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%
113.573174731509316513139031678315950.46
213.593135131779315650.96
单位质量响应值RSD%判断
2328.302322.660.18数据可信
长期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%
5min121843-2184359.30558.524.1859.3058.524.18
221708-2170858.93858.94
320228-2022854.92054.92
422580-2258061.30661.31
520735-2073556.29756.30
622238-2223860.37760.38
10min132185-3218587.38486.311.7787.7186.631.77
232098-3209887.14887.48
331569-3156985.71286.02
432344-3234487.81688.16
531727-3172786.14186.45
630807-3080783.64383.98
15min134631-3463194.02592.282.1894.8493.092.17
234255-3425593.00493.82
332654-3265488.65789.44
434586-3458693.90394.73
534111-3411192.61393.40
633699-3369991.49592.29
20min133890-3389092.01394.773.2493.3596.093.21
236929-36929100.264101.59
334433-3443393.48794.76
435306-3530695.85897.21
534916-3491694.79996.10
633968-3396892.22593.53
30min133854-3385491.91593.722.5493.7695.562.51
234303-3430393.13595.02
334659-3465994.10195.89
436100-3610098.01399.90
534578-3457893.88195.71
633615-3361591.26793.09
45min135380-3538096.05996.421.9598.4298.791.92
236391-3639198.804101.21
335985-3598597.701100.02
435780-3578097.14599.57
535093-3509395.27997.63
634454-3445493.54495.87
60min136502-3650299.10597.572.70102.00100.472.66
236774-3677499.843102.80
336255-3625598.434101.29
436528-3652899.176102.14
535289-3528995.81298.69
634264-3426493.02995.88
90min133859-3385991.92994.323.2895.3797.773.22
236379-3637998.771102.28
334709-3470994.23797.64
435360-3536096.00499.52
535005-3500595.04098.46
633136-3313689.96693.33
120min135983-3598397.69695.542.85101.6599.512.76
236610-3661099.398103.45
335482-3548296.336100.26
434125-3412592.65196.70
534711-3471194.24298.19
634234-3423492.94796.81
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135710-3571096.95599.532.62101.45104.022.56
236913-36913100.221104.83
337025-37025100.525104.99
438152-38152103.585108.15
536606-3660699.387103.85
635535-3553596.479100.86
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%
115.152084584207399320858952085532208598620831980.25
215.202082721207405820783900.30
单位质量响应值RSD%判断
137504.82136736.180.40数据可信
长期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%
5min1546050-54605023.89423.094.1523.8923.094.15
2505578-50557822.12322.12
3517472-51747222.64322.64
4549816-54981624.05924.06
5501781-50178121.95721.96
6544980-54498023.84723.85
10min11072257-107225746.91946.731.1847.0546.861.19
21060415-106041546.40146.52
31058892-105889246.33446.46
41091157-109115747.74647.88
51058186-105818646.30446.43
61066612-106661246.67246.80
15min11369679-136967959.93459.371.7760.3359.761.77
21365732-136573259.76160.14
31320667-132066757.78958.17
41388463-138846360.75661.15
51339262-133926258.60358.98
61357373-135737359.39559.79
20min11543046-154304667.52067.501.0568.2568.221.05
21560517-156051768.28469.00
31546887-154688767.68868.39
41556282-155628268.09968.84
51531522-153152267.01667.72
61516874-151687466.37567.10
30min11738200-173820076.05977.791.4277.1678.881.41
21787572-178757278.22079.31
31789342-178934278.29779.38
41809551-180955179.18180.30
51782814-178281478.01179.09
61758954-175895476.96778.06
45min11994504-199450487.27486.341.5588.8087.871.53
22000676-200067687.54589.07
32001284-200128487.57189.09
41968811-196881186.15087.70
51939128-193912884.85186.36
61934962-193496284.66986.19
60min12070931-207093190.61990.991.1292.6393.001.10
22118160-211816092.68594.70
32095323-209532391.68693.69
42073329-207332990.72492.76
52057196-205719690.01892.00
62061599-206159990.21092.20
90min12118804-211880492.71493.731.3895.2396.241.35
22136708-213670893.49796.02
32200290-220029096.27998.79
42135049-213504993.42495.96
52137441-213744193.52996.01
62124463-212446392.96195.45
120min12177364-217736495.27694.231.7598.3097.261.70
22192327-219232795.93198.98
32189975-218997595.82898.87
42105272-210527292.12195.18
52129714-212971493.19196.19
62126551-212655193.05396.06
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12214698-221469896.91098.741.31100.47102.291.27
22290178-2290178100.212103.79
32283866-228386699.936103.51
42243967-224396798.190101.76
52269527-226952799.309102.83
62236585-223658597.867101.39
