恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.582947082950182948602950852946982948740.06
210.572954202950412952300.10
单位质量响应值RSD%判断
27870.8927930.940.16数据可信
供试品溶液-25102201批-恩格列净-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%
5min1281487-28148789.25691.363.9489.2691.363.94
2299960-29996095.11395.11
3303925-30392596.37196.37
4277492-27749287.98987.99
5287491-28749191.16091.16
6278324-27832488.25388.25
10min1288252-28825291.40194.733.2691.5594.883.26
2309191-30919198.04098.20
3311282-31128298.70398.86
4291354-29135492.38492.53
5300002-30000295.12795.28
6292382-29238292.71092.86
15min1290085-29008591.98295.163.0592.2895.473.05
2308620-30862097.85998.18
3311915-31191598.90499.23
4290105-29010591.98892.29
5301684-30168495.66095.97
6298236-29823694.56794.87
20min1289259-28925991.72094.953.2292.1795.423.22
2308914-30891497.95398.44
3311944-31194498.91399.40
4290800-29080092.20992.66
5301996-30199695.75996.23
6293762-29376293.14893.61
30min1289118-28911891.67594.893.1892.2895.523.18
2308636-30863697.86498.51
3311637-31163798.81699.47
4290194-29019492.01792.62
5301248-30124895.52296.15
6294752-29475293.46294.08
45min1288791-28879191.57294.843.2292.3395.633.22
2308568-30856897.84398.65
3311815-31181598.87299.69
4290607-29060792.14892.91
5301017-30101795.44996.24
6293819-29381993.16693.94
60min1289653-28965391.84594.873.1492.7695.823.14
2308607-30860797.85598.83
3311511-31151198.77699.76
4290356-29035692.06892.98
5301134-30113495.48696.43
6293948-29394893.20794.13
极限1288893-28889391.60494.693.1492.6795.793.15
2308089-30808997.69198.83
3310999-31099998.61499.76
4290131-29013191.99793.06
5300199-30019995.18996.30
6293416-29341693.03894.12
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201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1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.017970487992127987458002277995947989650.16
221.988027778025758026760.02
单位质量响应值RSD%判断
36300.0936518.470.43数据可信
供试品溶液-25102201批-非奈利酮-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%
5min1410727-41072750.76447.686.8150.7647.686.80
2396645-39664549.02449.02
3410733-41073350.76550.76
4385100-38510047.59747.60
5367644-36764445.43945.44
6343956-34395642.51242.51
10min1622374-62237476.92372.955.6277.0173.035.62
2617064-61706476.26776.35
3621573-62157376.82476.91
4561332-56133269.37869.46
5564575-56457569.77969.85
6554624-55462468.54968.62
15min1696723-69672386.11283.483.5086.3283.683.50
2698397-69839786.31986.53
3694003-69400385.77685.99
4645921-64592179.83380.03
5654581-65458180.90481.10
6663107-66310781.95782.14
20min1733630-73363090.67488.852.5091.0389.192.51
2739468-73946891.39591.75
3731049-73104990.35590.71
4697089-69708986.15786.49
5703142-70314286.90687.23
6708979-70897987.62787.95
30min1774313-77431395.70294.461.7296.2194.951.73
2778861-77886196.26496.77
3772262-77226295.44895.95
4747123-74712392.34192.81
5750912-75091292.81093.28
6762225-76222594.20894.68
45min1808681-80868199.95098.941.65100.6299.591.66
2818055-818055101.108101.77
3806523-80652399.683100.35
4784596-78459696.97397.60
5786274-78627497.18097.81
6798978-79897898.75099.38
60min1830545-830545102.652101.431.64103.49102.241.65
2838002-838002103.574104.41
3823740-823740101.811102.64
4803664-80366499.330100.12
5806386-80638699.666100.45
6821797-821797101.571102.36
极限1839284-839284103.732102.461.67104.74103.441.68
2846533-846533104.628105.63
3830091-830091102.596103.60
4813221-813221100.511101.46
5812246-812246100.390101.34
