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%
113.813254832636325293248732557325510.17
213.863261832566325920.12
单位质量响应值RSD%判断
2357.062351.520.17数据可信
中间条件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%
5min123935-2393564.19061.373.4664.1961.373.46
223541-2354163.13363.13
322829-2282961.22461.22
422335-2233559.89959.90
522918-2291861.46261.46
621754-2175458.34158.34
10min133611-3361190.13985.833.9690.5086.173.95
229985-2998580.41580.77
331428-3142884.28584.62
432551-3255187.29687.63
532793-3279387.94588.29
631661-3166184.91085.23
15min134924-3492493.66092.692.2794.5293.512.27
234306-3430692.00392.80
333667-3366790.28991.10
435136-3513694.22995.05
535597-3559795.46596.30
633743-3374390.49391.29
20min135778-3577895.95194.921.6697.3396.261.66
235425-3542595.00496.31
334535-3453592.61793.93
435278-3527894.61095.95
536252-3625297.22298.58
635100-3510094.13295.43
30min135291-3529194.64594.453.7096.5696.313.65
235328-3532894.74496.58
332810-3281087.99189.82
435492-3549295.18497.05
536772-3677298.616100.52
635613-3561395.50897.33
45min137416-37416100.34398.592.20102.78100.982.14
237974-37974101.840104.20
336813-3681398.726101.04
435915-3591596.31898.71
536411-3641197.648100.10
636053-3605396.68899.04
60min135623-3562395.53595.282.1598.5398.212.12
235311-3531194.69897.63
335107-3510794.15197.01
436384-3638497.576100.51
536345-3634597.471100.46
634398-3439892.25095.14
90min136379-3637997.562100.463.30101.09103.923.20
236748-3674898.552102.01
336513-3651397.922101.31
437089-3708999.466102.94
539214-39214105.165108.70
638813-38813104.090107.49
120min134794-3479493.31293.100.9097.3897.120.88
234741-3474193.17097.17
334182-3418291.67095.60
434823-3482393.38997.41
534621-3462192.84896.96
635127-3512794.20598.18
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135873-3587396.20593.831.95100.7998.361.92
234210-3421091.74596.27
334313-3431392.02296.46
435326-3532694.73899.28
535511-3551195.23599.87
634685-3468593.01997.52
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%
115.272106801210685021076322106590210681521069380.02
215.252104701210273821037200.07
单位质量响应值RSD%判断
137978.91137948.850.02数据可信
中间条件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%
5min1546022-54602223.74621.697.9723.7521.697.99
2541210-54121023.53723.54
3489646-48964621.29521.29
4480496-48049620.89720.90
5494607-49460721.51021.51
6440214-44021419.14519.14
10min11078669-107866946.91144.713.4347.0444.823.43
21051343-105134345.72345.85
3989477-98947743.03243.15
41031245-103124544.84844.96
51028686-102868644.73744.86
6988348-98834842.98343.09
15min11326601-132660157.69357.371.9758.0957.741.98
21327641-132764157.73958.12
31276614-127661455.51955.88
41337760-133776058.17958.54
51346025-134602558.53858.91
61299931-129993156.53456.88
20min11513832-151383265.83665.751.7266.5566.441.72
21517530-151753065.99766.70
31465883-146588363.75164.42
41533508-153350866.69267.38
51537654-153765466.87267.57
61503143-150314365.37166.03
30min11740672-174067275.70176.332.1776.7877.382.15
21751380-175138076.16777.24
31688282-168828273.42374.44
41778183-177818377.33378.39
51791643-179164377.91878.98
61781108-178110877.46078.48
45min11997503-199750386.87185.941.1488.3787.421.14
22007496-200749687.30588.80
31954518-195451885.00186.43
41970750-197075085.70787.20
51951996-195199684.89286.39
61974410-197441085.86687.32
60min12019016-201901687.80689.541.4889.7991.491.45
22051882-205188289.23691.22
32037499-203749988.61090.51
42106896-210689691.62893.59
52070958-207095890.06592.03
62066443-206644389.86991.80
90min12119726-211972692.18696.423.1294.6698.873.03
22172757-217275794.49296.97
32212706-221270696.23098.62
42238890-223889097.36999.84
52233392-223339297.12999.60
62325232-2325232101.124103.55
120min12113918-211391891.93492.990.9494.9295.980.92
22164050-216405094.11497.11
32129396-212939692.60795.53
42160791-216079193.97296.99
52126462-212646292.47995.49
62134498-213449892.82995.82
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12199450-219945095.65394.231.6899.1597.741.65
22168892-216889294.32497.85
32096940-209694091.19594.64
42178120-217812094.72698.26
52189388-218938895.21698.74
62168210-216821094.29597.80
