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%
113.663273032709327473265332644326970.15
213.723249632402324490.21
单位质量响应值RSD%判断
2393.632365.090.85数据可信
供试品溶液-24032001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%
5min135302-3530293.68089.862.9493.6889.862.94
234279-3427990.96590.97
332307-3230785.73285.73
433622-3362289.22289.22
534157-3415790.64190.64
633514-3351488.93588.93
10min139522-39522104.878101.142.39105.40101.642.38
237459-3745999.40499.91
338081-38081101.054101.53
436931-3693198.00398.50
538011-38011100.868101.37
638666-38666102.607103.10
15min139292-39292104.268100.662.38105.37101.722.37
237358-3735899.136100.19
338249-38249101.500102.54
436697-3669797.38298.42
537655-3765599.924100.99
638352-38352101.773102.84
20min139376-39376104.491100.122.89106.17101.742.88
236780-3678097.60299.21
338086-38086101.068102.67
436275-3627596.26297.84
537909-37909100.598102.22
637948-37948100.701102.33
30min138830-38830103.04299.692.93105.30101.862.91
236758-3675897.54399.69
337803-37803100.317102.48
435913-3591395.30197.42
537527-3752799.584101.76
638570-38570102.352104.54
45min138677-38677102.63699.203.12105.47101.933.09
236907-3690797.939100.63
338605-38605102.445105.17
435596-3559694.46097.11
536958-3695898.074100.81
637552-3755299.650102.41
60min138800-38800102.96297.693.47106.37100.973.43
235910-3591095.29398.53
337384-3738499.205102.49
435211-3521193.43896.61
536305-3630596.34199.62
637265-3726598.889102.20
90min137299-3729998.97996.323.15102.96100.153.12
235215-3521593.44997.21
337380-3738099.194103.03
434593-3459391.79895.49
536529-3652996.936100.75
636776-3677697.591101.45
120min1-0.0000.00-4.534.362.56
2-0.0004.29
3-0.0004.39
4-0.0004.20
5-0.0004.35
6-0.0004.40
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1-0.0000.00-4.534.362.56
2-0.0004.29
3-0.0004.39
4-0.0004.20
5-0.0004.35
6-0.0004.40
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%
114.952046849204689320470292045827204411020461420.07
215.092040133203832520392290.07
单位质量响应值RSD%判断
136865.69135137.770.90数据可信
供试品溶液-24032001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%
5min1270864-27086411.95011.553.1411.9511.543.13
2272299-27229912.01412.01
3260063-26006311.47411.47
4258836-25883611.42011.42
5251520-25152011.09711.10
6256559-25655911.31911.32
10min1564400-56440024.90124.391.4524.9724.451.46
2560581-56058124.73224.80
3543636-54363623.98524.05
4550296-55029624.27824.34
5547365-54736524.14924.21
6550440-55044024.28524.35
15min1732131-73213132.30131.711.0432.5131.911.05
2722143-72214331.86032.06
3712949-71294931.45531.65
4714997-71499731.54531.74
5718219-71821931.68731.88
6712598-71259831.43931.64
20min1855941-85594137.76336.981.2738.1537.351.27
2832734-83273436.73937.12
3835005-83500536.83937.21
4830424-83042436.63737.01
5845886-84588637.32037.69
6828903-82890336.57036.94
30min11018063-101806344.91644.601.0345.5145.181.03
21004739-100473944.32844.91
31007422-100742244.44645.02
4995856-99585643.93644.51
51014383-101438344.75345.33
61025037-102503745.22345.80
45min11204564-120456453.14452.541.3453.9953.381.33
21195036-119503652.72453.56
31211786-121178653.46354.29
41170920-117092051.66052.48
51187244-118724452.38053.21
61176313-117631351.89852.72
60min11325843-132584358.49557.061.3559.6358.181.34
21285809-128580956.72857.85
31298322-129832257.28058.40
41277727-127772756.37257.48
51282348-128234856.57657.69
61290414-129041456.93258.05
90min11365726-136572660.25460.121.0761.7261.561.05
21347505-134750559.45060.89
31379403-137940360.85862.30
41346877-134687759.42360.84
51378792-137879260.83162.26
61358103-135810359.91861.35
120min1-0.0000.00-1.801.770.98
2-0.0001.77
3-0.0001.78
4-0.0001.75
5-0.0001.77
6-0.0001.76
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1-0.0000.00-1.801.770.98
2-0.0001.77
3-0.0001.78
4-0.0001.75
5-0.0001.77
6-0.0001.76
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%
113.663242432419323763244432460324250.10
213.723220532196322000.02
单位质量响应值RSD%判断
2373.722346.940.81数据可信
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%
5min117824-1782447.68051.175.1447.6851.175.14
