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%
110.004158854415629641561144155978415723441568950.03
210.064248958424414042465490.09
单位质量响应值RSD%判断
415689.50422122.171.09数据可信
供试品溶液-2025081922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%
5min1166834-1668343.9834.257.303.984.257.31
2172149-1721494.1104.11
3183516-1835164.3814.38
4189073-1890734.5144.51
5194579-1945794.6454.65
6161983-1619833.8673.87
10min1348604-3486048.3228.215.668.348.235.61
2311536-3115367.4377.46
3365710-3657108.7318.75
4330649-3306497.8947.92
5353122-3531228.4308.45
6352910-3529108.4258.44
15min1498655-49865511.90411.702.7211.9711.762.72
2471150-47115011.24811.31
3504902-50490212.05412.12
4476548-47654811.37711.44
5496806-49680611.86011.93
6492236-49223611.75111.81
20min1617422-61742214.74014.642.6414.8614.762.64
2587225-58722514.01914.13
3627841-62784114.98915.11
4600988-60098814.34714.47
5616068-61606814.70714.83
6628835-62883515.01215.13
30min1817986-81798619.52819.611.9119.7219.801.92
2798805-79880519.07019.25
3839482-83948220.04120.24
4819553-81955319.56519.76
5812963-81296319.40819.61
6838894-83889420.02720.22
45min11068810-106881025.51625.461.3825.8125.751.39
21045658-104565824.96325.24
31074299-107429925.64725.95
41054560-105456025.17625.46
51067865-106786525.49325.79
61087195-108719525.95526.25
60min11273488-127348830.40230.471.0730.8230.891.08
21259449-125944930.06730.47
31281296-128129630.58931.02
41272585-127258530.38130.79
51300227-130022731.04031.46
61271228-127122830.34830.77
120min11940985-194098546.33746.420.5246.9147.000.51
21938220-193822046.27146.83
31953428-195342846.63447.22
41955982-195598246.69547.26
51929891-192989146.07346.65
61948884-194888446.52647.10
180min12414662-241466257.64658.021.2158.4558.831.21
22401643-240164357.33558.12
32472326-247232659.02259.84
42443474-244347458.33359.13
52400694-240069457.31258.12
62450470-245047058.50059.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12819957-281995767.32166.931.4368.4168.021.42
22735685-273568565.30966.38
32814694-281469467.19668.31
42843999-284399967.89568.99
52776949-277694966.29467.39
62829042-282904267.53868.64
360min13327519-332751979.43879.700.9780.8781.130.97
23282881-328288178.37379.77
33358347-335834780.17481.62
43343327-334332779.81681.25
53378347-337834780.65282.08
63339793-333979379.73181.17
480min13685927-368592787.99588.100.6589.8289.930.66
23644337-364433787.00288.79
33703661-370366188.41890.27
43702160-370216088.38290.21
53706971-370697188.49790.33
63699345-369934588.31590.15
600min13949614-394961494.29093.181.7496.5695.451.70
23836932-383693291.60093.83
33874975-387497592.50894.80
43874189-387418992.48994.76
53864563-386456392.25994.53
64017786-401778695.91798.20
720min14015925-401592595.87395.031.2598.6197.771.24
23932229-393222993.87596.56
34053727-405372796.77599.53
43948388-394838894.26096.99
53935568-393556893.95496.69
63998962-399896295.46898.23
极限14042158-404215896.49995.430.8799.7298.640.85
23970180-397018094.78197.93
33962123-396212394.58897.82
43969980-396998094.77697.98
54010071-401007195.73398.94
64029717-402971796.20299.44
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%
113.001650916639165671664716409165540.60
213.021683016754167920.33
单位质量响应值RSD%判断
1273.381289.710.91数据可信
供试品溶液-2025081922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%
5min118057-1805790.63192.083.4790.6392.083.47
217623-1762388.45288.45
318890-1889094.81294.81
417667-1766788.67388.67
518869-1886994.70694.71
618963-1896395.17895.18
10min118492-1849292.81494.473.5193.2794.943.50
217925-1792589.96890.41
319128-1912896.00696.48
418404-1840492.37292.82
519287-1928796.80497.28
619701-1970198.88299.36
15min119010-1901095.41494.741.5796.3395.681.58
218549-1854993.10093.99
318876-1887694.74195.70
418496-1849692.83493.74
519183-1918396.28297.24
619146-1914696.09697.07
20min118879-1887994.75695.861.8396.1597.261.83
218833-1883394.52595.88
319011-1901195.41996.85
418839-1883994.55695.92
