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%
110.069166791718918089161591583916780.10
210.089172391870917960.12
单位质量响应值RSD%判断
9113.129106.750.05数据可信
加速3月-供试品溶液-24091001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%
5min159705-5970558.98544.8019.7458.9844.8019.74
251402-5140250.78250.78
336311-3631135.87335.87
441930-4193041.42441.42
537339-3733936.88836.89
645373-4537344.82544.83
10min195995-9599594.83781.2711.6894.9381.3511.68
287078-8707886.02786.11
370405-7040569.55569.62
483387-8338782.38182.45
572157-7215771.28671.35
684578-8457883.55783.63
15min199137-9913797.94195.643.8598.2095.853.86
298849-9884997.65697.88
390644-9064489.55089.73
497785-9778596.60596.81
594033-9403392.89893.08
6100419-10041999.20799.42
20min199160-9916097.96398.261.5298.3898.621.51
298744-9874497.55297.94
397736-9773696.55796.88
498491-9849197.30297.67
5101392-101392100.168100.50
6101216-10121699.995100.37
30min199019-9901997.82498.321.6898.4198.861.67
298935-9893597.74198.29
398340-9834097.15397.64
497684-9768496.50597.03
5101669-101669100.442100.94
6101499-101499100.274100.82
45min198750-9875097.55898.381.6598.3099.081.63
298467-9846797.27998.00
398888-9888897.69598.34
498075-9807596.89197.58
5101816-101816100.587101.26
6101510-101510100.285101.00
60min198546-9854697.35798.221.6998.2799.081.67
298428-9842897.24098.12
398492-9849297.30398.11
497942-9794296.76097.61
5101734-101734100.506101.34
6101393-101393100.169101.05
极限198856-9885697.66398.401.6198.7399.421.59
298650-9865097.46098.50
398895-9889597.70298.67
498045-9804596.86297.87
5102066-102066100.834101.84
6101112-10111299.892100.94
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20
标示量(mg)500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%
19.885118825155545166525130945128605140080.39
29.865138305158825148560.29
单位质量响应值RSD%判断
52025.1052216.630.26数据可信
加速3月-供试品溶液-24091001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%
5min1360564-36056462.26149.4616.7062.2649.4616.70
2323669-32366955.89055.89
3239059-23905941.28041.28
4266927-26692746.09246.09
5242555-24255541.88341.88
6285943-28594349.37649.38
10min1548826-54882694.76983.429.6794.8783.509.68
2509806-50980688.03188.12
3425467-42546773.46873.54
4486266-48626683.96784.04
5433898-43389874.92474.99
6494195-49419585.33685.42
15min1562012-56201297.04695.862.9497.3196.082.95
2566595-56659597.83798.08
3529181-52918191.37791.57
4556886-55688696.16196.38
5542981-54298193.76093.95
6573086-57308698.95899.18
20min1561621-56162196.97998.061.6997.4098.441.67
2566092-56609297.75198.15
3562694-56269497.16497.51
4558105-55810596.37196.75
5583170-583170100.700101.05
6575523-57552399.37999.77
30min1561121-56112196.89297.971.4497.4898.521.42
2565658-56565897.67698.24
3565455-56545597.64198.15
4558013-55801396.35696.89
5579459-579459100.059100.58
6574462-57446299.19699.75
45min1560649-56064996.81197.821.4197.5698.521.39
2564824-56482497.53298.26
3564271-56427197.43698.10
4557242-55724296.22296.92
5578371-57837199.871100.56
6573462-57346299.02399.74
60min1559309-55930996.57997.651.4797.4998.521.45
2563580-56358097.31798.21
3564505-56450597.47798.31
4555412-55541295.90696.77
5577787-57778799.770100.62
6572338-57233898.82999.71
极限1558687-55868796.47297.521.4497.5498.551.42
2562697-56269797.16498.22
3562407-56240797.11498.11
4555712-55571295.95896.98
5576647-57664799.573100.59
6572326-57232698.82799.88
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%
