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%
110.094289458428667042832854283224429225542869780.10
210.144356882436032443586030.06
单位质量响应值RSD%判断
424873.93429842.500.83数据可信
供试品溶液-YA0011批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122208-1222082.8602.864.842.862.864.82
2132871-1328713.1093.11
3117309-1173092.7452.75
4124012-1240122.9022.90
5117659-1176592.7532.75
6118598-1185982.7752.78
10min1283074-2830746.6247.095.096.647.105.08
2319745-3197457.4827.50
3320936-3209367.5107.52
4289746-2897466.7806.79
5303407-3034077.1007.11
6299844-2998447.0167.03
15min1431639-43163910.10110.424.2710.1510.474.25
2482397-48239711.28811.34
3439194-43919410.27710.33
4437239-43723910.23210.28
5433651-43365110.14810.20
6446673-44667310.45210.50
20min1549261-54926112.85313.353.8412.9513.453.83
2611191-61119114.30214.41
3561955-56195513.15013.25
4566627-56662713.25913.36
5557505-55750513.04613.15
6575411-57541113.46513.57
30min1762037-76203717.83218.412.9817.9918.583.00
2830173-83017319.42619.61
3780276-78027618.25918.43
4784304-78430418.35318.52
5773029-77302918.08918.25
6790346-79034618.49418.66
45min11035242-103524224.22524.542.0024.4824.802.01
21084145-108414525.36925.65
31021337-102133723.90024.16
41050201-105020124.57524.83
51049017-104901724.54724.80
61051501-105150124.60624.87
60min11262231-126223129.53729.851.9429.9130.241.94
21322538-132253830.94831.35
31250251-125025129.25629.64
41275632-127563229.85030.23
51270388-127038829.72830.11
61273669-127366929.80430.19
120min11952434-195243445.68845.952.0046.2146.482.00
22037210-203721047.67148.23
31922589-192258944.98945.51
41943290-194329045.47446.00
51966380-196638046.01446.54
61960891-196089145.88646.42
180min12417506-241750656.57157.401.7157.3258.161.71
22502637-250263758.56359.36
32415872-241587256.53257.28
42468104-246810457.75558.51
52497990-249799058.45459.21
62415737-241573756.52957.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12855846-285584666.82867.321.5767.8668.371.57
22945433-294543368.92470.01
32819723-281972365.98367.02
42848972-284897266.66767.71
52883268-288326867.47068.52
62907530-290753068.03769.08
360min13479803-347980381.42980.911.2182.7982.301.21
23512904-351290482.20383.64
33394969-339496979.44480.81
43463980-346398081.05882.44
53468909-346890981.17482.56
63425227-342522780.15281.54
480min13822876-382287689.45789.201.0991.2390.991.09
23845546-384554689.98791.83
33748388-374838887.71489.47
43823240-382324089.46591.25
53855024-385502490.20992.00
63776779-377677988.37890.16
600min13989153-398915393.34893.861.6095.5796.101.59
24071501-407150195.27597.57
33896158-389615891.17293.37
44064902-406490295.12097.35
54020813-402081394.08896.33
64024569-402456994.17696.40
720min14069539-406953995.22995.701.0397.9298.411.02
24097705-409770595.88898.66
34052520-405252094.83097.49
44170494-417049497.591100.30
54073719-407371995.32798.04
64074403-407440395.34398.04
极限14043865-404386594.62895.731.3297.7998.911.31
24118331-411833196.37099.62
34008677-400867793.80596.93
44153592-415359297.196100.39
54118070-411807096.36499.56
64102645-410264596.00399.18
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%
113.001678816705167091666716699167140.27
213.021678616833168100.20
单位质量响应值RSD%判断
1285.691291.090.30数据可信
供试品溶液-YA0011批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112130-1213060.55764.8612.7760.5664.8612.77
215385-1538576.80676.81
313435-1343567.07167.07
411952-1195259.66859.67
510855-1085554.19154.19
614194-1419470.86170.86
10min118450-1845092.10891.343.7892.4191.673.80
219517-1951797.43597.82
318465-1846592.18392.52
417768-1776888.70389.00
517631-1763188.01988.29
617950-1795089.61289.97
15min119417-1941796.93594.444.3697.7095.224.37
220219-20219100.939101.81
318947-1894794.58995.39
417975-1797589.73690.48
518188-1818890.80091.51
618754-1875493.62594.43
20min119582-1958297.75995.263.9399.0196.513.95
220266-20266101.174102.55
318911-1891194.40995.68
418477-1847792.24393.43
