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%
113.98366783681836508365583691836690.03
213.898263382642826380.01
单位质量响应值RSD%判断
6019.355949.460.83数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min111363-1136313.26315.0514.1113.2615.0514.11
212957-1295715.12415.12
313046-1304615.22815.23
411644-1164413.59113.59
512010-1201014.01914.02
616330-1633019.06119.06
10min135396-3539641.31642.267.1741.3442.297.17
234577-3457740.36040.38
335967-3596741.98242.01
433064-3306438.59438.62
537817-3781744.14244.16
640424-4042447.18547.22
15min154803-5480363.96864.355.0664.0664.445.07
253106-5310661.98862.08
356167-5616765.56165.66
451124-5112459.67459.76
556463-5646365.90666.00
659102-5910268.98669.10
20min165110-6511075.99976.724.0076.2076.924.00
263757-6375774.42074.62
369415-6941581.02481.23
462750-6275073.24473.43
564939-6493975.80076.01
668382-6838279.81880.04
30min172198-7219884.27385.333.0084.6085.663.00
272050-7205084.10084.42
377151-7715190.05490.39
471370-7137083.30683.61
571784-7178483.78984.12
674093-7409386.48586.84
45min173983-7398386.35687.922.1286.8288.392.13
274840-7484087.35687.82
377624-7762490.60691.10
474184-7418486.59187.04
574250-7425086.66887.14
677035-7703589.91990.42
60min175246-7524687.83089.401.1288.4490.021.13
276146-7614688.88189.49
377747-7774790.75091.39
476595-7659589.40590.00
576677-7667789.50190.12
677145-7714590.04790.70
极限178820-7882092.00292.241.3992.7693.011.38
278044-7804491.09691.85
377873-7787390.89791.69
479209-7920992.45693.20
580915-8091594.44795.21
679289-7928992.55093.35
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%
119.534135002414093341425314143957414616841417180.11
219.554121390412573941235640.08
单位质量响应值RSD%判断
212069.53210923.990.39数据可信
影响因素30天-供试品溶液-2024050521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%
5min1802188-80218820.06022.6111.8220.0622.6111.82
2922007-92200723.05623.06
3902205-90220522.56122.56
4841089-84108921.03321.03
5853844-85384421.35221.35
61103768-110376827.60227.60
10min12100119-210011952.51753.445.4952.5553.485.49
22092801-209280152.33452.37
32104904-210490452.63752.67
41987964-198796449.71349.75
52207800-220780055.21055.25
62329486-232948658.25358.30
15min12979136-297913674.49974.943.6974.6275.073.69
22962500-296250074.08374.21
33021199-302119975.55175.68
42822337-282233770.57870.70
53033897-303389775.86876.00
63161370-316137079.05679.20
20min13448775-344877586.24386.112.7786.4986.362.77
23395606-339560684.91385.16
33571035-357103589.30089.55
43325977-332597783.17283.41
53380378-338037884.53384.79
63538703-353870388.49288.77
30min13700481-370048192.53793.331.9892.9393.721.98
23726263-372626393.18293.57
33863216-386321696.60797.01
43678551-367855191.98992.36
53660258-366025891.53191.93
63763735-376373594.11994.54
45min13793253-379325394.85795.781.2695.4096.341.27
23841333-384133396.06096.61
33873463-387346396.86397.42
43800699-380069995.04395.57
53776112-377611294.42994.98
63897054-389705497.45398.03
60min13842455-384245596.08896.970.5296.7997.670.52
23891482-389148297.31498.02
33875794-387579496.92197.64
43891928-389192897.32598.01
53868546-386854696.74097.44
63895049-389504997.40398.14
极限13935334-393533498.41098.491.0199.2799.361.00
23936215-393621598.43299.30
33868357-386835796.73597.62
43958728-395872898.99599.84
53988276-398827699.734100.60
63944431-394443198.63899.54
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%
