.10
41936455-193645584.28785.77
52012308-201230887.58989.18
61995843-199584386.87288.41
60min12046574-204657489.08088.831.1691.0290.841.16
22054371-205437189.41991.48
32009342-200934287.46089.49
42013019-201301987.62089.57
52056449-205644989.51091.59
62064832-206483289.87591.89
90min12088813-208881390.91993.322.4993.3595.822.47
22120329-212032992.29094.84
32125030-212503092.49595.01
42113721-211372192.00394.44
52231874-223187497.14699.72
62184147-218414795.06897.59
120min12143043-214304393.27994.792.2196.2297.812.19
22172978-217297894.58297.65
32114123-211412392.02095.05
42170313-217031394.46697.41
52241691-224169197.573100.69
62224189-222418996.81199.86
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12168468-216846894.38695.251.6197.8498.791.61
22184524-218452495.08598.68
32152832-215283293.70597.24
42161757-216175794.09497.56
52239462-223946297.476101.13
62222318-222231896.730100.31
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%
114.023295632931327583291132911328930.24
214.073286232864328630.01
单位质量响应值RSD%判断
2346.152335.680.32数据可信
长期3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%
5min124316-2431665.58462.969.4565.5862.969.46
223119-2311962.35662.36
324358-2435865.69865.70
423164-2316462.47762.48
525785-2578569.54669.55
619306-1930652.07152.07
10min132146-3214686.70387.453.6087.0787.803.61
232046-3204686.43386.78
332562-3256287.82588.19
433467-3346790.26690.61
533785-3378591.12491.51
630526-3052682.33482.62
15min134827-3482793.93494.142.3894.7894.982.41
234938-3493894.23495.06
334966-3496694.30995.16
435248-3524895.07095.92
535997-3599797.09097.98
633452-3345290.22690.97
20min135294-3529495.19495.692.4896.5697.052.49
236257-3625797.79199.14
334833-3483393.95095.33
436394-3639498.16199.54
535931-3593196.91298.34
634154-3415492.11993.37
30min137306-37306100.62099.622.30102.52101.512.28
235789-3578996.52998.42
336270-3627097.82699.72
438002-38002102.498104.42
537610-37610101.440103.41
636632-3663298.803100.56
45min136262-3626297.80598.231.84100.26100.671.85
235782-3578296.51098.94
336405-3640598.190100.63
437521-37521101.200103.69
536787-3678799.221101.75
635751-3575196.42698.73
60min135760-3576096.45197.641.3699.45100.631.38
236319-3631997.958100.92
336494-3649498.430101.42
436798-3679899.250102.30
536357-3635798.061101.15
635472-3547295.67498.52
90min136307-3630797.92698.761.49101.46102.291.51
236442-3644298.290101.80
337253-37253100.477104.01
437102-37102100.070103.68
536803-3680399.264102.89
635796-3579696.54899.92
120min136554-3655498.59298.171.72102.67102.251.73
235618-3561896.068100.12
336635-3663598.811102.90
436608-3660898.738102.90
537261-37261100.499104.68
635705-3570596.302100.21
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135683-3568396.24397.011.57100.87101.631.58
235168-3516894.85499.44
336128-3612897.443102.08
436461-3646198.341103.05
536682-3668298.937103.68
635672-3567296.213100.66
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%
115.372112940211114321119122114320211322221127070.06
215.322110650211026221104560.02
单位质量响应值RSD%判断
137456.54137758.220.16数据可信
长期3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%
5min1604555-60455526.36024.5110.4526.3624.5010.45
2567897-56789724.76224.76
3581336-58133625.34825.35
4561342-56134224.47624.48
5608322-60832226.52426.52
6448644-44864419.56219.56
10min11084066-108406647.26847.433.5947.4147.563.60
21106519-110651948.24748.38
31083268-108326847.23347.37
41112271-111227148.49848.63
51125250-112525049.06449.21
61015482-101548244.27744.39
15min11388242-138824260.53160.312.4760.9460.712.49
21406476-140647661.32661.73
31378380-137838060.10160.50
41410365-141036561.49561.90
51398307-139830760.96961.39
61317905-131790557.46457.82
20min11568300-156830068.38268.312.0369.1369.052.05
21595590-159559069.57170.32
31547963-154796367.49568.23
41600387-160038769.78170.53
51573066-157306668.58969.35
61515031-151503166.05966.73
30min11829115-182911579.75479.261.8380.8880.381.82
21812484-181248479.02980.16
31768388-176838877.10678.22
41871130-187113081.58682.72
51817347-181734779.24180.38
61808562-180856278.85879.90
45min11957440-195744085.34985.821.3186.9287.381.32
21987158-198715886.64588.22
31938389-193838984.51886.06
42008951-200895187.59589.18
51965964-196596485.72187.30
61951546-195154685.09286.57
60min12028172-202817288.43389.511.4490.4891.541.43
22091174-209117491.18093.23
32025090-202509088.29990.31
42088200-208820091.05093.13
52038839-203883988.89890.95
62045343-204534389.18291.13
