氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.616729946725246730766726156722786726970.05
214.606708906703796706340.06
单位质量响应值RSD%判断
46043.6045933.840.17数据可信
供试品溶液-2025011021批-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%
5min1257763-25776332.52430.908.8032.5230.908.79
2276473-27647334.88534.88
3236872-23687229.88829.89
4211976-21197626.74726.75
5243751-24375130.75630.76
6242593-24259330.61030.61
10min1559217-55921770.56167.823.9270.6267.873.93
2564956-56495671.28571.34
3526149-52614966.38866.44
4508950-50895064.21864.26
5534430-53443067.43367.48
6531202-53120267.02667.08
15min1733239-73323992.51991.052.0892.6991.222.09
2741093-74109393.51093.69
3706830-70683089.18689.35
4717757-71775790.56590.72
5703167-70316788.72488.89
6727667-72766791.81691.98
20min1786844-78684499.28398.961.5899.6199.281.57
2786777-78677799.27499.61
3765670-76567096.61196.92
4793043-793043100.065100.37
5774101-77410197.67597.99
6799107-799107100.830101.15
30min1784684-78468499.01099.171.4299.5099.651.42
2786097-78609799.18899.69
3777188-77718898.06498.53
4793610-793610100.136100.61
5771613-77161397.36197.83
6802479-802479101.255101.74
45min1785017-78501799.05299.061.9399.7199.711.92
2792885-792885100.045100.71
3762983-76298396.27296.91
4797344-797344100.607101.24
5771280-77128097.31997.96
6800902-800902101.056101.71
极限1783855-78385598.90598.712.0599.7399.522.05
2782860-78286098.78099.61
3762301-76230196.18696.98
4789258-78925899.587100.39
5768099-76809996.91797.72
6807407-807407101.877102.70
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.616712336710246724626705696709586712490.11
214.606717456708956713200.09
单位质量响应值RSD%判断
45944.4945980.820.06数据可信
供试品溶液-2025011021批-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%
5min1235777-23577729.76730.457.3129.7730.457.30
2272243-27224334.37134.37
3222040-22204028.03228.03
4247740-24774031.27731.28
5240129-24012930.31630.32
6229128-22912828.92728.93
10min1540116-54011668.18967.145.0368.2467.195.03
2570548-57054872.03172.09
3512456-51245664.69764.74
4495080-49508062.50462.56
5547139-54713969.07669.13
6525276-52527666.31666.36
15min1715562-71556290.33990.633.9790.5090.793.97
2751238-75123894.84395.02
3706300-70630089.17089.32
4671755-67175584.80984.97
5743820-74382093.90794.07
6718303-71830390.68590.84
20min1783405-78340598.90598.232.6699.2298.552.66
2788364-78836499.53199.87
3774854-77485497.82598.13
4743404-74340493.85494.15
5805627-805627101.710102.03
6772908-77290897.57997.89
30min1788361-78836199.53098.822.06100.0199.302.07
2787404-78740499.40999.91
3789315-78931599.651100.12
4756439-75643995.50095.95
5802749-802749101.347101.84
6772299-77229997.50297.97
45min1788071-78807199.49498.581.91100.1499.221.91
2784186-78418699.00399.67
3786298-78629899.27099.90
4756862-75686295.55396.17
5798930-798930100.865101.53
6770580-77058097.28597.92
极限1787837-78783799.46498.432.28100.2799.242.28
2785062-78506299.11499.95
3785542-78554299.17499.97
4750380-75038094.73595.51
5800901-800901101.113101.94
6768226-76822696.98897.79
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.616722226722496724286725436730086724900.05
214.606714176720556717360.07
单位质量响应值RSD%判断
46029.4346009.320.04数据可信
供试品溶液-2025011121批-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%
5min1308835-30883538.94233.078.8838.9433.078.88
2258929-25892932.64932.65
3250178-25017831.54631.55
4253052-25305231.90831.91
5246082-24608231.02931.03
6256314-25631432.32032.32
10min1562101-56210170.87869.401.7770.9469.451.77
2561647-56164770.82070.87
3550997-55099769.47769.53
4540225-54022568.11968.17
5546277-54627768.88268.93
6541062-54106268.22568.28
15min1736970-73697092.92792.381.3593.1192.551.36
2739211-73921193.21093.38
3745216-74521693.96794.14
4722751-72275191.13491.30
5731828-73182892.27992.45
6719589-71958990.73690.90
20min1803368-803368101.300100.111.22101.64100.431.22
2804138-804138101.397101.72
3789517-78951799.55399.88
4785731-78573199.07699.39
5799280-799280100.784101.10
6781360-78136098.52598.84
30min1808257-808257101.916100.331.18102.42100.821.18
2802769-802769101.224101.72
3793530-793530100.059100.55
4788615-78861599.44099.92
5798115-798115100.637101.13
6782727-78272798.69799.18
45min1813000-813000102.514100.491.40103.19101.151.40
2803893-803893101.366102.03
3792344-79234499.910100.57
4788726-78872699.454100.10
5801324-801324101.042101.70
6782572-78257298.67899.33
极限1808777-808777101.982100.121.33102.83100.951.33
2802279-802279101.162102.00
3789651-78965199.570100.39
4786731-78673199.202100.02
5796474-796474100.431101.25
6780164-78016498.37499.19
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.616715606717816717996719776716316717500.03
214.606717276724016720640.08
单位质量响应值RSD%判断
45978.7846031.780.09数据可信
供试品溶液-2025011121批-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%
5min1251107-25110731.67330.746.1131.6730.746.11
2264633-26463333.37933.38
3222073-22207328.01128.01
4240795-24079530.37230.37
5249926-24992631.52431.52
6233690-23369029.47629.48
10min1548101-54810169.13367.563.6669.1967.613.67
2563071-56307171.02271.08
3505531-50553163.76463.81
4526401-52640166.39666.45
5538473-53847367.91967.97
6532091-53209167.11467.16
15min1750956-75095694.72092.102.2894.8992.262.28
2745700-74570094.05794.23
3705682-70568289.00989.16
4723103-72310391.20791.37
5723080-72308091.20491.37
6732562-73256292.40092.56
20min1807102-807102101.802100.641.49102.13100.961.50
2805437-805437101.592101.92
3780316-78031698.42398.72
4789907-78990799.63399.95
5793559-793559100.094100.41
6811001-811001102.294102.61
30min1807030-807030101.793100.891.14102.29101.381.14
2806887-806887101.775102.27
3791420-79142099.824100.29
4789340-78934099.561100.04
5794747-794747100.243100.73
6810032-810032102.171102.66
45min1810511-810511102.232101.011.27102.90101.661.27
2808661-808661101.998102.67
3790684-79068499.731100.36
4791642-79164299.852100.50
5792528-79252899.964100.62
6810860-810860102.276102.93
极限1807535-807535101.856100.751.18102.69101.571.18
2802959-802959101.279102.12
3790662-79066299.728100.53
4789206-78920699.545100.36
5791599-79159999.846100.66
6810590-810590102.242103.07
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