西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908253982499825038249682450824970.04
213.898218082213821960.03
单位质量响应值RSD%判断
5935.045917.640.21数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min112045-1204514.19714.3215.3414.2014.3215.33
213642-1364216.07916.08
314500-1450017.09017.09
412655-1265514.91614.92
59644-964411.36711.37
610403-1040312.26112.26
10min132629-3262938.45840.069.1538.4840.099.16
236661-3666143.21043.24
337499-3749944.19844.23
435939-3593942.35942.38
531065-3106536.61536.63
630154-3015435.54135.56
15min150838-5083859.92061.924.1360.0162.024.14
254169-5416963.84663.94
353242-5324262.75362.86
455651-5565165.59365.69
551276-5127660.43660.52
650051-5005158.99259.07
20min163010-6301074.26675.732.0674.4575.922.06
264546-6454676.07776.28
363509-6350974.85475.06
466597-6659778.49478.70
564553-6455376.08576.27
663296-6329674.60374.78
30min173377-7337786.48586.921.3386.8087.241.32
273306-7330686.40286.73
373243-7324386.32786.66
473611-7361186.76187.10
573229-7322986.31186.62
675726-7572689.25489.56
45min176542-7654290.21690.861.0290.6791.321.01
276728-7672890.43590.91
377030-7703090.79191.27
476845-7684590.57391.05
576736-7673690.44490.90
678648-7864892.69893.15
60min177408-7740891.23692.000.5991.8492.620.59
277983-7798391.91492.54
377859-7785991.76892.39
477992-7799291.92592.56
578339-7833992.33492.94
678769-7876992.84093.45
极限179001-7900193.11493.581.1493.8794.351.12
278834-7883492.91793.70
378849-7884992.93593.71
478758-7875892.82893.61
579920-7992094.19794.95
681015-8101595.48896.25
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.534081125408288940861974088580408885740855300.09
219.554066200407292740695640.12
单位质量响应值RSD%判断
209192.52208161.840.35数据可信
影响因素30天-供试品溶液-2024050521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%
5min1795288-79528820.15620.9313.1720.1620.9413.15
2912156-91215623.11823.12
3970344-97034424.59324.59
4861436-86143621.83321.83
5686766-68676617.40617.41
6729766-72976618.49618.50
10min11884880-188488047.77250.247.8447.8150.277.84
22113015-211301553.55453.59
32160624-216062454.76054.80
42084891-208489152.84152.88
51855697-185569747.03247.06
61793300-179330045.45145.48
15min12749860-274986069.69472.573.6169.8172.693.62
22939963-293996374.51274.64
32903669-290366973.59373.72
43005816-300581676.18176.31
52822298-282229871.53071.64
62759063-275906369.92870.03
20min13284895-328489583.25585.502.0183.4885.742.02
23388521-338852185.88186.13
33349045-334904584.88085.14
43479845-347984588.19688.45
53408173-340817386.37986.61
63331115-333111584.42684.65
30min13722835-372283594.35495.761.1094.7296.141.09
23767249-376724995.48095.87
33763640-376364095.38895.78
43784009-378400995.90496.30
53783174-378317495.88396.25
63849267-384926797.55897.92
45min13853345-385334597.66299.110.8498.1999.650.83
23904388-390438898.95599.51
33917381-391738199.28599.84
43911059-391105999.12599.68
53923387-392338799.43799.97
63952429-3952429100.173100.70
60min13886286-388628698.49799.930.7599.18100.630.75
23948013-3948013100.061100.78
33948230-3948230100.067100.79
43944728-394472899.978100.70
53973481-3973481100.707101.40
63955277-3955277100.245100.94
极限13921569-392156999.391100.941.31100.24101.811.29
23965801-3965801100.512101.40
33966365-3966365100.526101.41
43957863-3957863100.311101.20
54014527-4014527101.747102.61
64069509-4069509103.140104.00
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908214582150821668220282206821740.04
