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%
110.004096494411032941060294090198407352040953140.36
210.064146120414355441448370.05
单位质量响应值RSD%判断
409531.40412011.630.43数据可信
供试品溶液-2025081821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%
5min1163542-1635423.9814.497.413.984.497.44
2191532-1915324.6634.66
3176625-1766254.3004.30
4203947-2039474.9654.97
5185441-1854414.5144.51
6185202-1852024.5094.51
10min1340835-3408358.2988.634.048.328.664.04
2357885-3578858.7138.74
3347563-3475638.4618.48
4380271-3802719.2589.28
5344297-3442978.3828.40
6357131-3571318.6948.72
15min1489146-48914611.90812.142.8811.9712.212.88
2509343-50934312.40012.47
3479036-47903611.66211.73
4519242-51924212.64112.71
5495200-49520012.05512.12
6500171-50017112.17612.24
20min1628739-62873915.30615.261.8215.4315.381.82
2640048-64004815.58215.71
3631792-63179215.38115.50
4628896-62889615.31015.44
5605878-60587814.75014.87
6625749-62574915.23415.36
30min1809502-80950219.70720.092.2119.9020.292.20
2827762-82776220.15220.36
3813355-81335519.80120.00
4844648-84464820.56320.77
5807029-80702919.64719.85
6848647-84864720.66020.86
45min11068125-106812526.00326.452.5426.3026.752.54
21104388-110438826.88627.19
31065801-106580125.94726.24
41134065-113406527.60827.92
51066228-106622825.95726.25
61079895-107989526.29026.60
60min11286555-128655531.32131.351.9931.7531.781.99
21299318-129931831.63132.07
31271682-127168230.95931.39
41332294-133229432.43432.89
51260520-126052030.68731.11
61275777-127577731.05831.50
120min11926612-192661246.90347.281.2247.4947.871.23
21941957-194195747.27647.88
31929002-192900246.96147.54
41989289-198928948.42949.04
51931514-193151447.02247.60
61934784-193478447.10247.69
180min12416262-241626258.82359.081.3859.6459.911.38
22405907-240590758.57159.41
32401028-240102858.45259.27
42464390-246439059.99560.85
52399591-239959158.41759.23
62473920-247392060.22761.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12740957-274095766.72867.191.3767.8468.311.36
22778552-277855267.64368.77
32781324-278132467.71068.82
42802665-280266568.23069.39
52760195-276019567.19668.30
62695690-269569065.62666.76
360min13285389-328538979.98280.431.2381.4381.891.22
23312667-331266780.64682.11
33318271-331827180.78282.23
43349715-334971581.54883.04
53324475-332447580.93382.38
63232958-323295878.70580.16
480min13615927-361592788.02888.011.9289.8789.871.89
23656677-365667789.02190.89
33655403-365540388.99090.84
43620275-362027588.13490.04
53662633-366263389.16691.01
63479315-347931584.70386.55
600min13793804-379380492.35993.491.2894.6495.801.25
23905404-390540495.07697.39
33821889-382188993.04395.34
43807228-380722892.68695.03
53899748-389974894.93897.23
63814404-381440492.86095.14
720min13914294-391429495.29295.220.7798.0497.990.77
23916208-391620895.33998.13
33883279-388327994.53797.30
43964502-396450296.51499.32
53907590-390759095.12997.90
63883086-388308694.53297.27
极限13921461-392146195.46795.191.2398.6998.431.21
23941854-394185495.96399.23
33956798-395679896.32799.56
43916152-391615295.33798.63
53904379-390437995.05198.29
63819741-381974192.99096.20
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%
113.001596015934159471587715946159330.21
213.021591916051159850.59
单位质量响应值RSD%判断
1225.621227.730.13数据可信
供试品溶液-2025081821批-达格列净-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%
5min117906-1790693.88992.321.4593.8992.321.45
217741-1774193.02493.02
317696-1769692.78892.79
417197-1719790.17290.17
517425-1742591.36791.37
617680-1768092.70492.70
10min118719-1871998.15295.921.6198.6296.381.61
218165-1816595.24895.71
318385-1838596.40196.87
418021-1802194.49294.94
518501-1850197.00997.47
617963-1796394.18894.65
15min118901-1890199.10795.912.03100.0796.852.02
218533-1853397.17798.12
318294-1829495.92496.87
417925-1792593.98994.91
518009-1800994.43095.37
618087-1808794.83995.77
20min119247-19247100.92197.592.45102.3899.012.44
218939-1893999.306100.73
318479-1847996.89498.32
417935-1793594.04295.43