113.98260282342823038223982227823430.19
213.898207682092820840.02
单位质量响应值RSD%判断
5923.965909.580.18数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min113724-1372416.20213.5812.2516.2013.5812.25
29937-993711.73111.73
311356-1135613.40613.41
410922-1092212.89412.89
512580-1258014.85114.85
610499-1049912.39512.39
10min134412-3441240.62538.7510.6540.6538.7710.65
233581-3358139.64439.66
330327-3032735.80235.82
430043-3004335.46735.49
538744-3874445.73945.76
629837-2983735.22435.24
15min154257-5425764.05361.578.6464.1561.668.64
255128-5512865.08165.17
347765-4776556.38956.47
447871-4787156.51456.59
558647-5864769.23669.34
649272-4927258.16858.25
20min168256-6825680.58077.406.5180.7877.586.52
267719-6771979.94680.14
360378-6037871.27971.46
461533-6153372.64372.82
571380-7138084.26884.48
664084-6408475.65475.83
30min177716-7771691.74790.222.4992.0890.542.50
277963-7796392.03992.37
373254-7325486.48086.77
475137-7513788.70389.00
576513-7651390.32790.68
677948-7794892.02192.32
45min178961-7896193.21793.461.3593.7193.931.33
279166-7916693.45993.94
379454-7945493.79994.24
479238-7923893.54493.99
577417-7741791.39591.90
680743-8074395.32195.78
60min179316-7931693.63693.881.2994.2894.511.26
279415-7941593.75394.39
380075-8007594.53295.13
479672-7967294.05794.66
577793-7779391.83892.50
680867-8086795.46796.08
极限180320-8032094.82295.021.2595.6295.801.22
280050-8005094.50395.30
381402-8140296.09996.85
480889-8088995.49396.25
578799-7879993.02693.84
681474-8147496.18496.96
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%
119.534111491410693241034514100723410168441048560.11
219.554101692410589841037950.08
单位质量响应值RSD%判断
210182.08209912.790.10数据可信
影响因素30天-供试品溶液-2024050521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%
5min1985903-98590324.82420.8911.2324.8220.8911.22
2720520-72052018.14218.14
3826222-82622220.80420.80
4790555-79055519.90619.91
5880069-88006922.15922.16
6775075-77507519.51619.52
10min12057318-205731851.80249.768.3251.8449.798.32
22001810-200181050.40450.43
31872038-187203847.13647.17
41845225-184522546.46146.49
52254384-225438456.76456.80
61826704-182670445.99546.03
15min12970600-297060074.79772.077.0874.9372.197.08
22956540-295654074.44374.56
32668186-266818667.18367.30
42682996-268299667.55667.67
53171306-317130679.85179.98
62723831-272383168.58468.69
20min13582221-358222190.19786.115.5390.4586.355.54
23472903-347290387.44587.68
33198743-319874380.54280.77
43256517-325651781.99682.22
53677494-367749492.59692.86
63332531-333253183.91084.13
30min13897274-389727498.13096.171.8598.5396.561.86
23852475-385247597.00297.39
33706314-370631493.32293.68
43765490-376549094.81295.17
53835246-383524696.56896.99
63860697-386069797.20997.57
45min13933056-393305699.03198.420.8099.6098.960.78
23886452-388645297.85898.40
33919791-391979198.69799.21
43900489-390048998.21198.73
53864218-386421897.29897.88
63948388-394838899.41799.94
60min13942069-394206999.25898.600.8099.9999.310.78
23888473-388847397.90998.62
33936225-393622599.11199.79
43912735-391273598.52099.20
53870911-387091197.46698.21
63946272-394627299.364100.06
极限13947701-394770199.40098.700.86100.3099.570.84
23890952-389095297.97198.84
33946727-394672799.375100.22
43918163-391816398.65699.50
53868714-386871497.41198.32
63946064-394606499.359100.22
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%
113.98259082579825668257382609825830.03
