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%
114.556745546743426744906760706741766747260.12
214.586740776746746743760.07
单位质量响应值RSD%判断
46372.9246253.500.19数据可信
供试品溶液-2025011021批-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%
5min1274665-27466534.41431.3410.7234.4131.3410.72
2265241-26524133.23333.23
3267081-26708133.46433.46
4223548-22354828.00928.01
5209440-20944026.24226.24
6260724-26072432.66732.67
10min1549465-54946568.84563.287.9168.9063.337.91
2526627-52662765.98366.04
3515068-51506864.53564.59
4477626-47762659.84459.89
5438913-43891354.99355.04
6522406-52240665.45465.51
15min1714796-71479689.56084.486.0189.7384.646.01
2697914-69791487.44587.61
3683185-68318585.59985.76
4656000-65600082.19382.34
5601689-60168975.38875.52
6691872-69187286.68786.85
20min1775827-77582797.20796.413.8197.5396.713.82
2791761-79176199.20399.51
3781838-78183897.96098.27
4772218-77221896.75497.04
5711293-71129389.12189.38
6783786-78378698.20498.51
30min1776418-77641897.28199.962.0997.76100.422.08
2805079-805079100.872101.35
3809378-809378101.410101.88
4819671-819671102.700103.14
5781889-78188997.96698.38
6794346-79434699.527100.00
45min1774890-77489097.08999.942.1597.73100.572.14
2804652-804652100.818101.46
3811464-811464101.672102.31
4818855-818855102.598103.21
5782290-78229098.01698.59
6793908-79390899.472100.11
极限1774818-77481897.08099.802.1197.89100.592.10
2804327-804327100.777101.59
3809166-809166101.384102.19
4817397-817397102.415103.20
5780221-78022197.75798.49
6793055-79305599.365100.17
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%
114.556714426714516715216711316714096713910.03
214.586704146710376707260.07
单位质量响应值RSD%判断
46143.7146003.160.22数据可信
供试品溶液-2025011021批-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%
5min1302959-30295938.15733.3519.6538.1633.3519.65
2283950-28395035.76235.76
3298840-29884037.63837.64
4270288-27028834.04234.04
5270409-27040934.05734.06
6162362-16236220.44920.45
10min1580124-58012473.06467.4311.7073.1367.4911.71
2564047-56404771.04071.10
3578314-57831472.83672.90
4536055-53605567.51467.57
5540742-54074268.10468.16
6413257-41325752.04852.08
15min1737018-73701892.82587.947.8593.0188.117.87
2717412-71741290.35590.53
3734014-73401492.44692.63
4705590-70559088.86689.04
5705593-70559388.86789.04
6589801-58980174.28374.40
20min1776905-77690597.84896.544.0798.1996.854.09
2762620-76262096.04996.38
3788299-78829999.28399.62
4794958-794958100.122100.44
5768270-76827096.76197.08
6707911-70791189.15989.40
30min1784926-78492698.85898.161.5099.3698.641.51
2762918-76291896.08796.58
3789819-78981999.47599.98
4792937-79293799.867100.35
5772001-77200197.23197.71
6773894-77389497.46997.86
45min1776150-77615097.75398.181.2898.4298.821.29
2768859-76885996.83597.48
3789600-78960099.447100.12
4793978-79397899.999100.65
5773712-77371297.44698.09
6774734-77473497.57598.13
极限1772484-77248497.29197.791.6398.1298.591.63
2759503-75950395.65796.47
3792741-79274199.843100.68
4790127-79012799.514100.33
5770796-77079697.07997.88
6772966-77296697.35298.07
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%
114.556745456747916744486741526739456743760.05
214.586735216730226732720.06
单位质量响应值RSD%判断
46348.8746177.780.27数据可信
供试品溶液-2025011121批-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%
5min1245083-24508330.74131.7726.5230.7431.7726.52
2313901-31390139.37239.37
3264029-26402933.11733.12
4124612-12461215.63015.63
5285573-28557335.81935.82
6286500-28650035.93635.94
10min1498216-49821662.49164.1918.2062.5464.2418.21
2587230-58723073.65673.72
3539510-53951067.67067.73
4331275-33127541.55241.58
5553422-55342269.41569.48
6560887-56088770.35270.41
15min1670275-67027584.07284.7714.2684.2384.9314.27
2743594-74359493.26993.46
3704298-70429888.34088.51
4486027-48602760.96261.06
5723108-72310890.69990.87
6727683-72768391.27391.45
20min1773704-77370497.04594.6010.0197.3494.9010.03
2780541-78054197.90398.25
3781031-78103197.96498.28
4601123-60112375.39975.60
5795656-79565699.799100.13
6793055-79305599.47299.80
30min1801025-801025100.47298.253.08100.9398.713.12
2781015-78101597.96298.47
3784030-78403098.34098.82
4737350-73735092.48592.81
5800701-800701100.431100.92
6795843-79584399.822100.32
45min1802249-802249100.62699.241.24101.2599.861.26
2781422-78142298.01398.68
3785707-78570798.55199.19
4780564-78056497.90698.38
5799256-799256100.250100.91
6798230-798230100.122100.78
极限1801082-801082100.47999.181.19101.2799.971.20
2779349-77934997.75398.59
3785466-78546698.52199.33
4782502-78250298.14998.79
5798215-798215100.120100.95
6797659-797659100.050100.88
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%
