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%
110.004168720417478541682214172749417776941724490.10
210.064210208420699642086020.06
单位质量响应值RSD%判断
417244.90418350.100.19数据可信
供试品溶液-2025081921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%
5min1194905-1949054.6654.765.424.674.765.41
2211877-2118775.0715.07
3183429-1834294.3904.39
4201949-2019494.8344.83
5192774-1927744.6144.61
6209421-2094215.0135.01
10min1371109-3711098.8838.821.178.918.851.18
2371869-3718698.9018.93
3372583-3725838.9188.94
4364444-3644448.7238.75
5362129-3621298.6688.69
6369027-3690278.8338.86
15min1518500-51850012.41012.282.6012.4812.352.59
2496756-49675611.89011.96
3517909-51790912.39612.46
4495674-49567411.86411.93
5524755-52475512.56012.63
6524514-52451412.55412.62
20min1648614-64861415.52515.251.7115.6515.381.69
2639649-63964915.31015.44
3647152-64715215.49015.62
4624331-62433114.94315.07
5623786-62378614.93015.06
6639564-63956415.30815.44
30min1869126-86912620.80319.982.1021.0120.182.09
2821344-82134419.65919.86
3834255-83425519.96820.17
4826276-82627619.77719.98
5831311-83131119.89720.10
6825387-82538719.75619.96
45min11082318-108231825.90525.791.3526.2226.101.34
21068169-106816925.56725.87
31104509-110450926.43726.74
41076775-107677525.77326.07
51066559-106655925.52825.83
61067688-106768825.55525.86
60min11310276-131027631.36230.940.9631.8031.370.96
21296727-129672731.03731.47
31293989-129398930.97231.41
41294340-129434030.98031.41
51286834-128683430.80031.23
61272560-127256030.45930.89
120min11941184-194118446.46246.370.8947.0646.960.89
21913280-191328045.79546.38
31949205-194920546.65447.25
41923136-192313646.03046.61
51937485-193748546.37446.96
61960589-196058946.92747.51
180min12415490-241549057.81557.890.6258.6558.710.61
22437443-243744358.34059.16
32399655-239965557.43658.26
42434873-243487358.27959.09
52414857-241485757.80058.62
62408230-240823057.64158.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12773918-277391866.39466.300.6367.5167.410.62
22741509-274150965.61866.73
32766199-276619966.20967.32
42789801-278980166.77467.88
52764072-276407266.15867.26
62784997-278499766.65967.77
360min13322976-332297679.53679.330.8080.9980.780.79
23305534-330553479.11880.55
33357891-335789180.37181.82
43303624-330362479.07380.51
53278810-327881078.47979.92
63318077-331807779.41880.86
480min13658168-365816887.55987.530.4689.4189.360.45
23652472-365247287.42289.25
33668214-366821487.79989.65
43629986-362998686.88488.72
53679193-367919388.06289.89
63652907-365290787.43389.27
600min13805298-380529891.08091.770.6493.3794.050.63
23817212-381721291.36593.63
33850014-385001492.15094.44
43842533-384253391.97194.24
53820014-382001491.43293.70
63870815-387081592.64894.93
720min13922848-392284893.89494.190.7496.6496.930.72
23905100-390510093.46996.19
33962400-396240094.84097.59
43971342-397134295.05497.78
53945965-394596594.44797.17
63904107-390410793.44596.19
极限13890386-389038693.11794.180.8496.3397.390.82
23925435-392543593.95697.15
33988691-398869195.47098.69
43932864-393286494.13397.34
53920737-392073793.84397.04
63951180-395118094.57297.78
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%
113.001660316712166221657516476165980.52
213.021674816618166830.56
单位质量响应值RSD%判断
1276.771281.340.26数据可信
供试品溶液-2025081921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%
5min119160-1916096.35195.061.0496.3595.061.04
218618-1861893.62593.63
318921-1892195.14995.15
419077-1907795.93395.93
518845-1884594.76794.77
618798-1879894.53094.53
10min119160-1916096.35196.431.6796.8396.911.66
219054-1905495.81896.29
319662-1966298.87599.35
419439-1943997.75498.23
518851-1885194.79795.27
618892-1889295.00395.48
15min119280-1928096.95497.301.0797.9298.261.06
219053-1905395.81396.76
319652-1965298.82599.79
419240-1924096.75397.72
519401-1940197.56398.51
619466-1946697.88998.84
20min119062-1906295.85897.021.0397.3198.461.02
219441-1944197.76499.19
319438-1943897.74999.21
419497-1949798.04599.50
519260-1926096.85398.29
