恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.109491694966948059451894609947630.21
210.149494194971949560.03
单位质量响应值RSD%判断
9382.489364.500.14数据可信
供试品溶液-2024112921批-恩格列净-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%
5min148719-4871946.77843.4610.9346.7843.4610.93
238633-3863337.09437.09
350607-5060748.59148.59
445739-4573943.91743.92
548090-4809046.17446.17
639821-3982138.23438.23
10min193660-9366089.92881.308.8790.0181.378.87
277491-7749174.40374.47
389114-8911485.56385.64
490292-9029286.69486.77
582446-8244679.16179.24
675018-7501872.02972.09
15min199950-9995095.96893.523.5596.2093.723.56
294334-9433490.57590.76
3101523-10152397.47897.70
4100038-10003896.05296.27
594365-9436590.60590.81
694165-9416590.41390.60
20min1100571-10057196.56496.961.2696.9597.321.26
2101538-10153897.49297.83
3102128-10212898.05998.44
4101388-10138897.34897.73
598604-9860494.67595.04
6101651-10165197.60197.94
30min1100657-10065796.64697.621.6197.2098.151.59
2102979-10297998.87699.38
3101955-10195597.89398.44
4101246-10124697.21297.75
599326-9932695.36895.89
6103869-10386999.730100.23
45min1100220-10022096.22797.391.6096.9498.081.58
2102983-10298398.88099.54
3101965-10196597.90298.61
4101154-10115497.12497.83
599049-9904995.10295.78
6103217-10321799.10499.77
60min199804-9980495.82797.201.6496.7098.051.62
2103035-10303598.93099.76
3101549-10154997.50398.38
4101044-10104497.01897.88
598961-9896195.01895.85
6102989-10298998.88599.71
极限199681-9968195.70997.241.7796.7498.251.75
2103493-10349399.369100.36
3101696-10169697.64498.68
4100760-10076096.74597.77
599004-9900495.05996.05
6102990-10299098.88699.88
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.089672889680759700859691439680659685310.12
210.119756699758959757820.02
单位质量响应值RSD%判断
96084.4296516.520.32数据可信
供试品溶液-2024112921批-二甲双胍-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%
5min1568039-56803953.08849.459.9753.0949.469.97
2457570-45757042.76442.76
3584719-58471954.64754.65
4528960-52896049.43649.44
5562111-56211152.53452.53
6473584-47358444.26044.26
10min1987810-98781092.31984.347.6892.4184.427.69
2832075-83207577.76477.84
3943800-94380088.20688.30
4948911-94891188.68388.77
5887080-88708082.90582.99
6814858-81485876.15576.23
15min11032234-103223496.47094.362.8696.7194.592.87
2980839-98083991.66791.87
31044023-104402397.57297.81
41029938-102993896.25696.49
5990432-99043292.56492.79
6980598-98059891.64591.85
20min11038291-103829197.03797.240.8797.4497.620.86
21044514-104451497.61897.97
31049489-104948998.08398.48
41039999-103999997.19697.59
51024292-102429295.72896.11
61046506-104650697.80498.16
30min11037332-103733296.94797.691.2297.5198.241.20
21055601-105560198.65499.17
31045360-104536097.69798.26
41039123-103912397.11497.67
51030145-103014596.27596.81
61064422-106442299.479100.00
45min11032992-103299296.54197.321.2097.2798.031.18
21053303-105330398.44099.12
31045074-104507497.67098.40
41032155-103215596.46397.18
51026941-102694195.97696.68
61057509-105750998.83399.51
60min11029280-102928096.19497.161.2097.0898.031.18
21053244-105324498.43499.28
31042503-104250397.43098.32
41034073-103407396.64297.52
51024566-102456695.75496.61
61054297-105429798.53299.38
极限11026358-102635895.92196.881.2196.9797.911.19
21051382-105138298.26099.27
31039090-103909097.11198.16
41030016-103001696.26397.30
51022027-102202795.51796.54
61050759-105075998.20299.21
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.109448794600946349478794593946200.12