90min12154875-215487593.95893.910.7196.4996.440.71
22165252-216525294.41096.97
32136018-213601893.13595.64
42173759-217375994.78197.36
52136608-213660893.16195.71
62155982-215598294.00696.45
120min12181563-218156395.12194.541.1198.1897.591.10
22177110-217711094.92798.01
32121164-212116492.48895.51
42182098-218209895.14598.25
52182587-218258795.16698.23
62164356-216435694.37197.34
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12150426-215042693.76494.761.2697.3598.341.24
22192856-219285695.61499.23
32138873-213887393.26096.79
42209959-220995996.359100.00
52161756-216175694.25897.85
62185541-218554195.29598.79
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%
114.023298332940328863291932939329330.11
214.073271932671326950.11
单位质量响应值RSD%判断
2349.002323.740.77数据可信
长期3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%
5min124229-2422965.47862.244.0965.4862.244.09
222066-2206659.63359.63
321991-2199159.43059.43
423865-2386564.49564.49
523385-2338563.19763.20
622646-2264661.20061.20
10min131214-3121484.35584.872.0084.7285.222.00
230922-3092283.56683.90
330936-3093683.60483.93
432562-3256287.99888.36
531146-3114684.17184.52
631646-3164685.52385.86
15min133327-3332790.06590.222.0390.9091.042.00
232661-3266188.26689.06
333782-3378291.29592.09
432505-3250587.84488.69
534101-3410192.15792.98
633937-3393791.71492.53
20min133847-3384791.47192.511.2592.8093.821.25
233729-3372991.15292.44
334047-3404792.01193.31
434704-3470493.78795.12
534724-3472493.84195.17
634331-3433192.77994.10
30min135014-3501494.62494.992.2196.4796.822.19
233873-3387391.54193.33
335293-3529395.37897.19
436232-3623297.91699.77
534971-3497194.50896.36
635512-3551295.97097.81
45min134801-3480194.04996.011.9196.4298.371.89
234842-3484294.16096.46
335662-3566296.37698.72
436642-3664299.024101.42
535707-3570796.49798.87
635513-3551395.97398.35
60min134898-3489894.31196.712.7397.2099.612.68
234780-3478093.99296.82
336414-3641498.408101.29
437362-37362100.970103.92
535742-3574296.59299.51
635520-3552095.99298.90
90min134821-3482194.10396.902.3597.52100.332.31
235169-3516995.04398.39
335468-3546895.85199.28
437042-37042100.105103.62
536320-3632098.154101.60
636315-3631598.140101.58
120min133711-3371191.10395.033.3095.0499.003.22
234566-3456693.41497.29
334744-3474493.89597.85
437014-37014100.029104.10
535009-3500994.61198.61
635946-3594697.143101.13
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135908-3590897.04097.482.29101.48101.982.25
235186-3518695.08999.48
335464-3546495.841100.32
437107-37107100.281104.90
535694-3569496.462100.98
637066-37066100.170104.69
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%
115.372110691211171821115272111345211259021115740.04
215.322099287210481921020530.19
单位质量响应值RSD%判断
137382.82137209.730.09数据可信
长期3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%
5min1608500-60850026.59224.195.3326.5924.195.32
2543542-54354223.75323.75
3535359-53535923.39623.40
4543695-54369523.76023.76
5562690-56269024.59024.59
6526950-52695023.02823.03
10min11079272-107927247.16546.881.8547.3147.011.85
21075884-107588447.01747.15
31042341-104234145.55145.68
41071271-107127146.81646.95
51102812-110281248.19448.33
61064575-106457546.52346.65
15min11342697-134269758.67758.971.4759.0959.371.47
21333501-133350158.27658.67
31355219-135521959.22559.61
41329918-132991858.11958.51
51384738-138473860.51560.92
61350481-135048159.01859.40
20min11535185-153518567.08967.081.0967.8367.811.08
21548654-154865467.67868.39
31530242-153024266.87367.59
41506982-150698265.85766.57
51554515-155451567.93468.67
61534926-153492667.07867.79
30min11776605-177660577.64077.730.8678.7578.830.85
21759588-175958876.89677.99
31793975-179397578.39979.48
41762029-176202977.00378.08
51791197-179119778.27779.40
61789224-178922478.19179.28
45min11928287-192828784.26885.450.9685.8186.980.95
21963832-196383285.82287.34
31951362-195136285.27786.80
41966264-196626485.92887.44
51980341-198034186.54388.10
61941453-194145384.84486.37
60min12037339-203733989.03490.221.0991.0492.231.06
22052812-205281289.71091.71
32089810-208981091.32793.32
42083045-208304591.03193.02
52079844-207984490.89292.93
62044718-204471889.35691.35
90min12147283-214728393.83994.790.8896.3497.290.86
22174007-217400795.00797.50
32148541-214854193.89496.39
42197916-219791696.05198.54
52169654-216965494.81697.35
62177216-217721695.14797.64
120min12154051-215405194.13495.070.8597.1698.100.82
22198454-219845496.07599.10
32178487-217848795.20298.22
42193351-219335195.85298.88
52156122-215612294.22597.29