6832546-832546102.899103.86
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.582950242950412953122950162952562951300.05
210.572955762952182953970.09
单位质量响应值RSD%判断
27895.0927946.740.14数据可信
供试品溶液-25102201批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1291967-29196792.51385.4120.4792.5185.4220.47
2283937-28393789.96889.97
3157702-15770249.96949.97
4289742-28974291.80891.81
5303395-30339596.13496.13
6290657-29065792.09792.10
10min1305315-30531596.74295.033.8196.9095.183.83
2292657-29265792.73192.88
3281711-28171189.26389.35
4300636-30063695.25995.41
5314627-31462799.69399.85
6304611-30461196.51996.67
15min1306669-30666997.17196.262.5097.4996.562.51
2294192-29419293.21893.52
3297795-29779594.35994.59
4301768-30176895.61895.93
5315527-31552799.978100.30
6306837-30683797.22497.54
20min1305957-30595796.94596.412.4497.4296.872.45
2294000-29400093.15793.62
3300254-30025495.13895.53
4302306-30230695.78996.26
5316090-316090100.156100.65
6306944-30694497.25897.73
30min1307038-30703897.28896.432.3297.9397.062.33
2294261-29426193.23993.85
3300841-30084195.32495.87
4302299-30229995.78696.42
5315248-31524899.889100.55
6306357-30635797.07297.71
45min1306997-30699797.27596.482.4198.0897.262.41
2293924-29392493.13393.90
3301530-30153095.54396.25
4301968-30196895.68196.47
5315871-315871100.087100.91
6306632-30663297.15997.96
60min1307652-30765297.48296.492.4198.4597.442.42
2294486-29448693.31194.24
3300574-30057495.24096.11
4301751-30175195.61396.56
5315894-315894100.094101.09
6306758-30675897.19998.16
极限1307276-30727697.36396.312.3898.4997.412.38
2294373-29437393.27594.36
3300049-30004995.07396.10
4301554-30155495.55096.66
5315578-31557899.994101.15
6304863-30486396.59997.72
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201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1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.018019088015398013618014738018618016280.04
221.988020998018378019680.03
单位质量响应值RSD%判断
36421.0836486.260.13数据可信
供试品溶液-25102201批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152795-15279518.86222.5910.6918.8622.5910.69
2202234-20223424.96524.96
3166901-16690120.60320.60
4184198-18419822.73822.74
5200196-20019624.71324.71
6191627-19162723.65523.66
10min1303679-30367937.48739.346.2437.5239.386.24
2312338-31233838.55638.60
3335266-33526641.38741.42
4299280-29928036.94436.98
5350327-35032743.24643.29
6311162-31116238.41138.45
15min1389426-38942648.07248.914.6248.1749.014.62
2384758-38475847.49647.60
3413572-41357251.05351.16
4375924-37592446.40646.51
5423491-42349152.27852.39
6389882-38988248.12948.23
20min1441971-44197154.55955.363.2254.7355.543.22
2433718-43371853.54053.73
3460443-46044356.83957.03
4437021-43702153.94854.12
5470838-47083858.12258.32
6446569-44656955.12655.31
30min1509737-50973762.92463.381.8863.1963.661.89
2499571-49957161.66961.94
3520042-52004264.19664.48
4510294-51029462.99363.26
5527685-52768565.14065.44
6513291-51329163.36363.64
45min1569745-56974570.33270.801.3970.7071.181.40
2560399-56039969.17869.56
3577474-57747471.28671.68
4574396-57439670.90671.28
5584145-58414572.10972.52
6574831-57483170.96071.34
60min1608431-60843175.10775.431.0275.5975.931.03
2600522-60052274.13174.62
3611681-61168175.50976.02
4612548-61254875.61676.11
5619226-61922676.44076.97
6613670-61367075.75476.25
极限1628142-62814277.54177.860.9478.1578.480.95
2621613-62161376.73577.35
3630271-63027177.80378.44
4633596-63359678.21478.83
5639359-63935978.92579.58
6631193-63119377.91778.54