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%
113.573100530880309893132530792309980.66
213.593094731149310480.47
单位质量响应值RSD%判断
2284.302284.620.01数据可信
长期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%
5min122896-2289663.28058.705.6063.2858.705.60
220144-2014455.67455.67
322506-2250662.20262.20
420320-2032056.16056.16
520432-2043256.47056.47
621140-2114058.42758.43
10min132662-3266290.27186.823.5290.6287.153.52
232361-3236189.43989.75
331553-3155387.20687.55
431291-3129186.48286.79
531075-3107585.88586.20
629542-2954281.64881.97
15min133544-3354492.70993.922.7593.5694.732.72
234299-3429994.79695.60
333435-3343592.40893.24
433930-3393093.77694.57
535665-3566598.57199.36
633018-3301891.25592.03
20min133763-3376393.31495.202.2794.6896.532.23
235324-3532497.62898.96
333391-3339192.28693.63
435175-3517597.21798.53
534795-3479596.16697.50
634222-3422294.58395.87
30min136009-3600999.52298.562.99101.41100.422.96
236812-36812101.741103.62
334977-3497796.66998.53
435621-3562198.449100.30
536584-36584101.111102.98
633958-3395893.85395.66
45min133880-3388093.63896.182.3796.0898.592.33
235447-3544797.968100.41
334609-3460995.65298.05
435851-3585199.085101.49
535138-3513897.11499.55
633869-3386993.60795.94
60min135076-3507696.94397.361.9299.90100.301.89
235918-3591899.270102.25
334759-3475996.06798.99
436158-3615899.933102.88
535034-3503496.82799.80
634425-3442595.14498.00
90min134827-3482796.255100.032.9299.75103.512.85
236453-36453100.749104.29
336915-36915102.026105.48
437215-37215102.855106.36
536837-36837101.810105.32
634908-3490896.47999.86
120min133468-3346892.49995.883.9696.5399.913.86
235707-3570798.687102.78
333796-3379693.40597.43
435948-3594899.353103.43
536112-3611299.806103.88
633109-3310991.50795.42
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134260-3426094.68897.134.5999.23101.704.46
236691-36691101.407106.05
333867-3386793.60298.15
436791-36791101.683106.31
536188-36188100.016104.65
633058-3305891.36695.79
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%
115.152080715207897320808192081556208026820804660.05
215.202086899208372720853130.11
单位质量响应值RSD%判断
137324.49137191.640.07数据可信
长期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%
5min1581332-58133225.41223.855.3525.4123.855.34
2525935-52593522.99022.99
3572657-57265725.03325.03
4523358-52335822.87822.88
5511203-51120322.34622.35
6558758-55875824.42524.43
10min11115331-111533148.75547.861.9648.9048.001.98
21090448-109044847.66747.79
31119413-111941348.93349.07
41073241-107324146.91547.04
51067987-106798746.68546.81
61103315-110331548.23048.37
15min11401414-140141461.26061.120.7161.6761.520.72
21397190-139719061.07661.47
31391759-139175960.83861.25
41382762-138276260.44560.83
51407627-140762761.53261.92
61408761-140876161.58261.99
20min11554423-155442367.94968.771.2968.7069.511.27
21564195-156419568.37669.11
31556516-155651668.04068.79
41590344-159034469.51970.24
51569011-156901168.58769.31
61605238-160523870.17070.92
30min11832616-183261680.11079.430.6881.2480.550.68
21823385-182338579.70680.82
31801457-180145778.74879.87
41803430-180343078.83479.94
51818372-181837279.48780.59
61822908-182290879.68580.82
45min12011444-201144487.92788.301.4789.5089.861.45
22034056-203405688.91590.47
32063599-206359990.20791.77
41982639-198263986.66888.22
51994671-199467187.19488.74
62033474-203347488.89090.47
60min12101131-210113191.84792.581.4193.9194.641.39
22125140-212514092.89794.95
32112819-211281992.35894.42
42117360-211736092.55794.59
52081410-208141090.98593.02
62170158-217015894.86596.94
90min12186097-218609795.56196.681.8598.1499.251.81
22259738-225973898.781101.35
32200237-220023796.18098.76
42158827-215882794.36996.91
52205336-220533696.40298.94
62260394-226039498.809101.41
120min12159802-215980294.41295.420.8697.5298.530.85
22188643-218864395.67398.79
32182269-218226995.39498.51
42190463-219046395.75298.82
52165004-216500494.63997.71
62211175-221117596.65899.81
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12194850-219485095.94495.960.4799.5799.590.48
22199780-219978096.16099.80
32184911-218491195.51099.15
42194941-219494195.94899.55
52184567-218456795.49599.09
62212204-221220496.703100.39
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%
