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%
110.004161488416040041591864157538415719141591610.05
210.064185444418539741854200.01
单位质量响应值RSD%判断
415916.10416045.730.03数据可信
供试品溶液-2025081922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%
5min1197923-1979234.7584.7210.474.764.7210.52
2186791-1867914.4904.49
3166156-1661563.9943.99
4222001-2220015.3375.34
5188596-1885964.5344.53
6215934-2159345.1915.19
10min1367023-3670238.8239.284.568.859.304.56
2399710-3997109.6099.63
3364140-3641408.7548.77
4392008-3920089.4249.45
5384164-3841649.2359.26
6407882-4078829.8059.83
15min1519429-51942912.48712.812.7812.5512.882.79
2541361-54136113.01413.08
3514322-51432212.36412.43
4528478-52847812.70412.78
5553546-55354613.30713.38
6540197-54019712.98613.06
20min1643561-64356115.47116.134.2915.6016.264.28
2668848-66884816.07916.21
3630239-63023915.15115.28
4689629-68962916.57816.72
5703319-70331916.90717.04
6689183-68918316.56816.71
30min1854699-85469920.54720.881.8820.7521.091.90
2887740-88774021.34121.56
3849696-84969620.42620.63
4860577-86057720.68820.91
5871143-87114320.94221.16
6886999-88699921.32321.55
45min11115981-111598126.82827.281.7127.1427.601.71
21147056-114705627.57527.90
31111700-111170026.72527.03
41153049-115304927.71928.04
51155592-115559227.78028.10
61126493-112649327.08027.41
60min11319966-131996631.73132.601.5932.1833.051.57
21380779-138077933.19333.65
31362118-136211832.74533.18
41356987-135698732.62133.08
51371480-137148032.97033.43
61345057-134505732.33532.80
120min11974095-197409547.45648.661.6048.0649.281.60
22041929-204192949.08749.71
32017635-201763548.50349.10
42028266-202826648.75949.38
52071039-207103949.78750.42
62012267-201226748.37449.00
180min12471566-247156659.41560.621.2660.2661.481.26
22508672-250867260.30761.18
32507712-250771260.28461.13
42544689-254468961.17362.04
52541796-254179661.10461.98
62555689-255568961.43862.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12858305-285830568.71269.611.0769.8570.781.06
22950534-295053470.93072.10
32887393-288739369.41270.56
42904896-290489669.83271.01
52887045-288704569.40370.59
62886591-288659169.39270.57
360min13389302-338930281.47783.201.6882.9684.711.66
23525385-352538584.74986.28
33480071-348007183.65985.15
43475126-347512683.54185.06
53505427-350542784.26985.80
63390575-339057581.50883.03
480min13777480-377748090.80991.150.6292.7093.080.63
23798284-379828491.30993.26
33785990-378599091.01492.92
43801742-380174291.39293.33
53827485-382748592.01193.96
63758555-375855590.35492.28
600min14023623-402362396.72695.871.3399.0798.261.31
24002642-400264296.22298.63
33935045-393504594.59796.96
43959719-395971995.19097.59
54068458-406845897.804100.22
63938523-393852394.68097.06
720min14090666-409066698.33897.741.40101.16100.611.37
24067897-406789797.790100.68
34077518-407751898.022100.86
44085578-408557898.216101.09
54118880-411888099.016101.92
63955361-395536195.08597.94
极限14050194-405019497.36597.761.45100.68101.111.42
24109675-410967598.795102.17
34075708-407570897.978101.31
44086649-408664998.241101.61
54118917-411891799.017102.41
63957632-395763295.14098.47
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%
113.001636316292162881615916363162930.52
213.021668916431165601.11
单位质量响应值RSD%判断
1253.311271.891.05数据可信
供试品溶液-2025081922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%
5min118224-1822492.84393.303.5992.8493.303.59
218290-1829093.17993.18
317301-1730188.14088.14
418192-1819292.68092.68
518529-1852994.39794.40
619342-1934298.53898.54
10min119012-1901296.85795.972.3597.3296.442.35
218559-1855994.54995.02
318127-1812792.34992.79
418873-1887396.14996.61
519057-1905797.08697.56
619396-1939698.81499.31
15min119284-1928498.24397.862.5499.1998.802.54
219000-1900096.79697.73
318646-1864694.99395.90
418955-1895596.56797.51
519288-1928898.26399.22
620075-20075102.273103.26
20min119072-1907297.16397.221.8598.6098.661.86
218783-1878395.69197.11
318571-1857194.61195.99
419461-1946199.145100.57
519197-1919797.80099.25
