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%
114.023273132860327773254832663327160.37
214.073247532351324130.28
单位质量响应值RSD%判断
2333.522303.700.91数据可信
加速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%
5min122901-2290162.36465.984.3362.3665.974.33
223419-2341963.77563.77
324229-2422965.98165.98
425874-2587470.46070.46
524825-2482567.60467.60
624115-2411565.67065.67
10min131538-3153885.88586.231.2686.2386.601.27
231788-3178886.56586.92
331533-3153385.87186.24
432153-3215387.55987.95
531967-3196787.05387.43
631020-3102084.47484.84
15min134570-3457094.14191.372.0494.9692.222.02
232989-3298989.83690.67
333821-3382192.10292.95
433896-3389692.30693.18
533366-3336690.86391.72
632682-3268289.00089.83
20min134346-3434693.53192.712.7394.8894.072.71
232700-3270089.04990.38
334686-3468694.45795.81
434798-3479894.76296.15
534704-3470494.50695.87
633042-3304289.98091.31
30min134744-3474494.61594.871.8196.4896.741.80
235036-3503695.41097.24
335004-3500495.32397.20
435769-3576997.40699.32
534631-3463194.30796.20
633841-3384192.15693.98
45min135223-3522395.92094.792.6698.3197.182.62
233328-3332890.75993.12
334691-3469194.47196.88
436140-3614098.417100.88
534491-3449193.92696.34
634966-3496695.22097.56
60min135956-3595697.91697.312.44100.84100.232.41
235608-3560896.96899.83
336242-3624298.695101.63
436928-36928100.563103.57
535278-3527896.06999.00
634384-3438493.63596.50
90min135411-3541196.43297.111.4999.90100.581.50
235388-3538896.36999.77
335736-3573697.317100.80
436657-3665799.825103.39
535624-3562497.012100.48
635151-3515195.72499.11
120min135550-3555096.81096.302.03100.81100.302.01
234802-3480294.77398.71
334795-3479594.75498.78
436549-3654999.531103.65
535722-3572297.278101.29
634757-3475794.65198.57
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136465-3646599.30298.832.00103.84103.371.98
236242-3624298.695103.16
335723-3572397.281101.83
437506-37506102.137106.81
536417-3641799.171103.72
635407-3540796.421100.87
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%
115.372095532209489820947952092581209095520937520.10
215.322080903207898120799420.07
单位质量响应值RSD%判断
136223.29135766.450.24数据可信
加速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%
5min1471237-47123720.79121.852.7920.7921.852.80
2496447-49644721.90321.90
3490078-49007821.62221.62
4511493-51149322.56722.57
5499022-49902222.01722.02
6503557-50355722.21722.22
10min1937878-93787841.37943.132.8741.4943.252.87
21000943-100094344.16144.28
3973349-97334942.94443.06
4951996-95199642.00242.13
5993772-99377243.84543.97
61006893-100689344.42444.55
15min11224074-122407454.00555.582.3754.3555.942.36
21265032-126503255.81256.18
31273330-127333056.17956.54
41222307-122230753.92754.29
51281506-128150656.53956.91
61292491-129249157.02457.39
20min11383328-138332861.03263.623.2161.6864.293.19
21439776-143977663.52264.20
31447574-144757463.86664.54
41397022-139702261.63662.29
51500624-150062466.20766.89
61483348-148334865.44466.13
30min11634016-163401672.09274.342.3873.0875.372.38
21699831-169983174.99676.03
31689611-168961174.54575.57
41638859-163885972.30673.31
51721443-172144375.94977.00
61726161-172616176.15777.21
45min11845995-184599581.44483.982.9382.8385.422.92
21915946-191594684.53085.98
31894593-189459383.58885.03
41846360-184636081.46082.86
51923545-192354584.86686.34
61994551-199455187.99889.47
60min11969395-196939586.88989.061.9088.7390.961.90
22057339-205733990.76992.68
32028970-202897089.51791.42
41973209-197320987.05788.91
52031851-203185189.64491.59
62050785-205078590.47992.44
90min12093154-209315492.34995.022.8794.6797.422.85
22216001-221600197.769100.19
32157007-215700795.16697.57
42065871-206587191.14593.48
52183659-218365996.34298.78
62207001-220700197.37299.84
120min12129135-212913593.93695.742.6596.7798.662.64
22208884-220888497.455100.42
32134657-213465794.18097.11
42094859-209485992.42495.27
52233294-223329498.532101.51
62219013-221901397.902100.91
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12191924-219192496.70697.782.02100.06101.242.03
22250863-225086399.307102.81
32172637-217263795.85699.31
42164815-216481595.51098.87
52253498-225349899.423102.94
62264159-226415999.893103.44
