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%
113.573154431447316043194031486316040.63
213.593207231869319700.45
单位质量响应值RSD%判断
2328.962352.470.72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%
5min119662-1966253.03751.772.6453.0451.772.64
218419-1841949.68449.68
319550-1955052.73552.74
418781-1878150.66150.66
519594-1959452.85452.85
619149-1914951.65351.65
10min131389-3138984.67084.241.4284.9684.531.42
231053-3105383.76484.04
331978-3197886.25986.55
430988-3098883.58983.87
531294-3129484.41484.71
630679-3067982.75583.04
15min133926-3392691.51492.351.5092.2893.111.49
233889-3388991.41492.16
335254-3525495.09695.87
434195-3419592.23992.99
534037-3403791.81392.58
634126-3412692.05392.80
20min135661-3566196.19495.711.0597.4796.981.06
235218-3521894.99996.25
336092-3609297.35698.66
435589-3558996.00097.26
535237-3523795.05096.32
635097-3509794.67295.93
30min134565-3456593.23792.992.7895.0594.792.72
234748-3474893.73195.51
334778-3477893.81295.65
435146-3514694.80596.60
532570-3257087.85689.66
635034-3503494.50296.29
45min135917-3591796.88496.311.5299.2198.631.48
235524-3552495.82498.12
334864-3486494.04496.41
436461-3646198.352100.67
535494-3549495.74398.03
635969-3596997.02599.33
60min137026-3702699.87697.401.90102.74100.261.87
235672-3567296.22399.05
336110-3611097.405100.29
436644-3664498.845101.71
535095-3509594.66797.49
636113-3611397.413100.26
90min134751-3475193.73995.602.9997.1698.992.88
235026-3502694.48197.85
335345-3534595.34198.77
434567-3456793.24396.66
535463-3546395.66099.01
637483-37483101.109104.50
120min136555-3655598.60596.201.57102.55100.131.51
236103-3610397.386101.28
335557-3555795.91399.87
435192-3519294.92998.86
535455-3545595.63899.52
635117-3511794.72698.68
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137142-37142100.18998.101.76104.68102.561.69
236453-3645398.330102.76
335743-3574396.415100.90
435775-3577596.501100.96
535990-3599097.081101.49
637103-37103100.083104.56
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%
115.152042590204397720415232039457203186320398820.24
215.202036415203731920368670.04
单位质量响应值RSD%判断
134645.68134004.410.34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%
5min1476147-47614721.26921.342.7621.2721.342.76
2463152-46315220.68820.69
3501951-50195122.42122.42
4477444-47744421.32621.33
5469764-46976420.98320.98
6478130-47813021.35721.36
10min11016757-101675745.41745.571.7745.5345.681.78
21011012-101101245.16045.27
31056269-105626947.18147.31
41015504-101550445.36145.48
51007528-100752845.00445.12
61013778-101377845.28345.40
15min11266705-126670556.58158.522.1756.9558.892.16
21303260-130326058.21458.58
31352579-135257960.41760.80
41321524-132152459.03059.40
51299706-129970658.05558.42
61317204-131720458.83759.21
20min11486099-148609966.38167.511.8667.0768.201.86
21483650-148365066.27266.96
31555068-155506869.46270.18
41532821-153282168.46869.17
51511692-151169267.52468.21
61498648-149864866.94267.64
30min11655322-165532273.94076.101.6374.9977.171.62
21714525-171452576.58477.64
31732257-173225777.37678.48
41715342-171534276.62177.70
51688003-168800375.40076.46
61716583-171658376.67677.75
45min11869770-186977083.51984.881.4184.9886.381.40
21897121-189712184.74186.22
31899593-189959384.85186.39
41940129-194012986.66288.17
51875065-187506583.75585.24
61919805-191980585.75487.25
60min11964809-196480987.76489.391.7289.6991.361.71
21993132-199313289.02990.98
32025600-202560090.48092.49
42046738-204673891.42493.41
51961308-196130887.60889.56
62016295-201629590.06492.04
90min12017012-201701290.09693.021.6092.5195.481.59
22095057-209505793.58296.03
32110851-211085194.28896.80
42097327-209732793.68396.18
52089077-208907793.31595.75
62085597-208559793.15995.63
120min12109428-210942894.22494.640.7197.1497.620.70
22142672-214267295.70998.68
32116424-211642494.53697.57
42128291-212829195.06798.08
52100141-210014193.80996.76
62115381-211538194.49097.48
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12152827-215282796.16396.130.7699.6099.630.76
22157175-215717596.35799.86
32156412-215641296.32399.88
42168312-216831296.854100.40
52120640-212064094.72598.20
62156843-215684396.34299.86
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%