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.582949292943932944552948902946902946710.09
210.572938432940502939460.05
单位质量响应值RSD%判断
27851.7027809.460.11数据可信
供试品溶液-25102201批-恩格列净-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%
5min1275839-27583987.68687.250.9987.6987.250.99
2272278-27227886.55486.55
3274005-27400587.10387.10
4271682-27168286.36486.36
5279134-27913488.73388.73
6273841-27384187.05187.05
10min1295672-29567293.99195.142.7494.1495.282.73
2299416-29941695.18195.32
3285605-28560590.79090.94
4301709-30170995.91096.05
5303520-30352096.48596.63
6309775-30977598.47498.62
15min1296348-29634894.20595.482.7994.5195.792.78
2299178-29917895.10595.41
3286851-28685191.18691.48
4303399-30339996.44796.75
5305361-30536197.07197.38
6311064-31106498.88399.19
20min1297033-29703394.42395.682.8894.8896.142.87
2299414-29941495.18095.64
3287052-28705291.25091.70
4303681-30368196.53797.00
5306555-30655597.45097.92
6312097-31209799.21299.69
30min1296685-29668594.31395.672.9494.9396.302.93
2300252-30025295.44696.07
3286817-28681791.17691.78
4303309-30330996.41897.04
5305987-30598797.27097.90
6312760-31276099.423100.06
45min1298398-29839894.85795.822.9795.6396.602.97
2300426-30042695.50296.28
3286323-28632391.01991.77
4304273-30427396.72597.51
5306236-30623697.34998.14
6312876-31287699.459100.26
60min1299371-29937195.16695.672.7796.1096.622.77
2299329-29932995.15396.09
3286782-28678291.16592.07
4303692-30369296.54097.49
5304832-30483296.90297.86
6311804-31180499.119100.09
极限1297035-29703594.42495.482.8795.5196.582.86
2298879-29887995.01096.11
3285984-28598490.91191.97
4304635-30463596.84097.95
5304557-30455796.81597.93
6311030-31103098.873100.01
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201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1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.018004777996227999617999857997857999660.05
221.987969277975237972250.06
单位质量响应值RSD%判断
36345.5736270.470.15数据可信
供试品溶液-25102201批-非奈利酮-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%
5min1255311-25531131.64325.0219.7731.6425.0219.77
2184827-18482722.90722.91
3248794-24879430.83530.84
4187936-18793623.29323.29
5164891-16489120.43720.44
6169427-16942720.99921.00
10min1524703-52470365.03261.803.9665.0861.843.97
2489370-48937060.65260.69
3516148-51614863.97164.02
4503982-50398262.46362.50
5473510-47351058.68758.72
6483974-48397459.98460.02
15min1610634-61063475.68274.741.2975.8474.891.30
2599471-59947174.29874.44
3612092-61209275.86276.02
4605399-60539975.03375.18
5591866-59186673.35673.49
6598820-59882074.21874.35
20min1659474-65947481.73581.210.7182.0281.480.73
2651297-65129780.72280.98
3662210-66221082.07482.36
4653085-65308580.94381.21
5650754-65075480.65480.91
6654523-65452381.12181.38
30min1708903-70890387.86188.120.4588.2888.520.45
2708469-70846987.80788.21
3714742-71474288.58589.01
4710707-71070788.08588.49
5707942-70794287.74288.13
6714964-71496488.61289.01
45min1755732-75573293.66593.900.4394.2494.450.42
2752396-75239693.25293.80
3758335-75833593.98894.56
4758794-75879494.04594.59
5758432-75843294.00094.53
6761843-76184394.42394.96
60min1779511-77951196.61296.850.5197.3497.560.51
2775305-77530596.09196.79
3784683-78468397.25397.98
4780717-78071796.76297.47
5782175-78217596.94397.63
6786386-78638697.46498.16
极限1787646-78764697.62198.220.5898.5199.100.58
2786223-78622397.44498.30
3793038-79303898.28999.18
4797414-79741498.83199.70
5794605-79460598.48399.34
6796191-79619198.68099.54