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%
114.023254732494325503257032597325520.12
214.073254032445324920.21
单位质量响应值RSD%判断
2321.832309.310.39数据可信
加速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%
5min123685-2368564.58264.503.7764.5864.503.77
224405-2440566.54566.54
324982-2498268.11868.12
422892-2289262.41962.42
522709-2270961.92061.92
623249-2324963.39363.39
10min132458-3245888.50385.602.0088.8685.962.00
231485-3148585.85086.22
331239-3123985.17985.56
431606-3160686.18086.53
530693-3069383.69084.03
630880-3088084.20084.55
15min133789-3378992.13291.092.0592.9891.922.05
233617-3361791.66392.51
333290-3329090.77291.62
434262-3426293.42294.25
532230-3223087.88188.69
633250-3325090.66391.48
20min134699-3469994.61493.230.9695.9894.570.97
234225-3422593.32194.68
334210-3421093.28094.64
434300-3430093.52694.87
533714-3371491.92893.22
634005-3400592.72194.04
30min135547-3554796.92694.461.8698.8196.311.82
233740-3374091.99993.87
334448-3444893.92995.80
435016-3501695.47897.34
534887-3488795.12696.93
634210-3421093.28095.12
45min135337-3533796.35396.251.1398.7898.631.10
234749-3474994.75097.14
335056-3505695.58797.98
435898-3589897.883100.28
535541-3554196.90999.25
635214-3521496.01898.37
60min136222-3622298.76696.751.55101.7399.661.53
235575-3557597.00299.91
335378-3537896.46599.39
435897-3589797.880100.82
535137-3513795.80898.68
634682-3468294.56797.46
90min135506-3550696.81496.680.83100.32100.130.80
235165-3516595.88499.33
335098-3509895.70199.16
435846-3584697.741101.22
535698-3569897.337100.74
635433-3543396.615100.03
120min135105-3510595.72195.591.3799.7799.581.32
234311-3431193.55697.54
334680-3468094.56298.56
435587-3558797.035101.06
535222-3522296.04099.99
635428-3542896.601100.55
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136718-36718100.11995.634.14104.70100.153.98
234650-3465094.48098.98
335329-3532996.331100.85
435970-3597098.079102.64
535269-3526996.168100.65
632485-3248588.57793.07
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%
115.372087682208834820877122089123208883820883410.04
215.322084826208234920835880.09
单位质量响应值RSD%判断
135871.24136004.440.07数据可信
加速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%
5min1464016-46401620.48121.415.4620.4821.415.47
2522376-52237623.05723.06
3509547-50954722.49022.49
4482765-48276521.30821.31
5453130-45313020.00020.00
6478289-47828921.11121.11
10min1937137-93713741.36342.211.5041.4842.331.51
2972939-97293942.94343.07
3962177-96217742.46842.59
4968416-96841642.74442.86
5942084-94208441.58241.69
6955554-95555442.17642.29
15min11191281-119128152.58155.012.6452.9255.372.64
21236990-123699054.59854.96
31277489-127748956.38656.75
41280702-128070256.52756.88
51238086-123808654.64654.99
61253941-125394155.34655.70
20min11392891-139289161.47963.402.2762.1164.062.26
21421197-142119762.72963.40
31485163-148516365.55266.23
41458169-145816964.36065.03
51441194-144119463.61164.26
61419725-141972562.66463.32
30min11652928-165292872.95774.082.1073.9375.092.09
21668143-166814373.62874.65
31713487-171348775.63076.67
41717921-171792175.82576.85
51689206-168920674.55875.56
61628276-162827671.86972.88
45min11847777-184777781.55784.612.3482.9486.042.33
21909178-190917884.26785.69
31950922-195092286.10987.57
41965576-196557686.75688.20
51942665-194266585.74587.16
61885909-188590983.24084.65
60min11987849-198784987.73989.201.7889.5791.091.77
21975716-197571687.20489.10
32062505-206250591.03492.97
42050123-205012390.48892.42
52042741-204274190.16292.05
62006128-200612888.54690.42
90min12087322-208732292.13094.552.2594.4596.942.24
22097428-209742892.57694.96
32197015-219701596.97199.41
42187495-218749596.55198.98
52169415-216941595.75398.14
62114009-211400993.30895.67
120min12088016-208801692.16095.602.0095.0098.521.98
22150255-215025594.90897.80
32184589-218458996.42399.40
42207297-220729797.425100.40
52195914-219591496.92399.85
62169760-216976095.76998.65
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12140511-214051194.47896.051.9697.8299.501.95
22113411-211341193.28196.70
32199725-219972597.091100.61
42210283-221028397.557101.07
52222340-222234098.089101.55
62170907-217090795.81999.23
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%