213.898214082218821790.07
单位质量响应值RSD%判断
5911.805916.410.06数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min112484-1248414.74513.3418.7214.7413.3418.71
213537-1353715.98815.99
38735-873510.31710.32
49059-905910.69910.70
513283-1328315.68815.69
610667-1066712.59912.60
10min136668-3666843.30840.379.1543.3340.409.15
236903-3690343.58543.61
329390-2939034.71234.73
431801-3180137.55937.58
536698-3669843.34343.37
633635-3363539.72639.75
15min157149-5714967.49764.443.7267.5964.533.73
256349-5634966.55366.65
351995-5199561.41061.49
452784-5278462.34262.42
555214-5521465.21265.31
653879-5387963.63563.72
20min169005-6900581.50079.402.1881.7179.602.19
268585-6858581.00481.21
364929-6492976.68676.86
467059-6705979.20279.39
566580-6658078.63678.84
667218-6721879.39079.58
30min176847-7684790.76290.542.0391.1190.872.02
277945-7794592.05992.40
378365-7836592.55592.86
476804-7680490.71191.03
574010-7401087.41287.75
675972-7597289.72990.05
45min179455-7945593.84393.592.1694.3494.072.15
281818-8181896.63397.13
379842-7984294.30094.76
479230-7923093.57794.04
576620-7662090.49490.98
678468-7846892.67793.15
60min179690-7969094.12094.011.2894.7794.651.27
280897-8089795.54696.21
379975-7997594.45795.07
479986-7998694.47095.09
577881-7788191.98492.62
679154-7915493.48794.12
极限180454-8045495.02295.150.7095.8395.940.70
281354-8135496.08596.90
380573-8057395.16395.94
480903-8090395.55396.33
579670-7967094.09694.88
680422-8042294.98595.77
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.534071763407361140741874075859407487640740590.04
219.554063930407530340696160.20
单位质量响应值RSD%判断
208605.17208164.500.15数据可信
影响因素30天-供试品溶液-2024050521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%
5min1788271-78827120.00618.8015.2320.0118.8015.26
2850500-85050021.58621.59
3601846-60184615.27515.27
4621524-62152415.77415.77
5864299-86429921.93621.94
6717525-71752518.21118.21
10min12039380-203938051.76049.007.3351.7949.037.34
22043306-204330651.85951.90
31711386-171138643.43543.46
41821350-182135046.22646.25
52054318-205431852.13952.18
61914052-191405248.57948.61
15min12958180-295818075.07972.522.9775.2072.632.98
22926841-292684174.28474.41
32745594-274559469.68369.78
42782092-278209270.61070.71
52901198-290119873.63373.76
62829331-282933171.80971.92
20min13464126-346412687.92086.221.6088.1686.451.61
23447130-344713087.48987.73
33312800-331280084.07984.29
43388210-338821085.99386.21
53374373-337437385.64285.89
63396758-339675886.21086.44
30min13807814-380781496.64396.281.7897.0396.661.77
23850722-385072297.73298.12
33872513-387251398.28598.64
43791965-379196596.24096.60
53687894-368789493.59993.99
63750311-375031195.18395.56
45min13883976-388397698.57698.782.1199.1399.322.10
24028902-4028902102.254102.81
33927236-392723699.674100.19
43878483-387848398.43698.96
53786122-378612296.09296.64
63846642-384664297.62898.16
60min13894121-389412198.83398.771.1299.5599.471.12
23942840-3942840100.070100.80
33921934-392193499.539100.22
43903029-390302999.05999.75
53819656-381965696.94397.65
63867345-386734598.15498.85
极限13907826-390782699.18199.220.69100.06100.090.69
23942807-3942807100.069100.96
33927799-392779999.688100.54
43918693-391869399.457100.31
53866823-386682398.14099.01
63892716-389271698.79899.66
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908217982182821768217982122821680.04
213.898167581672816740.01
