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%
110.529800398766989319950599767989940.70
210.439829599529989120.89
单位质量响应值RSD%判断
9410.089483.410.55数据可信
供试品溶液-206397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%
5min140726-4072638.80139.2118.4838.8039.2018.48
247836-4783645.57445.57
333810-3381032.21232.21
430661-3066129.21129.21
544376-4437642.27842.28
649502-4950247.16247.16
10min170780-7078067.43474.6712.8267.5074.7412.82
285912-8591281.85081.93
373070-7307069.61669.67
465024-6502461.95062.00
585684-8568481.63381.70
689785-8978585.54085.62
15min190753-9075386.46389.703.1786.6489.893.19
296402-9640291.84492.06
394316-9431689.85790.03
490224-9022485.95986.11
596271-9627191.72091.93
696948-9694892.36592.59
20min197862-9786293.23594.550.8993.5694.890.88
299676-9967694.96495.33
3100377-10037795.63295.95
499299-9929994.60494.90
599582-9958294.87495.23
698668-9866894.00394.38
30min199617-9961794.90795.331.3095.3895.831.29
299130-9913094.44394.97
3101648-10164896.84297.32
4100276-10027695.53595.99
598316-9831693.66894.19
6101396-10139696.60297.13
45min199415-9941594.71594.291.4395.3594.941.40
298939-9893994.26294.94
3100905-10090596.13596.77
499703-9970394.98995.60
597992-9799293.35994.03
696832-9683292.25492.95
60min198973-9897394.29494.691.2895.0995.511.26
299533-9953394.82795.67
3101535-10153596.73597.54
499273-9927394.58095.35
599461-9946194.75995.59
697584-9758492.97193.82
极限199007-9900794.32694.461.1095.2895.431.07
299674-9967494.96295.96
3100023-10002395.29496.26
4100376-10037695.63196.56
598184-9818493.54294.53
697591-9759192.97793.98
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%
110.181082961108867011020921099257109291610931790.72
210.161098530111243411054820.89
单位质量响应值RSD%判断
107384.97108807.280.94数据可信
供试品溶液-206397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%
5min1587086-58708648.88249.1216.1148.8849.1216.11
2677214-67721456.38756.39
3497039-49703941.38541.38
4457836-45783638.12138.12
5632321-63232152.64952.65
6687916-68791657.27857.28
10min1901019-90101975.02181.5810.4775.1081.6610.48
21053481-105348187.71687.81
3925503-92550377.06077.13
4845792-84579270.42370.49
51050596-105059687.47687.56
61102411-110241191.79091.89
15min11098589-109858991.47293.522.2791.6893.742.29
21150539-115053995.79796.04
31122030-112203093.42393.62
41088848-108884890.66190.84
51130417-113041794.12294.36
61148467-114846795.62595.87
20min11151848-115184895.90696.810.7996.2797.180.78
21170136-117013697.42997.83
31174696-117469697.80998.16
41166904-116690497.16097.49
51157071-115707196.34196.73
61155546-115554696.21496.62
30min11170783-117078397.48397.100.9198.0097.640.88
21153871-115387196.07596.64
31178731-117873198.14498.66
41175889-117588997.90898.40
51155086-115508696.17696.73
61162900-116290096.82697.39
45min11162035-116203596.75496.561.3397.4497.261.30
21164468-116446896.95797.68
31178746-117874698.14698.83
41167791-116779197.23497.89
51150613-115061395.80396.51
61134392-113439294.45395.18
60min11168209-116820997.26896.871.0198.1197.720.99
21161972-116197296.74997.63
31180132-118013298.26199.10
41162600-116260096.80197.62
51163391-116339196.86797.74
61143917-114391795.24696.13
极限11165170-116517097.01596.390.8998.0297.410.87
21167428-116742897.20398.25
31159568-115956896.54997.56
41163618-116361896.88697.87
51148796-114879695.65296.68
61141608-114160895.05496.10
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%
