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%
110.209406093755939099373393920938750.15
210.109446394284943740.14
单位质量响应值RSD%判断
9203.439343.961.08数据可信
供试品溶液-2024092321批-恩格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min127816-2781626.72438.7322.6526.7238.7322.66
236791-3679135.34735.35
346266-4626644.45044.45
454352-5435252.21852.22
536339-3633934.91234.91
640328-4032838.74538.74
10min163058-6305860.58275.5915.3760.6375.6515.37
274501-7450171.57671.64
389153-8915385.65385.73
496422-9642292.63692.72
572379-7237969.53769.60
676537-7653773.53273.60
15min188193-8819384.73192.555.0784.8892.745.09
296748-9674892.95093.13
3100132-10013296.20196.42
4101592-10159297.60497.84
593485-9348589.81589.99
697838-9783893.99794.18
20min198925-9892595.04196.331.5895.3396.681.60
2101883-10188397.88398.22
3101035-10103597.06897.45
4101535-10153597.54997.95
597845-9784594.00494.33
6100387-10038796.44696.79
30min1100973-10097397.00997.091.4197.4597.591.42
2102650-10265098.62099.12
3101538-10153897.55298.09
4101715-10171597.72298.29
598437-9843794.57295.05
6101003-10100397.03897.54
45min1101409-10140997.42897.331.2598.0398.001.26
2102874-10287498.83599.50
3101610-10161097.62198.32
4101566-10156697.57998.31
598994-9899495.10895.75
6101403-10140397.42298.09
60min1100985-10098597.02097.301.5397.7998.131.54
2103094-10309499.04799.87
3101043-10104397.07697.94
4102311-10231198.29499.19
598582-9858294.71295.51
6101630-10163097.64098.47
极限1102515-10251598.49098.231.2199.4299.231.21
2103821-10382199.745100.74
3101981-10198197.97799.00
4102745-10274598.71199.77
5100070-10007096.14197.10
6102352-10235298.33499.33
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%
110.194651884649594652494652814636224648600.16
210.094662244672284667260.16
单位质量响应值RSD%判断
45619.2346256.290.99数据可信
供试品溶液-2024092321批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179669-17966935.20247.1218.6235.2047.1218.62
2223038-22303843.69943.70
3269333-26933352.77052.77
4309667-30966760.67260.67
5220534-22053443.20843.21
6240847-24084747.18847.19
10min1344061-34406167.41180.4412.3167.4780.5212.32
2392682-39268276.93777.01
3455537-45553789.25289.34
4483187-48318794.66994.77
5384489-38448975.33275.40
6403509-40350979.05879.14
15min1448484-44848487.87093.933.6388.0494.143.65
2481295-48129594.29994.50
3491566-49156696.31196.55
4494342-49434296.85597.11
5471036-47103692.28992.49
6489752-48975295.95596.17
20min1487813-48781395.57696.290.9595.8996.660.97
2496793-49679397.33597.69
3492479-49247996.49096.89
4495071-49507196.99897.42
5484286-48428694.88595.24
6492259-49225996.44796.82
30min1488542-48854295.71896.020.7996.2096.550.80
2495628-49562897.10797.63
3490879-49087996.17696.73
4490377-49037796.07896.66
5483863-48386394.80295.31
6491145-49114596.22896.76
45min1489661-48966195.93896.010.5896.5796.700.58
2494617-49461796.90997.59
3489782-48978295.96196.68
4489398-48939895.88696.63
5485793-48579395.18095.85
6490860-49086096.17396.86
60min1486592-48659295.33695.710.8796.1396.560.88
2493469-49346996.68497.53
3488654-48865495.74096.62
4491178-49117896.23597.14
5481291-48129194.29895.12
6489810-48981095.96796.82
极限1487149-48714995.44595.360.7296.4096.370.73
2490968-49096896.19497.20
3486277-48627795.27596.31
4487457-48745795.50696.57
5480384-48038494.12095.10
6488164-48816495.64496.66
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