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%
114.243377933647336723355733575336460.27
214.133344033511334760.15
单位质量响应值RSD%判断
2362.782369.140.20数据可信
供试品溶液-24032501批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135170-3517093.85595.343.9893.8595.343.98
235880-3588095.74995.75
335774-3577495.46795.47
437944-37944101.257101.26
536036-3603696.16696.17
633550-3355089.53289.53
10min138737-38737103.374103.421.80103.89103.951.80
237745-37745100.726101.26
338289-38289102.178102.71
439664-39664105.847106.41
538740-38740103.382103.92
639359-39359105.033105.53
15min137336-3733699.635102.462.45100.73103.562.44
237750-37750100.740101.83
337979-37979101.351102.45
439921-39921106.533107.68
538378-38378102.416103.52
638999-38999104.073105.15
20min137140-3714099.112101.042.88100.76102.712.85
236966-3696698.647100.30
337308-3730899.560101.22
438926-38926103.878105.62
537290-3729099.512101.19
639543-39543105.524107.18
30min137506-37506100.089101.531.89102.29103.771.88
237901-37901101.143103.34
337498-37498100.067102.28
438974-38974104.006106.33
537477-37477100.011102.24
638924-38924103.873106.12
45min136841-3684198.31499.941.63101.07102.741.63
236920-3692098.525101.29
337395-3739599.792102.56
438377-38377102.413105.31
537196-3719699.261102.05
637970-37970101.327104.15
60min136980-3698098.685100.672.23101.99104.022.21
237209-3720999.296102.60
337287-3728799.504102.83
438556-38556102.891106.36
537305-3730599.552102.89
639002-39002104.081107.47
90min136631-3663197.75499.542.17101.60103.452.15
237190-3719099.245103.11
336481-3648197.353101.23
438320-38320102.261106.30
536910-3691098.498102.39
638264-38264102.111106.07
120min1-0.0000.00-4.394.471.92
2-0.0004.41
3-0.0004.42
4-0.0004.61
5-0.0004.44
6-0.0004.53
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1-0.0000.00-4.394.471.92
2-0.0004.41
3-0.0004.42
4-0.0004.61
5-0.0004.44
6-0.0004.53
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100607-201804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%
114.842025080202054720209132020616202505820224430.12
214.902017098201994220185200.10
单位质量响应值RSD%判断
136283.22135471.140.43数据可信
供试品溶液-24032501批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1326165-32616514.40314.685.2614.4014.685.25
2324014-32401414.30814.31
3341546-34154615.08215.08
4351463-35146315.52015.52
5346328-34632815.29315.29
6304607-30460713.45113.45
10min1753908-75390833.29131.644.5033.3731.724.49
2748485-74848533.05233.13
3729543-72954332.21532.30
4698213-69821330.83230.92
5695114-69511430.69530.78
6673967-67396729.76129.84
15min1966728-96672842.68941.523.6742.9541.783.66
2979930-97993043.27243.53
3963093-96309342.52842.79
4928482-92848241.00041.26
5907241-90724140.06240.32
6896649-89664939.59439.83
20min11125410-112541049.69648.132.9050.2048.622.89
21122585-112258549.57150.07
31099798-109979848.56549.06
41064846-106484647.02147.51
51046969-104696946.23246.71
61080634-108063447.71948.18
30min11366334-136633460.33458.473.2261.1159.223.21
21378538-137853860.87361.65
31335160-133516058.95859.73
41297661-129766157.30258.05
51274611-127461156.28457.02
61291997-129199757.05257.78
45min11566243-156624369.16267.112.8670.2868.202.86
21557246-155724668.76569.88
31553937-155393768.61969.72
41485585-148558565.60066.67
51476090-147609065.18166.23
61479987-147998765.35366.40
60min11721466-172146676.01674.611.9277.5176.061.92
21715526-171552675.75477.25
31704483-170448375.26676.74
41641914-164191472.50473.93
51657954-165795473.21274.62
61695995-169599574.89276.30
90min11816432-181643280.21078.722.1782.1380.592.18
21834329-183432981.00082.92
31788931-178893178.99580.89
41743152-174315276.97478.81
51737790-173779076.73778.55
61775555-177555578.40580.23
120min1-0.0000.00-2.372.302.56
2-0.0002.37
3-0.0002.33
4-0.0002.26
5-0.0002.24
6-0.0002.26
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1-0.0000.00-2.372.302.56
2-0.0002.37
3-0.0002.33
4-0.0002.26
5-0.0002.24
6-0.0002.26
