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%
110.582970892968232968132968002972572969560.07
210.572979372975782977580.09
单位质量响应值RSD%判断
28067.6728170.100.26数据可信
供试品溶液-25102202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%
5min1252941-25294179.58383.002.9179.5882.992.91
2274331-27433186.31386.31
3257709-25770981.08381.08
4263969-26396983.05283.05
5268910-26891084.60784.61
6264867-26486783.33583.33
10min1314260-31426098.87597.511.6399.0197.651.63
2309116-30911697.25797.40
3315952-31595299.40899.54
4311757-31175798.08898.23
5302987-30298795.32995.47
6305415-30541596.09396.23
15min1317478-31747899.88899.371.70100.1999.671.70
2315221-31522199.17899.48
3323091-323091101.654101.95
4319296-319296100.460100.76
5308056-30805696.92397.22
6311891-31189198.13098.43
20min1318109-318109100.08699.381.66100.5599.841.65
2313369-31336998.59599.07
3323406-323406101.753102.22
4318764-318764100.293100.76
5308780-30878097.15197.61
6312745-31274598.39998.86
30min1318393-318393100.17699.591.67100.81100.221.67
2314849-31484999.06199.70
3324612-324612102.132102.77
4318868-318868100.325100.96
5309603-30960397.41098.03
6312797-31279798.41599.04
45min1318931-318931100.34599.681.65101.14100.481.64
2314733-31473399.02499.82
3324551-324551102.113102.92
4319574-319574100.547101.35
5310007-31000797.53798.32
6313191-31319198.53999.33
60min1318875-318875100.32799.661.72101.29100.621.71
2314612-31461298.98699.95
3325217-325217102.323103.30
4318933-318933100.346101.32
5309848-30984897.48798.44
6313034-31303498.49099.44
极限1319132-319132100.40899.571.64101.54100.701.63
2314760-31476099.033100.16
3323605-323605101.816102.97
4319253-319253100.446101.58
5309268-30926897.30598.42
6312810-31281098.41999.54
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%
122.014090524087754091484088104086484088870.06
221.984101874099424100640.05
单位质量响应值RSD%判断
18577.3318656.230.30数据可信
供试品溶液-25102202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%
5min180972-8097219.57219.4317.6119.5719.4317.61
290135-9013521.78721.79
366319-6631916.03116.03
483996-8399620.30320.30
599140-9914023.96423.96
661843-6184314.94914.95
10min1173202-17320241.86640.084.3241.9040.114.32
2165401-16540139.98040.02
3165913-16591340.10440.13
4169853-16985341.05741.09
5168039-16803940.61840.66
6152421-15242136.84336.87
15min1212140-21214051.27850.453.7751.3850.553.76
2208971-20897150.51250.62
3211721-21172151.17751.27
4219645-21964553.09253.19
5202391-20239148.92249.03
6197388-19738847.71247.80
20min1236213-23621357.09756.754.0757.2856.944.07
2234103-23410356.58756.77
3239823-23982357.97058.15
4249537-24953760.31860.51
5224691-22469154.31254.50
6224353-22435354.23054.40
30min1267690-26769064.70664.884.3964.9965.164.38
2266608-26660864.44464.73
3277791-27779167.14767.42
4285799-28579969.08369.37
5254889-25488961.61161.89
6257701-25770162.29162.55
45min1299869-29986972.48472.844.0372.8773.234.03
2298782-29878272.22172.61
3312554-31255475.55075.94
4318368-31836876.95577.36
5285988-28598869.12969.51
6292619-29261970.73171.09
60min1322195-32219577.88078.093.7778.3978.603.77
2319681-31968177.27377.78
3334120-33412080.76381.28
4339799-33979982.13682.67
5306338-30633874.04874.55
6316242-31624276.44276.92
极限1337828-33782881.65981.433.4782.3082.063.46
2332466-33246680.36381.00
3346034-34603483.64384.29
4352831-35283185.28685.96
5319477-31947777.22377.84
6332602-33260280.39681.00
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%
110.582925702931382929912931572925982928910.10
210.572933822931512932660.06
单位质量响应值RSD%判断
27683.4627745.130.16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%
5min1289469-28946992.40585.7911.6092.4085.7911.60
2279335-27933589.17089.17
3206221-20622165.83065.83
4276392-27639288.23088.23
5286242-28624291.37591.37
6274804-27480487.72387.72
10min1304452-30445297.18893.114.4697.3493.264.47
2289601-28960192.44792.60
3268748-26874885.79085.90
4292862-29286293.48893.64
5303846-30384696.99497.15
6290598-29059892.76592.91
15min1306655-30665597.89194.103.2798.2194.403.29