113.573154131349310633106531422312880.69
213.593149031741316160.57
单位质量响应值RSD%判断
2305.672326.420.64数据可信
长期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%
5min122793-2279362.13761.167.6562.1461.167.64
222894-2289462.41362.41
319829-1982954.05754.06
423646-2364664.46364.46
524441-2444166.63066.63
620997-2099757.24157.24
10min131784-3178486.64885.621.8886.9985.961.90
231536-3153685.97286.32
330373-3037382.80283.10
432107-3210787.52987.89
531348-3134885.46085.83
631288-3128885.29685.61
15min134193-3419393.21692.762.7494.0493.572.73
235478-3547896.71997.54
333541-3354191.43892.20
434519-3451994.10594.95
533643-3364391.71692.56
632770-3277089.33690.13
20min135547-3554796.90795.932.3898.2597.262.38
236321-3632199.017100.38
333862-3386292.31393.58
435199-3519995.95897.33
535485-3548596.73898.09
634721-3472194.65595.94
30min134674-3467494.52795.821.5896.4197.691.58
235344-3534496.35498.27
334938-3493895.24797.03
435976-3597698.07799.98
535475-3547596.71198.60
634489-3448994.02395.84
45min135325-3532596.30295.601.4098.7198.001.39
234946-3494695.26997.72
335203-3520395.96998.28
435207-3520795.98098.43
535559-3555996.94099.37
634158-3415893.12095.46
60min135707-3570797.34396.082.50100.2999.012.47
234638-3463894.42997.41
334506-3450694.06996.91
436740-36740100.159103.14
535326-3532696.30599.27
634542-3454294.16797.02
90min136607-3660799.79797.753.10103.28101.213.05
235496-3549696.768100.27
334969-3496995.33198.70
437062-37062101.037104.57
536714-36714100.088103.59
634280-3428093.45396.83
120min137001-37001100.871100.112.81104.91104.112.77
237195-37195101.400105.44
336159-3615998.575102.47
438397-38397104.677108.77
536054-3605498.289102.35
635521-3552196.836100.73
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136643-3664399.89598.431.83104.49102.991.81
235753-3575397.469102.07
334974-3497495.34599.79
436553-3655399.650104.33
536630-3663099.859104.46
636073-3607398.341102.78
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%
115.152080731208103720822772081446207883820808660.07
215.202076630207349720750640.11
单位质量响应值RSD%判断
137350.89136517.370.44数据可信
长期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%
5min1564943-56494324.75424.997.0424.7524.997.04
2579901-57990125.41025.41
3515958-51595822.60822.61
4591743-59174325.92825.93
5629819-62981927.59727.60
6539157-53915723.62423.62
10min11064590-106459046.64747.232.9246.7847.362.94
21083651-108365147.48247.62
31040214-104021445.57945.70
41105167-110516748.42548.57
51121411-112141149.13749.29
61051875-105187546.09046.22
15min11353756-135375659.31859.982.3959.7160.382.40
21402947-140294761.47361.88
31330324-133032458.29158.67
41404087-140408761.52361.94
51384536-138453660.66661.09
61337575-133757558.60959.00
20min11534781-153478167.25068.842.5967.9869.582.60
21616470-161647070.82971.58
31542047-154204767.56868.27
41602648-160264870.22370.98
51604295-160429570.29671.06
61526863-152686366.90367.62
30min11740173-174017376.24978.171.8077.3579.281.81
21800256-180025678.88280.02
31777632-177763277.89178.97
41826376-182637680.02681.17
51802896-180289678.99880.15
61756563-175656376.96778.05
45min11970743-197074386.35286.321.9987.8887.881.99
21997339-199733987.51889.10
31940698-194069885.03686.55
41986914-198691487.06188.65
52015344-201534488.30789.90
61909276-190927683.65985.17
60min12082465-208246591.24891.031.5793.2593.061.57
22103104-210310492.15294.22
32066936-206693690.56792.55
42118321-211832192.81994.89
52069005-206900590.65892.74
62024845-202484588.72390.70
90min12165772-216577294.89894.872.0097.4197.412.00
22179122-217912295.48398.06
32165527-216552794.88797.37
42217020-221702097.14399.73
52178136-217813695.44098.03
62085684-208568491.38993.86
120min12208368-220836896.76498.421.9799.80101.481.97
22289464-2289464100.318103.42
32230503-223050397.734100.75
42279911-227991199.899103.03
52283262-2283262100.046103.16
62185573-218557395.76598.74
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12181232-218123295.57597.071.4599.15100.681.47
22236890-223689098.014101.68
32207072-220707296.707100.26
42257237-225723798.906102.59
52232007-223200797.800101.47
62177938-217793895.43198.94
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%