619419-1941998.931100.43
30min119174-1917497.68397.071.2899.6198.991.30
218933-1893396.45598.36
318837-1883795.96697.82
418978-1897896.68498.61
518904-1890496.30798.24
619493-1949399.308101.30
45min119669-19669100.20498.291.99102.62100.691.98
218982-1898296.70499.09
318844-1884496.00198.33
419421-1942198.941101.35
519072-1907297.16399.58
619767-19767100.704103.19
60min119196-1919697.79597.751.04100.71100.651.06
218991-1899196.75099.62
318921-1892196.39499.20
419411-1941198.890101.79
519232-1923297.978100.88
619374-1937498.701101.69
120min119163-1916397.62797.781.17101.03101.171.15
218853-1885396.04799.40
319090-1909097.255100.55
419342-1934298.538101.93
519511-1951199.399102.79
619204-1920497.835101.32
180min119180-1918097.71397.422.14101.61101.292.11
218637-1863794.94798.78
318752-1875295.53399.31
419602-1960299.863103.75
518983-1898396.709100.60
619576-1957699.731103.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119203-1920397.83096.981.18102.21101.341.17
218805-1880595.803100.11
319005-1900596.822101.08
419196-1919697.795102.18
518735-1873595.44699.82
619267-1926798.156102.63
360min118813-1881395.84396.721.02100.71101.571.00
218803-1880395.792100.58
318996-1899696.776101.52
419335-1933598.503103.38
518955-1895596.567101.42
619006-1900696.827101.79
480min118950-1895096.54195.861.73101.89101.201.70
218280-1828093.12898.39
318711-1871195.324100.55
419250-1925098.070103.44
518751-1875195.528100.86
618960-1896096.592102.04
600min119087-1908797.23995.901.45103.07101.711.44
218396-1839693.71999.45
318577-1857794.641100.34
418953-1895396.557102.42
518959-1895996.587102.40
618973-1897396.659102.59
720min119076-1907697.18395.281.82103.50101.571.76
218085-1808592.13598.33
318654-1865495.033101.21
418929-1892996.434102.78
518723-1872395.385101.68
618751-1875195.528101.94
极限118746-1874695.50295.071.01102.31101.840.98
218313-1831393.29699.95
318788-1878895.716102.37
418821-1882195.884102.71
518707-1870795.303102.08
618589-1858994.702101.60
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%
110.004226009422332242271304221002421899042232910.09
210.064231365423021842307920.02
单位质量响应值RSD%判断
422329.10420555.860.30数据可信
供试品溶液-2025081922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%
5min1186393-1863934.4234.6710.434.424.6610.45
2218584-2185845.1875.19
3220938-2209385.2425.24
4196948-1969484.6734.67
5166966-1669663.9623.96
6189977-1899774.5084.51
10min1399673-3996739.4839.154.909.519.184.92
2411869-4118699.7739.80
3389451-3894519.2419.27
4366890-3668908.7068.73
5362516-3625168.6028.62
6384414-3844149.1219.14
15min1542624-54262412.87512.573.3012.9412.643.30
2536240-53624012.72412.80
3528192-52819212.53312.61
4514059-51405912.19812.26
5505192-50519211.98712.05
6551336-55133613.08213.15
20min1667941-66794115.84915.904.7215.9816.034.72
2692798-69279816.43916.58
3689219-68921916.35416.49
4640850-64085015.20615.33
5624943-62494314.82914.95
6705044-70504416.72916.86
30min1883354-88335420.96020.561.7121.1720.771.71
2884930-88493020.99821.22
3857359-85735920.34420.56
4854379-85437920.27320.48
5851231-85123120.19820.40
6867810-86781020.59220.81
45min11144628-114462827.16026.941.8227.4827.261.82
21127863-112786326.76227.09
31148950-114895027.26227.58
41111408-111140826.37226.68
51115094-111509426.45926.76
61163939-116393927.61827.94
60min11381678-138167832.78532.131.5033.2432.581.50
21344810-134481031.91032.37
31364464-136446432.37632.83
41324667-132466731.43231.87
51343364-134336431.87632.31
61364346-136434632.37332.83
120min12047712-204771248.58848.151.3049.2148.761.30
22013548-201354847.77848.40
32034327-203432748.27148.89
41988460-198846047.18247.78
52028029-202802948.12148.71
62063732-206373248.96949.59
180min12497044-249704459.25059.601.1560.1160.451.16
22540655-254065560.28561.14
32529808-252980860.02860.89
42473099-247309958.68259.51
52490318-249031859.09159.92
62540656-254065660.28561.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12935880-293588069.66369.000.6670.8270.150.66
