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%
110.004126675412460641298364130718412329641270260.08
210.064165005416397941644920.02
单位质量响应值RSD%判断
412702.60413965.410.22数据可信
供试品溶液-2025081821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%
5min1182926-1829264.4264.5712.574.434.5812.52
2228254-2282545.5225.52
3193596-1935964.6844.68
4155717-1557173.7673.77
5179696-1796964.3474.35
6194185-1941854.6984.70
10min1361847-3618478.7548.854.448.788.884.45
2364891-3648918.8288.86
3373540-3735409.0379.06
4346807-3468078.3908.41
5354557-3545578.5788.60
6393244-3932449.5149.54
15min1518876-51887612.55312.723.3612.6212.783.38
2537304-53730412.99913.07
3534507-53450712.93213.00
4492760-49276011.92211.98
5531793-53179312.86612.93
6539088-53908813.04213.11
20min1695905-69590516.83616.174.6016.9716.304.58
2654721-65472115.84015.98
3682736-68273616.51816.65
4633717-63371715.33215.45
5636967-63696715.41115.54
6705445-70544517.06717.20
30min1834292-83429220.18420.723.1020.4020.933.08
2848933-84893320.53920.75
3899872-89987221.77121.99
4870949-87094921.07121.27
5826998-82699820.00820.21
6857658-85765820.75020.97
45min11113770-111377026.94626.981.9127.2627.301.91
21135890-113589027.48127.80
31140202-114020227.58627.91
41081866-108186626.17426.48
51106785-110678526.77727.08
61112268-111226826.91027.24
60min11333241-133324132.25632.501.3932.7032.951.40
21334488-133448832.28632.74
31380008-138000833.38733.85
41331734-133173432.21932.65
51335417-133541732.30832.75
61346249-134624932.57133.03
120min12002723-200272348.45348.640.9749.0649.250.97
22015157-201515748.75449.37
32047043-204704349.52550.15
42001369-200136948.42049.01
52005328-200532848.51649.12
61991381-199138148.17948.80
180min12532263-253226361.26461.201.0262.1262.061.00
22495964-249596460.38661.25
32540776-254077661.47062.35
42561829-256182961.98062.82
52502407-250240760.54261.39
62545454-254545461.58462.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12860045-286004569.19570.281.3670.3571.441.36
22884006-288400669.77470.94
32970885-297088571.87673.06
42918904-291890470.61971.77
52879592-287959269.66870.81
62916300-291630070.55671.73
360min13389951-338995182.01583.321.1183.5284.841.09
23434474-343447483.09284.60
33453957-345395783.56485.11
43506305-350630584.83086.33
53429225-342922582.96584.46
63449716-344971683.46184.99
480min13838644-383864492.87092.530.8294.7894.460.82
23806415-380641592.09194.02
33871429-387142993.66495.63
43800695-380069591.95293.88
53788405-378840591.65593.56
63841151-384115192.93194.87
600min13997475-399747596.71396.801.0699.0999.191.05
23986364-398636496.44498.83
34029338-402933897.48499.91
43989754-398975496.52698.91
53940054-394005495.32497.69
64064199-406419998.327100.73
720min14091843-409184398.99698.541.29101.86101.421.27
23983458-398345896.37499.24
34119472-411947299.665102.58
44119918-411991899.676102.54
54042191-404219197.795100.64
64081106-408110698.737101.63
极限14056839-405683998.14999.791.33101.51103.161.30
24052835-405283598.053101.40
34171472-4171472100.923104.34
44151056-4151056100.429103.79
54166131-4166131100.794104.13
64150667-4150667100.419103.81
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%
113.001587315981160231598315773159270.65
213.021609216160161260.30
单位质量响应值RSD%判断
1225.151238.560.77数据可信
供试品溶液-2025081821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%
5min118433-1843396.24995.932.4296.2595.942.42
218626-1862697.25797.26
318981-1898199.11099.11
417646-1764692.13992.14
518241-1824195.24695.25
618308-1830895.59695.60
10min118877-1887798.56798.481.5499.0598.961.54
218896-1889698.66699.15
319398-19398101.288101.78
418691-1869197.59698.06
518571-1857196.96997.45
618727-1872797.78498.26
15min119293-19293100.73998.961.83101.7199.931.83
219186-19186100.181101.16
319103-1910399.747100.75
418372-1837295.93096.88
518705-1870597.66998.63
619049-1904999.465100.43
20min118975-1897599.07999.181.77100.56100.641.77
219008-1900899.251100.73
319510-19510101.872103.37
418457-1845796.37497.80
519066-1906699.554101.00
