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%
113.863190231890319193200831907319250.15
213.973176031965318620.46
单位质量响应值RSD%判断
2303.392280.740.70数据可信
影响因素30天-供试品溶液-2024042411批-左氨氯地平-磷酸盐缓冲液(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%
5min119298-1929853.16044.9811.1153.1644.9811.10
217453-1745348.07848.08
314953-1495341.19141.19
416566-1656645.63445.63
514818-1481840.81940.82
614875-1487540.97640.98
10min130540-3054084.12882.692.3584.4282.942.37
231158-3115885.83186.10
329669-2966981.72981.96
429906-2990682.38282.64
529578-2957881.47881.71
629253-2925380.58380.81
15min132176-3217688.63589.602.4889.4090.312.47
233938-3393893.48994.23
332695-3269590.06590.75
431647-3164787.17887.89
531994-3199488.13488.81
632708-3270890.10190.78
20min133070-3307091.09891.841.5992.3593.041.60
234401-3440194.76496.03
333278-3327891.67192.85
433046-3304691.03292.23
533218-3321891.50692.67
633022-3302290.96692.14
30min133165-3316591.36093.111.9893.1294.831.97
235045-3504596.53898.33
333843-3384393.22794.92
433295-3329591.71893.42
533707-3370792.85394.53
633756-3375692.98894.67
45min132462-3246289.42392.362.1991.6994.602.11
233135-3313591.27793.60
334013-3401393.69595.91
433651-3365192.69894.91
533330-3333091.81494.01
634583-3458395.26697.46
60min133628-3362892.63593.881.6795.4096.621.65
235173-3517396.89199.72
333868-3386893.29696.03
433681-3368192.78195.51
534101-3410193.93896.64
634024-3402493.72696.45
90min132018-3201888.20093.402.7791.4896.672.68
234275-3427594.41797.79
334225-3422594.27997.53
434405-3440594.77598.02
534021-3402193.71896.94
634488-3448895.00498.25
120min132434-3243489.34692.772.0793.1296.562.00
234093-3409393.91697.81
333668-3366892.74596.52
433474-3347492.21195.98
533938-3393893.48997.23
634448-3444894.89498.67
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133709-3370992.85893.811.2697.1298.111.26
234738-3473895.693100.11
333960-3396093.54997.84
433617-3361792.60596.88
533912-3391293.41797.68
634384-3438494.71799.02
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%
115.02 2059254205984620597902059806206035920598110.02
215.082058865205829720585810.02
单位质量响应值RSD%判断
137137.88136510.680.33数据可信
影响因素30天-供试品溶液-2024042411批-厄贝沙坦-磷酸盐缓冲液(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%
5min1431726-43172618.93215.7012.8518.9315.7012.85
2386204-38620416.93616.94
3340888-34088814.94914.95
4361474-36147415.85115.85
5321119-32111914.08214.08
6306348-30634813.43413.43
10min1948291-94829141.58540.542.9941.6940.633.01
2962142-96214242.19242.29
3917291-91729140.22540.31
4927590-92759040.67740.76
5904327-90432739.65739.73
6887590-88759038.92339.00
15min11226788-122678853.79753.821.6954.1354.131.70
21265946-126594655.51455.84
31220940-122094053.54153.85
41224111-122411153.68053.99
51223019-122301953.63253.93
61203341-120334152.76953.06
20min11412013-141201361.92062.321.4362.5562.941.44
21458138-145813863.94264.58
31421073-142107362.31762.92
41416881-141688162.13362.75
51422270-142227062.37062.97
61396980-139698061.26161.84
30min11639844-163984471.91172.900.9772.8973.860.97
21687371-168737173.99574.99
31669667-166966773.21874.17
41656139-165613972.62573.58
51666597-166659773.08474.03
61655215-165521572.58573.51
45min11817201-181720179.68881.311.0981.0782.681.06
21863502-186350281.71883.12
31871017-187101782.04883.40
41851940-185194081.21182.57
51870529-187052982.02783.38
61851295-185129581.18382.51
60min11926919-192691984.49985.780.8986.3287.600.88
21971711-197171186.46488.32
31965468-196546886.19088.00
41952446-195244685.61987.43
51971426-197142686.45188.26
61948954-194895485.46687.24
90min11986221-198622187.10090.061.6389.3992.361.59
22062642-206264290.45192.79
32068736-206873690.71893.01
42071219-207121990.82793.12
52072309-207230990.87593.16
62061653-206165390.40892.66
120min12044512-204451289.65691.681.1492.4394.471.11
22088804-208880491.59894.44
32108147-210814792.44795.24
42093808-209380891.81894.61
52103441-210344192.24095.03
62105393-210539392.32695.08
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12079962-207996291.21192.470.7794.4895.770.75
22108869-210886992.47895.83
32121443-212144393.03096.34
42104187-210418792.27395.58
52125068-212506893.18996.49
62112558-211255892.64095.91