113.573206631869316843147531789317770.69
213.593204532096320700.12
单位质量响应值RSD%判断
2341.712359.820.55数据可信
长期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%
5min117815-1781547.84947.3711.7347.8547.3611.73
217290-1729046.43946.44
321160-2116056.83356.83
416647-1664744.71244.71
514866-1486639.92839.93
618033-1803348.43548.43
10min133141-3314189.01386.904.3289.2887.164.34
232256-3225686.63686.89
333956-3395691.20291.52
433270-3327089.35989.61
530207-3020781.13381.35
631301-3130184.07184.34
15min135983-3598396.64694.212.7597.4194.962.75
235873-3587396.35197.09
335104-3510494.28595.11
435298-3529894.80695.55
533324-3332489.50490.18
634869-3486993.65494.39
20min137572-37572100.91495.243.14102.2196.513.10
234912-3491293.77095.04
334849-3484993.60094.95
435616-3561695.66196.93
535341-3534194.92296.09
634463-3446392.56493.82
30min137259-37259100.07398.072.31101.9399.872.30
237765-37765101.432103.23
336443-3644397.88299.75
436190-3619097.20299.01
535797-3579796.14797.84
635625-3562595.68597.46
45min134378-3437892.33592.932.6894.7595.272.66
233707-3370790.53392.89
335861-3586196.31998.73
435503-3550395.35797.70
533582-3358290.19792.43
634559-3455992.82295.12
60min136643-3664398.41997.141.87101.35100.001.88
236910-3691099.136102.00
336143-3614397.076100.02
436343-3634397.613100.49
534971-3497193.92896.66
635980-3598096.63899.46
90min137035-3703599.47296.763.25102.95100.163.20
237305-37305100.197103.61
335845-3584596.27699.76
436635-3663598.397101.81
534436-3443692.49195.75
634907-3490793.75697.11
120min136215-3621597.26996.142.32101.30100.082.30
236615-3661598.344102.31
335353-3535394.95498.97
436695-3669598.559102.52
534679-3467993.14496.91
635209-3520994.56798.44
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135939-3593996.52895.331.35101.0999.801.35
236211-3621197.259101.77
335149-3514994.40698.95
435436-3543695.17799.69
535168-3516894.45798.74
635045-3504594.12798.53
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%
115.152076825207405120771932078024207605320764290.08
215.202075019207497420749960.01
单位质量响应值RSD%判断
137058.02136512.890.29数据可信
长期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%
5min1444408-44440819.49419.2011.9819.4919.2011.98
2405965-40596517.80717.81
3530219-53021923.25823.26
4411947-41194718.07018.07
5380768-38076816.70216.70
6452322-45232219.84119.84
10min11061858-106185846.57846.423.4446.6946.533.46
21033467-103346745.33245.43
31107625-110762548.58548.71
41079874-107987447.36847.47
51003041-100304143.99844.09
61063970-106397046.67046.78
15min11402320-140232061.51260.481.8161.8860.851.81
21364212-136421259.84060.19
31372634-137263460.21060.61
41412896-141289661.97662.34
51345301-134530159.01159.35
61375741-137574160.34660.72
20min11612995-161299570.75368.382.5171.4669.082.50
21505859-150585966.05466.74
31552824-155282468.11468.85
41593588-159358869.90270.61
51533864-153386467.28267.95
61553952-155395268.16368.87
30min11814622-181462279.59778.381.2580.7079.461.24
21770720-177072077.67278.72
31777231-177723177.95779.07
41809990-180999079.39480.49
51790658-179065878.54679.59
61758502-175850277.13678.22
45min11916192-191619284.05385.142.0885.6086.652.06
21874992-187499282.24683.73
31951213-195121385.58987.13
41979584-197958486.83388.37
51943212-194321285.23886.71
61980116-198011686.85788.37
60min12096003-209600391.94090.841.5793.9592.831.54
22078161-207816191.15793.10
32020231-202023188.61690.64
42100912-210091292.15594.18
52042756-204275689.60491.55
62087875-208787591.58493.58
90min12132543-213254393.54393.472.1096.0695.962.06
22134186-213418693.61596.06
32071030-207103090.84593.36
42201036-220103696.54799.08
52097353-209735391.99994.45
62149114-214911494.27096.77
120min12130475-213047593.45296.062.0596.4999.072.00
22171249-217124995.24198.21
32170567-217056795.21198.23
42262510-226251099.244102.31
52193565-219356596.22099.18
62211032-221103296.986100.01
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12175270-217527095.41796.021.4598.9899.571.41
22197044-219704496.37299.87
32132410-213241093.53797.08
42220195-222019597.388101.01
52200067-220006796.505100.00
62209538-220953896.920100.49
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