22901467-290146768.84670.01
32926172-292617269.43370.59
42887828-288782868.52369.65
52903688-290368868.89970.02
62892709-289270968.63969.80
360min13513881-351388183.37882.191.6884.8883.681.66
23393370-339337080.51882.02
33481391-348139182.60784.11
43393450-339345080.52081.99
53472704-347270482.40183.87
63527376-352737683.69885.21
480min13832348-383234890.93489.960.6992.8691.870.69
23765995-376599589.36091.27
33779406-377940689.67891.60
43786646-378664689.85091.72
53770380-377038089.46491.35
63812780-381278090.47092.40
600min13954703-395470393.83894.401.6096.2196.761.56
23958186-395818693.92096.27
33921065-392106593.04095.41
44007869-400786995.09997.42
53935858-393585893.39195.72
64093169-409316997.12399.50
720min14067226-406722696.50896.451.5699.3599.271.53
23965579-396557994.09696.92
34085424-408542496.93999.77
44024271-402427195.48898.28
54096467-409646797.202100.00
64149424-414942498.458101.32
极限14103637-410363797.37296.571.29100.7099.881.27
23974839-397483994.31697.61
34066748-406674896.49699.81
44061124-406112496.36399.63
54085903-408590396.951100.23
64126279-412627997.909101.27
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%
113.001671316670167291663216498166480.56
213.021668516758167220.31
单位质量响应值RSD%判断
1280.621284.330.21数据可信
供试品溶液-2025081922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%
5min118409-1840992.32791.643.5392.3391.643.53
219229-1922996.44096.44
317950-1795090.02590.02
418086-1808690.70790.71
517335-1733586.94186.94
618628-1862893.42593.43
10min118750-1875094.03795.522.0794.5095.982.07
219590-1959098.25098.73
319046-1904695.52295.97
419182-1918296.20496.66
518469-1846992.62893.06
619236-1923696.47596.94
15min119081-1908195.69795.981.6196.6396.921.62
219584-1958498.22099.19
319123-1912395.90896.84
419138-1913895.98396.92
518633-1863393.45094.35
619267-1926796.63097.58
20min118774-1877494.15896.412.2595.5797.832.24
219651-1965198.556100.02
319603-1960398.31599.72
419301-1930196.80198.22
518617-1861793.37094.74
619395-1939597.27298.70
30min118834-1883494.45995.571.4496.3497.461.43
219516-1951697.87999.84
318842-1884294.49996.40
419206-1920696.32498.22
519087-1908795.72797.56
618843-1884394.50496.42
45min118951-1895195.04596.101.3497.4098.481.35
219511-1951197.854100.30
319338-1933896.98699.36
419288-1928896.73599.12
518851-1885194.54496.85
619030-1903095.44297.83
60min118925-1892594.91596.061.6897.7498.921.67
219316-1931696.87699.81
319540-1954097.999100.86
419147-1914796.02898.89
518653-1865393.55196.33
619345-1934597.02199.89
120min118736-1873693.96796.311.4197.2799.641.40
219403-1940397.312100.73
319510-1951097.849101.20
419199-1919996.28999.63
519105-1910595.81899.07
619262-1926296.60599.96
180min118401-1840192.28796.172.5496.0699.992.49
219717-1971798.887102.79
319680-1968098.701102.54
419087-1908795.72799.55
519016-1901695.37199.10
619150-1915096.04399.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118703-1870393.80295.641.8198.0499.931.77
219437-1943797.483101.88
319295-1929596.771101.10
419297-1929796.781101.08
519081-1908195.69799.90
618599-1859993.28097.60
360min118673-1867393.65195.731.2998.35100.511.26
219073-1907395.657100.55
319332-1933296.956101.77
418953-1895395.05599.84
519241-1924196.500101.19
619258-1925896.585101.37
480min118603-1860393.30094.101.2098.4799.361.19
219010-1901095.341100.71
319055-1905595.567100.86
418740-1874093.98799.25
518674-1867493.65698.82
618495-1849592.75898.02
600min117993-1799390.24193.311.8895.8899.041.84
218807-1880794.323100.17
318787-1878794.223100.00
418831-1883194.443100.18
518371-1837192.13697.77
618844-1884494.509100.24
720min118074-1807490.64793.681.6696.7499.881.59
218659-1865993.58199.90
318804-1880494.308100.55
418812-1881294.348100.55
518942-1894295.000101.10
618783-1878394.203100.41
极限118189-1818991.22493.501.3397.77100.161.29
218624-1862493.405100.19
318906-1890694.820101.54
418761-1876194.092100.77
518769-1876994.133100.70
618609-1860993.330100.00
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