518212-1821290.92092.08
619041-1904195.05896.33
30min119354-1935496.62195.283.5298.3697.013.55
220196-20196100.824102.71
319129-1912995.49897.24
418545-1854592.58294.23
518284-1828491.27992.90
619002-1900294.86496.61
45min119599-1959997.84494.983.37100.0697.183.39
219910-1991099.397101.78
318734-1873493.52695.74
418451-1845192.11394.23
518314-1831491.42993.50
619145-1914595.57797.80
60min119844-1984499.06795.803.68101.7898.483.70
220141-20141100.550103.43
319154-1915495.62298.31
418612-1861292.91795.49
518290-1829091.30993.84
619094-1909495.32398.02
120min119863-1986399.16295.094.28102.3798.254.27
220170-20170100.695104.08
318743-1874393.57196.74
418157-1815790.64593.68
518342-1834291.56994.56
619005-1900594.87998.05
180min119475-1947597.22594.073.21100.9397.703.24
219746-1974698.578102.47
318557-1855792.64296.27
418402-1840291.86895.36
518368-1836891.69895.15
618508-1850892.39796.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119729-1972998.49393.904.20102.6898.004.18
219878-1987899.237103.62
318490-1849092.30896.40
418176-1817690.74094.69
518093-1809390.32694.23
618482-1848292.26896.38
360min119695-1969598.32393.843.51103.0098.423.51
219545-1954597.574102.45
318607-1860792.89297.45
418246-1824691.08995.50
518178-1817890.75095.11
618514-1851492.42797.00
480min119576-1957697.72992.663.61102.9097.713.59
219230-1923096.002101.37
318302-1830291.36996.39
418013-1801389.92694.79
518081-1808190.26695.08
618163-1816390.67595.71
600min119084-1908495.27391.593.24100.9397.103.25
219128-1912895.493101.34
318004-1800489.88195.36
418034-1803490.03195.34
517838-1783889.05394.32
617989-1798989.80695.29
720min119357-1935796.63691.753.51102.7797.713.51
218948-1894894.594100.92
318244-1824491.07997.01
417908-1790889.40295.16
517670-1767088.21493.92
618140-1814090.56096.50
极限118895-1889594.32991.092.88100.9597.512.93
218808-1880893.895100.69
318106-1810690.39096.77
417770-1777088.71394.92
517623-1762387.97994.13
618271-1827191.21497.60
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%
110.094355665435755543629544356405436733743599830.12
210.144365150436580043654750.02
单位质量响应值RSD%判断
432109.32430520.220.27数据可信
供试品溶液-YA0011批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115258-1152582.6722.657.352.672.657.37
2115462-1154622.6772.68
3108506-1085062.5162.52
4113473-1134732.6312.63
5128511-1285112.9802.98
6103670-1036702.4042.40
10min1278687-2786876.4616.391.656.476.401.63
2271172-2711726.2876.30
3280579-2805796.5056.52
4277106-2771066.4256.44
5276906-2769066.4206.43
6268916-2689166.2356.25
15min1421315-4213159.7689.642.609.819.682.56
2395572-3955729.1719.22
3420858-4208589.7589.80
4422647-4226479.7999.84
5422281-4222819.7919.84
6410813-4108139.5259.57
20min1528525-52852512.25412.432.4912.3512.522.49
2513418-51341811.90411.99
3545019-54501912.63612.73
4536616-53661612.44112.54
5548932-54893212.72712.82
6544562-54456212.62612.72
30min1750666-75066617.40417.141.5917.5617.301.58
2717055-71705516.62516.78
3741608-74160817.19417.35
4738077-73807717.11217.27
5742964-74296417.22617.39
6745556-74555617.28617.44
45min11002110-100211023.23423.191.0923.4823.431.11
2984289-98428922.82123.05
31002524-100252423.24423.49
4998840-99884023.15823.40
51017566-101756623.59223.84
6995186-99518623.07323.31
60min11228802-122880228.49027.971.5428.8528.331.53
21181929-118192927.40327.75
31200815-120081527.84128.20
41202017-120201727.86928.23
51197378-119737827.76128.12
61228316-122831628.47928.83
120min11881576-188157643.62443.071.0844.1343.571.08
21851941-185194142.93743.42
31823336-182333642.27442.77
41855012-185501243.00843.51
51870612-187061243.37043.87
61863877-186387743.21443.71
180min12453982-245398256.89657.191.3757.6257.901.35
22475861-247586157.40358.10
32462500-246250057.09357.80
42477149-247714957.43358.14
52414009-241400955.96956.69
62517177-251717758.36159.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12839109-283910965.82565.931.6466.8366.931.62