519338-1933897.06098.50
619693-1969398.842100.29
30min119043-1904395.57996.181.2397.4598.071.25
219040-1904095.56497.39
319166-1916696.19798.10
418897-1889794.84796.69
519259-1925996.66498.59
619572-1957298.235100.18
45min119010-1901095.41495.121.1897.7697.481.19
218848-1884894.60196.91
318970-1897095.21397.60
418573-1857393.22095.54
519088-1908895.80598.21
619218-1921896.45898.89
60min118615-1861593.43194.671.4796.2597.511.46
218969-1896995.20897.99
318776-1877694.23997.10
418525-1852592.98095.76
519267-1926796.70499.59
619013-1901395.42998.35
120min119098-1909895.85696.080.6699.1599.390.66
219304-1930496.889100.15
319089-1908995.81099.14
418945-1894595.08898.34
519227-1922796.50399.87
619189-1918996.31299.71
180min118824-1882494.48095.591.1998.2599.391.16
219017-1901795.44999.19
319065-1906595.69099.50
419144-1914496.08699.81
518807-1880794.39598.25
619414-1941497.442101.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119112-1911295.92695.491.08100.1799.761.09
218751-1875194.11498.33
319023-1902395.47999.77
418865-1886594.68698.89
519055-1905595.64099.96
619344-1934497.090101.45
360min118734-1873494.02995.071.1398.7599.821.11
218798-1879894.35099.04
318897-1889794.84799.61
418931-1893195.01799.69
519342-1934297.080101.88
618949-1894995.10899.96
480min118810-1881094.41095.110.9199.60100.340.92
218892-1889294.82299.98
318854-1885494.63199.87
418822-1882294.47099.62
519238-1923896.558101.85
619079-1907995.760101.09
600min118781-1878194.26494.531.5799.93100.241.53
218741-1874194.06499.70
318514-1851492.92498.64
418727-1872793.99399.62
518858-1885894.651100.42
619388-1938897.311103.12
720min118547-1854793.09093.881.3499.23100.051.30
218617-1861793.44199.55
319065-1906595.690101.87
418487-1848792.78998.88
518534-1853493.02599.27
618973-1897395.228101.52
极限118760-1876094.15994.241.35100.76100.881.30
218795-1879594.335100.91
318470-1847092.70499.36
418585-1858593.28199.84
519203-1920396.383103.09
618838-1883894.551101.32
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%
110.004210353420764842091844207783420970542089350.03
210.064225509422337042244400.04
单位质量响应值RSD%判断
420893.50419924.450.17数据可信
供试品溶液-2025081922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%
5min1197319-1973194.6944.139.914.694.139.90
2159043-1590433.7833.78
3163858-1638583.8983.90
4187410-1874104.4584.46
5154260-1542603.6693.67
6180304-1803044.2894.29
10min1343146-3431468.1628.293.638.198.313.61
2337045-3370458.0178.04
3346307-3463078.2378.26
4371743-3717438.8428.86
5339907-3399078.0858.10
6353151-3531518.4008.42
15min1482340-48234011.47311.663.9011.5411.723.90
2475853-47585311.31911.38
3484715-48471511.53011.59
4495204-49520411.77911.85
5476988-47698811.34611.40
6526613-52661312.52612.59
20min1596787-59678714.19514.673.1514.3214.793.14
2594742-59474214.14714.26
3619144-61914414.72714.85
4619361-61936114.73214.86
5622356-62235614.80414.92
6647729-64772915.40715.53
30min1801035-80103519.05419.471.9119.2519.661.90
2813146-81314619.34219.53
3806796-80679619.19119.38
4814921-81492119.38419.58
5841616-84161620.01920.21
6832626-83262619.80520.01
45min11044977-104497724.85625.171.6025.1425.461.58
21043171-104317124.81325.10
31083566-108356625.77426.06
41074082-107408225.54925.84
51057521-105752125.15525.44
61046864-104686424.90125.20
60min11248380-124838029.69430.322.0530.1130.742.03
21246971-124697129.66130.07
31268836-126883630.18130.60
41272832-127283230.27630.70
51307198-130719831.09431.51
61303443-130344331.00431.43
120min11889612-188961244.94746.141.6245.5146.711.60
21979051-197905147.07447.63
31922724-192272445.73546.30
41958331-195833146.58247.16
51952817-195281746.45047.02
61935813-193581346.04646.63
180min12348543-234854355.86357.141.5356.6557.941.51
22426055-242605557.70758.50
32410862-241086257.34658.14
42404746-240474657.20058.01
52449835-244983558.27359.08
62372648-237264856.43757.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12745833-274583365.31366.491.4566.3867.571.44