114.556742986744276748906748316744566745800.04
214.586751026745886748450.06
单位质量响应值RSD%判断
46362.8946285.670.12数据可信
供试品溶液-2025011121批-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%
5min1288320-28832036.11635.924.6336.1235.924.62
2311107-31110738.97138.97
3285666-28566635.78435.78
4273872-27387234.30634.31
5276102-27610234.58634.59
6285397-28539735.75035.75
10min1565642-56564270.85570.943.9670.9171.003.97
2610564-61056476.48276.55
3561349-56134970.31770.38
4549477-54947768.83068.89
5552633-55263369.22569.28
6558498-55849869.96070.02
15min1734674-73467492.02892.042.7292.2192.222.72
2773961-77396196.94997.14
3730906-73090691.55691.73
4719563-71956390.13590.31
5725487-72548790.87791.05
6723844-72384490.67290.85
20min1798004-79800499.96199.831.68100.29100.161.69
2816233-816233102.245102.60
3808192-808192101.237101.57
4780418-78041897.75898.08
5787988-78798898.70799.03
6790703-79070399.04799.37
30min1802142-802142100.48099.881.82100.98100.381.83
2817991-817991102.465102.99
3807517-807517101.153101.65
4778663-77866397.53898.02
5790016-79001698.96199.45
6787677-78767798.66899.16
45min1804202-804202100.73899.981.86101.40100.651.86
2818994-818994102.591103.29
3808584-808584101.287101.95
4779723-77972397.67198.32
5787904-78790498.69699.35
6789688-78968898.92099.58
极限1803098-803098100.59999.841.81101.43100.671.82
2817268-817268102.374103.24
3806340-806340101.005101.84
4777752-77775297.42498.23
5788720-78872098.79899.62
6789118-78911898.84899.67
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%
114.556710146721146716326713696722036716660.08
214.586709896715036712460.06
单位质量响应值RSD%判断
46162.6146038.820.19数据可信
供试品溶液-2025011221批-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%
5min1174636-17463621.98232.6420.9721.9832.6420.97
2296050-29605037.26437.26
3264372-26437233.27733.28
4320553-32055340.34940.35
5216081-21608127.19827.20
6283988-28398835.74635.75
10min1408574-40857451.42864.9314.6751.4664.9814.67
2571389-57138971.92271.98
3525576-52557666.15566.21
4606923-60692376.39476.46
5444311-44431155.92655.97
6538136-53813667.73667.80
15min1581129-58112973.14886.1511.0573.2786.3211.06
2742157-74215793.41793.60
3693976-69397687.35287.52
4775855-77585597.65897.85
5608778-60877876.62876.77
6704710-70471088.70388.88
20min1697962-69796287.85495.875.7188.1096.175.73
2801819-801819100.926101.26
3782395-78239598.48198.79
4794096-79409699.954100.31
5716456-71645690.18190.45
6777084-77708497.81398.13
30min1773565-77356597.37099.231.4697.7699.701.49
2803728-803728101.167101.67
3794090-79409099.953100.43
4796129-796129100.210100.73
5782894-78289498.54498.96
6779645-77964598.13598.62
45min1772497-77249797.23599.111.5397.7999.741.56
2803575-803575101.147101.82
3792836-79283699.796100.44
4795777-795777100.166100.86
5783481-78348198.61899.20
6776231-77623197.70598.35
极限1773503-77350397.36299.071.4898.0899.871.51
2803227-803227101.103101.95
3792233-79223399.720100.53
4794914-794914100.057100.92
5782709-78270998.52199.27
6775915-77591597.66698.48
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%
114.556707336710816708146706416715856709710.06
214.586708636707376708000.02
单位质量响应值RSD%判断
46114.8546008.230.17数据可信
供试品溶液-2025011221批-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%
5min1282732-28273235.61832.9325.6035.6232.9325.60
2293260-29326036.94436.94
3288138-28813836.29936.30
4288117-28811736.29736.30
5291120-29112036.67536.67
6125045-12504515.75315.75
10min1543137-54313768.42466.1219.6768.4866.1719.68
2573114-57311472.20072.26
3567454-56745471.48771.55
4577736-57773672.78272.84
5571970-57197072.05672.12
6315671-31567139.76839.79
15min1708965-70896589.31487.7216.2389.4987.8816.24
2739011-73901193.10093.28
3731413-73141392.14292.32
4748800-74880094.33394.51
5779171-77917198.15998.34
6470529-47052959.27759.37
20min1781277-78127798.42495.0710.8798.7595.3810.90
2795604-795604100.229100.57
3779702-77970298.22698.56
4799168-799168100.678101.02
5784010-78401098.76999.11
6588017-58801774.07874.27
30min1782100-78210098.52898.273.0999.0198.743.15
2796968-796968100.401100.91
3784695-78469598.85599.35
4799704-799704100.746101.25
5783614-78361498.71999.23
6733293-73329392.37992.69
45min1779409-77940998.18999.300.9498.8499.930.95
2795859-795859100.261100.93
3784887-78488798.87999.54
4797943-797943100.524101.20
5782595-78259598.59099.26
6788526-78852699.33799.81
极限1778479-77847998.07299.211.0198.89100.011.00
2795074-795074100.162101.00
3783065-78306598.64999.48
4797072-797072100.414101.26
5780178-78017898.28699.12
6791043-79104399.655100.29
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