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%
114.243422133780340363373933739339030.64
214.133335633270333130.19
单位质量响应值RSD%判断
2380.832357.610.70数据可信
供试品溶液-24032501批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132517-3251786.65890.513.0986.6690.503.09
232911-3291187.70887.71
335294-3529494.05894.06
434414-3441491.71391.71
534504-3450491.95391.95
634125-3412590.94390.94
10min135229-3522993.88594.701.0994.3795.201.09
235386-3538694.30394.79
336064-3606496.11096.63
435701-3570195.14395.65
535035-3503593.36893.88
635788-3578895.37595.88
15min134781-3478192.69193.421.4293.6994.441.41
235208-3520893.82994.84
335826-3582695.47696.53
435337-3533794.17395.21
534620-3462092.26293.29
634544-3454492.05993.09
20min135125-3512593.60893.961.6295.1395.501.61
234773-3477392.67094.20
335878-3587895.61597.20
435963-3596395.84197.40
534564-3456492.11393.65
635231-3523193.89095.44
30min133951-3395190.47993.131.6292.5295.201.60
234960-3496093.16895.22
335472-3547294.53396.65
435474-3547494.53896.63
535045-3504593.39595.45
634776-3477692.67894.75
45min135715-3571595.18096.361.2797.7298.951.26
236300-3630096.73999.30
336785-3678598.032100.68
436487-3648797.23899.86
536057-3605796.09298.66
635600-3560094.87497.46
60min134647-3464792.33493.891.2695.4097.011.25
235213-3521393.84296.94
335612-3561294.90698.09
435431-3543194.42397.58
535718-3571895.18898.29
634763-3476392.64395.75
90min135300-3530094.07496.051.9497.6699.691.90
235701-3570195.14398.77
337223-3722399.199102.91
436218-3621896.521100.20
535522-3552294.66698.30
636283-3628396.694100.32
120min1-0.0000.00-4.114.181.37
2-0.0004.15
3-0.0004.27
4-0.0004.22
5-0.0004.16
6-0.0004.16
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1-0.0000.00-4.114.181.37
2-0.0004.15
3-0.0004.27
4-0.0004.22
5-0.0004.16
6-0.0004.16
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100607-201804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%
114.842036308203543920412022039168203170920367650.18
214.902011836200858320102100.12
单位质量响应值RSD%判断
137248.32134913.421.22数据可信
供试品溶液-24032501批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128672-286721.2641.348.581.261.348.61
226496-264961.1681.17
333301-333011.4681.47
429566-295661.3041.30
531513-315131.3901.39
632700-327001.4421.44
10min161069-610692.6932.723.312.702.723.34
258631-586312.5852.59
364250-642502.8332.84
460726-607262.6782.68
561581-615812.7152.72
663562-635622.8032.81
15min179197-791973.4923.481.933.513.501.90
277008-770083.3963.42
381586-815863.5983.62
478207-782073.4493.47
578571-785713.4653.49
679075-790753.4873.51
20min191773-917734.0474.031.844.094.071.89
288788-887883.9153.95
393415-934154.1194.16
491823-918234.0494.09
590213-902133.9784.02
692607-926074.0834.13
30min1104628-1046284.6144.681.104.684.751.13
2104977-1049774.6294.69
3107281-1072814.7314.80
4106360-1063604.6904.75
5107300-1073004.7314.80
6106823-1068234.7104.78
45min1124848-1248485.5055.490.575.595.580.55
2123607-1236075.4505.54
3125422-1254225.5305.62
4123960-1239605.4665.56
5124797-1247975.5035.59
6123859-1238595.4625.55
60min1131760-1317605.8105.770.965.935.900.96
2130143-1301435.7395.86
3130737-1307375.7655.89
4130540-1305405.7565.88
5133008-1330085.8655.99
6129511-1295115.7115.83
90min1137555-1375556.0656.121.456.226.281.46
2137922-1379226.0826.23
3141757-1417576.2516.41
4137470-1374706.0626.21
5137466-1374666.0626.22
6141150-1411506.2246.38
120min1-0.0000.00-0.190.192.17
2-0.0000.18
3-0.0000.19
4-0.0000.19
5-0.0000.19
6-0.0000.19
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1-0.0000.00-0.190.192.17
2-0.0000.18
3-0.0000.19
4-0.0000.19
5-0.0000.19
6-0.0000.19
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%
114.243349933530338003336333472335330.49
214.133337833494334360.25
单位质量响应值RSD%判断
2354.852366.310.35数据可信
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%
5min121313-2131357.00657.208.8657.0157.208.86
222166-2216659.28759.29
317923-1792347.93947.94