618946-1894698.927100.39
30min118210-1821095.08497.751.5897.0699.721.55
218708-1870897.68599.66
319018-1901899.303101.31
418789-1878998.108100.02
518613-1861397.18999.14
618987-1898799.142101.10
45min118696-1869697.62298.162.01100.07100.611.99
219049-1904999.465101.93
319352-19352101.047103.55
418233-1823395.20497.61
518703-1870397.659100.09
618762-1876297.967100.42
60min118645-1864597.35698.361.78100.29101.301.77
218857-1885798.463101.43
319460-19460101.611104.62
418478-1847896.48499.36
518783-1878398.076101.00
618800-1880098.165101.11
120min118785-1878598.08798.771.73101.51102.201.71
219246-19246100.494103.95
319352-19352101.047104.57
418734-1873497.820101.18
518888-1888898.625102.04
618489-1848996.54199.98
180min118770-1877098.00898.850.69101.92102.780.64
218786-1878698.092102.05
318960-1896099.001103.03
419092-1909299.690103.54
518958-1895898.990102.90
619024-1902499.335103.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118283-1828395.46697.881.4599.87102.301.42
218749-1874997.899102.35
319127-1912799.873104.39
418757-1875797.941102.29
518728-1872897.789102.19
618823-1882398.285102.70
360min118219-1821995.13197.471.60100.01102.381.52
218869-1886998.525103.46
318735-1873597.826102.85
418943-1894398.912103.75
518857-1885798.463103.35
618380-1838095.972100.88
480min118595-1859597.09598.171.22102.45103.571.20
218958-1895898.990104.42
318938-1893898.886104.39
418434-1843496.254101.59
518964-1896499.021104.40
618916-1891698.771104.16
600min118601-1860197.12697.551.41102.97103.441.37
218651-1865197.387103.31
318868-1886898.520104.52
418218-1821895.126100.94
518938-1893898.886104.76
618820-1882098.270104.15
720min118494-1849496.56796.731.15102.90103.101.07
218265-1826595.372101.78
318555-1855596.886103.38
418533-1853396.771103.06
518899-1889998.682105.05
618402-1840296.087102.46
极限118464-1846496.41197.671.43103.22104.531.38
218791-1879198.118105.01
318749-1874997.899104.88
418418-1841896.170102.94
519158-19158100.034106.90
618653-1865397.398104.25
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%
110.004207513420550542066134206983421579142084810.10
210.064183107418307441830900.01
单位质量响应值RSD%判断
420848.10415814.120.86数据可信
供试品溶液-2025081821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%
5min1155014-1550143.7064.5012.563.714.5012.55
2194443-1944434.6484.65
3226586-2265865.4175.42
4193811-1938114.6334.63
5180278-1802784.3104.31
6179082-1790824.2814.28
10min1351699-3516998.4078.723.978.438.743.97
2390224-3902249.3289.35
3361291-3612918.6378.66
4371918-3719188.8918.91
5359319-3593198.5908.61
6353101-3531018.4418.46
15min1483265-48326511.55312.484.0011.6112.544.02
2536923-53692312.83512.91
3535502-53550212.80112.87
4528769-52876912.64012.71
5513067-51306712.26512.33
6534227-53422712.77112.83
20min1630211-63021115.06515.925.1215.1816.055.12
2713316-71331617.05217.19
3653280-65328015.61715.75
4674376-67437616.12116.25
5694407-69440716.60016.73
6630661-63066115.07615.20
30min1889243-88924321.25820.453.6121.4520.663.57
2850649-85064920.33520.55
3841310-84131020.11220.32
4897155-89715521.44721.66
5831150-83115019.86920.08
6822902-82290219.67219.87
45min11081357-108135725.85026.521.7726.1526.831.77
21104152-110415226.39526.72
31133230-113323027.09027.40
41130641-113064127.02827.35
51105384-110538426.42526.73
61101776-110177626.33826.64
60min11329563-132956331.78431.951.2432.2132.391.25
21340940-134094032.05632.51
31331299-133129931.82532.27
41367718-136771832.69633.15
51322585-132258531.61732.06
61326466-132646631.71032.14
120min12170446-217044651.88548.593.5352.4749.193.48
21976403-197640347.24747.86
32008279-200827948.00948.62
42047838-204783848.95449.57
52000193-200019347.81548.41
61991500-199150047.60848.20
180min12549587-254958760.94960.201.2361.8061.051.21
22542520-254252060.78061.63
32467611-246761158.98959.84
42522941-252294160.31261.17
52530096-253009660.48361.32
62497711-249771159.70960.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12903480-290348069.40969.001.1870.5670.151.18