114.023268632582325943268832685326470.17
214.073268932665326770.06
单位质量响应值RSD%判断
2328.602322.460.19数据可信
加速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%
5min123371-2337163.45265.465.8663.4565.465.85
222954-2295462.32062.32
324748-2474867.19167.19
423390-2339063.50463.50
526709-2670972.51572.51
623490-2349063.77563.78
10min130179-3017981.93685.274.7582.2985.644.76
230405-3040582.54982.90
332090-3209087.12487.50
431357-3135785.13485.49
534060-3406092.47392.88
630357-3035782.41982.77
15min132292-3229287.67390.354.4888.4891.184.49
232271-3227187.61688.42
334422-3442293.45694.31
433185-3318590.09790.92
535663-3566396.82597.74
631825-3182586.40587.22
20min133434-3343490.77393.593.7892.0794.933.79
234142-3414292.69593.99
335797-3579797.18998.57
433648-3364891.35492.68
536397-3639798.818100.27
633401-3340190.68491.98
30min134126-3412692.65294.653.2994.4596.513.30
234415-3441593.43795.24
335562-3556296.55198.47
435296-3529695.82997.66
536491-3649199.073101.08
633291-3329190.38592.18
45min133659-3365991.38494.513.7293.7096.903.73
233580-3358091.17093.50
335513-3551396.41898.87
434467-3446793.57895.94
537022-37022100.515103.07
634620-3462093.99396.29
60min133486-3348690.91495.584.0893.7498.494.07
235074-3507495.22698.06
336115-3611598.052101.04
435473-3547396.30999.20
537300-37300101.269104.38
633777-3377791.70494.52
90min133269-3326990.32594.984.3093.6598.424.29
233904-3390492.04995.41
336134-3613498.104101.64
434822-3482294.54297.96
537342-37342101.383105.06
634438-3443893.49996.83
120min132470-3247088.15694.144.8091.9898.114.76
233414-3341490.71994.59
335238-3523895.67199.75
434703-3470394.21998.16
537326-37326101.340105.58
634896-3489694.74398.59
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134205-3420592.86696.473.4797.18100.963.48
234825-3482594.55098.93
337381-37381101.489106.10
435532-3553296.469100.94
536596-3659699.358104.16
634649-3464994.07298.45
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%
115.372088213208776020802482087014208397820854430.17
215.322085111208634620857280.05
单位质量响应值RSD%判断
135682.69136144.130.25数据可信
加速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%
5min1540316-54031623.85323.473.5923.8523.473.59
2536562-53656223.68723.69
3528719-52871923.34123.34
4499067-49906722.03222.03
5556891-55689124.58424.58
6528669-52866923.33923.34
10min11002028-100202844.23544.982.9244.3745.112.92
21016598-101659844.87945.01
31035389-103538945.70845.84
4975147-97514743.04943.17
51062722-106272246.91547.05
61021929-102192945.11445.24
15min11265679-126567955.87557.472.7656.2557.852.76
21296447-129644757.23357.61
31333720-133372058.87859.26
41258637-125863755.56455.93
51348277-134827759.52159.92
61308538-130853857.76758.15
20min11480377-148037765.35366.552.7566.0467.252.75
21519786-151978667.09267.79
31536374-153637467.82568.54
41436820-143682063.43064.10
51547417-154741768.31269.04
61523808-152380867.27067.97
30min11723514-172351476.08677.481.9977.1478.552.00
21768555-176855578.07479.15
31791767-179176779.09980.19
41701209-170120975.10176.12
51770731-177073178.17079.28
61774695-177469578.34579.42
45min11908898-190889884.27085.601.8585.7487.101.86
21939597-193959785.62587.13
31961963-196196386.61388.14
41883861-188386183.16584.60
51971370-197137087.02888.57
61968560-196856086.90488.41
60min12041702-204170290.13391.181.4492.0893.161.46
22072099-207209991.47593.46
32090798-209079892.30094.31
42017505-201750589.06590.97
52090737-209073792.29794.32
62080078-208007891.82793.82
90min12107054-210705493.01896.182.1395.4698.662.12
22198745-219874597.06699.55
32216265-221626597.839100.36
42138663-213866394.41396.81
52223989-222398998.180100.72
62187988-218798896.59199.09
120min12126789-212678993.88996.782.0196.8599.792.00
22212688-221268897.681100.71
32205834-220583497.378100.44
42148545-214854594.84997.77
52234156-223415698.629101.71
62225359-222535998.240101.28
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12194150-219415096.86397.931.81100.34101.481.80
22252221-225222199.426103.00
32248187-224818799.248102.85
42157146-215714695.22998.68
52202033-220203397.211100.84
62255870-225587099.587103.17
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%