110.521002341005601005301008041006621005580.21
210.439986999638997540.17
单位质量响应值RSD%判断
9558.759564.140.04数据可信
供试品溶液-311952B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%
5min129136-2913627.42528.4619.4327.4328.4619.43
225072-2507223.60023.60
337830-3783035.60935.61
426502-2650224.94624.95
525498-2549824.00124.00
637342-3734235.14935.15
10min159652-5965256.14957.6516.2256.1957.7016.22
254168-5416850.98751.03
372536-7253668.27768.34
451755-5175548.71648.76
554715-5471551.50251.54
674675-7467570.29070.35
15min182952-8295278.08177.348.2678.2277.498.28
277361-7736172.81872.94
390925-9092585.58685.76
474802-7480270.41070.53
577495-7749572.94573.07
689474-8947484.22084.40
20min193597-9359788.10187.944.3588.3788.224.38
290939-9093985.59985.84
398105-9810592.34492.66
488641-8864183.43683.68
590876-9087685.54085.79
698420-9842092.64192.96
30min1100233-10023394.34793.450.8494.7693.870.85
298698-9869892.90393.29
3100014-10001494.14194.61
499768-9976893.91094.29
598192-9819292.42692.82
698783-9878392.98393.45
45min1100742-10074294.82693.811.0695.4094.391.06
298842-9884293.03893.58
399614-9961493.76594.39
4100986-10098695.05695.59
598279-9827992.50893.05
699541-9954193.69694.32
60min1100110-10011094.23293.371.0494.9694.101.03
298280-9828092.50993.21
399299-9929993.46894.25
4100685-10068594.77395.47
598170-9817092.40693.10
698647-9864792.85593.64
极限1100380-10038094.48693.151.1595.3794.041.13
298416-9841692.63793.49
399356-9935693.52294.46
4100020-10002094.14795.00
597943-9794392.19293.04
697643-9764391.90992.85
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%
110.181115232112189511228091122736111927611203900.29
210.161113326110969611115110.24
单位质量响应值RSD%判断
110057.96109400.690.43数据可信
供试品溶液-311952B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%
5min1445096-44509636.50736.9416.4136.5136.9316.41
2387623-38762331.79331.79
3542665-54266544.51044.51
4394810-39481032.38332.38
5390923-39092332.06432.06
6540766-54076644.35444.35
10min1792235-79223564.98065.7313.3865.0465.7913.38
2721129-72112959.14859.20
3930081-93008176.28676.36
4701916-70191657.57257.63
5724991-72499159.46459.52
6937941-93794176.93177.00
15min11027121-102712184.24582.986.7584.4183.156.76
2961964-96196478.90179.05
31093842-109384289.71889.92
4938316-93831676.96177.11
5960793-96079378.80578.96
61088105-108810589.24789.45
20min11130860-113086092.75491.663.3893.0691.963.40
21094146-109414689.74390.03
31160555-116055595.19095.54
41075720-107572088.23188.51
51084643-108464388.96389.25
61158875-115887595.05295.40
30min11182701-118270197.00695.641.2397.4796.101.23
21158481-115848195.01995.45
31170736-117073696.02596.53
41179014-117901496.70497.13
51144600-114460093.88194.31
61160665-116066595.19995.71
45min11182602-118260296.99895.801.3497.6296.421.33
21158100-115810094.98895.58
31169889-116988995.95596.62
41185233-118523397.21497.80
51143582-114358293.79794.39
61168621-116862195.85196.52
60min11183235-118323597.05095.421.3997.8496.201.39
21149357-114935794.27195.02
31165034-116503495.55796.39
41180964-118096496.86497.61
51144317-114431793.85894.60
61157337-115733794.92695.75
极限11182215-118221596.96695.401.4697.9296.341.45
21153917-115391794.64595.55
31170603-117060396.01497.00
41180490-118049096.82597.73
51144632-114463293.88494.78
61146548-114654894.04195.03
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%
110.529797899115992489898999144988950.53