518392-1839296.43897.85
618680-1868097.94899.36
30min118932-1893299.26997.021.66101.2398.931.66
218339-1833996.16098.08
318804-1880498.598100.51
418131-1813195.06996.93
518330-1833096.11398.01
618483-1848396.91598.81
45min119041-1904199.84197.871.86102.30100.271.85
218857-1885798.876101.28
319007-1900799.663102.07
418226-1822695.56797.91
518402-1840296.49098.87
618458-1845896.78499.17
60min118918-1891899.19696.771.65102.1599.651.64
218707-1870798.089100.99
318397-1839796.46499.37
418372-1837296.33399.15
518220-1822095.53698.40
618113-1811394.97597.84
120min118968-1896899.45896.821.68102.91100.191.67
218289-1828995.89899.29
318628-1862897.675101.06
418061-1806194.70298.00
518382-1838296.38599.72
618461-1846196.800100.14
180min119070-1907099.99397.311.64103.94101.161.63
218568-1856897.361101.23
318673-1867397.911101.78
418339-1833996.16099.93
518196-1819695.41099.23
618499-1849996.999100.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118683-1868397.96495.302.10102.4199.642.07
218198-1819895.42199.78
318543-1854397.230101.59
417777-1777793.21397.47
518086-1808694.83399.13
617766-1776693.15597.47
360min118858-1885898.88196.451.57103.82101.261.57
218416-1841696.564101.40
318513-1851397.072101.92
418038-1803894.58299.30
518385-1838596.401101.17
618151-1815195.17499.95
480min118673-1867397.91194.972.52103.34100.262.47
218283-1828395.866101.18
318456-1845696.773102.11
417471-1747191.60996.80
518077-1807794.786100.04
617708-1770892.85198.10
600min118374-1837496.34395.572.26102.27101.352.18
218755-1875598.341104.14
317996-1799694.361100.18
417545-1754591.99797.65
518338-1833896.155101.88
618354-1835496.239101.96
720min118543-1854397.23094.531.69103.63100.781.67
217882-1788293.764100.05
318205-1820595.457101.75
417704-1770492.83098.94
517836-1783693.52299.73
617997-1799794.367100.56
极限118792-1879298.53594.232.55105.43100.952.49
218156-1815695.200101.96
317921-1792193.968100.73
417517-1751791.85098.42
517778-1777893.21899.89
617664-1766492.62199.29
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%
110.004190051419067941945094193365417827741893760.16
210.064214673421333842140060.03
单位质量响应值RSD%判断
418937.60418887.280.01数据可信
供试品溶液-2025081821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%
5min1172026-1720264.1064.184.464.114.184.43
2176630-1766304.2164.22
3171696-1716964.0994.10
4164272-1642723.9213.92
5187430-1874304.4744.47
6178394-1783944.2594.26
10min1355095-3550958.4778.474.108.508.504.09
2365998-3659988.7378.76
3373957-3739578.9278.95
4334122-3341227.9768.00
5357156-3571568.5268.55
6343288-3432888.1958.22
15min1503305-50330512.01511.863.2512.0811.923.25
2511896-51189612.22012.28
3506560-50656012.09212.16
4471815-47181511.26311.32
5505871-50587112.07612.14
6481693-48169311.49911.56
20min1627360-62736014.97614.692.3715.1014.812.38
2622934-62293414.87015.00
3626619-62661914.95815.08
4589576-58957614.07414.19
5617897-61789714.75014.88
6607507-60750714.50214.62
30min1823099-82309919.64819.431.8919.8519.631.90
2834301-83430119.91620.12
3817814-81781419.52219.72
4792741-79274118.92419.11
5816285-81628519.48619.68
6799462-79946219.08419.28
45min11063939-106393925.39825.461.5125.6925.751.51
21091714-109171426.06126.36
31080246-108024625.78726.08
41052247-105224725.11925.40
51056713-105671325.22525.52
61054090-105409025.16325.45
60min11279304-127930430.53930.391.3330.9630.811.32
21300883-130088331.05431.48
31278597-127859730.52230.95
41261610-126161030.11630.52
51254500-125450029.94730.37
61263423-126342330.16030.57
120min11939249-193924946.29246.071.7746.8746.641.77
21990961-199096147.52748.11
31930966-193096646.09546.67
41895431-189543145.24645.80
51903955-190395545.45046.02
61918769-191876945.80446.37
180min12433500-243350058.09157.202.2958.9058.002.28
22489809-248980959.43560.26
32370216-237021656.58057.39
42372359-237235956.63157.41
52343348-234334855.93956.74
62367997-236799756.52757.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12789311-278931166.58565.861.8267.6866.941.81