210.149503094989950100.04
单位质量响应值RSD%判断
9368.329369.820.02数据可信
供试品溶液-2024120321批-恩格列净-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%
5min130597-3059729.39235.8514.4929.3935.8514.49
238400-3840036.88736.89
338363-3836336.85236.85
432782-3278231.49131.49
546149-4614944.33144.33
637625-3762536.14336.14
10min166285-6628563.67472.629.7363.7272.689.73
277203-7720374.16274.22
377981-7798174.90974.97
468722-6872266.01566.07
586872-8687283.45083.52
676540-7654073.52573.59
15min188751-8875185.25590.654.3385.4190.834.34
293743-9374390.05090.24
396541-9654192.73892.92
491363-9136387.76487.93
5100428-10042896.47296.68
695378-9537891.62191.80
20min198249-9824994.37995.981.2794.6896.321.29
299078-9907895.17595.51
3101287-10128797.29797.64
499350-9935095.43695.75
5101434-10143497.43897.81
6100119-10011996.17596.51
30min199969-9996996.03196.861.1796.4997.351.18
299639-9963995.71496.21
3102770-10277098.72299.22
4100068-10006896.12696.59
5101400-10140097.40697.94
6101150-10115097.16597.66
45min1102817-10281798.76799.441.3499.38100.101.35
2102185-10218598.16098.81
3105844-105844101.675102.34
4102434-10243498.39999.03
5104323-104323100.213100.91
6103527-10352799.449100.11
60min1102492-10249298.45599.231.4099.23100.051.41
2101723-10172397.71698.53
3105618-105618101.457102.29
4102456-10245698.42099.21
5104358-104358100.247101.11
6103176-10317699.11299.94
极限1102934-10293498.87999.571.3299.82100.561.33
2102626-10262698.58399.56
3106051-106051101.873102.88
4102455-10245598.41999.38
5104351-104351100.240101.27
6103510-10351099.432100.42
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.089689369708399706969708239708289704240.09
210.119735139735879735500.01
单位质量响应值RSD%判断
96272.2296295.750.02数据可信
供试品溶液-2024120321批-二甲双胍-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%
5min1376810-37681035.22241.8012.5235.2241.8012.52
2458135-45813542.82342.82
3454202-45420242.45642.46
4400955-40095537.47937.48
5538512-53851250.33750.34
6454405-45440542.47542.47
10min1736790-73679068.87076.578.0468.9376.648.04
2834885-83488578.04078.11
3835984-83598478.14278.21
4756616-75661670.72470.79
5920629-92062986.05486.14
6829875-82987577.57177.64
15min1943358-94335888.17992.303.2188.3592.503.22
2983910-98391091.97092.17
3999287-99928793.40793.61
4964626-96462690.16790.35
51034840-103484096.73096.96
6998953-99895393.37693.58
20min11024519-102451995.76596.650.7196.0997.000.72
21028827-102882796.16896.52
31040997-104099797.30697.66
41029536-102953696.23496.56
51041870-104187097.38797.78
61037871-103787197.01397.37
30min11037517-103751796.98097.140.6797.4697.660.68
21031512-103151296.41996.93
31050916-105091698.23398.75
41033282-103328296.58497.08
51040584-104058497.26797.82
61041665-104166597.36897.89
45min11062888-106288899.35299.360.8299.99100.030.82
21054191-105419198.53999.21
31078115-1078115100.775101.46
41055008-105500898.61599.27
51064125-106412599.467100.18
61063335-106333599.394100.07
60min11060160-106016099.09799.120.8599.9099.960.86
21048686-104868698.02498.86
31075122-1075122100.495101.35
41054255-105425598.54599.36
51063494-106349499.408100.29
61060574-106057499.13699.98
极限11055904-105590498.69998.900.8499.6799.900.84
21050872-105087298.22999.23
31072801-1072801100.278101.30
41047986-104798697.95998.94
51059835-105983599.066100.11
61060944-106094499.170100.18
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.109513995248953589513695267952300.10
210.149514395012950780.10
单位质量响应值RSD%判断
9428.719376.530.40数据可信
