达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204207911420445242056714204312420281042050310.05
210.274191376419348041924280.04
单位质量响应值RSD%判断
412257.94408220.840.70数据可信
中间条件6月-供试品溶液-2025081921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%
5min1224391-2243915.4705.078.215.475.078.24
2199149-1991494.8554.85
3207322-2073225.0545.05
4189842-1898424.6284.63
5232558-2325585.6695.67
6194650-1946504.7454.74
10min1408336-4083369.9549.365.269.989.385.25
2404062-4040629.8509.87
3385752-3857529.4039.43
4354365-3543658.6388.66
5379216-3792169.2449.27
6372437-3724379.0799.10
15min1531784-53178412.96312.652.8013.0412.722.79
2524271-52427112.78012.85
3531656-53165612.96013.03
4493042-49304212.01912.09
5519713-51971312.66912.74
6513734-51373412.52312.59
20min1665269-66526916.21715.732.1916.3615.872.21
2649884-64988415.84215.98
3649747-64974715.83915.98
4622048-62204815.16315.29
5642990-64299015.67415.81
6642170-64217015.65415.79
30min1884983-88498321.57320.703.0521.8020.913.06
2862832-86283221.03321.25
3854928-85492820.84021.06
4807657-80765719.68819.89
5844245-84424520.58020.80
6839762-83976220.47120.68
45min11125263-112526327.43026.732.3427.7627.052.35
21115163-111516327.18427.51
31097832-109783226.76127.08
41051242-105124225.62625.93
51099804-109980426.80927.13
61089274-108927426.55326.87
60min11341521-134152132.70232.092.7033.1732.542.69
21371666-137166633.43733.89
31308364-130836431.89332.35
41270374-127037430.96731.40
51297325-129732531.62432.08
61308674-130867431.90132.35
120min11994690-199469048.62448.151.2849.2648.761.30
21995346-199534648.64049.26
31989786-198978648.50449.12
41934210-193421047.14947.73
51983526-198352648.35248.96
61954229-195422947.63748.24
180min12498020-249802060.89359.751.2161.7760.601.22
22478463-247846360.41761.28
32435604-243560459.37260.23
42431362-243136259.26860.09
52432391-243239159.29360.15
62429811-242981159.23160.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12876581-287658170.12167.064.9971.3068.214.91
22826549-282654968.90270.07
32782990-278299067.84068.99
42771893-277189367.56968.69
52484940-248494060.57461.72
62763872-276387267.37468.51
360min13407779-340777983.07081.051.5184.6082.541.52
23338929-333892981.39282.91
33318845-331884580.90282.39
43283127-328312780.03181.49
53264672-326467279.58281.03
63335968-333596881.32082.80
480min13683426-368342689.78989.231.3391.7391.121.33
23715841-371584190.58092.50
33689980-368998089.94991.85
43579776-357977687.26389.12
53660023-366002389.21991.07
63633071-363307188.56290.44
600min13893302-389330294.90593.411.2997.3095.751.30
23895749-389574994.96597.34
33819425-381942593.10595.45
43797356-379735692.56794.86
53794113-379411392.48894.78
63792542-379254292.44994.77
720min13897541-389754195.00995.021.2397.8897.821.24
23980707-398070797.03699.89
33912671-391267195.37898.19
43840342-384034293.61496.37
53866083-386608394.24297.00
63889999-388999994.82597.61
极限13945496-394549696.17894.681.0199.5297.961.02
23905159-390515995.19598.53
33863004-386300494.16797.46
43830086-383008693.36496.59
53885941-388594194.72697.96
63874181-387418194.43997.70
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611680716823167201673016965168090.59
212.741669416576166350.51
单位质量响应值RSD%判断
1332.991305.731.47数据可信
中间条件6月-供试品溶液-2025081921批-达格列净-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%
5min119365-1936594.41692.461.4094.4292.461.40
219126-1912693.25193.25
318839-1883991.85291.85
418587-1858790.62390.62
518975-1897592.51592.51
618885-1888592.07692.08
10min119350-1935094.34393.201.9394.8293.661.92
219615-1961595.63596.10
318809-1880991.70592.16
418727-1872791.30691.76
519344-1934494.31494.78
618845-1884591.88192.34
15min119065-1906592.95492.430.8793.9093.360.86
218769-1876991.51092.45
319059-1905992.92493.84
418908-1890892.18893.10
519165-1916593.44194.38
618783-1878391.57992.50
20min119075-1907593.00292.380.8594.4193.760.84
218747-1874791.40392.81
318943-1894392.35993.74
418756-1875691.44792.82