210.4310007599627998510.32
单位质量响应值RSD%判断
9400.679573.441.29数据可信
供试品溶液-301793A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%
5min147978-4797845.51934.1418.6345.5234.1418.63
235360-3536033.54733.55
334923-3492333.13333.13
432323-3232330.66630.67
537369-3736935.45335.45
627985-2798526.55026.55
10min179899-7989975.80367.149.1775.8867.209.18
271903-7190368.21768.27
366415-6641563.01163.07
470538-7053866.92266.97
574653-7465370.82670.89
661190-6119058.05358.10
15min195760-9576090.85186.413.9491.0586.583.95
291676-9167686.97787.15
386872-8687282.41982.58
492091-9209187.37087.53
593299-9329988.51688.69
686783-8678382.33482.48
20min198644-9864493.58793.691.6293.9494.001.63
2100102-10010294.97195.29
398990-9899093.91694.21
497732-9773292.72293.03
5100723-10072395.56095.88
696319-9631991.38291.66
30min198480-9848093.43295.491.4293.9495.951.41
2102062-10206296.83097.30
3101457-10145796.25696.71
4100739-10073995.57596.04
5101754-10175496.53897.02
699375-9937594.28194.71
45min198942-9894293.87095.311.0794.5495.941.05
2100260-10026095.12195.75
3100872-10087295.70196.32
4101842-10184296.62297.24
5101222-10122296.03396.68
699636-9963694.52995.12
60min199762-9976294.64895.221.1995.4796.011.19
2100666-10066695.50696.30
3101661-10166196.45097.22
4100381-10038195.23596.02
5101350-10135096.15596.96
698369-9836993.32794.07
极限199445-9944594.34796.031.5795.3396.981.56
2102754-10275497.48798.44
3102086-10208696.85397.79
4102772-10277297.50498.45
5100987-10098795.81096.78
699250-9925094.16295.06
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%
110.181089180110319611038571102567110343011004460.58
210.161109756111210311109300.15
单位质量响应值RSD%判断
108098.82109343.500.81数据可信
供试品溶液-301793A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%
5min1680319-68031956.31943.8515.6356.3243.8515.63
2516827-51682742.78542.78
3515060-51506042.63842.64
4483256-48325640.00640.01
5546226-54622645.21845.22
6436159-43615936.10736.11
10min1996895-99689582.52675.017.1682.6275.087.16
2913584-91358475.62975.70
3848912-84891270.27670.35
4900012-90001274.50674.57
5954695-95469579.03379.11
6822301-82230168.07368.13
15min11142351-114235194.56891.102.8494.8091.302.85
21097955-109795590.89291.09
31052864-105286487.16087.35
41106112-110611291.56891.76
51121973-112197392.88193.09
61081784-108178489.55489.73
20min11155376-115537695.64696.230.8296.0396.580.81
21159368-115936895.97696.33
31157169-115716995.79496.13
41154402-115440295.56595.91
51177574-117757497.48397.85
61170545-117054596.90297.22
30min11157342-115734295.80997.490.9396.3698.000.90
21180539-118053997.72998.24
31181052-118105297.77198.26
41174546-117454697.23397.74
51186524-118652498.22498.75
61185947-118594798.17798.66
45min11156993-115699395.78097.221.0496.4997.891.02
21162410-116241096.22896.90
31174826-117482697.25697.91
41187482-118748298.30498.97
51181939-118193997.84598.53
61182796-118279697.91698.56
60min11163739-116373996.33897.130.7597.2197.960.73
21164438-116443896.39697.23
31181446-118144697.80498.62
41173887-117388797.17898.01
51184942-118494298.09398.94
61171108-117110896.94897.76
极限11160286-116028696.05297.530.7997.0898.520.77
21180375-118037597.71598.71
31181317-118131797.79398.77
41187720-118772098.32399.31
51178534-117853497.56398.58
61180282-118028297.70898.68
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-02-05 16:17:59 完成)
生成报告数据部分(等待生成报告)
Current page cost:48 ms