113.573175431576315603184231312316090.65
213.593172831760317440.08
单位质量响应值RSD%判断
2329.332335.840.20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%
5min122021-2202159.60658.547.9659.6158.547.97
219763-1976353.49453.49
320687-2068755.99556.00
421966-2196659.45759.46
520653-2065355.90355.90
624666-2466666.76666.77
10min130868-3086883.55384.111.1683.8884.441.18
231042-3104284.02484.32
330585-3058582.78783.10
431290-3129084.69585.03
531025-3102583.97884.29
631637-3163785.63586.01
15min134507-3450793.40391.052.0694.2091.842.06
233346-3334690.26191.02
333287-3328790.10190.87
432669-3266988.42889.23
533679-3367991.16291.94
634332-3433292.92993.78
20min134452-3445293.25493.611.3494.5794.901.35
234286-3428692.80594.07
334193-3419392.55393.82
434233-3423392.66293.95
535089-3508994.97996.26
635242-3524295.39396.76
30min135324-3532495.61595.712.0297.4597.532.02
234968-3496894.65196.43
335091-3509194.98496.77
434588-3458893.62295.43
535530-3553096.17297.98
636659-3665999.228101.12
45min133186-3318689.82892.291.9692.1994.641.94
234224-3422492.63794.94
333785-3378591.44993.76
433744-3374491.33893.66
534578-3457893.59595.94
635057-3505794.89297.34
60min134767-3476794.10795.111.3796.9797.981.32
235698-3569896.62799.45
335703-3570396.64199.46
434771-3477194.11896.95
534651-3465193.79396.66
635242-3524295.39398.36
90min134194-3419492.55692.411.7095.9495.801.69
233771-3377191.41194.77
333632-3363291.03594.39
433584-3358490.90594.26
534736-3473694.02397.41
634923-3492394.52998.03
120min135816-3581696.94696.551.43100.85100.451.39
235019-3501994.78998.66
335733-3573396.722100.59
435254-3525495.42599.29
536483-3648398.752102.66
635705-3570596.646100.67
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136181-3618197.93497.711.29102.37102.151.23
236763-3676399.510103.90
335812-3581296.936101.34
436032-3603297.531101.92
535424-3542495.885100.34
636379-3637998.470103.03
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100607-202305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%
115.152038978204020820397212038566203769020390330.05
215.202038183203898920385860.03
单位质量响应值RSD%判断
134589.64134117.500.25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%
5min1560788-56078825.04423.478.7325.0423.478.72
2468759-46875920.93420.93
3498618-49861822.26722.27
4537144-53714423.98823.99
5496630-49663022.17922.18
6591453-59145326.41326.41
10min11081470-108147048.29746.932.0448.4447.062.05
21025095-102509545.77945.90
31027809-102780945.90046.02
41052647-105264747.01047.14
51057521-105752147.22747.35
61060745-106074547.37147.52
15min11349774-134977460.27959.381.3260.6959.781.34
21297472-129747257.94358.31
31327311-132731159.27659.65
41334733-133473359.60760.00
51336374-133637459.68060.07
61332853-133285359.52359.93
20min11523380-152338068.03267.601.6168.7768.321.62
21468814-146881465.59566.29
31505265-150526567.22367.93
41518128-151812867.79768.52
51531753-153175368.40669.12
61534432-153443268.52569.27
30min11745442-174544277.94977.941.2379.0779.031.24
21711131-171113176.41677.47
31742260-174226077.80778.89
41737481-173748177.59378.70
51760673-176067378.62979.73
61773945-177394579.22280.34
45min11895146-189514684.63485.070.7886.1986.600.78
21891422-189142284.46885.95
31889984-188998484.40485.92
41915804-191580485.55787.09
51925530-192553085.99187.53
61911107-191110785.34786.91
60min12040554-204055491.12890.291.0093.1592.290.97
22016880-201688090.07192.02
32018988-201898890.16592.15
42049619-204961991.53393.54
52008210-200821089.68391.70
61995988-199598889.13891.17
90min12128573-212857395.05994.650.9797.5997.150.95
22112038-211203894.32096.77
32107004-210700494.09596.58
42142193-214219395.66798.18
52137746-213774695.46897.98
62088880-208888093.28695.82
120min12206115-220611598.52296.641.32101.5899.671.30
22132244-213224495.22398.20
32149849-214984996.00999.02
42183130-218313097.495100.54
52173547-217354797.067100.11
62138985-213898595.52498.57
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12202107-220210798.34398.050.98101.95101.610.95
22207454-220745498.581102.09
32172690-217269097.029100.57
42224287-222428799.333102.92
52197859-219785998.153101.73
62168356-216835696.835100.42
