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%
110.039371293580936379364193787936710.09
210.129505495173951140.09
单位质量响应值RSD%判断
9339.089398.620.45数据可信
供试品溶液-2024092521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%
5min141548-4154839.51032.2912.8039.5132.2912.80
235182-3518233.45633.46
329296-2929627.85927.86
434829-3482933.12033.12
531625-3162530.07330.07
631252-3125229.71929.72
10min184047-8404779.92366.4710.9079.9966.5210.90
270775-7077567.30367.36
361847-6184758.81358.86
469587-6958766.17366.23
567517-6751764.20464.25
665617-6561762.39862.45
15min198452-9845293.62286.784.6393.8286.944.65
293774-9377489.17389.34
386455-8645582.21382.36
489643-8964385.24585.41
589630-8963085.23385.39
689578-8957885.18385.34
20min1100012-10001295.10594.040.9895.4694.351.00
2100214-10021495.29795.61
398620-9862093.78194.06
498104-9810493.29193.60
598173-9817393.35693.66
698225-9822593.40693.70
30min1100929-10092995.97795.580.4796.4996.050.47
2100333-10033395.41095.89
3101070-10107096.11196.55
499955-9995595.05195.51
5100746-10074695.80396.26
6100064-10006495.15595.61
45min199587-9958794.70195.490.5895.3796.120.56
2100161-10016195.24795.88
3101320-10132096.34996.95
4100396-10039695.47096.09
5100731-10073195.78996.40
6100327-10032795.40596.01
60min199749-9974994.85595.330.4995.6996.110.47
2100240-10024095.32296.12
3101029-10102996.07296.83
499862-9986294.96395.74
5100581-10058195.64696.42
6100015-10001595.10895.88
极限1100199-10019995.28396.280.6496.2797.230.61
2101766-10176696.77397.73
3102004-10200496.99997.92
4100947-10094795.99496.93
5101225-10122596.25997.19
6101370-10137096.39797.32
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%
110.129090589077099078969086799082829083250.07
210.179197139204079200600.06
单位质量响应值RSD%判断
89755.4390468.040.56数据可信
供试品溶液-2024092521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%
5min1477256-47725647.66739.2711.9247.6739.2711.92
2402628-40262840.21440.21
3343138-34313834.27234.27
4399778-39977839.92939.93
5371434-37143437.09837.10
6364991-36499136.45436.45
10min1821879-82187982.08770.359.0982.1770.429.09
2711407-71140771.05471.12
3632256-63225663.14863.21
4702632-70263270.17770.24
5687387-68738768.65568.72
6670703-67070366.98867.05
15min1916993-91699391.58786.563.6591.8086.753.66
2889878-88987888.87989.06
3827584-82758482.65782.82
4854794-85479485.37585.56
5856489-85648985.54485.72
6854497-85449785.34585.52
20min1920958-92095891.98391.610.7192.3591.930.73
2928058-92805892.69293.03
3913617-91361791.25091.55
4912244-91224491.11391.44
5917449-91744991.63391.95
6910772-91077290.96691.28
30min1922548-92254892.14292.280.2992.6692.760.29
2925924-92592492.47992.97
3924033-92403392.29092.74
4924737-92473792.36092.84
5926686-92668692.55593.03
6919503-91950391.83892.30
45min1917346-91734691.62292.130.3592.3092.760.33
2924820-92482092.36993.01
3923298-92329892.21792.82
4924395-92439592.32692.96
5924885-92488592.37593.00
6919777-91977791.86592.48
60min1915642-91564291.45291.940.3692.2892.730.35
2922274-92227492.11492.91
3921567-92156792.04492.80
4922177-92217792.10592.89
5924234-92423492.31093.09
6917368-91736891.62492.40
极限1914303-91430391.31891.850.3192.3092.790.28
2920460-92046091.93392.88
3920265-92026591.91492.83
4919374-91937491.82592.76
5922233-92223392.11093.04
6921247-92124792.01292.94
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%