供试品溶液-2024120321批-恩格列净-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%
5min137295-3729535.69835.4515.1835.7035.4515.18
229481-2948128.21928.22
335054-3505433.55333.55
435544-3554434.02234.02
538118-3811836.48636.49
646697-4669744.69844.70
10min177328-7732874.01774.1311.5774.0874.1911.57
267414-6741464.52864.57
373893-7389370.72970.79
474165-7416570.99071.05
577781-7778174.45174.51
694087-9408790.05990.13
15min195009-9500990.94192.844.7791.1293.024.79
292188-9218888.24188.40
395577-9557791.48591.66
497718-9771893.53493.71
595758-9575891.65891.84
6105696-105696101.171101.40
20min1101555-10155597.20798.481.8697.5498.821.88
2101748-10174897.39297.69
3101588-10158897.23997.57
4102995-10299598.58698.92
5102845-10284598.44298.78
6106557-106557101.995102.39
30min1101952-10195297.58799.581.5498.08100.081.56
2103930-10393099.48099.94
3103509-10350999.07899.57
4103252-10325298.83299.33
5104954-104954100.461100.96
6106627-106627102.062102.63
45min1104234-10423499.771102.221.91100.43102.891.92
2107047-107047102.464103.09
3105328-105328100.819101.47
4106178-106178101.632102.29
5108045-108045103.419104.09
6109937-109937105.230105.96
60min1104032-10403299.578102.021.90100.40102.861.91
2107293-107293102.699103.50
3104812-104812100.325101.15
4106064-106064101.523102.35
5107839-107839103.222104.06
6109481-109481104.794105.70
极限1104818-104818100.330102.231.63101.32103.241.65
2106867-106867102.292103.26
3105320-105320100.811101.80
4106224-106224101.676102.67
5108194-108194103.562104.58
6109375-109375104.692105.78
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.089750639757239761519743529756349753850.08
210.119732289726669729470.05
单位质量响应值RSD%判断
96764.3896236.100.39数据可信
供试品溶液-2024120321批-二甲双胍-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%
5min1443952-44395241.40541.2512.7941.4141.2512.79
2366655-36665534.19634.20
3420192-42019239.18939.19
4429024-42902440.01340.01
5454138-45413842.35542.36
6539548-53954850.32150.32
10min1830374-83037477.44577.409.7677.5177.469.76
2738871-73887168.91168.97
3797957-79795774.42174.49
4798197-79819774.44474.51
5834013-83401377.78477.85
6979752-97975291.37691.46
15min1987505-98750592.09993.413.8292.3093.613.83
2960903-96090389.61889.79
3986702-98670292.02492.21
41009070-100907094.11194.30
5992189-99218992.53692.74
61072945-1072945100.068100.30
20min11043270-104327097.30097.901.3197.6598.251.33
21041855-104185597.16897.49
31036372-103637296.65797.00
41050589-105058997.98398.33
51050554-105055497.98098.33
61075286-1075286100.286100.69
30min11039820-103982096.97998.611.2897.4999.121.29
21058336-105833698.70599.19
31046740-104674097.62498.13
41054257-105425798.32598.84
51068619-106861999.664100.18
61075935-1075935100.347100.92
45min11061432-106143298.994100.711.4999.67101.391.50
21081553-1081553100.871101.52
31065138-106513899.340100.01
41075143-1075143100.273100.95
51092824-1092824101.922102.61
61102879-1102879102.860103.60
60min11060185-106018598.878100.561.4299.72101.411.43
21083584-1083584101.060101.88
31062611-106261199.10499.94
41074536-1074536100.216101.06
51089362-1089362101.599102.45
61099043-1099043102.502103.41
极限11058920-105892098.760100.301.3599.77101.321.36
21076239-1076239100.375101.36
31061210-106121098.97399.97
41072510-1072510100.027101.04
51088270-1088270101.497102.52
61095236-1095236102.147103.23
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2025-01-02 15:09:58 完成)
生成报告数据部分下载报告(谢超君 于 2025-01-02 15:10:18 完成)
Current page cost:57 ms