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%
110.354260309426131342590934260806427098442625010.12
210.374289715429712042934180.13
单位质量响应值RSD%判断
411835.85414022.950.38数据可信
供试品溶液-YA0011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%
5min1112450-1124502.7232.856.492.722.846.45
2109405-1094052.6502.65
3111769-1117692.7072.71
4121990-1219902.9542.95
5120209-1202092.9112.91
6129346-1293463.1323.13
10min1277393-2773936.7186.884.776.736.894.73
2279823-2798236.7776.79
3284170-2841706.8826.90
4303873-3038737.3597.37
5293470-2934707.1077.12
6264711-2647116.4116.43
15min1413925-41392510.02410.406.1510.0710.446.11
2423672-42367210.26010.31
3441570-44157010.69410.74
4434530-43453010.52310.57
5470033-47003311.38311.43
6392205-3922059.4989.55
20min1540028-54002813.07813.092.9113.1813.192.91
2548625-54862513.28613.38
3549277-54927713.30213.40
4544926-54492613.19713.30
5550401-55040113.32913.44
6509314-50931412.33412.43
30min1737012-73701217.84917.892.6718.0118.062.68
2750685-75068518.18018.34
3745913-74591318.06418.23
4747369-74736918.09918.27
5752119-75211918.21418.39
6700226-70022616.95817.11
45min1988313-98831323.93424.222.4424.1924.472.43
21013973-101397324.55624.81
31022983-102298324.77425.03
41017160-101716024.63324.89
51000352-100035224.22624.49
6957586-95758623.19023.43
60min11196558-119655828.97828.931.9529.3529.311.95
21212098-121209829.35429.73
31219546-121954629.53429.92
41197826-119782629.00829.39
51189230-118923028.80029.19
61152889-115288927.92028.28
120min11886692-188669245.69144.961.7246.2145.481.72
21875027-187502745.40845.93
31880577-188057745.54346.07
41832752-183275244.38444.91
51858305-185830545.00345.53
61805004-180500443.71244.21
180min12318631-231863156.15156.221.3556.9056.971.35
22364417-236441757.26058.01
32350566-235056656.92557.68
42310886-231088655.96456.71
52305792-230579255.84056.60
62278668-227866855.18355.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12708564-270856465.59465.421.1666.6266.441.16
22744393-274439366.46267.50
32720569-272056965.88566.93
42698773-269877365.35766.39
52654605-265460564.28865.32
62680480-268048064.91465.91
360min13256824-325682478.87278.721.1980.2380.081.18
23275261-327526179.31880.69
33246034-324603478.61079.98
43307087-330708780.08981.45
53213625-321362577.82679.18
63204330-320433077.60078.92
480min13612188-361218887.47887.501.1089.2389.241.09
23653402-365340288.47690.24
33618729-361872987.63689.40
43643785-364378588.24390.00
53541175-354117585.75887.50
63608903-360890387.39889.10
600min13794147-379414791.88492.431.3294.0794.621.31
23872762-387276293.78896.00
33861866-386186693.52495.73
43846134-384613493.14395.34
53772915-377291591.37093.54
63753083-375308390.89093.03
720min13915775-391577594.83094.360.8597.4797.010.85
23890596-389059694.22096.90
33929513-392951395.16397.83
43925457-392545795.06497.73
53869217-386921793.70296.33
63848594-384859493.20395.80
极限13886167-388616794.11394.561.3397.2397.681.32
23959798-395979895.89699.05
33927269-392726995.10898.25
43959496-395949695.88999.03
53844182-384418293.09696.19
63851906-385190693.28396.34
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12500
标示量(mg)5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%
112.511578715719158021586715947158240.55
212.541591315815158640.44
单位质量响应值RSD%判断
1264.911265.070.01数据可信
供试品溶液-YA0011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%
5min112970-1297065.94869.239.2865.9569.239.28
213579-1357969.04469.04
313751-1375169.91969.92
414204-1420472.22272.22
515494-1549478.78178.78
611700-1170059.49059.49
10min117875-1787590.88893.834.1391.2294.184.13
218761-1876195.39395.74
319858-19858100.970101.32
418211-1821192.59692.96
518161-1816192.34292.74
617856-1785690.79191.09
15min118202-1820292.55095.413.5593.3396.223.55
218869-1886995.94296.76
319942-19942101.398102.25
418885-1888596.02396.85
518588-1858894.51395.37
618095-1809592.00692.76
20min118509-1850994.11195.543.3595.3696.843.34
218899-1889996.09497.40
320013-20013101.759103.12