213.898243782464824500.03
单位质量响应值RSD%判断
5941.225935.930.07数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min113353-1335315.70613.2020.4815.7113.2020.49
29214-921410.83810.84
314808-1480817.41717.42
49635-963511.33311.33
510409-1040912.24312.24
69892-989211.63511.64
10min136393-3639342.80639.0510.7942.8339.0710.80
229811-2981135.06435.08
338587-3858745.38645.42
431600-3160037.16837.19
532874-3287438.66738.69
629925-2992535.19835.22
15min156653-5665366.63662.926.7966.7363.006.80
250049-5004958.86858.94
358895-5889569.27369.38
453087-5308762.44262.52
552479-5247961.72661.81
649795-4979558.56958.65
20min168662-6866280.76178.493.0980.9778.683.11
264180-6418075.48975.66
369359-6935981.58181.80
467417-6741779.29779.48
565313-6531376.82277.01
665465-6546577.00177.18
30min178351-7835192.15791.181.2892.5091.511.29
277317-7731790.94191.24
378626-7862692.48192.84
478050-7805091.80392.12
576179-7617989.60389.92
676612-7661290.11290.42
45min180990-8099095.26193.730.8595.7694.200.86
279439-7943993.43793.89
379307-7930793.28293.79
479605-7960593.63294.10
579089-7908993.02593.49
679699-7969993.74394.20
60min181066-8106695.35194.140.7496.0194.770.74
279605-7960593.63294.24
379371-7937193.35794.02
479944-7994494.03194.66
580010-8001094.10994.73
680225-8022594.36294.97
极限182106-8210696.57495.151.0197.3995.941.01
280401-8040194.56995.33
380030-8003094.13294.95
480342-8034294.49995.28
580840-8084095.08595.86
681646-8164696.03396.80
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%
119.534116224412036541180104118870411976441186470.04
219.554139112414462041418660.10
单位质量响应值RSD%判断
210888.22211860.150.33数据可信
影响因素30天-供试品溶液-2024050521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%
5min1922921-92292123.09320.0017.5923.0920.0017.59
2680414-68041417.02517.02
31025186-102518625.65125.65
4710981-71098117.79017.79
5740038-74003818.51718.52
6715576-71557617.90517.90
10min12125108-212510853.17349.599.2953.2149.629.29
21814145-181414545.39245.42
32271693-227169356.84156.88
41909544-190954447.77947.81
51965463-196546349.17849.21
61805515-180551545.17645.21
15min13024710-302471075.68272.515.9275.8172.625.93
22755521-275552168.94769.05
33158182-315818279.02279.16
42899289-289928972.54472.65
52853783-285378371.40571.52
62695582-269558267.44767.55
20min13501541-350154187.61386.112.7487.8786.342.75
23348198-334819883.77684.00
33572696-357269689.39389.66
43493327-349332787.40787.64
53383035-338303584.64884.88
63349135-334913583.80084.02
30min13861658-386165896.62496.281.2597.0296.661.26
23842991-384299196.15796.52
33903893-390389397.68098.10
43891915-389191597.38197.76
53806267-380626795.23895.61
63781780-378178094.62594.98
45min13957847-395784799.03098.180.5299.5998.720.53
23916039-391603997.98498.50
33921330-392133098.11798.70
43935889-393588998.48199.02
53912737-391273797.90298.43
63900233-390023397.58998.10
60min13961277-396127799.11698.440.4299.8499.150.43
23924157-392415798.18798.87
33922600-392260098.14898.89
43939633-393963398.57599.28
53941839-394183998.63099.32
63917069-391706998.01098.69
极限13967361-396736199.26898.540.41100.1699.410.41
23928336-392833698.29299.14
33922553-392255398.14799.06
43933305-393330598.41699.28
53942484-394248498.64699.51
63934832-393483298.45599.30
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%
113.98238482501824438237782388824190.07
213.898238782458824220.07
单位质量响应值RSD%判断