421614-2161457.81157.81
521631-2163157.85657.86
623673-2367363.31863.32
10min130512-3051281.61084.433.1981.9384.743.21
232176-3217686.06186.39
330364-3036481.21581.48
431411-3141184.01584.34
531967-3196785.50285.82
632959-3295988.15588.51
15min133411-3341189.36489.983.8490.1390.763.85
234697-3469792.80493.61
331766-3176684.96485.68
433087-3308788.49889.29
533433-3343389.42390.22
635452-3545294.82395.66
20min133975-3397590.87391.533.1392.1492.823.15
234640-3464092.65293.97
332273-3227386.32087.51
434448-3444892.13893.42
534525-3452592.34493.64
635459-3545994.84296.21
30min134438-3443892.11193.852.3793.8895.652.39
235606-3560695.23597.07
334117-3411791.25392.92
434684-3468492.76994.56
535352-3535294.55696.36
636340-3634097.19899.09
45min133805-3380590.41892.413.5592.7094.733.54
234346-3434691.86594.23
333340-3334089.17491.35
434881-3488193.29695.60
534116-3411691.25093.58
636818-3681898.477100.91
60min134586-3458692.50795.133.8495.2997.963.83
235775-3577595.68798.56
333747-3374790.26392.93
435526-3552695.02197.85
536010-3601096.31699.15
637754-37754100.981103.96
90min135254-3525494.29495.692.4197.5999.052.43
236377-3637797.297100.71
334902-3490293.35296.53
434913-3491393.38296.73
536301-3630197.094100.47
636908-3690898.718102.26
120min133568-3356889.78492.083.4893.6195.973.48
234280-3428091.68995.64
332967-3296788.17791.87
434524-3452492.34196.21
534749-3474992.94396.86
636469-3646997.544101.64
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136041-3604196.39995.821.67100.72100.221.71
235917-3591796.067100.53
335286-3528694.37998.56
435184-3518494.10798.49
535688-3568895.45599.88
636823-3682398.490103.12
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100607-201804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%
114.842013623201982620164532016955201404720161810.13
214.902013112202113420171230.29
单位质量响应值RSD%判断
135861.25135377.380.26数据可信
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%
5min1605343-60534326.78125.839.0526.7825.839.04
2615948-61594827.25127.25
3480734-48073421.26821.27
4583046-58304625.79525.79
5592721-59272126.22326.22
6625500-62550027.67327.67
10min11122003-112200349.63950.682.6349.7950.832.65
21172478-117247851.87252.02
31098619-109861948.60548.72
41145662-114566250.68650.83
51161220-116122051.37451.52
61173830-117383051.93252.09
15min11444269-144426963.89763.662.5764.3264.092.58
21466496-146649664.88065.32
31376928-137692860.91861.31
41430807-143080763.30163.73
51431064-143106463.31363.74
61484522-148452265.67866.12
20min11627444-162744472.00171.651.7872.7872.431.80
21631684-163168472.18872.99
31562162-156216269.11369.84
41630810-163081072.15072.93
51623094-162309471.80872.59
61642062-164206272.64773.45
30min11822834-182283480.64581.891.4681.8283.061.47
21861349-186134982.34983.55
31830817-183081780.99882.11
41838341-183834181.33182.51
51854548-185454882.04883.23
61897560-189756083.95185.16
45min12012025-201202589.01589.651.3690.6491.291.36
22014014-201401489.10390.76
32004339-200433988.67590.24
42013875-201387589.09790.73
52036676-203667690.10691.74
62077913-207791391.93093.61
60min12123605-212360593.95294.061.5596.0796.191.55
22101928-210192892.99395.15
32095815-209581592.72294.78
42111446-211144693.41495.54
52138561-213856194.61396.75
62185406-218540696.68698.87
90min12197737-219773797.23196.750.5199.8899.400.53
22185941-218594196.71099.38
32177023-217702396.31598.88
42176221-217622196.28098.92
52181253-218125396.50299.17
62202587-220258797.446100.17
120min12174214-217421496.19196.991.2199.37100.181.20
22164522-216452295.76298.97
32193270-219327097.034100.14
42197011-219701197.199100.38
52183918-218391896.62099.82
62240488-224048899.123102.39
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12243662-224366299.26398.210.96102.98101.940.93
22214643-221464397.979101.72
32227647-222764798.555102.20
42210192-221019297.782101.50
52185387-218538796.685100.42
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