单位质量响应值RSD%判断
5911.375880.060.38数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min18280-82809.81013.8020.079.8113.8020.07
213536-1353616.03716.04
310408-1040812.33112.33
410878-1087812.88812.89
514840-1484017.58217.58
611929-1192914.13314.13
10min128896-2889634.23540.3310.0234.2540.3510.03
236946-3694643.77343.80
332232-3223238.18838.21
433653-3365339.87139.89
538488-3848845.59945.63
634016-3401640.30140.32
15min146983-4698355.66463.327.3955.7463.417.40
257429-5742968.04068.14
351340-5134060.82660.91
453583-5358363.48463.57
557389-5738967.99368.10
653953-5395363.92264.01
20min161642-6164273.03278.644.0373.2078.844.04
267881-6788180.42380.64
365068-6506877.09177.28
467719-6771980.23180.43
569053-6905381.81282.03
666909-6690979.27279.47
30min174909-7490988.75091.502.2589.0491.832.26
276598-7659890.75191.10
376324-7632490.42690.74
480014-8001494.79895.13
577985-7798592.39492.75
677575-7757591.90992.24
45min178410-7841092.89895.391.3493.3395.871.35
281092-8109296.07596.57
381223-8122396.23196.70
481223-8122396.23196.72
580525-8052595.40495.91
680617-8061795.51396.00
60min179926-7992694.69496.751.5695.2897.391.58
282582-8258297.84198.50
381856-8185696.98197.61
481163-8116396.16096.81
583501-8350198.93099.60
680927-8092795.88096.52
极限181136-8113696.12896.721.2096.8897.521.20
283364-8336498.76799.59
382256-8225697.45498.24
481022-8102295.99296.80
581071-8107196.05196.88
680953-8095395.91196.71
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.534072260407297040738544071915407052440723050.04
219.554060156406905440646050.16
单位质量响应值RSD%判断
208515.36207908.180.21数据可信
影响因素30天-供试品溶液-2024050521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%
5min1577055-57705514.65819.2815.7814.6619.2815.77
2837429-83742921.27221.27
3704104-70410417.88517.89
4729532-72953218.53118.53
5926893-92689323.54423.54
6778957-77895719.78619.79
10min11663320-166332042.25048.628.5042.2748.668.52
22033749-203374951.66051.70
31824080-182408046.33446.36
41918228-191822848.72548.76
52130924-213092454.12854.17
61915295-191529548.65148.68
15min12504232-250423263.61170.996.3263.7171.116.32
22948283-294828374.89075.01
32685792-268579268.22268.33
42818835-281883571.60271.71
52978170-297817075.64975.78
62834145-283414571.99172.10
20min13133874-313387479.60484.913.5879.8185.143.60
23403115-340311586.44386.69
33271882-327188283.11083.33
43398318-339831886.32186.55
53462552-346255287.95388.21
63385843-338584386.00586.24
30min13686993-368699393.65496.182.0893.9996.552.08
23745667-374566795.14595.53
33724007-372400794.59494.95
43887586-388758698.74999.12
53838005-383800597.49097.89
63835874-383587497.43697.81
45min13863133-386313398.128100.501.2698.62101.031.27
23964184-3964184100.695101.24
33944100-3944100100.185100.70
43985323-3985323101.232101.77
53981153-3981153101.126101.69
64000133-4000133101.608102.15
60min13951591-3951591100.375102.451.71101.03103.151.72
24040959-4040959102.645103.36
33994651-3994651101.469102.15
44000602-4000602101.620102.33
54149542-4149542105.403106.14
64061427-4061427103.165103.87
极限14041072-4041072102.648103.600.74103.47104.470.75
24123969-4123969104.754105.64
34069986-4069986103.383104.24
44056724-4056724103.046103.92
54079425-4079425103.622104.53
64099523-4099523104.133105.01
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-06-20 19:01:34 完成)
生成报告数据部分下载报告(孙文新 于 2024-06-21 15:59:07 完成)
Current page cost:77 ms