22813103-281310367.15368.27
32731271-273127165.19966.29
42787718-278771866.54767.61
52674401-267440163.84264.92
62757622-275762265.82866.90
360min13344808-334480879.84578.281.8081.2879.701.79
23329884-332988479.48980.94
33299535-329953578.76480.18
43279498-327949878.28679.69
53191134-319113476.17777.58
63230702-323070277.12178.53
480min13655229-365522987.25586.490.5689.0988.310.57
23633350-363335086.73388.59
33624657-362465786.52588.34
43622234-362223486.46888.26
53601646-360164685.97687.76
63602896-360289686.00687.80
600min13909415-390941593.32391.101.5495.5993.351.53
23835108-383510891.54993.84
33804563-380456390.82093.07
43834801-383480191.54293.76
53737692-373769289.22491.43
63777268-377726890.16892.39
720min13974906-397490694.88692.902.2497.6295.602.21
23928602-392860293.78196.53
33920813-392081393.59596.29
43864489-386448992.25194.93
53729326-372932689.02491.68
63932791-393279193.88196.55
极限13969592-396959294.75993.582.0697.9796.752.04
24049966-404996696.67899.89
33916311-391631193.48896.66
43905579-390557993.23196.37
53853002-385300291.97695.08
63827747-382774791.37394.51
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%
113.001614716282162941613716272162260.48
213.021647316538165060.28
单位质量响应值RSD%判断
1248.151267.741.11数据可信
供试品溶液-2025081821批-达格列净-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%
5min117562-1756289.80290.191.0889.8090.181.08
217857-1785791.31091.31
317363-1736388.78488.78
417635-1763590.17590.17
517557-1755789.77689.78
617850-1785091.27491.27
10min118241-1824193.27493.971.3193.7294.421.31
218730-1873095.77496.23
318339-1833993.77594.22
418264-1826493.39193.84
518088-1808892.49192.94
618598-1859895.09995.56
15min118447-1844794.32794.081.3495.2495.001.33
218800-1880096.13297.07
318502-1850294.60895.52
418306-1830693.60694.52
518089-1808992.49693.41
618252-1825293.33094.26
20min118572-1857294.96694.621.4596.3596.011.42
218377-1837793.96995.39
318849-1884996.38297.77
418089-1808992.49693.88
518702-1870295.63197.00
618434-1843494.26095.66
30min118640-1864095.31494.220.7797.1896.080.75
218267-1826793.40695.29
318407-1840794.12295.99
418411-1841194.14395.99
518298-1829893.56595.42
618530-1853094.75196.62
45min118314-1831493.64794.841.5295.9997.181.50
218996-1899697.13499.49
318754-1875495.89798.24
418304-1830493.59695.91
518351-1835193.83696.16
618570-1857094.95697.30
60min118168-1816892.90093.840.8695.7196.640.84
218370-1837093.93396.77
318212-1821293.12595.94
418290-1829093.52496.31
518523-1852394.71597.50
618543-1854394.81897.64
120min118450-1845094.34294.841.2197.6198.121.19
218955-1895596.924100.23
318481-1848194.50197.78
418359-1835993.87797.13
518388-1838894.02597.29
618652-1865295.37598.67
180min118583-1858395.02294.501.8198.7798.261.76
219035-1903597.334101.13
318201-1820193.06996.82
418619-1861995.20698.93
518145-1814592.78396.52
618306-1830693.60697.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118070-1807092.39994.311.4996.6298.541.44
218691-1869195.57599.85
318381-1838193.98998.21
418675-1867595.49399.69
518181-1818192.96797.16
618666-1866695.44799.68
360min118281-1828193.47893.391.4298.1698.091.35
218363-1836393.89798.65
318356-1835693.86298.55
418640-1864095.31499.99
518025-1802592.16996.83
617921-1792191.63796.35
480min118040-1804092.24693.170.8497.3998.330.79
218287-1828793.50998.74
318199-1819993.05998.22
418387-1838794.02099.17
518361-1836193.88799.01
618048-1804892.28797.46
600min118513-1851394.66493.121.35100.2798.741.29
218375-1837593.95999.65
317977-1797791.92497.55
418367-1836793.91899.54
517901-1790191.53597.13
618127-1812792.69198.32
720min117990-1799091.99092.331.7198.0798.421.63
218300-1830093.57599.74
317935-1793591.70997.79
418084-1808492.47198.56
517571-1757189.84895.90
618456-1845694.373100.47
极限117935-1793591.70992.342.0898.2598.891.97
218746-1874695.856102.49
317907-1790791.56698.11
418069-1806992.39498.95
518068-1806892.38998.89
617621-1762190.10396.67
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