519065-1906592.95494.35
619092-1909293.08594.46
30min119449-1944994.82692.911.1996.7094.761.18
219008-1900892.67694.53
318830-1883091.80893.65
419139-1913993.31495.14
519055-1905592.90594.77
618856-1885691.93593.78
45min119244-1924493.82692.700.8696.1795.010.86
219035-1903592.80795.13
318824-1882491.77994.08
418932-1893292.30594.60
519154-1915493.38795.72
618883-1888392.06694.37
60min118907-1890792.18392.431.1295.0095.211.08
219173-1917393.48096.27
318727-1872791.30694.07
419255-1925593.88096.64
518894-1889492.12094.92
618790-1879091.61394.38
120min118944-1894492.36492.920.7995.6496.160.75
218891-1889192.10595.36
319102-1910293.13496.35
419284-1928494.02197.25
519156-1915693.39796.66
618970-1897092.49095.71
180min118922-1892292.25692.901.4896.0096.601.42
218943-1894392.35996.07
318867-1886791.98895.67
419617-1961795.64599.34
519022-1902292.74496.47
618950-1895092.39396.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118964-1896492.46190.224.1696.6694.393.97
218609-1860990.73094.91
318669-1866991.02395.17
419165-1916593.44197.61
517001-1700182.89087.08
618620-1862090.78494.93
360min119005-1900592.66192.160.8897.3296.780.85
218769-1876991.51096.14
318745-1874591.39395.99
419151-1915193.37398.01
518775-1877591.54096.14
618967-1896792.47697.08
480min118717-1871791.25791.820.6396.3896.910.58
218762-1876291.47696.56
318921-1892192.25197.31
418920-1892092.24797.35
518972-1897292.50097.56
618709-1870991.21896.28
600min118789-1878991.60891.490.5897.1997.020.56
218848-1884891.89697.44
318766-1876691.49697.01
418856-1885691.93597.50
518763-1876391.48197.00
618561-1856190.49696.01
720min118401-1840189.71690.790.9595.7696.790.89
218640-1864090.88196.89
318447-1844789.94095.92
418878-1887892.04298.07
518718-1871891.26297.24
618641-1864190.88696.86
极限118434-1843489.87789.831.0396.3796.280.98
218381-1838189.61996.08
318135-1813588.41994.84
418602-1860290.69697.18
518659-1865990.97497.41
618338-1833889.40995.83
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204196848420019942016634199776420053741998050.05
210.274265418426226342638400.06
单位质量响应值RSD%判断
411745.59415174.290.59数据可信
中间条件6月-供试品溶液-2025081921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%
5min1207829-2078295.0274.667.605.034.667.58
2199330-1993304.8214.82
3188605-1886054.5624.56
4197780-1977804.7844.78
5197652-1976524.7814.78
6165679-1656794.0074.01
10min1380539-3805399.2048.735.749.238.765.74
2345483-3454838.3568.38
3369794-3697948.9448.97
4368044-3680448.9028.93
5375212-3752129.0759.10
6326500-3265007.8977.92
15min1511143-51114312.36312.304.3112.4312.374.31
2504636-50463612.20512.27
3523130-52313012.65312.72
4512249-51224912.39012.46
5531711-53171112.86012.93
6468381-46838111.32911.39
20min1637850-63785015.42715.294.7715.5615.424.78
2627083-62708315.16715.29
3661733-66173316.00516.14
4656851-65685115.88716.02
5631418-63141815.27215.41
6577371-57737113.96514.08
30min1838468-83846820.28020.222.1020.4920.422.12
2836140-83614020.22320.43
3856235-85623520.70920.92
4852573-85257320.62120.83
5821995-82199519.88120.09
6810469-81046919.60219.79
45min11080722-108072226.13926.272.9026.4526.572.90
21098714-109871426.57426.88
31136102-113610227.47827.79
41066371-106637125.79226.10
51091690-109169026.40426.71
61043073-104307325.22825.51
60min11314133-131413331.78431.242.2532.2331.682.26
21296758-129675831.36431.80
31329623-132962332.15932.61
41277542-127754230.89931.34
51284406-128440631.06531.51
61246980-124698030.16030.57
120min11918175-191817546.39446.782.8547.0047.372.83
21973436-197343647.73148.32
32016456-201645648.77149.38
41858195-185819544.94345.54
51931646-193164646.72047.32
61906129-190612946.10346.66
180min12418808-241880858.50358.471.6159.3459.301.62
22438813-243881358.98659.82
32475217-247521759.86760.72
42398540-239854058.01258.83
52413711-241371158.37959.21
62359674-235967457.07257.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12753655-275365566.60167.232.4867.7368.352.47