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%
113.573139231235311783165431405313730.60
213.593087330768308200.25
单位质量响应值RSD%判断
2311.942267.841.37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%
5min118958-1895852.27753.557.7252.2853.557.72
220213-2021355.73755.74
317086-1708647.11547.11
418831-1883151.92751.93
519934-1993454.96854.97
621499-2149959.28459.28
10min128816-2881679.46082.126.1479.7582.426.14
231539-3153986.96987.28
326719-2671973.67873.94
429662-2966281.79382.08
531435-3143586.68286.99
630510-3051084.13184.46
15min133437-3343792.20389.325.9392.9390.085.93
233377-3337792.03792.83
328602-2860278.87079.54
432747-3274790.30091.04
533765-3376593.10793.89
632429-3242989.42390.22
20min133992-3399293.73393.516.8594.9894.766.84
236338-36338100.202101.51
329601-2960181.62582.73
434451-3445194.99996.24
535373-3537397.54198.85
633702-3370292.93394.23
30min131986-3198688.20290.325.9989.9792.095.99
233546-3354692.50394.36
329234-2923480.61382.18
433175-3317591.48093.25
534885-3488596.19698.04
633705-3370592.94294.75
45min133576-3357692.58694.014.5894.8496.284.60
236116-3611699.590101.96
331626-3162687.20989.22
434529-3452995.21497.49
535196-3519697.05399.43
633515-3351592.41894.74
60min133416-3341692.14593.426.3494.9196.216.32
235823-3582398.782101.71
329833-2983382.26584.76
434629-3462995.49098.30
535278-3527897.279100.20
634293-3429394.56397.40
90min133950-3395093.61793.916.6496.9097.226.59
234348-3434894.71598.19
330077-3007782.93785.89
435366-3536697.522100.86
536844-36844101.597105.06
633743-3374393.04696.41
120min134708-3470895.70796.214.5999.51100.054.63
236227-3622799.896103.90
331887-3188787.92991.34
435121-3512196.846100.73
536233-3623399.913103.94
635170-3517096.981100.86
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135414-3541497.65495.986.37101.99100.356.33
236350-36350100.235104.79
330486-3048684.06587.97
435289-3528997.310101.73
536504-36504100.660105.24
634795-3479595.947100.37
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%
115.152035007203396920348332034819203289520343050.05
215.202032548203133020319390.05
单位质量响应值RSD%判断
134277.56133680.200.32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%
5min1508495-50849522.77222.605.4522.7722.605.45
2502182-50218222.48922.49
3491922-49192222.03022.03
4471794-47179421.12921.13
5499045-49904522.34922.35
6554401-55440124.82824.83
10min11000315-100031544.79845.661.5944.9245.781.60
21039708-103970846.56246.69
31016934-101693445.54245.66
41002249-100224944.88445.00
51033811-103381146.29846.42
61024377-102437745.87546.01
15min11302696-130269658.33958.110.7458.7158.490.74
21300204-130020458.22858.61
31295234-129523458.00558.38
41287934-128793457.67858.04
51312183-131218358.76459.15
61287013-128701357.63758.03
20min11490983-149098366.77166.750.7967.4767.460.78
21471473-147147365.89866.60
31487587-148758766.61967.32
41501547-150154767.24467.93
51504370-150437067.37168.08
61487633-148763366.62167.33
30min11670808-167080874.82477.444.5475.8978.514.49
21695370-169537075.92477.00
31721516-172151677.09578.16
41689693-168969375.67076.73
51712774-171277476.70477.79
61885183-188518384.42585.51
45min11890025-189002584.64285.041.3886.1386.541.34
21928645-192864586.37187.87
31933586-193358686.59388.09
41888735-188873584.58486.07
51882653-188265384.31285.82
61869493-186949383.72285.27
60min11988438-198843889.04989.451.0991.0191.431.06
22006878-200687889.87591.85
32035772-203577291.16993.15
41989941-198994189.11691.07
51989954-198995489.11791.09
61973363-197336388.37490.39
90min12111889-211188994.57896.111.8497.0398.591.80
22110534-211053494.51796.99
32188995-218899598.031100.51
42164877-216487796.95199.40
52189995-218999598.075100.55
62110875-211087594.53297.04
120min12181354-218135497.68897.841.63100.66100.841.59
22198336-219833698.449101.45
32249016-2249016100.719103.75
42156687-215668796.58499.57
52154955-215495596.50699.52
62167508-216750897.068100.10
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12201361-220136198.58498.061.27102.10101.611.24
22185501-218550197.874101.42
32239537-2239537100.294103.88
42163639-216363996.895100.42
52179098-217909897.587101.14
62169218-216921897.145100.72