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%
113.863186831995318363184031665318410.37
213.973176131644317020.27
单位质量响应值RSD%判断
2297.332269.290.87数据可信
影响因素30天-供试品溶液-2024042411批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114879-1487941.14546.8111.6941.1446.8111.68
215975-1597544.17644.18
315458-1545842.74642.75
416638-1663846.00946.01
519977-1997755.24255.24
618631-1863151.52051.52
10min130980-3098085.66986.012.9985.9086.273.01
230175-3017583.44383.69
329864-2986482.58382.82
431861-3186188.10588.36
532140-3214088.87789.18
631600-3160087.38387.67
15min134146-3414694.42494.183.1595.1394.923.15
232644-3264490.27090.98
332939-3293991.08691.78
435425-3542597.96198.71
534491-3449195.37896.18
634705-3470595.97096.74
20min133926-3392693.81595.942.7695.0497.202.78
233923-3392393.80795.02
333650-3365093.05294.25
435754-3575498.870100.16
535343-3534397.73499.06
635563-3556398.34299.65
30min134899-3489996.50696.652.6998.2698.442.69
234008-3400894.04295.77
334114-3411494.33596.05
436595-36595101.196103.03
535256-3525697.49399.37
634840-3484096.34398.19
45min134123-3412394.36096.413.3896.6598.743.37
233420-3342092.41694.67
333989-3398993.99096.23
435578-3557898.384100.78
535684-3568498.677101.09
636393-36393100.637103.02
60min135419-3541997.94498.412.97100.75101.272.97
234402-3440295.13297.90
334446-3444695.25398.02
437031-37031102.402105.35
535788-3578898.964101.93
636431-36431100.743103.69
90min135602-3560298.45098.282.75101.80101.702.76
234344-3434494.97198.27
334451-3445195.26798.56
436839-36839101.871105.39
535927-3592799.349102.86
636087-3608799.791103.30
120min133458-3345892.52195.304.1096.4299.264.05
232871-3287190.89894.72
333764-3376493.36897.19
436664-36664101.387105.47
535502-3550298.174102.24
634515-3451595.44499.50
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135206-3520697.35597.342.54101.77101.832.55
234320-3432094.90599.23
334267-3426794.75899.10
436668-36668101.398106.04
535112-3511297.095101.71
635632-3563298.533103.12
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%
115.02 2059030205960220586442058537205873420589090.03
215.082050474204174220461080.31
单位质量响应值RSD%判断
137077.83135683.550.73数据可信
影响因素30天-供试品溶液-2024042411批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1372659-37265916.39518.758.8616.4018.758.86
2432574-43257419.03119.03
3407835-40783517.94317.94
4413445-41344518.19018.19
5483227-48322721.26021.26
6447708-44770819.69719.70
10min11031845-103184545.39746.061.5345.4946.161.55
21043186-104318645.89646.00
31029383-102938345.28845.39
41048009-104800946.10846.21
51072154-107215447.17047.29
61056477-105647746.48046.59
15min11351344-135134459.45359.840.7559.8060.200.76
21355099-135509959.61859.98
31347175-134717559.27059.62
41368855-136885560.22460.58
51367032-136703260.14360.52
61371070-137107060.32160.69
20min11545429-154542967.99268.310.5768.6769.010.57
21553646-155364668.35469.05
31543438-154343867.90568.59
41561757-156175768.71169.40
51564384-156438468.82669.54
61547828-154782868.09868.80
30min11778793-177879378.25978.560.5779.3179.640.56
21792150-179215078.84779.92
31790428-179042878.77179.83
41797278-179727879.07280.15
51769342-176934277.84378.94
61786377-178637778.59379.67
45min11957798-195779886.13586.310.6987.6287.820.68
21954773-195477386.00287.51
31987282-198728287.43288.93
41947990-194799085.70387.22
51962297-196229786.33387.86
61960729-196072986.26487.78
60min12053740-205374090.35690.580.6792.3292.570.65
22051625-205162590.26392.25
32085168-208516891.73893.72
42061537-206153790.69992.69
52054222-205422290.37792.39
62046990-204699090.05992.06
90min12125805-212580593.52693.670.7495.9996.170.72
22123737-212373793.43595.92
32157646-215764694.92797.42
42123454-212345493.42395.92
52133129-213312993.84896.36
62111325-211132592.88995.39
120min12101726-210172692.46793.851.0495.4596.861.01
22126249-212624993.54696.55
32161810-216181095.11098.13
42154139-215413994.77397.78
52132376-213237693.81596.85
62122043-212204393.36196.37
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12135830-213583093.96794.100.6297.4797.630.60
22135268-213526893.94297.47
32163121-216312195.16898.71
42142795-214279594.27497.81
52128000-212800093.62397.18
62127950-212795093.62197.15