22907750-290775069.51170.66
32848906-284890668.10469.25
42934868-293486870.15971.32
52855588-285558868.26469.40
62868535-286853568.57369.70
360min13496708-349670883.59082.141.0585.0983.641.04
23433646-343364682.08383.58
33406989-340698981.44582.93
43458320-345832082.67284.19
53404137-340413781.37782.86
63417286-341728681.69283.16
480min13780709-378070990.37990.860.9292.3092.760.91
23832195-383219591.61093.52
33767280-376728090.05891.95
43852929-385292992.10694.03
53798348-379834890.80192.69
63772590-377259090.18592.06
600min13969083-396908394.88294.971.0797.2597.331.06
24033218-403321896.41698.78
33953652-395365294.51496.85
44011471-401147195.89698.28
53951424-395142494.46096.80
63918512-391851293.67396.00
720min14073597-407359797.38196.961.40100.2299.791.36
24047188-404718896.75099.60
33963563-396356394.75097.56
44087946-408794697.724100.59
54032939-403293996.40999.22
64130136-413013698.732101.53
极限14260426-4260426101.84798.372.20105.18101.682.15
24139854-413985498.965102.30
34065521-406552197.188100.47
44162780-416278099.513102.87
54031838-403183896.38399.68
64029061-402906196.31699.61
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%
113.001632616250163301606716178162300.69
213.021630616204162550.45
单位质量响应值RSD%判断
1248.461248.460.00数据可信
供试品溶液-2025081821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%
5min117277-1727789.01094.473.5489.0194.473.54
218299-1829994.27594.28
318834-1883497.03297.03
419121-1912198.51098.51
518026-1802692.86992.87
618462-1846295.11595.12
10min118645-1864596.05896.621.4996.5097.101.49
218619-1861995.92496.40
318695-1869596.31596.80
419314-1931499.504100.00
518567-1856795.65696.12
618687-1868796.27496.75
15min118443-1844395.01796.861.4795.9497.821.46
218866-1886697.19698.15
319178-1917898.80499.77
418515-1851595.38896.38
518868-1886897.20798.15
618934-1893497.54798.50
20min118444-1844495.02297.481.7296.4298.921.72
219058-1905898.18699.62
318959-1895997.67699.14
419431-19431100.107101.57
518805-1880596.88298.31
618831-1883197.01698.46
30min118929-1892997.52196.121.3799.4098.041.35
218523-1852395.42997.36
318901-1890197.37799.33
418805-1880596.88298.85
518318-1831894.37396.29
618462-1846295.11597.04
45min118311-1831194.33796.191.5196.7098.601.50
218513-1851395.37897.78
318938-1893897.567100.00
419027-1902798.026100.48
518485-1848595.23497.62
618748-1874896.58898.99
60min118590-1859095.77496.501.5198.6199.391.50
218787-1878796.78999.67
318703-1870396.35799.28
419256-1925699.206102.15
518435-1843594.97697.84
618618-1861895.91998.81
120min118703-1870396.35797.711.3699.67101.081.34
218630-1863095.98199.35
319039-1903998.088101.49
419322-1932299.546102.98
519036-1903698.072101.41
619064-1906498.217101.58
180min119054-1905498.16597.460.86101.96101.320.82
218890-1889097.320101.17
318679-1867996.233100.13
418956-1895697.660101.60
518801-1880196.862100.69
619119-1911998.500102.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118969-1896997.72796.531.63102.01100.881.57
218972-1897297.743102.07
318466-1846695.13699.51
418903-1890397.387101.81
518248-1824894.01398.32
618863-1886397.181101.53
360min118739-1873996.54295.801.24101.32100.631.21
218499-1849995.306100.13
318789-1878996.800101.65
418825-1882596.985101.90
518230-1823093.92098.70
618491-1849195.264100.10
480min118551-1855195.57495.981.13100.83101.291.12
218676-1867696.218101.52
318573-1857395.687101.02
418978-1897897.773103.17
518339-1833994.48199.73
618664-1866496.156101.47
600min118366-1836694.62094.950.65100.36100.740.61
218606-1860695.857101.64
318523-1852395.429101.24
418283-1828394.193100.08
518360-1836094.590100.31
618446-1844695.033100.83
720min118322-1832294.39494.991.70100.60101.251.61
218101-1810193.25599.51
318214-1821493.837100.13
418545-1854595.543101.90
518455-1845595.079101.27
618985-1898597.810104.08
极限118746-1874696.57895.351.71103.26102.091.63
218403-1840394.811101.54
318381-1838194.698101.46
418849-1884997.109103.94
517989-1798992.67899.35
618675-1867596.212102.97
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