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%
113.843220432196322613228632160322210.16
214.013221132180321960.07
单位质量响应值RSD%判断
2328.112298.070.92数据可信
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%
5min114441-1444139.42028.5023.6539.4228.5023.65
211924-1192432.54932.55
39671-967126.39926.40
49309-930925.41125.41
510074-1007427.49927.50
67236-723619.75219.75
10min129486-2948680.48876.803.1680.7176.963.20
228721-2872178.40078.58
328272-2827277.17477.32
427750-2775075.74975.89
527569-2756975.25575.41
627004-2700473.71373.82
15min132899-3289989.80587.392.7290.4787.972.75
232604-3260488.99989.62
332862-3286289.70490.28
431366-3136685.62086.18
531398-3139885.70786.28
630952-3095284.49085.01
20min133817-3381792.31189.982.9693.4891.062.97
233456-3345691.32592.44
334131-3413193.16894.24
432249-3224988.03089.07
531694-3169486.51587.56
632441-3244188.55589.54
30min133521-3352191.50392.772.6193.1894.342.59
234508-3450894.19795.81
335325-3532596.42798.02
434204-3420493.36794.89
533532-3353291.53393.06
632812-3281289.56791.05
45min135113-3511395.84894.803.3698.0396.883.35
235854-3585497.871100.01
336240-3624098.925101.05
433710-3371092.01994.06
533538-3353891.54993.59
633920-3392092.59294.57
60min134481-3448194.12394.962.6996.8497.582.68
236085-3608598.502101.19
335786-3578697.685100.36
433941-3394192.64995.21
533878-3387892.47795.02
634563-3456394.34796.84
90min134632-3463294.53595.762.1097.7898.902.09
235669-3566997.366100.60
336269-3626999.004102.22
434337-3433793.73096.80
534865-3486595.17198.23
634718-3471894.77097.79
120min134200-3420093.35695.233.2197.1298.903.16
235221-3522196.14399.92
336940-36940100.835104.60
434765-3476594.89898.49
534405-3440593.91697.50
633790-3379092.23795.78
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134051-3405192.94994.551.2897.2398.761.29
235260-3526096.250100.56
335062-3506295.709100.04
434490-3449094.14898.27
534488-3448894.14298.25
634483-3448394.12998.18
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%
114.982064196206366520537862065927205763120610410.25
215.102063293205444920588710.31
单位质量响应值RSD%判断
137586.18136349.070.64数据可信
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%
5min1369885-36988516.20411.4824.4416.2011.4824.44
2299324-29932413.11213.11
3238609-23860910.45310.45
4238507-23850710.44810.45
5240398-24039810.53110.53
6185223-1852238.1148.11
10min1944216-94421641.36337.066.3741.4537.126.40
2868013-86801338.02538.10
3821038-82103835.96736.03
4825310-82531036.15436.21
5823762-82376236.08636.14
6792903-79290334.73534.78
15min11256657-125665755.05050.055.4655.3750.325.49
21170940-117094051.29551.58
31121740-112174049.14049.40
41113282-111328248.76949.03
51091687-109168747.82348.08
61100978-110097848.23048.47
20min11448177-144817763.44057.455.7364.0758.005.75
21340162-134016258.70859.28
31289781-128978156.50157.03
41266198-126619855.46856.00
51236644-123664454.17354.70
61287296-128729656.39256.90
30min11701041-170104174.51768.485.0375.5069.355.05
21602396-160239670.19671.09
31537010-153701067.33268.18
41534443-153444367.21968.06
51476340-147634064.67465.50
61528534-152853466.96067.78
45min11933992-193399284.72277.926.1286.1179.176.12
21866037-186603781.74583.03
31779082-177908277.93679.15
41701684-170168474.54575.76
51633258-163325871.54872.73
61758909-175890977.05278.24
60min11999630-199963087.59884.454.9589.4686.134.93
21969886-196988686.29588.03
32035450-203545089.16790.82
41820301-182030179.74281.37
51803897-180389779.02380.61
61937399-193739984.87186.49
90min12080599-208059991.14589.902.0093.4992.052.02
22073270-207327090.82393.04
32049525-204952589.78391.93
41981270-198127086.79388.86
52034457-203445789.12391.14
62094236-209423691.74293.83
120min12077960-207796091.02991.641.6893.8894.291.64
22076787-207678790.97893.70
32160556-216055694.64797.29
42066328-206632890.51993.07
52074366-207436690.87193.39
62096128-209612891.82594.43
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12073916-207391690.85291.781.5494.2194.931.46
22099023-209902391.95295.18
32065923-206592390.50293.67
42074499-207449990.87793.93
52103665-210366592.15595.18
62153012-215301294.31797.43
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