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%
113.813259832451325813263832582325700.22
213.863256632453325100.25
单位质量响应值RSD%判断
2358.442345.600.39数据可信
中间条件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%
5min123918-2391864.20660.384.9664.2160.384.96
221805-2180558.53458.53
322306-2230659.87959.88
422802-2280261.21161.21
520798-2079855.83155.83
623328-2332862.62362.62
10min132355-3235586.85587.031.6887.2187.371.67
232028-3202885.97786.30
331668-3166885.01185.34
433231-3323189.20789.55
532676-3267687.71788.03
632567-3256787.42487.77
15min134755-3475593.29893.441.5394.1494.261.53
234487-3448792.57893.38
334253-3425391.95092.75
435747-3574795.96196.80
534564-3456492.78593.58
635039-3503994.06094.89
20min135964-3596496.54396.321.5797.9097.661.57
235545-3554595.41896.74
335077-3507794.16295.48
436717-3671798.56499.93
535775-3577596.03697.35
636209-3620997.20198.56
30min136454-3645497.85896.282.1699.7598.152.14
234623-3462392.94394.79
335203-3520394.50096.34
436141-3614197.01898.93
536238-3623897.27999.13
636532-3653298.06899.96
45min136059-3605996.79898.031.5699.24100.441.54
236476-3647697.918100.28
335696-3569695.82498.19
437144-3714499.711102.17
537074-3707499.523101.91
636655-3665598.398100.84
60min136147-3614797.03498.721.29100.01101.671.21
236923-3692399.117102.03
337418-37418100.446103.34
436297-3629797.437100.45
536891-3689199.032101.97
636971-3697199.246102.23
90min135964-3596496.54398.752.20100.06102.252.15
236214-3621497.214100.67
336107-3610796.927100.38
437865-37865101.646105.20
537041-3704199.434102.92
637531-37531100.750104.29
120min136392-3639297.69295.051.70101.7499.101.62
235897-3589796.363100.36
334872-3487293.61297.60
435098-3509894.21898.33
535096-3509694.21398.26
635087-3508794.18998.29
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135373-3537394.95794.301.3799.5598.881.33
235387-3538794.99499.53
334268-3426891.99096.50
435498-3549895.29299.93
535391-3539195.00599.57
634854-3485493.56398.19
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%
115.272097643209510120976772095968209581820964410.06
215.252101598209976321006800.07
单位质量响应值RSD%判断
137291.49137749.510.24数据可信
中间条件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%
5min1526637-52663722.97721.166.0022.9821.166.01
2490412-49041221.39721.40
3492003-49200321.46621.47
4490556-49055621.40321.40
5438030-43803019.11119.11
6471654-47165420.57820.58
10min11019872-101987244.49744.482.0644.6244.602.06
21040315-104031545.38945.51
31018494-101849444.43744.56
41040671-104067145.40445.52
51013788-101378844.23244.34
6983620-98362042.91543.03
15min11315734-131573457.40557.291.7857.7857.661.78
21326941-132694157.89458.27
31313802-131380257.32157.69
41344723-134472358.67059.04
51301829-130182956.79957.15
61275934-127593455.66956.02
20min11514583-151458366.08166.241.4866.7766.921.48
21538432-153843267.12267.81
31510404-151040465.89966.58
41540937-154093767.23167.93
51524671-152467166.52167.19
61479927-147992764.56965.23
30min11759172-175917276.75376.501.0177.8177.551.01
21777720-177772077.56278.63
31739874-173987475.91176.96
41738352-173835275.84476.91
51769004-176900477.18278.22
61736440-173644075.76176.78
45min11943486-194348684.79485.811.3686.2887.291.35
21979479-197947986.36587.86
31940122-194012284.64786.12
41990725-199072586.85588.35
52000878-200087887.29888.76
61946154-194615484.91186.35
60min12010364-201036487.71290.211.6789.6792.171.63
22092147-209214791.28093.26
32079901-207990190.74692.69
42045230-204523089.23391.21
52104499-210449991.81993.77
62074133-207413390.49492.41
90min12127122-212712292.80695.001.2795.2597.451.25
22191293-219129395.60698.09
32172406-217240694.78297.23
42191933-219193395.63498.10
52205949-220594996.24698.71
62175274-217527494.90797.32
120min12143762-214376293.53294.001.2596.4996.981.23
22177521-217752195.00598.02
32141543-214154393.43596.41
42157878-215787894.14897.15
52190160-219016095.55798.55
62115938-211593892.31895.26
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12130425-213042592.95094.251.2696.4397.751.24
22194198-219419895.73399.28
32149829-214982993.79797.29
42161016-216101694.28597.81
52190064-219006495.55299.08
62135324-213532493.16496.62
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%
