二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.149310793456933929351893400933750.17
210.089348993459934740.03
单位质量响应值RSD%判断
9208.589273.210.50数据可信
加速3月-供试品溶液-24071601-2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%
5min132520-3252031.35337.9116.9231.3537.9116.92
237841-3784136.48336.48
351432-5143249.58649.59
441756-4175640.25740.26
536714-3671435.39635.40
635677-3567734.39634.40
10min167645-6764565.21772.309.1165.2772.369.12
272554-7255469.95070.01
387476-8747684.33684.42
476834-7683474.07674.14
574055-7405571.39771.46
671385-7138568.82368.88
15min188123-8812384.96087.172.4185.1287.362.43
288973-8897385.77985.96
394105-9410590.72790.95
491764-9176488.47088.66
589722-8972286.50286.68
689824-8982486.60086.77
20min194171-9417190.79190.800.8491.0991.130.85
293392-9339290.04090.36
395317-9531791.89692.27
494574-9457491.17991.52
593212-9321289.86690.19
694443-9444391.05391.37
30min194964-9496491.55591.330.8992.0191.810.90
293826-9382690.45890.93
395610-9561092.17892.71
495337-9533791.91592.40
593545-9354590.18790.66
695071-9507191.65992.13
45min195301-9530191.88091.450.6792.4992.080.69
294101-9410190.72391.34
395622-9562292.19092.87
495199-9519991.78292.43
594124-9412490.74691.37
694784-9478491.38292.00
60min195056-9505691.64491.450.8892.4092.240.89
294413-9441391.02491.80
395483-9548392.05692.89
496010-9601092.56493.36
593690-9369090.32791.10
694488-9448891.09691.87
极限196090-9609092.64192.330.9293.5593.260.93
295842-9584292.40293.33
396830-9683093.35494.34
496184-9618492.73293.68
594265-9426590.88191.81
695373-9537391.95092.87
二甲双胍恩格列净片项目信息
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%
110.169208699219769222809231779227959222190.10
210.239190429178939184680.09
单位质量响应值RSD%判断
90769.5989781.820.78数据可信
加速3月-供试品溶液-24071601-2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%
5min1418354-41835441.70948.7713.7041.7148.7713.70
2475704-47570447.42747.43
3610291-61029160.84560.84
4513823-51382351.22751.23
5464004-46400446.26046.26
6452629-45262945.12645.13
10min1760135-76013575.78482.647.4275.8582.727.42
2808031-80803180.55980.64
3940604-94060493.77693.88
4843179-84317984.06384.15
5823860-82386082.13782.21
6797318-79731879.49179.57
15min1936065-93606593.32395.331.8693.5295.551.88
2946762-94676294.39094.60
3987307-98730798.43298.69
4964508-96450896.15996.38
5952366-95236694.94995.16
6950337-95033794.74694.95
20min1981126-98112697.81697.970.6798.1798.350.69
2978549-97854997.55997.93
3993488-99348899.04899.47
4986051-98605198.30798.69
5974546-97454697.16097.53
6982211-98221197.92498.29
30min1983848-98384898.08798.140.6898.6098.680.70
2982154-98215497.91898.45
3993609-99360999.06099.65
4989490-98949098.65099.20
5974318-97431897.13797.67
6982707-98270797.97498.50
45min1984083-98408398.11197.970.6598.7998.680.67
2980879-98087997.79198.49
3990748-99074898.77599.53
4986926-98692698.39499.11
5972064-97206496.91297.61
6981203-98120397.82498.52
60min1980874-98087497.79197.940.8098.6398.810.81
2980449-98044997.74898.61
3990035-99003598.70499.62
4992406-99240698.94099.82
5970935-97093596.80097.66
6979659-97965997.67098.52
极限1979208-97920897.62597.620.6298.6398.660.63
2980199-98019997.72398.75
3986122-98612298.31499.40
4983562-98356298.05999.10
5968645-96864596.57297.59
6977439-97743997.44898.47
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