418465-1846593.88895.19
518324-1832493.17194.50
618535-1853594.24495.45
30min118410-1841093.60895.622.4895.3397.402.49
218903-1890396.11597.90
319691-19691100.121101.99
418537-1853794.25496.03
518719-1871995.17996.97
618579-1857994.46796.15
45min118345-1834593.27796.163.3795.4698.413.35
219301-1930198.138100.40
320007-20007101.728104.10
418756-1875695.36797.61
518386-1838693.48695.76
618681-1868194.98697.14
60min117863-1786390.82794.513.8493.4897.243.81
218620-1862094.67697.43
319942-19942101.398104.28
418290-1829092.99895.72
518293-1829393.01395.75
618515-1851594.14296.77
120min118775-1877595.46495.862.9298.5799.062.91
218861-1886195.90199.13
319862-19862100.991104.38
418186-1818692.46995.66
518734-1873495.25598.46
618695-1869595.05798.16
180min118103-1810392.04794.472.9495.6398.162.92
218935-1893596.27799.98
319468-1946898.987102.88
418200-1820092.54096.19
518137-1813792.22095.90
618640-1864094.77798.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118021-1802191.63093.942.9495.6798.102.91
218885-1888596.023100.21
319235-1923597.803102.19
418369-1836993.39997.51
517772-1777290.36494.50
618574-1857494.44298.49
360min118020-1802091.62594.272.5096.1398.892.50
218571-1857194.42799.09
319352-1935298.398103.27
418592-1859294.53399.11
518175-1817592.41397.00
618529-1852994.21398.74
480min118135-1813592.21093.252.5197.1798.342.50
218540-1854094.26999.41
319091-1909197.071102.44
417894-1789490.98496.04
517903-1790391.03096.08
618473-1847393.92898.92
600min117495-1749588.95692.883.2594.3898.443.22
218727-1872795.220100.83
319172-1917297.482103.34
418166-1816692.36797.87
517996-1799691.50397.01
618046-1804691.75797.22
720min117690-1769089.94792.232.8695.8198.262.85
218275-1827592.92299.01
319120-1912097.218103.56
417869-1786990.85796.83
517897-1789791.00096.97
617985-1798591.44797.37
极限117324-1732488.08691.163.4994.4097.643.44
218203-1820392.55599.11
319024-1902496.730103.56
417754-1775490.27296.69
517402-1740288.48394.90
617861-1786190.81697.20
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%
110.354363659436861343576154355547435568543602240.14
210.374376956431577543463661.00
单位质量响应值RSD%判断
421277.68419128.830.37数据可信
供试品溶液-YA0011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%
5min1136128-1361283.2402.859.843.242.859.85
2123289-1232892.9342.93
3106909-1069092.5442.54
4113737-1137372.7072.71
5129984-1299843.0933.09
6109353-1093532.6022.60
10min1278795-2787956.6356.602.906.656.622.92
2292119-2921196.9526.97
3276401-2764016.5786.59
4268719-2687196.3956.41
5276761-2767616.5866.60
6272159-2721596.4776.49
15min1420206-42020610.00010.053.0910.0510.103.08
2433597-43359710.31910.37
3424641-42464110.10610.15
4425909-42590910.13610.18
5431537-43153710.27010.32
6397520-3975209.4609.51
20min1541958-54195812.89812.672.6413.0012.772.64
2549711-54971113.08213.18
3526812-52681212.53712.63
4517251-51725112.31012.41
5542573-54257312.91213.01
6517271-51727112.31012.40
30min1744491-74449117.71817.422.6117.8817.582.61
2758774-75877418.05718.22
3733064-73306417.44617.60
4708215-70821516.85417.01
5735005-73500517.49217.66
6712679-71267916.96017.11
45min1968641-96864123.05223.212.9123.3023.462.91
21005524-100552423.93024.19
31005050-100505023.91824.16
4948088-94808822.56322.80
5985485-98548523.45323.70
6938802-93880222.34222.58
60min11172354-117235427.90027.841.9228.2728.211.93
21193424-119342428.40128.78
31187577-118757728.26228.63
41145361-114536127.25727.61
51181676-118167628.12228.49
61139763-113976327.12427.48
120min11827590-182759043.49343.091.6444.0043.591.64
21823612-182361243.39943.92
31805850-180585042.97643.48
41801259-180125942.86743.36
51845199-184519943.91244.42
61759423-175942341.87142.36
180min12300838-230083854.75654.641.5755.4855.361.56
22300908-230090854.75755.49
32300347-230034754.74455.47
42260261-226026153.79054.50
52356280-235628056.07556.80
62257918-225791853.73454.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12746767-274676765.36863.341.9166.3764.331.90
22619742-261974262.34563.35