22754319-275431965.51566.59
32852538-285253867.85268.93
42809305-280930566.82367.92
52818637-281863767.04568.14
62790018-279001866.36467.46
360min13273044-327304477.85479.251.7879.2580.671.76
23289642-328964278.24979.66
33304409-330440978.60080.02
43357254-335725479.85781.29
53436114-343611481.73383.16
63330246-333024679.21580.64
480min13610252-361025285.87587.481.1987.6689.291.18
23655814-365581486.95988.76
33691343-369134387.80489.62
43731314-373131488.75590.58
53712740-371274088.31390.15
63664162-366416287.15788.98
600min13829592-382959291.09291.871.1793.3094.121.15
23850303-385030391.58593.82
33823602-382360290.95093.20
43939452-393945293.70595.98
53838223-383822391.29793.58
63891489-389148992.56494.82
720min13944930-394493093.83694.631.0396.5097.331.02
23979634-397963494.66197.35
33973925-397392594.52597.23
44038644-403864496.06598.80
54006349-400634995.29798.03
63925382-392538293.37196.09
极限13908548-390854892.97094.121.3496.1097.301.32
23911466-391146693.04096.20
33964545-396454594.30297.48
43982795-398279594.73697.96
54045877-404587796.23799.45
63926869-392686993.40696.59
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%
113.001647116673166311644016603165640.62
213.021678516629167070.67
单位质量响应值RSD%判断
1274.151283.180.50数据可信
供试品溶液-2025081922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%
5min118292-1829292.01491.181.8692.0191.171.86
218113-1811391.11491.11
318194-1819491.52191.52
417695-1769589.01189.01
517824-1782489.66089.66
618634-1863493.73593.73
10min118561-1856193.36794.101.2193.8394.561.21
218737-1873794.25394.71
318947-1894795.30995.77
418600-1860093.56494.01
518416-1841692.63893.09
618983-1898395.49095.96
15min118828-1882894.71194.001.9695.6494.931.95
218824-1882494.69095.62
318701-1870194.07295.01
418070-1807090.89891.81
518536-1853693.24294.15
619161-1916196.38697.33
20min118714-1871494.13794.911.4295.5496.301.42
218841-1884194.77696.18
319093-1909396.04497.45
418669-1866993.91195.28
518604-1860493.58494.96
619281-1928196.98998.42
30min118980-1898095.47595.401.3197.3597.271.31
218885-1888594.99796.87
318963-1896395.39097.27
418578-1857893.45395.29
519035-1903595.75297.60
619347-1934797.32199.23
45min118677-1867793.95194.871.8196.3097.221.78
218775-1877594.44496.79
319514-1951498.161100.52
418732-1873294.22896.53
518556-1855693.34295.67
618905-1890595.09897.50
60min118873-1887394.93795.160.8997.7697.980.90
218743-1874394.28397.10
318994-1899495.54698.40
418737-1873794.25397.03
518978-1897895.46598.26
619174-1917496.45199.33
120min118747-1874794.30395.631.2297.6098.931.19
219404-1940497.608100.90
318946-1894695.30498.63
418935-1893595.24998.50
518892-1889295.03298.30
619142-1914296.29099.65
180min118593-1859393.52895.031.3297.2998.801.27
219316-1931697.165100.95
318982-1898295.48599.29
418842-1884294.78198.50
518897-1889795.05898.80
618718-1871894.15798.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118815-1881594.64595.811.2998.88100.061.26
218891-1889195.02799.29
319474-1947497.960102.24
418874-1887494.94299.14
519070-1907095.928100.15
619150-1915096.330100.64
360min118956-1895695.35495.170.82100.0699.900.78
218784-1878494.48999.23
318871-1887194.92799.70
418804-1880494.59099.26
519209-1920996.627101.33
618894-1889495.04399.83
480min118781-1878194.47494.720.8599.6699.930.82
218704-1870494.08799.30
319040-1904095.777101.03
418969-1896995.420100.56
518620-1862093.66498.85
618867-1886794.907100.17
600min118751-1875194.32393.851.4199.9899.521.35
218655-1865593.84099.52
318675-1867593.94199.67
418824-1882494.690100.31
518151-1815191.30596.95
618881-1888194.977100.72
720min118793-1879394.53493.750.73100.6699.900.69
218711-1871194.122100.28
318748-1874894.308100.51
418603-1860393.57999.67
518463-1846392.87498.98
618508-1850893.10199.32
极限118512-1851293.12193.170.7199.7299.790.64
218528-1852893.20199.83
318602-1860293.574100.24
418515-1851593.13699.70
518682-1868293.976100.55
618291-1829192.00998.69
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