113.813275032794326443266932743327200.19
213.863261932561325900.13
单位质量响应值RSD%判断
2369.302351.370.54数据可信
中间条件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%
5min123932-2393264.01859.4611.2364.0259.4611.23
222814-2281461.02761.03
317530-1753046.89346.89
424633-2463365.89365.89
522081-2208159.06759.07
622381-2238159.86959.87
10min132422-3242286.72985.332.7087.0885.662.73
231502-3150284.26884.61
330683-3068382.07782.34
433183-3318388.76489.13
531550-3155084.39684.72
632054-3205485.74486.08
15min133884-3388490.64091.851.3091.4892.651.29
234539-3453992.39293.20
334563-3456392.45693.17
435019-3501993.67694.53
533956-3395690.83291.63
634055-3405591.09791.91
20min134584-3458492.51293.401.4493.8594.721.41
235410-3541094.72296.04
335285-3528594.38795.62
435060-3506093.78595.17
534074-3407491.14892.45
635092-3509293.87195.19
30min135445-3544594.81594.952.2196.6796.782.15
235505-3550594.97696.82
336726-3672698.242100.00
435909-3590996.05697.96
534910-3491093.38495.19
634480-3448092.23494.07
45min135941-3594196.14295.322.7398.5297.682.68
235892-3589296.01198.39
336486-3648697.60099.90
436495-3649597.624100.06
534994-3499493.60995.94
634000-3400090.95093.30
60min134945-3494593.47894.992.8096.3997.882.73
235268-3526894.34297.25
336933-3693398.796101.64
436340-3634097.209100.19
535427-3542794.76797.61
634157-3415791.37094.22
90min136202-3620296.84096.212.47100.2899.632.42
236040-3604096.40799.84
337134-3713499.333102.72
436518-3651897.686101.20
534668-3466892.73796.11
635242-3524294.27297.63
120min134625-3462592.62294.872.3296.5998.822.26
236122-3612296.626100.59
335246-3524694.28398.23
436496-3649697.627101.69
534477-3447792.22696.11
635834-3583495.85699.74
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135219-3521994.21198.533.1398.70103.013.03
237748-37748100.976105.48
337960-37960101.543106.01
437564-37564100.484105.09
535657-3565795.38299.78
636850-3685098.574102.99
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%
115.272110025210815421087732105588210960821084300.09
215.252096826209824120975340.05
单位质量响应值RSD%判断
138076.62137543.210.28数据可信
中间条件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%
5min1569671-56967124.80322.3911.4824.8022.4011.47
2546999-54699923.81523.82
3409891-40989117.84617.85
4558298-55829824.30724.31
5494935-49493521.54921.55
6506432-50643222.04922.05
10min11068023-106802346.50045.373.7846.6445.493.80
21068515-106851546.52146.65
3965861-96586142.05242.15
41065335-106533546.38346.52
51039858-103985845.27445.39
61044770-104477045.48845.61
15min11352555-135255558.88858.481.9259.2858.861.94
21373490-137349059.80060.19
31301647-130164756.67257.00
41363257-136325759.35459.75
51336517-133651758.19058.56
61332169-133216958.00058.38
20min11534571-153457166.81366.721.9067.5467.421.92
21571319-157131968.41369.14
31481034-148103464.48265.13
41533601-153360166.77167.49
51534900-153490066.82767.52
61538661-153866166.99167.69
30min11763306-176330676.77276.940.8377.8778.010.86
21794454-179445478.12879.23
31755662-175566276.43977.44
41772566-177256677.17578.27
51756582-175658276.47977.54
61760801-176080176.66277.73
45min11943410-194341084.61385.321.4586.1386.821.44
21978229-197822986.12987.67
31931882-193188284.11185.54
41948208-194820884.82286.34
51948050-194805084.81586.31
62008134-200813487.43188.93
60min12000150-200015087.08388.631.4489.0790.601.41
22053330-205333089.39991.41
32036744-203674488.67790.57
42070844-207084490.16192.15
52051723-205172389.32991.29
62000911-200091187.11689.10
90min12130382-213038292.75392.770.6995.2395.240.68
22144621-214462193.37395.89
32128795-212879592.68495.07
42111141-211114191.91694.41
52120182-212018292.30994.77
62149960-214996093.60696.07
120min12115139-211513992.09093.991.8795.0896.971.84
22194432-219443295.54298.57
32114392-211439292.05794.96
42141325-214132593.23096.23
52183950-218395095.08698.06
62203668-220366895.94498.93
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12155191-215519193.83495.231.6697.3498.731.61
22189022-218902295.30798.87
32175381-217538194.71398.13
42149815-214981593.59997.12
52247899-224789997.870101.37
62205630-220563096.03099.55
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%