32667532-266753263.48264.48
42634701-263470162.70163.68
52688107-268810763.97264.98
62612534-261253462.17463.14
360min13203436-320343676.23676.221.2777.5677.521.26
23193646-319364676.00377.32
33219264-321926476.61377.93
43138542-313854274.69275.98
53263494-326349477.66578.99
63197620-319762076.09777.37
480min13624692-362469286.26185.231.0887.9786.921.08
23539794-353979484.24185.94
33622193-362219386.20287.90
43556131-355613184.62986.29
53598627-359862785.64187.36
63546421-354642184.39886.05
600min13819216-381921690.89090.570.8893.0392.690.87
23747249-374724989.17891.30
33833151-383315191.22293.35
43785560-378556090.08992.17
53826788-382678891.07193.22
63823684-382368490.99793.07
720min13885544-388554492.46992.320.8095.0694.880.80
23924271-392427193.39095.96
33885150-388515092.45995.04
43868026-386802692.05294.59
53882429-388242992.39595.00
63829079-382907991.12593.66
极限13882965-388296592.40792.340.6395.4695.370.62
23838868-383886891.35894.39
33892384-389238492.63295.68
43865243-386524391.98694.98
53903098-390309892.88795.95
63898519-389851992.77895.77
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12500
标示量(mg)5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%
112.511627516088160741603016019160970.65
212.541574415919158320.79
单位质量响应值RSD%判断
1286.731262.521.35数据可信
供试品溶液-YA0011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%
5min113646-1364668.86766.967.7268.8766.967.72
214463-1446372.99072.99
314190-1419071.61271.61
412502-1250263.09363.09
513020-1302065.70765.71
611793-1179359.51559.52
10min118004-1800490.86089.982.9991.2090.323.00
218557-1855793.65194.02
318184-1818491.76892.13
417075-1707586.17186.49
517450-1745088.06488.39
617711-1771189.38189.68
15min118350-1835092.60692.363.0293.4093.153.03
218676-1867694.25195.08
318935-1893595.55896.38
417359-1735987.60588.35
518037-1803791.02691.80
618454-1845493.13193.88
20min118760-1876094.67593.212.1595.9494.462.16
218894-1889495.35196.66
318511-1851193.41894.71
417777-1777789.71490.90
518300-1830092.35493.58
618578-1857893.75794.97
30min118807-1880794.91293.213.9496.6594.923.92
219365-1936597.72899.51
318609-1860993.91395.67
417251-1725187.06088.69
518072-1807291.20392.89
618713-1871394.43896.12
45min118068-1806891.18391.552.7393.3993.732.74
218627-1862794.00496.27
318736-1873694.55496.79
417370-1737087.66089.73
518067-1806791.17893.32
617979-1797990.73492.88
60min118263-1826392.16791.832.6194.8394.472.62
218835-1883595.05497.79
318541-1854193.57096.27
417532-1753288.47890.98
517807-1780789.86692.46
618203-1820391.86494.47
120min118444-1844493.08091.672.1296.2194.772.14
218598-1859893.85797.07
318179-1817991.74394.91
417561-1756188.62491.57
517877-1787790.21993.27
618332-1833292.51595.58
180min118350-1835092.60692.392.0596.2095.942.06
218765-1876594.70098.38
318327-1832792.49096.12
417656-1765689.10492.50
518208-1820891.88995.39
618535-1853593.54097.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118670-1867094.22191.882.4398.2895.892.43
218341-1834192.56196.72
318495-1849593.33897.43
417441-1744188.01991.86
517959-1795990.63394.59
618326-1832692.48596.48
360min118254-1825492.12191.213.3996.6595.683.35
218502-1850293.37397.99
318567-1856793.70198.26
417010-1701085.84390.12
517680-1768089.22593.64
618425-1842592.98497.44
480min118400-1840092.85891.542.4897.8496.472.48
218402-1840292.86897.96
318575-1857593.74198.77
417495-1749588.29193.00
517654-1765489.09393.95
618306-1830692.38497.31
600min118189-1818991.79391.092.3997.2496.472.37
218283-1828392.26897.82
318252-1825292.11197.61
417524-1752488.43793.59
517507-1750788.35293.65
618537-1853793.55098.93
720min117996-1799690.81990.673.1896.7396.513.12
218759-1875994.670100.68
318225-1822591.97597.93
417440-1744088.01393.60
517190-1719086.75292.50
618188-1818891.78897.64
极限117904-1790490.35589.932.1396.7296.222.15
218263-1826392.16798.65
317826-1782689.96196.38
417224-1722486.92392.95
517568-1756888.65994.84
618131-1813191.50197.81
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