22890758-289075867.02268.01
32812375-281237565.20566.20
42859109-285910966.28867.29
52771211-277121164.25165.25
62890037-289003767.00668.01
360min13472662-347266280.51479.561.0981.8580.891.08
23419391-341939179.27980.60
33415246-341524679.18280.50
43459238-345923880.20281.53
53371386-337138678.16679.49
63452185-345218580.03981.38
480min13827062-382706288.73088.540.6190.4790.260.61
23844227-384422789.12890.85
33797915-379791588.05589.77
43803569-380356988.18689.92
53793970-379397087.96389.67
63845503-384550389.15890.90
600min13996877-399687792.66893.351.4394.8595.521.40
24014285-401428593.07195.23
34131890-413189095.79897.96
43974164-397416492.14194.31
53991550-399155092.54494.70
64047952-404795293.85296.04
720min14019545-401954593.19394.511.1295.8497.141.10
24124070-412407095.61798.25
34047951-404795193.85296.49
44122176-412217695.57398.21
54040552-404055293.68096.29
64102510-410251095.11797.77
极限14067627-406762794.30895.091.3997.4298.201.36
24137378-413737895.92599.03
34108784-410878495.26298.37
44044872-404487293.78096.89
54056899-405689994.05997.14
64192955-419295597.214100.35
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%
113.001701716746168731698716859168960.65
213.021692416986169550.26
单位质量响应值RSD%判断
1299.691302.230.14数据可信
供试品溶液-YA0011批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110762-1076253.20857.4910.8153.2157.4910.81
29739-973948.15048.15
313200-1320065.26165.26
412519-1251961.89561.89
512141-1214160.02660.03
611404-1140456.38256.38
10min117454-1745486.29386.923.7386.5687.213.74
216587-1658782.00782.25
318164-1816489.80490.13
417202-1720285.04785.36
517698-1769887.50087.80
618383-1838390.88691.17
15min118126-1812689.61690.642.7390.3191.362.74
217723-1772387.62388.27
318872-1887293.30494.08
418133-1813389.65090.39
518129-1812989.63190.37
619011-1901193.99194.73
20min118490-1849091.41592.082.9792.5693.262.98
217678-1767887.40188.49
319019-1901994.03195.27
418723-1872392.56793.75
518552-1855291.72292.91
619289-1928995.36696.57
30min118995-1899593.91293.062.8995.5194.692.89
217977-1797788.87990.41
319108-1910894.47196.18
418885-1888593.36895.01
518442-1844291.17892.82
619527-1952796.54298.23
45min118826-1882693.07793.292.1395.1595.392.16
218196-1819689.96291.93
319237-1923795.10997.29
418923-1892393.55695.67
518727-1872792.58794.69
619309-1930995.46597.63
60min118967-1896793.77492.992.8496.3195.562.85
217916-1791688.57891.00
319190-1919094.87697.54
418865-1886593.26995.85
518503-1850391.48094.04
619409-1940995.95998.60
120min118986-1898693.86892.931.7096.8795.961.74
218199-1819989.97792.84
318937-1893793.62596.76
418808-1880892.98896.03
518745-1874592.67695.70
619099-1909994.42697.55
180min119314-1931495.48994.173.4898.9797.673.32
219929-1992998.530101.84
318874-1887493.31496.92
418882-1888293.35396.87
517949-1794988.74192.22
619333-1933395.58399.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119194-1919494.89693.453.3998.8597.423.23
219555-1955596.681100.49
318553-1855391.72795.80
419000-1900093.93797.92
517794-1779487.97491.90
619316-1931695.49999.57
360min119411-1941195.96993.152.99100.4097.582.83
219319-1931995.51499.80
318248-1824890.21994.75
419089-1908994.37798.83
518063-1806389.30493.67
618914-1891493.51298.06
480min119099-1909994.42693.192.5699.3398.092.43
219459-1945996.206100.97
318459-1845991.26296.24
418821-1882193.05297.97
518140-1814089.68594.50
619115-1911594.50599.52
600min118843-1884393.16192.432.5398.5497.802.41
219245-1924595.148100.40
318838-1883893.13698.57
418576-1857691.84197.23
517839-1783988.19793.46
618830-1883093.09698.59
720min118411-1841191.02591.293.3596.8797.123.17
219188-1918894.866100.59
318062-1806289.29995.20
418902-1890293.45299.30
517489-1748986.46692.17
618737-1873792.63798.59
极限118735-1873592.62791.543.0898.9397.822.93
219161-1916194.733100.93
318243-1824390.19496.54
418418-1841891.05997.37
517576-1757686.89793.03
618954-1895493.709100.13
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