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.582940232936402942392939722941552940060.08
210.572961032960842960940.01
单位质量响应值RSD%判断
27788.8528012.680.57数据可信
供试品溶液-25102201批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1253296-25329680.31883.402.8780.3283.402.87
2273398-27339886.69386.69
3259134-25913482.17082.17
4259894-25989482.41182.41
5261921-26192183.05383.05
6270442-27044285.75585.76
10min1289435-28943591.77893.062.1091.9193.192.10
2299863-29986395.08595.23
3287759-28775991.24691.38
4286878-28687890.96791.10
5296671-29667194.07294.21
6300196-30019695.19095.33
15min1291754-29175492.51394.292.4192.8094.582.41
2301899-30189995.73096.03
3291856-29185692.54692.83
4289435-28943591.77892.07
5302766-30276696.00596.30
6306344-30634497.14097.44
20min1292000-29200092.59194.132.1893.0394.582.18
2301462-30146295.59296.05
3290591-29059192.14492.59
4290763-29076392.19992.64
5301274-30127495.53295.99
6305098-30509896.74597.21
30min1291516-29151692.43894.542.4593.0395.152.45
2305141-30514196.75897.38
3292123-29212392.63093.23
4290897-29089792.24192.84
5303676-30367696.29496.91
6305489-30548996.86897.49
45min1291563-29156392.45394.392.1393.2095.162.13
2303884-30388496.36097.14
3293960-29396093.21393.96
4290724-29072492.18792.94
5301243-30124395.52296.30
6304670-30467096.60997.39
60min1291276-29127692.36294.282.1593.2795.202.15
2302831-30283196.02696.97
3292534-29253492.76193.67
4291209-29120992.34093.24
5300614-30061495.32396.26
6305418-30541896.84697.79
极限1292231-29223192.66494.452.1093.7295.532.10
2302899-30289996.04797.15
3292616-29261692.78793.85
4291680-29168092.49093.55
5303761-30376196.32197.41
6304002-30400296.39797.51
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201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1000
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.017976237973377982647982847978927978800.06
221.988029158026338027740.03
单位质量响应值RSD%判断
36250.8036522.930.53数据可信
供试品溶液-25102201批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100398-10039812.41613.2914.2512.4213.2914.24
2104430-10443012.91512.92
3121545-12154515.03215.03
4129617-12961716.03016.03
587940-8794010.87610.88
6100926-10092612.48212.48
10min1260556-26055632.22432.592.4432.2432.612.45
2265857-26585732.87932.90
3265344-26534432.81632.84
4271526-27152633.58033.61
5252512-25251231.22931.25
6265252-26525232.80432.83
15min1351557-35155743.47843.781.0643.5543.861.06
2358651-35865144.35544.43
3352472-35247243.59143.67
4350266-35026643.31843.40
5352318-35231843.57243.64
6358837-35883744.37844.45
20min1411637-41163750.90850.771.2251.0650.921.21
2416895-41689551.55951.71
3406163-40616350.23150.38
4404314-40431450.00350.16
5408788-40878850.55650.70
6415223-41522351.35251.50
30min1486928-48692860.22059.791.7460.4560.031.73
2497263-49726361.49861.73
3478848-47884859.22059.46
4472678-47267858.45758.70
5480351-48035159.40659.63
6484892-48489259.96860.20
45min1555009-55500968.63967.611.9968.9767.941.98
2563513-56351369.69170.03
3545695-54569567.48867.82
4534685-53468566.12666.46
5537654-53765466.49366.82
6543488-54348867.21567.55
60min1597641-59764173.91272.542.0774.3672.992.06
2603566-60356674.64575.10
3586676-58667672.55673.00
4574983-57498371.11071.56
5573204-57320470.89071.33
6583268-58326872.13472.58
极限1622115-62211576.93975.641.7377.5176.201.72
2626729-62672977.50978.09
3608498-60849875.25575.82
4599258-59925874.11274.68
5605749-60574974.91575.47
6607158-60715875.08975.66
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