110.039448294353945229493994741946070.25
210.129493694945949400.01
单位质量响应值RSD%判断
9432.409381.420.39数据可信
供试品溶液-2024092521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%
5min134151-3415132.34439.3012.5332.3439.3012.53
238384-3838436.35336.35
346912-4691244.43044.43
446831-4683144.35344.35
543937-4393741.61241.61
638741-3874136.69136.69
10min169017-6901765.36574.128.8765.4274.198.87
272739-7273968.89068.95
384719-8471980.23680.31
483956-8395679.51479.59
584433-8443379.96580.03
674710-7471070.75770.82
15min190788-9078885.98489.293.2186.1589.483.22
291129-9112986.30786.48
396828-9682891.70591.91
497396-9739692.24292.45
596608-9660891.49691.70
692901-9290187.98588.16
20min196489-9648991.38392.251.5291.6992.591.53
296484-9648491.37991.70
398332-9833293.12993.49
499828-9982894.54694.91
597456-9745692.29992.65
695851-9585190.77991.10
30min198396-9839693.19094.183.4993.6594.683.49
296963-9696391.83292.30
3106079-106079100.466100.98
4100320-10032095.01295.53
597691-9769192.52293.03
697227-9722792.08292.56
45min199639-9963994.36793.171.3394.9893.821.32
297115-9711591.97692.60
398207-9820793.01193.69
4100306-10030694.99995.67
597487-9748792.32992.99
697510-9751092.35092.98
60min199325-9932594.06993.971.8094.8494.781.80
297292-9729292.14492.92
398368-9836893.16394.00
4100318-10031895.01095.84
5102135-10213596.73197.55
697891-9789192.71193.50
极限1101079-10107995.73194.611.2896.6695.571.27
298851-9885193.62194.55
399410-9941094.15095.14
4101783-10178396.39797.39
598588-9858893.37194.35
699669-9966994.39595.33
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%
110.129200759206049214249214289204949208050.07
210.179201019201189201100.01
单位质量响应值RSD%判断
90988.6490472.960.41数据可信
供试品溶液-2024092521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%
5min1409096-40909640.58048.0711.6540.5848.0711.65
2437478-43747843.39643.40
3544288-54428853.99153.99
4538910-53891053.45753.46
5515900-51590051.17551.17
6462012-46201245.82945.83
10min1739266-73926673.33281.457.1473.4081.547.14
2776514-77651477.02777.10
3877353-87735387.02987.12
4861292-86129285.43685.53
5876361-87636186.93187.02
6796004-79600478.96079.04
15min1922488-92248891.50794.112.1491.7094.322.16
2929078-92907892.16092.36
3969688-96968896.18996.42
4965131-96513195.73795.97
5963816-96381695.60695.84
6941998-94199893.44293.65
20min1962901-96290195.51596.130.6995.8696.510.70
2969224-96922496.14396.50
3976008-97600896.81597.21
4978153-97815397.02897.42
5966081-96608195.83196.22
6962518-96251895.47795.84
30min1973558-97355896.57296.480.5397.0797.010.54
2971805-97180596.39996.91
3976483-97648396.86397.42
4979719-97971997.18497.74
5966017-96601795.82496.37
6967972-96797296.01896.54
45min1974671-97467196.68396.300.5897.3597.000.58
2968875-96887596.10896.78
3973211-97321196.53897.26
4978279-97827997.04197.76
5963175-96317595.54296.25
6966823-96682395.90496.59
60min1973316-97331696.54896.210.5997.3797.060.58
2968049-96804996.02696.86
3972539-97253996.47197.35
4976843-97684396.89897.77
5960635-96063595.29196.16
6967965-96796596.01896.86
极限1972297-97229796.44796.030.5797.4397.050.56
2964988-96498895.72296.72
3968614-96861496.08297.12
4975568-97556896.77297.81
5960014-96001495.22996.26
6967212-96721295.94396.95
点击查看处理图标(自动生成)
　
原始图谱下载图谱(姜进硙 于 2024-10-17 14:30:41 完成)
生成报告数据部分(等待生成报告)
Current page cost:54 ms