218142-1814248.53148.53
320297-2029754.29654.30
419626-1962652.50152.50
519026-1902650.89650.90
619848-1984853.09453.09
10min131171-3117183.38483.141.8883.6583.431.88
230512-3051281.62181.89
330430-3043081.40281.70
431721-3172184.85585.15
531780-3178085.01385.30
630870-3087082.57982.87
15min133714-3371490.18790.471.5790.9191.221.56
233521-3352189.67090.39
333730-3373090.22990.98
433706-3370690.16590.93
534864-3486493.26394.02
633386-3338689.30990.06
20min134409-3440992.04691.782.1893.2893.032.15
234392-3439292.00093.22
333298-3329889.07490.33
435296-3529694.41995.68
534849-3484993.22394.50
633623-3362389.94391.19
30min134705-3470592.83893.241.6194.5895.001.58
234606-3460692.57394.31
334133-3413391.30893.06
435563-3556395.13396.92
534633-3463392.64594.44
635488-3548894.93296.68
45min136586-3658697.86995.772.46100.1398.042.41
236525-3652597.70699.95
334290-3429091.72893.98
435915-3591596.07498.39
536207-3620796.85699.16
635283-3528394.38496.66
60min135348-3534894.55896.492.9197.3699.302.86
236085-3608596.52999.32
334524-3452492.35395.12
436837-3683798.541101.39
537482-37482100.266103.11
636139-3613996.67499.48
90min137185-3718599.47298.301.82102.80101.641.78
237327-3732799.852103.18
335765-3576595.67398.95
437078-3707899.186102.58
537080-3708099.191102.59
636037-3603796.40199.74
120min137348-3734899.90897.482.67103.79101.382.57
237673-37673100.777104.66
335948-3594896.16399.97
435529-3552995.04298.99
536795-3679598.429102.38
635357-3535794.58298.46
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137544-37544100.43298.972.60104.87103.402.53
235912-3591296.066100.51
335669-3566995.41699.76
437964-37964101.556106.03
537586-37586100.544105.04
637303-3730399.787104.19
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100607-201804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%
114.952049543204985820497302049922205051620499140.02
215.092038942203981020393760.04
单位质量响应值RSD%判断
137117.99135147.511.03数据可信
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%
5min1515235-51523522.71024.094.8222.7124.094.82
2557303-55730324.56424.56
3570332-57033225.13825.14
4567634-56763425.02025.02
5511376-51137622.54022.54
6557350-55735024.56624.57
10min11102791-110279148.60849.641.7348.7349.771.74
21128689-112868949.74949.89
31110950-111095048.96749.11
41156422-115642250.97251.11
51119365-111936549.33849.46
61138371-113837150.17650.31
15min11415069-141506962.37263.220.8562.7763.630.85
21441661-144166163.54463.96
31423179-142317962.72963.14
41444075-144407563.65064.07
51442592-144259263.58563.98
61439324-143932463.44163.86
20min11576356-157635669.48170.391.2570.2271.151.25
21612487-161248771.07371.84
31574156-157415669.38470.14
41623102-162310271.54172.32
51590893-159089370.12270.87
61605210-160521070.75371.52
30min11807724-180772479.67981.171.7580.8182.321.74
21873615-187361582.58383.74
31807043-180704379.64980.79
41874867-187486782.63883.81
51824406-182440680.41481.56
61861086-186108682.03183.19
45min12002560-200256088.26789.152.0089.8490.751.97
22060128-206012890.80492.42
31961541-196154186.45988.05
42014116-201411688.77690.41
52024353-202435389.22790.82
62072623-207262391.35592.97
60min12129083-212908393.84395.852.2395.9197.952.20
22213139-221313997.54899.67
32099737-209973792.55094.62
42212306-221230697.51299.64
52203359-220335997.11799.20
62190618-219061896.55698.68
90min12254542-225454299.37399.502.34101.96102.142.30
22318083-2318083102.174104.84
32159506-215950695.18497.77
42273627-2273627100.215102.88
52268199-226819999.975102.60
62270971-2270971100.097102.76
120min12294906-2294906101.152101.391.78104.29104.581.75
22364891-2364891104.237107.47
32245057-224505798.955102.07
42289777-2289777100.926104.15
52325459-2325459102.499105.68
62282230-2282230100.594103.81
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12310284-2310284101.830102.192.43105.53105.942.38
22308528-2308528101.753105.57
32225394-222539498.089101.75
42356073-2356073103.848107.63
52317270-2317270102.138105.89
62392792-2392792105.467109.24
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