114.023265932707323523256932514325600.43
214.073256832373324700.43
单位质量响应值RSD%判断
2322.402307.750.45数据可信
加速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%
5min126088-2608871.14968.073.2871.1568.073.28
225259-2525968.88868.89
325293-2529368.98168.98
423742-2374264.75164.75
524349-2434966.40766.41
625022-2502268.24268.24
10min133037-3303790.10187.992.4090.5088.372.40
232738-3273889.28689.67
332860-3286089.61990.00
431339-3133985.47085.83
531294-3129485.34885.72
632302-3230288.09788.48
15min132935-3293589.82391.882.8190.7292.742.79
234311-3431193.57694.45
334925-3492595.25096.13
433719-3371991.96192.80
532306-3230688.10888.95
633934-3393492.54893.42
20min135693-3569397.34595.492.1398.7496.862.13
235478-3547896.75998.16
335798-3579897.63199.04
434506-3450694.10895.45
533991-3399192.70394.04
634606-3460694.38095.76
30min136009-3600998.20797.162.19100.1499.062.18
235837-3583797.73899.67
335993-3599398.163100.12
436310-3631099.028100.90
534138-3413893.10494.95
635459-3545996.70798.61
45min136232-3623298.81597.172.50101.3099.622.48
236337-3633799.101101.58
336622-3662299.879102.38
434752-3475294.77997.20
534524-3452494.15796.52
635312-3531296.30698.75
60min135181-3518195.94994.972.4298.9897.962.37
233820-3382092.23795.27
336014-3601498.220101.27
435303-3530396.28199.23
533981-3398192.67695.56
634635-3463594.46097.44
90min136725-36725100.16099.931.37103.72103.441.38
237014-37014100.948104.49
337200-37200101.455105.05
435935-3593598.005101.48
536139-3613998.561101.96
636832-36832100.451103.96
120min135597-3559797.08397.192.46101.20101.262.42
236095-3609598.441102.54
336795-36795100.350104.51
434609-3460994.38998.41
534636-3463694.46298.41
636094-3609498.439102.50
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136577-3657799.75699.181.74104.41103.801.73
236822-36822100.424105.07
337209-37209101.480106.20
436273-3627398.927103.48
535780-3578097.582102.06
635545-3554596.941101.55
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%
115.372080541208135120756012080631206945920775170.25
215.322071714207476120732380.11
单位质量响应值RSD%判断
135167.01135328.850.09数据可信
加速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%
5min1588754-58875426.11924.404.3526.1224.404.35
2553366-55336624.54924.55
3556811-55681124.70224.70
4520308-52030823.08223.08
5551321-55132124.45824.46
6529619-52961923.49523.50
10min11036545-103654545.98445.522.2946.1345.662.29
21037373-103737346.02146.16
31054928-105492846.80046.94
4986445-98644543.76243.89
51025666-102566645.50245.64
61016067-101606745.07645.21
15min11309538-130953858.09557.851.7758.5058.241.76
21284721-128472156.99457.39
31348029-134802959.80360.20
41296703-129670357.52657.90
51293398-129339857.37957.77
61292247-129224757.32857.71
20min11479419-147941965.63166.431.6766.3567.141.66
21503683-150368366.70867.42
31542322-154232268.42269.15
41479907-147990765.65366.34
51501203-150120366.59867.31
61477553-147755365.54966.25
30min11713459-171345976.01477.391.6477.1078.471.63
21731460-173146076.81377.89
31790348-179034879.42580.53
41726018-172601876.57177.63
51766112-176611278.35079.43
61739549-173954977.17278.24
45min11889667-188966783.83185.452.4585.3486.962.43
21933068-193306885.75787.26
32006018-200601888.99390.54
41877422-187742283.28884.77
51947838-194783886.41287.92
61903553-190355384.44785.94
60min11938059-193805985.97888.542.2987.9590.522.28
21982090-198209087.93189.91
32074083-207408392.01394.06
41977908-197790887.74689.69
52015529-201552989.41591.41
61986890-198689088.14490.11
90min12134342-213434294.68696.751.7897.1499.221.77
22197024-219702497.46799.94
32209849-220984998.036100.59
42137183-213718394.81297.24
52229155-222915598.892101.38
62177267-217726796.59099.04
120min12091853-209185392.80196.042.5195.7899.052.48
22166223-216622396.10099.11
32249288-224928899.785102.89
42122514-212251494.16197.12
52178438-217843896.64299.68
62180846-218084696.74999.74
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12152275-215227595.48197.961.9598.98101.511.93
22215922-221592298.305101.85
32268031-2268031100.617104.27
42197165-219716597.473100.95
52242066-224206699.465103.04
62174066-217406696.44899.97
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