22830686-283068668.46569.59
32893786-289378669.99171.15
42720088-272008865.79066.90
52756961-275696166.68167.80
62722324-272232465.84466.92
360min12995143-299514372.44278.184.9173.9079.634.83
23381284-338128481.78283.25
33381990-338199081.79983.30
43289339-328933979.55881.00
53087760-308776074.68276.14
63257983-325798378.79980.21
480min13479590-347959084.15986.514.3685.9888.364.31
23696374-369637489.40391.28
33720200-372020089.97991.89
43641234-364123488.06989.91
53613475-361347587.39889.23
63309435-330943580.04481.84
600min13761213-376121390.97191.811.5493.2194.091.55
23887899-388789994.03596.36
33844489-384448992.98595.35
43731120-373112090.24392.52
53772970-377297091.25593.52
63777937-377793791.37593.58
720min13757875-375787590.89092.962.9293.5995.702.89
24009651-400965196.98099.78
33939314-393931495.27898.11
43850611-385061193.13395.86
53777239-377723991.35894.08
63725128-372512890.09892.76
极限13845910-384591093.01992.561.6596.1795.761.61
23914593-391459394.68197.96
33744839-374483990.57593.88
43867511-386751193.54296.74
53819808-381980892.38895.57
63769058-376905891.16194.27
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611675916787167791677217010168210.63
212.741720217013171080.79
单位质量响应值RSD%判断
1333.941342.860.48数据可信
中间条件6月-供试品溶液-2025081921批-达格列净-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%
5min118828-1882890.48389.482.0290.4889.482.02
218973-1897391.18091.18
318837-1883790.52790.53
418735-1873590.03790.04
518353-1835388.20188.20
617983-1798386.42386.42
10min119235-1923592.43989.671.9092.8990.121.89
218297-1829787.93288.39
318702-1870289.87890.33
418828-1882890.48390.93
518593-1859389.35489.80
618300-1830087.94688.38
15min118919-1891990.92191.251.4191.8492.151.40
219328-1932892.88693.78
318803-1880390.36391.27
419217-1921792.35393.26
519051-1905191.55592.44
618608-1860889.42690.30
20min119040-1904091.50289.982.0292.8791.332.00
219078-1907891.68593.04
318832-1883290.50391.86
418880-1888090.73392.10
518289-1828987.89389.24
618215-1821587.53888.86
30min118808-1880890.38791.002.2492.2192.812.21
219477-1947793.60295.42
318925-1892590.95092.76
419288-1928892.69494.51
518260-1826087.75489.54
618861-1886190.64292.40
45min118710-1871089.91690.822.1492.2093.072.11
219621-1962194.29496.58
319067-1906791.63293.89
418845-1884590.56592.85
518512-1851288.96591.19
618627-1862789.51891.73
60min118937-1893791.00790.752.0793.7493.462.04
219504-1950493.73296.49
319014-1901491.37794.10
418832-1883290.50393.24
518323-1832388.05790.73
618687-1868789.80692.46
120min118656-1865689.65790.602.6392.8493.762.56
219567-1956794.03597.26
319303-1930392.76695.94
418266-1826687.78390.97
518498-1849888.89892.01
618824-1882490.46493.57
180min118937-1893791.00790.671.5894.6494.291.58
219294-1929492.72396.42
318993-1899391.27694.92
418889-1888990.77794.40
518423-1842388.53792.09
618665-1866589.70093.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118776-1877690.23491.002.8994.3295.072.82
219554-1955493.97398.13
319598-1959894.18498.28
418804-1880490.36894.45
518178-1817887.36091.36
618705-1870589.89293.90
360min117096-1709682.16088.445.5186.7092.975.29
219349-1934992.98797.62
319083-1908391.70996.28
418974-1897491.18595.72
517136-1713682.35286.78
618778-1877890.24394.70
480min118238-1823887.64888.674.0292.6093.633.88
219175-1917592.15197.25
318808-1880890.38795.41
419151-1915192.03697.02
518060-1806086.79391.64
617266-1726682.97787.88
600min118624-1862489.50389.701.6194.8995.111.60
219191-1919192.22897.78
318537-1853789.08594.56
418665-1866589.70095.15
518272-1827287.81193.09
618697-1869789.85495.18
720min118243-1824387.67288.553.6293.5194.403.51
219438-1943893.41599.43
318669-1866989.71995.64
418695-1869589.84495.74
517507-1750784.13589.85
617997-1799786.49092.26
极限118687-1868789.80687.802.9196.0894.102.78
218784-1878490.27296.76
317556-1755684.37190.74
418710-1871089.91696.26
517775-1777585.42391.56
618108-1810887.02393.23
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