62172143-217214394.92597.94
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12231041-223104197.49996.181.33101.0599.741.27
22184177-218417795.45199.01
32179402-217940295.24298.79
42173421-217342194.98198.54
52194292-219429295.89399.48
62243029-224302998.023101.57
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%
114.023270232610326403239932744326190.41
214.073268132667326740.04
单位质量响应值RSD%判断
2326.602322.250.14数据可信
长期3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%
5min117336-1733647.09058.8110.3347.0958.8210.33
223601-2360164.10764.11
321422-2142258.18858.19
422809-2280961.95661.96
522640-2264061.49761.50
622106-2210660.04660.05
10min129301-2930179.59082.852.7579.8583.182.77
231619-3161985.88686.24
330033-3003381.57881.90
430965-3096584.11084.45
530977-3097784.14284.48
630122-3012281.82082.15
15min132376-3237687.94288.672.1088.6589.462.11
233596-3359691.25692.09
331815-3181586.41987.20
433192-3319290.15990.97
532834-3283489.18790.00
632058-3205887.07987.87
20min133212-3321290.21390.221.9591.4191.501.96
233891-3389192.05893.40
332113-3211387.22888.48
433677-3367791.47692.79
533521-3352191.05392.36
632873-3287389.29290.56
30min134931-3493194.88391.992.5296.5893.782.48
234586-3458693.94595.80
332789-3278989.06490.81
434281-3428193.11794.94
533418-3341890.77392.58
633198-3319890.17591.94
45min134924-3492494.86492.673.0497.0894.963.00
234630-3463094.06596.44
332960-3296089.52991.76
435494-3549496.41298.75
533470-3347090.91493.23
633220-3322090.23592.50
60min135209-3520995.63892.912.0798.3995.722.03
234845-3484594.64997.55
333508-3350891.01793.75
434327-3432793.24296.12
533750-3375091.67594.49
633600-3360091.26794.04
90min136309-3630998.62696.932.43101.90100.252.40
236759-3675999.848103.27
334616-3461694.02797.27
436249-3624998.463101.85
535188-3518895.58198.91
634989-3498995.04098.32
120min137094-37094100.75896.483.06104.58100.342.97
236695-3669599.674103.65
334984-3498495.02798.79
435034-3503495.16299.10
534694-3469494.23998.10
634606-3460694.00097.81
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136190-3619098.30295.602.14102.69100.002.10
235864-3586497.417101.95
334945-3494594.92199.21
435382-3538296.108100.57
534316-3431693.21297.60
634473-3447393.63997.97
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%
115.372092378209199820924532091447210519920946950.29
215.322103801210348621036440.02
单位质量响应值RSD%判断
136284.65137313.580.54数据可信
长期3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%
5min1414520-41452018.18123.3711.7718.1823.3711.77
2599923-59992326.31326.31
3540115-54011523.69023.69
4548601-54860124.06224.06
5561924-56192424.64624.65
6531516-53151623.31323.31
10min1957031-95703141.97645.974.5442.0846.104.55
21092732-109273247.92848.07
31049964-104996446.05246.18
41067407-106740746.81746.95
51073102-107310247.06747.20
61047939-104793945.96346.09
15min11276606-127660655.99358.382.3056.3358.772.33
21354383-135438359.40459.82
31319448-131944857.87258.26
41350677-135067759.24159.64
51356426-135642659.49459.89
61329188-132918858.29958.68
20min11461452-146145264.10066.491.9764.7567.211.99
21537861-153786167.45168.19
31509066-150906666.18866.90
41532637-153263767.22267.95
51541487-154148767.61068.34
61513813-151381366.39767.11
30min11718025-171802575.35476.571.1076.3577.651.13
21760417-176041777.21378.33
31736977-173697776.18577.26
41766630-176663077.48578.58
51759147-175914777.15778.26
61733670-173367076.04077.12
45min11896421-189642183.17884.761.9384.6086.271.93
21939641-193964185.07486.62
31894493-189449383.09484.59
41991764-199176487.36088.89
51953525-195352585.68387.22
61919687-191968784.19985.70
60min12032121-203212189.13088.740.4891.0190.720.47
22017204-201720488.47690.49
32021329-202132988.65790.62
42029941-202994189.03491.05
52031287-203128789.09391.10
62007665-200766588.05790.03
90min12169378-216937895.15095.330.8097.5397.800.81
22183772-218377295.78198.29
32159907-215990794.73597.19
42186749-218674995.91298.42
52192455-219245596.16298.67
62148054-214805494.21596.67
120min12177284-217728495.49796.582.1598.4099.582.10
22284891-2284891100.217103.26
32227939-222793997.719100.70
42153376-215337694.44897.49
52185586-218558695.86198.90
62182966-218296695.74698.73
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12234509-223450998.00796.711.25101.44100.251.17
22202224-220222496.591100.19
32242892-224289298.374101.90
42179113-217911395.57799.14
52189273-218927396.02399.59
62182172-218217295.71199.22
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