619055-1905595.82397.26
30min119382-1938297.46796.641.6099.3998.561.58
219122-1912296.16098.07
319651-1965198.820100.77
419317-1931797.14099.08
519080-1908095.94897.87
618751-1875194.29496.21
45min119198-1919896.54296.961.1398.9699.381.12
219341-1934197.26199.66
319437-1943797.744100.19
419515-1951598.136100.56
519302-1930297.06599.46
618898-1889895.03397.42
60min119061-1906195.85397.051.7498.7599.941.70
219485-1948597.985100.87
319623-1962398.679101.61
419482-1948297.970100.89
519403-1940397.573100.46
618736-1873694.21897.08
120min119077-1907795.93396.621.1399.31100.001.12
219083-1908395.96399.34
319588-1958898.503101.93
419316-1931697.135100.54
519221-1922196.657100.03
618994-1899495.51698.85
180min119049-1904995.79296.531.5599.65100.391.53
219339-1933997.251101.10
319357-1935797.341101.26
419547-1954798.297102.19
519185-1918596.476100.33
618695-1869594.01297.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118814-1881494.61195.331.3398.9599.681.31
218836-1883694.72199.06
319236-1923696.733101.14
419158-1915896.341100.73
519108-1910896.089100.43
618586-1858693.46497.75
360min118866-1886694.87295.632.1699.68100.452.10
218968-1896895.385100.20
319745-1974599.292104.18
419137-1913796.235101.10
518861-1886194.84799.67
618520-1852093.13297.88
480min118856-1885694.82295.171.87100.10100.471.82
218972-1897295.405100.69
319356-1935697.336102.72
418904-1890495.063100.41
519150-1915096.300101.59
618310-1831092.07697.29
600min118575-1857593.40994.351.8299.17100.131.79
218843-1884394.756100.52
319172-1917296.411102.29
419042-1904295.757101.58
518725-1872594.16399.94
618220-1822091.62497.30
720min118461-1846192.83693.932.4699.06100.182.38
218668-1866893.876100.12
319161-1916196.356102.71
419111-1911196.104102.41
518756-1875694.319100.56
617916-1791690.09596.23
极限118466-1846692.86193.981.8599.55100.701.81
218790-1879094.490101.20
319118-1911896.139102.98
418993-1899395.511102.29
518559-1855993.328100.05
618201-1820191.52898.11
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%
110.004220426422709542219374217228421373642200840.12
210.064261257425511042581840.11
单位质量响应值RSD%判断
422008.40423278.730.22数据可信
供试品溶液-2025081921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%
5min1156935-1569353.7134.368.803.714.368.86
2196379-1963794.6464.65
3197645-1976454.6764.68
4180142-1801424.2624.26
5177583-1775834.2024.20
6197745-1977454.6794.68
10min1321361-3213617.6048.677.747.628.697.73
2408764-4087649.6729.69
3366666-3666668.6768.70
4357307-3573078.4548.48
5366803-3668038.6798.70
6376823-3768238.9168.94
15min1455070-45507010.76711.914.8310.8211.974.86
2514604-51460412.17612.25
3511740-51174012.10812.17
4503437-50343711.91211.98
5513121-51312112.14112.21
6521424-52142412.33712.41
20min1564783-56478313.36314.674.3913.4714.794.41
2627074-62707414.83714.97
3628715-62871514.87615.00
4633558-63355814.99015.11
5633760-63376014.99515.12
6632421-63242114.96315.09
30min1779843-77984318.45219.633.5118.6319.833.52
2842885-84288519.94320.15
3830419-83041919.64819.85
4818274-81827419.36119.56
5840020-84002019.87520.08
6866367-86636720.49920.70
45min1990726-99072623.44125.393.8723.7125.693.88
21086070-108607025.69726.00
31091552-109155225.82726.13
41074420-107442025.42125.72
51102089-110208926.07626.38
61094363-109436325.89326.20
60min11206216-120621628.54030.483.6028.9330.913.61
21347546-134754631.88432.32
31295586-129558630.65431.08
41278262-127826230.24530.67
51298230-129823030.71731.15
61304195-130419530.85831.29
120min11845675-184567543.67046.073.0744.2046.653.08
22020195-202019547.79948.39
31960023-196002346.37546.96
41917994-191799445.38145.95
51961391-196139146.40846.99
61977888-197788846.79847.39
180min12303100-230310054.49357.183.0055.2457.983.01
22478106-247810658.63459.47
32477908-247790858.62959.44
42351604-235160455.64056.44
52449322-244932257.95358.77
62439255-243925557.71458.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12648326-264832662.66165.962.6963.6867.052.70
22831807-283180767.00268.13