113.813255732699326353254232522325910.23
213.863255332581325670.07
单位质量响应值RSD%判断
2359.962349.710.31数据可信
中间条件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%
5min124561-2456165.85364.982.6065.8564.982.60
224674-2467466.15666.16
324334-2433465.24565.24
424763-2476366.39566.40
524012-2401264.38164.38
623077-2307761.87561.87
10min132000-3200085.79988.972.8886.1689.332.87
233258-3325889.17289.54
334290-3429091.93992.30
433990-3399091.13591.50
532094-3209486.05186.41
633460-3346089.71490.06
15min133426-3342689.62292.643.0590.4693.503.03
235066-3506694.02094.88
333786-3378690.58891.46
435900-3590096.25697.13
533672-3367290.28291.12
635459-3545995.07395.92
20min134171-3417191.62095.132.8392.9696.502.82
236189-3618997.03198.42
335586-3558695.41496.79
436419-3641997.64799.06
534311-3431191.99593.33
636214-3621497.09898.47
30min135737-3573795.81997.261.5397.6799.161.54
236617-3661798.178100.10
336487-3648797.83099.74
436952-3695299.076101.03
535492-3549295.16297.01
636362-3636297.49599.40
45min135538-3553895.28599.032.5097.67101.472.48
237561-37561100.709103.18
338111-38111102.184104.63
437209-3720999.765102.27
536259-3625997.21899.60
636930-3693099.017101.47
60min135243-3524394.49498.092.7897.41101.082.75
237708-37708101.103104.13
337403-37403100.286103.30
437048-3704899.334102.39
535489-3548995.15498.07
636622-3662298.192101.19
90min135086-3508694.07397.583.0397.51101.112.99
237246-3724699.865103.46
337480-37480100.492104.07
437101-3710199.476103.08
535006-3500693.85997.30
636444-3644497.714101.26
120min135321-3532194.70395.502.8298.6699.572.76
235971-3597196.446100.59
337193-3719399.723103.86
436050-3605096.658100.82
534532-3453292.58896.56
634633-3463392.85996.95
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136128-3612896.86796.441.88101.35101.041.86
235923-3592396.317101.00
336570-3657098.052102.74
436801-3680198.672103.37
535228-3522894.45498.94
635159-3515994.26998.87
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%
115.272101308210258921010962102758210188221019270.04
215.252094662209598720953240.05
单位质量响应值RSD%判断
137650.75137398.300.13数据可信
中间条件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%
5min1617776-61777626.95324.247.3926.9524.247.38
2581300-58130025.36125.36
3545762-54576223.81123.81
4528314-52831423.05023.05
5559943-55994324.43024.43
6500646-50064621.84221.84
10min11085062-108506247.34046.632.1747.4946.762.18
21095010-109501047.77447.91
31073681-107368146.84346.98
41029466-102946644.91445.04
51071993-107199346.77046.91
61057147-105714746.12246.24
15min11357317-135731759.21858.851.2459.6359.241.25
21359479-135947959.31259.72
31354953-135495359.11559.51
41315320-131532057.38657.76
51355222-135522259.12659.52
61350986-135098658.94259.32
20min11520151-152015166.32266.631.7867.0667.351.77
21560396-156039668.07868.81
31511923-151192365.96366.68
41485858-148585864.82665.52
51535706-153570667.00167.72
61549301-154930167.59468.30
30min11793885-179388578.26577.341.6779.3778.431.67
21785202-178520277.88679.00
31756851-175685176.64977.74
41722605-172260575.15576.21
51804087-180408778.71079.81
61773416-177341677.37278.45
45min12011770-201177087.77189.882.0789.3291.402.04
22078357-207835790.67692.22
32083563-208356390.90392.42
42002244-200224487.35588.83
52106131-210613191.88893.42
62078342-207834290.67592.19
60min12037267-203726788.88389.991.9190.9292.011.90
22112864-211286492.18194.23
32060616-206061689.90291.92
42001767-200176787.33489.29
52088653-208865391.12593.17
62074825-207482590.52292.54
90min12120022-212002292.49493.331.2995.0295.851.29
22157275-215727594.11996.68
32131572-213157292.99895.52
42098363-209836391.54993.99
52155157-215515794.02796.58
62172731-217273194.79397.31
120min12137454-213745493.25494.050.8196.2997.090.82
22178917-217891795.06398.15
32171582-217158294.74397.78
42136650-213665093.21996.17
52158461-215846194.17197.24
62151429-215142993.86496.91
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12182807-218280795.23394.910.6598.7998.480.66
22197206-219720695.86199.47
32178139-217813995.02998.59
42166231-216623194.51097.98
52172420-217242094.78098.38
62156206-215620694.07297.64
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