110.069302893201934579319993111931990.18
210.089254492515925300.03
单位质量响应值RSD%判断
9264.319179.560.65数据可信
加速3月-供试品溶液-24090901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%
5min152161-5216150.90740.4612.9750.9140.4612.98
241465-4146540.46840.47
338036-3803637.12137.12
439443-3944338.49538.49
538402-3840237.47937.48
639248-3924838.30438.30
10min189161-8916187.01777.586.6087.1077.656.61
280354-8035478.42278.49
373757-7375771.98372.05
479124-7912477.22177.29
577841-7784175.96976.03
676732-7673274.88774.95
15min198514-9851496.14593.301.7096.3893.501.72
295586-9558693.28893.49
393599-9359991.34891.53
495272-9527292.98193.17
595742-9574293.44093.63
694882-9488292.60092.79
20min198969-9896996.58996.460.6596.9896.810.65
298528-9852896.15996.51
397975-9797595.61995.95
499340-9934096.95197.30
599719-9971997.32197.67
698496-9849696.12896.47
30min198841-9884196.46496.980.7497.0297.500.73
298597-9859796.22696.74
399315-9931596.92797.42
499668-9966897.27197.78
5100662-10066298.24298.75
699143-9914396.75997.26
45min198739-9873996.36597.190.8897.0897.870.87
298604-9860496.23396.91
3100118-10011897.71198.37
4100071-10007197.66598.34
5100789-10078998.36599.04
699194-9919496.80997.47
60min198367-9836796.00297.181.1796.8798.021.15
298470-9847096.10296.94
3100488-10048898.07298.89
499639-9963997.24398.08
5101331-10133198.89499.73
699181-9918196.79697.62
极限199512-9951297.11998.421.0898.1599.421.06
299864-9986497.46398.46
3101934-10193499.483100.46
4101533-10153399.092100.09
5101937-10193799.486100.49
6100288-10028897.87698.86
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20
标示量(mg)500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%
19.889698219698659704769701189693649699290.05
29.869706339696919701620.07
单位质量响应值RSD%判断
98170.9598393.710.17数据可信
加速3月-供试品溶液-24090901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%
5min1646322-64632259.18648.6010.9559.1948.6010.95
2530745-53074548.60248.60
3491794-49179445.03545.04
4509966-50996646.69946.70
5499733-49973345.76245.76
6506072-50607246.34346.34
10min1996167-99616791.22283.405.2291.3283.485.22
2922911-92291184.51484.59
3857159-85715978.49378.57
4909256-90925683.26383.34
5895680-89568082.02082.10
6883611-88361180.91580.99
15min11065314-106531497.55495.991.0497.8096.211.05
21049342-104934296.09196.31
31033162-103316294.61094.82
41052027-105202796.33796.55
51049111-104911196.07096.28
61040631-104063195.29495.51
20min11064994-106499497.52598.250.6497.9498.630.63
21072814-107281498.24198.62
31071059-107105998.08098.44
41082410-108241099.12099.50
51079257-107925798.83199.20
61066917-106691797.70198.07
30min11062189-106218997.26898.420.8497.8498.960.82
21071108-107110898.08598.63
31079286-107928698.83399.36
41084676-108467699.32799.87
51083117-108311799.18499.72
61068237-106823797.82298.36
45min11059340-105934097.00798.280.9397.7498.980.92
21069058-106905897.89798.61
31080260-108026098.92399.61
41083200-108320099.19299.90
51081907-108190799.07499.78
61065370-106537097.55998.26
60min11058269-105826996.90998.100.9697.8198.970.95
21065991-106599197.61698.49
31078154-107815498.73099.59
41079756-107975698.87799.75
51082870-108287099.162100.03
61062605-106260597.30698.17
极限11054958-105495896.60697.770.9397.6798.810.92
21063551-106355197.39398.43
31077996-107799698.71599.74
41077463-107746398.66799.70
51073321-107332198.28799.32
61058821-105882196.95997.98
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