5929.425933.910.06数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min110830-1083012.75316.9317.2712.7516.9317.27
214001-1400116.48716.49
317564-1756420.68320.68
416761-1676119.73719.74
512882-1288215.17015.17
614240-1424016.76916.77
10min133902-3390239.92246.4310.6939.9446.4610.70
240257-4025747.40647.43
344478-4447852.37652.41
442567-4256750.12650.16
534844-3484441.03241.06
640540-4054047.73947.77
15min155894-5589465.82068.665.5765.9168.765.58
258040-5804068.34768.45
363847-6384775.18575.31
459539-5953970.11270.23
554513-5451364.19364.29
657982-5798268.27968.39
20min168690-6869080.88881.383.4881.0981.603.48
268151-6815180.25380.47
373153-7315386.14486.39
469766-6976682.15582.39
565810-6581077.49777.70
669082-6908281.35081.57
30min179982-7998294.18590.702.1094.5291.062.09
275154-7515488.50088.85
377041-7704190.72291.11
476145-7614589.66790.04
576832-7683290.47690.81
676996-7699690.66991.03
45min180812-8081295.16392.861.4795.6593.371.45
277671-7767191.46491.97
378302-7830292.20792.75
478121-7812191.99492.51
579619-7961993.75894.24
678635-7863592.59993.11
60min181047-8104795.43993.841.2696.0994.501.23
279172-7917293.23193.89
379028-7902893.06293.76
478820-7882092.81793.49
580875-8087595.23795.87
679171-7917193.23093.89
极限181666-8166696.16895.811.0296.9896.631.00
282255-8225596.86297.67
381317-8131795.75796.61
480436-8043694.72095.55
582146-8214696.73497.53
680353-8035394.62295.44
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%
119.534133714414075941360454134870413375941358290.08
219.554127198413302941301140.10
单位质量响应值RSD%判断
211768.00211259.030.18数据可信
影响因素30天-供试品溶液-2024050521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%
5min1798702-79870219.97125.0214.0519.9725.0214.06
2990522-99052224.76824.77
31179272-117927229.48729.49
41137106-113710628.43328.43
5917601-91760122.94422.94
6979930-97993024.50324.50
10min12054873-205487351.38157.588.7651.4157.628.77
22352638-235263858.82758.87
32545033-254503363.63863.69
42454607-245460761.37761.42
52065993-206599351.66051.70
62342696-234269658.57858.62
15min13048410-304841076.22578.514.6976.3478.654.70
23147845-314784578.71178.85
33378987-337898784.49184.65
43206272-320627280.17280.32
52946779-294677973.68373.81
63110690-311069077.78277.92
20min13596149-359614989.92189.653.0690.1789.923.06
23562849-356284989.08889.36
33748531-374853193.73194.03
43620640-362064090.53390.82
53408604-340860485.23185.48
63576256-357625689.42389.69
30min14013558-4013558100.35897.261.70100.7597.681.69
23832918-383291895.84196.26
33900489-390048997.53197.98
43875689-387568996.91097.34
53838239-383823995.97496.36
63877243-387724396.94997.37
45min14037238-4037238100.95099.070.96101.5199.650.95
23937523-393752398.45799.04
33957731-395773198.96299.58
43954310-395431098.87699.47
53943914-394391498.61699.17
63940692-394069298.53699.11
60min14040051-4040051101.02099.500.85101.75100.250.84
23987481-398748199.706100.45
33977167-397716799.448100.23
43962751-396275199.08799.85
53967241-396724199.20099.91
63941091-394109198.54699.29
极限14030065-4030065100.771100.070.76101.67100.980.76
24040496-4040496101.031101.94
34011171-4011171100.298101.24
43987689-398768999.711100.64
53981604-398160499.559100.44
63961838-396183899.06599.97
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-06-21 16:42:40 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-06-21 16:43:36 完成)
Current page cost:864 ms