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%
113.863174931755317883172131597317220.24
213.973136331396313800.08
单位质量响应值RSD%判断
2288.742246.241.33数据可信
影响因素30天-供试品溶液-2024042411批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117606-1760649.02842.5812.0449.0342.5912.04
215185-1518542.28642.29
315722-1572243.78143.78
416798-1679846.77846.78
513739-1373938.25938.26
612704-1270435.37735.38
10min130083-3008383.77385.001.7684.0585.241.76
230305-3030584.39184.63
330546-3054685.06285.31
431397-3139787.43287.69
530854-3085485.92086.13
629964-2996483.44283.64
15min132388-3238890.19292.702.1590.9393.412.14
233174-3317492.38193.08
333451-3345193.15293.87
434277-3427795.45296.20
533815-3381594.16694.86
632629-3262990.86391.52
20min133138-3313892.28094.151.7293.5295.371.72
234179-3417995.17996.40
334222-3422295.29996.53
434241-3424195.35296.63
534080-3408094.90496.12
632992-3299291.87493.04
30min133299-3329992.72994.911.9294.4896.661.91
234142-3414295.07696.82
334599-3459996.34998.11
434669-3466996.54498.35
534540-3454096.18497.92
633250-3325092.59294.27
45min133910-3391094.43095.931.5096.7098.211.51
234277-3427795.45297.73
334983-3498397.41899.72
434939-3493997.29699.64
534754-3475496.78099.06
633827-3382794.19996.39
60min132523-3252390.56894.582.4393.3697.382.40
234160-3416095.12697.93
334190-3419095.21098.05
434966-3496697.371100.25
534307-3430795.53698.35
633631-3363193.65396.37
90min132385-3238590.18394.423.1293.4897.763.06
233490-3349093.26196.59
334256-3425695.39498.76
435165-3516597.925101.35
534885-3488597.145100.49
633266-3326692.63795.87
120min133407-3340793.02994.381.7296.8298.241.73
233880-3388094.34798.20
334333-3433395.60899.51
434767-3476796.817100.78
533762-3376294.01897.90
633208-3320892.47596.22
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132893-3289391.59893.851.6095.9198.241.61
233756-3375694.00198.38
334043-3404394.80099.23
434438-3443895.900100.41
533745-3374593.97198.38
633339-3333992.84097.10
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%
115.02 2052242205081320517502049065203827220484280.29
215.082046977204997220484740.11
单位质量响应值RSD%判断
136380.03135840.450.29数据可信
影响因素30天-供试品溶液-2024042411批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1444397-44439719.59016.1015.7819.5916.1015.79
2396037-39603717.45817.46
3366869-36686916.17216.17
4386669-38666917.04517.05
5307805-30780513.56913.57
6290137-29013712.79012.79
10min11016140-101614044.79443.523.3544.9043.613.37
21020671-102067144.99345.09
3992156-99215643.73643.83
4999803-99980344.07344.17
5953554-95355442.03542.11
6940640-94064041.46541.54
15min11318943-131894358.14257.232.0258.5057.562.04
21326899-132689958.49258.84
31310222-131022257.75758.09
41300315-130031557.32157.66
51266521-126652155.83156.14
61266521-126652155.83156.13
20min11497816-149781666.02765.701.6266.7166.351.63
21527211-152721167.32367.99
31501269-150126966.17966.83
41487620-148762065.57766.24
51463769-146376964.52665.15
61465225-146522564.59065.20
30min11746003-174600376.96775.811.5978.0176.821.61
21751575-175157577.21378.26
31730333-173033376.27777.30
41709802-170980275.37276.39
51684605-168460574.26175.24
61695918-169591874.76075.73
45min11921272-192127284.69483.701.1286.1785.131.15
21912757-191275784.31885.79
31911452-191145284.26185.71
41897875-189787583.66285.10
51865032-186503282.21583.60
61883317-188331783.02184.41
60min12003188-200318888.30587.581.1190.2589.481.11
22007172-200717288.48090.42
31984639-198463987.48789.40
41979811-197981187.27489.18
51947744-194774485.86187.71
61998044-199804488.07889.92
90min12064002-206400290.98690.501.2693.4292.881.27
22079609-207960991.67494.11
32066398-206639891.09193.49
42064867-206486791.02493.41
52011999-201199988.69391.02
62030749-203074989.52091.86
120min12085027-208502791.91291.250.9894.8594.140.99
22085311-208531191.92594.87
32081847-208184791.77294.68
42058909-205890990.76193.66
52034189-203418989.67192.49
62074357-207435791.44294.28
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12089332-208933292.10291.001.4195.5594.401.42
22101854-210185492.65496.11
32069622-206962291.23394.65
42040758-204075889.96193.36
52024303-202430389.23692.55
62060319-206031990.82394.16
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