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%
113.573099531180310003123431475311770.64
213.593132731153312400.40
单位质量响应值RSD%判断
2297.492298.750.04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%
5min112940-1294035.55144.5814.4835.5544.5814.48
216386-1638645.01845.02
315613-1561342.89542.89
415180-1518041.70541.71
520004-2000454.95854.96
617241-1724147.36747.37
10min129647-2964781.45184.613.2081.6584.853.21
232307-3230788.75989.01
330076-3007682.63082.87
430248-3024883.10383.33
531244-3124485.83986.14
631252-3125285.86186.12
15min133196-3319691.20292.272.6991.8592.992.71
234398-3439894.50495.25
332168-3216888.37789.07
433444-3344491.88392.58
534697-3469795.32696.11
633607-3360792.33193.07
20min134062-3406293.58194.653.0094.7495.883.01
235697-3569798.07399.34
333031-3303190.74891.94
433827-3382792.93594.14
535552-3555297.67598.99
634536-3453694.88396.14
30min136773-36773101.02998.343.97102.71100.103.92
236407-36407100.024101.84
333324-3332491.55393.25
436915-36915101.419103.14
536504-36504100.290102.14
634851-3485195.74997.53
45min133417-3341791.80993.733.1294.0596.043.13
234802-3480295.61497.98
332706-3270689.85692.06
433680-3368092.53294.82
535674-3567498.010100.42
634428-3442894.58796.90
60min134434-3443494.60396.383.9597.3599.203.92
236574-36574100.482103.38
333002-3300290.66993.37
434308-3430894.25797.05
536049-3604999.040102.00
636120-3612099.235102.07
90min134979-3497996.10095.362.8399.3798.712.79
236040-3604099.015102.47
333161-3316191.10694.31
435010-3501096.18699.51
534066-3406693.59297.10
634990-3499096.13199.52
120min133473-3347391.96394.382.7595.7798.262.74
235971-3597198.826102.83
333466-3346691.94495.65
434140-3414093.79597.65
534243-3424394.07898.10
634819-3481995.66199.58
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134951-3495196.02395.722.91100.34100.132.88
236606-36606100.570105.13
333550-3355092.17496.40
434712-3471295.36799.74
534926-3492695.955100.50
634291-3429194.21098.66
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%
115.152037767203571120353222036032203730420364270.06
215.202037841203822120380310.02
单位质量响应值RSD%判断
134417.62134080.990.18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%
5min1315505-31550514.10117.0312.7414.1017.0312.75
2377914-37791416.89016.89
3377876-37787616.88816.89
4357860-35786015.99415.99
5463288-46328820.70620.71
6393352-39335217.58017.58
10min1917934-91793441.02544.534.3341.1044.634.35
21024269-102426945.77845.87
31000441-100044144.71344.81
4980836-98083643.83743.93
51036681-103668146.33246.45
61018415-101841545.51645.61
15min11254719-125471956.07758.532.3356.3858.872.36
21322274-132227459.09659.44
31307482-130748258.43558.78
41301542-130154258.17058.50
51339738-133973859.87760.25
61331689-133168959.51759.87
20min11486638-148663866.44267.351.0967.0668.021.12
21523371-152337168.08468.76
31500116-150011667.04567.71
41491256-149125666.64967.30
51520171-152017167.94168.65
61520605-152060567.96068.64
30min11721147-172114776.92377.871.1177.9178.911.13
21760746-176074678.69379.75
31756073-175607378.48479.52
41720525-172052576.89577.92
51760972-176097278.70379.79
61734778-173477877.53378.59
45min11876025-187602583.84585.871.3985.2687.351.40
21939493-193949386.68288.17
31942216-194221686.80488.28
41904373-190437385.11286.57
51941633-194163386.77788.30
61924579-192457986.01587.50
60min11966334-196633487.88189.251.3289.7691.201.32
22020592-202059290.30692.28
32017851-201785190.18492.14
41971632-197163288.11890.04
51983091-198309188.63090.63
62022542-202254290.39492.36
90min12070307-207030792.52893.461.4294.9095.901.40
22119677-211967794.73597.21
32099176-209917693.81996.28
42073495-207349592.67195.09
52054895-205489591.84094.33
62128801-212880195.14397.61
120min12102890-210289093.98595.381.3396.8798.351.32
22146080-214608095.91598.92
32162707-216270796.65899.64
42121178-212117894.80297.73
52105449-210544994.09997.10
62166627-216662796.83399.83
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12117939-211793994.65794.930.8898.0698.430.87
22146076-214607695.91599.45
32143085-214308595.78199.30
42106868-210686894.16297.62
52101334-210133493.91597.44
62129538-212953895.17698.71
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