32821667-282166766.76267.87
42756439-275643965.21966.30
52826421-282642166.87567.98
62841751-284175167.23868.35
360min13214399-321439976.05578.892.2677.3980.312.28
23423364-342336480.99982.46
33328544-332854478.75680.20
43292091-329209177.89379.30
53397531-339753180.38881.83
63348567-334856779.22980.68
480min13460188-346018881.87086.783.4083.5888.593.39
23748514-374851488.69290.56
33636258-363625886.03687.87
43615126-361512685.53687.33
53806671-380667190.06891.91
63738807-373880788.46390.31
600min13710394-371039487.79091.222.8589.9193.472.85
23911868-391186892.55794.87
33880851-388085191.82394.09
43738327-373832788.45190.67
53998094-399809494.59896.89
63891777-389177792.08294.37
720min13825890-382589090.52393.851.9593.0996.561.97
23983372-398337294.24997.02
33986673-398667394.32797.05
43963336-396333693.77596.44
54061639-406163996.10198.87
63977487-397748794.11096.86
极限13777331-377733189.37493.212.6992.3996.392.69
24000418-400041894.65397.90
33919342-391934292.73495.93
43863099-386309991.40394.54
54028509-402850995.31798.56
64048878-404887895.79999.02
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%
113.001678216597167591668116749167140.46
213.021689016807168480.35
单位质量响应值RSD%判断
1285.691294.010.46数据可信
供试品溶液-2025081921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%
5min118591-1859192.70795.682.0192.7195.682.01
219452-1945297.00197.00
319185-1918595.66995.67
418876-1887694.12894.13
519580-1958097.63997.64
619435-1943596.91696.92
10min119129-1912995.39096.982.0695.8597.462.06
219757-1975798.52299.01
319165-1916595.57096.05
419011-1901194.80295.27
519995-1999599.709100.20
619631-1963197.89398.38
15min119169-1916995.59097.401.3696.5398.361.36
219469-1946997.08698.06
319733-1973398.40299.36
419398-1939896.73297.68
519926-1992699.364100.35
619499-1949997.23598.21
20min119185-1918595.66996.061.7497.0997.511.73
219075-1907595.12196.58
319043-1904394.96196.41
419108-1910895.28596.71
519931-1993199.389100.87
619243-1924395.95997.42
30min119562-1956297.54997.640.8999.4599.580.89
219489-1948997.18599.12
319594-1959497.70999.63
419418-1941896.83198.74
519911-1991199.290101.27
619513-1951397.30599.25
45min118945-1894594.47396.991.7896.8699.411.76
219305-1930596.26898.69
319729-1972998.382100.79
419407-1940796.77699.17
519937-1993799.419101.90
619381-1938196.64799.07
60min118909-1890994.29396.831.8297.1599.741.81
219797-1979798.721101.63
319521-1952197.345100.25
419164-1916495.56598.44
519789-1978998.681101.66
619327-1932796.37799.29
120min119474-1947497.11197.461.34100.44100.851.31
219978-1997899.624103.02
319587-1958797.674101.06
419165-1916595.57098.92
519542-1954297.450100.92
619521-1952197.345100.74
180min119388-1938896.68296.792.30100.50100.672.24
219598-1959897.729101.63
320033-2003399.898103.78
418734-1873493.42097.25
519586-1958697.669101.62
619122-1912295.35599.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119153-1915395.51096.560.9799.81100.920.98
219466-1946697.071101.46
319494-1949497.210101.59
419103-1910395.26099.56
519538-1953897.430101.87
619429-1942996.886101.24
360min119239-1923995.93996.721.31100.71101.561.29
219767-1976798.572103.44
319388-1938896.682101.55
419202-1920295.754100.53
519630-1963097.888102.82
619144-1914495.465100.30
480min118726-1872693.38095.982.3798.64101.302.31
219515-1951597.315102.68
319145-1914595.470100.82
418827-1882793.88499.13
519955-1995599.509104.93
619313-1931396.308101.62
600min119060-1906095.04695.232.04100.77101.031.98
219206-1920695.774101.63
319397-1939796.727102.55
418479-1847992.14997.87
519564-1956497.559103.48
618871-1887194.10499.90
720min119060-1906095.04695.111.34101.24101.391.29
218790-1879093.700100.03
319432-1943296.901103.21
418933-1893394.413100.59
519323-1932396.358102.76
618894-1889494.218100.49
极限118653-1865393.01694.571.3999.69101.331.36
218912-1891294.308101.11
318930-1893094.398101.19
418745-1874593.475100.13
519312-1931296.303103.19
619235-1923595.919102.66
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