2290521-29052192.74193.04
3281449-28144989.84590.10
4294045-29404593.86694.17
5305314-30531497.46397.78
6290758-29075892.81693.12
20min1304321-30432197.14694.192.6997.6394.652.70
2290503-29050392.73593.19
3285280-28528091.06891.47
4294532-29453294.02194.48
5304760-30476097.28697.76
6291007-29100792.89693.35
30min1304890-30489097.32894.472.4197.9795.082.42
2290239-29023992.65193.26
3288868-28886892.21392.77
4294542-29454294.02494.64
5304646-30464697.25097.89
6292460-29246093.36093.97
45min1303864-30386497.00094.402.3697.8095.172.37
2290598-29059892.76593.53
3289773-28977392.50293.21
4294321-29432193.95494.73
5305067-30506797.38498.18
6290689-29068992.79493.56
60min1302685-30268596.62494.312.2697.5995.242.27
2289788-28978892.50793.43
3290238-29023892.65093.51
4294092-29409293.88194.81
5304882-30488297.32598.29
6291027-29102792.90293.82
极限1304400-30440097.17194.262.5198.3095.342.51
2288837-28883792.20393.28
3290541-29054192.74793.76
4293749-29374993.77194.86
5304700-30470097.26798.39
6289385-28938592.37893.45
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%
122.017920447931297932357937387927567929800.08
221.987934987929607932290.05
单位质量响应值RSD%判断
36028.1736088.670.12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%
5min1203696-20369625.42127.5915.9025.4227.5915.90
2244191-24419130.47430.47
3162733-16273320.30920.31
4254489-25448931.76031.76
5212803-21280326.55726.56
6248370-24837030.99631.00
10min1507098-50709863.28561.707.3363.3361.757.34
2508265-50826563.43063.48
3422424-42242452.71752.75
4521119-52111965.03465.09
5495318-49531861.81461.86
6512213-51221363.92363.97
15min1614095-61409576.63874.853.6976.7975.003.70
2614384-61438476.67476.83
3556675-55667569.47269.59
4612506-61250676.43976.60
5599108-59910874.76774.91
6601788-60178875.10275.26
20min1666784-66678483.21381.342.5183.4981.612.52
2662524-66252482.68182.97
3621499-62149977.56277.80
4659824-65982482.34482.63
5650132-65013281.13581.41
6649728-64972881.08481.37
30min1722374-72237490.15188.241.6390.5688.651.65
2712140-71214088.87389.30
3687958-68795885.85586.22
4711467-71146788.78989.22
5703324-70332487.77388.18
6705218-70521888.00988.43
45min1763984-76398495.34393.641.2595.9194.201.26
2753721-75372194.06394.63
3735978-73597891.84892.36
4751725-75172593.81394.39
5751767-75176793.81994.37
6745051-74505192.98193.55
60min1785642-78564298.04696.590.9498.7797.300.95
2774098-77409896.60697.33
3763041-76304195.22695.89
4775667-77566796.80197.53
5773111-77311196.48297.19
6772092-77209296.35597.08
极限1801654-801654100.04497.921.22100.9398.801.22
2783204-78320497.74298.63
3774499-77449996.65697.48
4785242-78524297.99698.89
5786321-78632198.13199.00
6777015-77701596.97097.85
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%
110.582942062942522942562938942943532941920.06
210.572956922968142962530.27
单位质量响应值RSD%判断
27806.4328027.720.57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%
5min1265960-26596084.28575.6312.7884.2875.6312.77
2274725-27472587.06387.06
3224985-22498571.30071.30
4254504-25450480.65480.65
5207952-20795265.90265.90
6203776-20377664.57864.58
10min1290122-29012291.94289.695.0992.0889.825.10
2304386-30438696.46296.61
3271500-27150086.04086.16
4291419-29141992.35392.49
5272221-27222186.26986.38
6268527-26852785.09885.21
15min1289684-28968491.80392.283.1192.1092.563.12
2306776-30677697.22097.53
3281673-28167389.26489.53
4296167-29616793.85894.15
5285785-28578590.56890.82
6286978-28697890.94691.20
20min1290143-29014391.94992.962.6392.4093.382.64
2307798-30779897.54498.01
3286148-28614890.68391.09
4295084-29508493.51493.96
5288719-28871991.49791.90
6292049-29204992.55392.95
30min1290339-29033992.01193.512.3192.6194.092.31
2307768-30776897.53498.16
3290902-29090292.18992.75
4295735-29573593.72194.32
5289754-28975491.82592.38
6295945-29594593.78794.34
45min1290295-29029591.99794.012.2592.7594.752.25
2307382-30738297.41298.20
3293206-29320692.91993.64
4295629-29562993.68794.44
5291578-29157892.40393.11
6301886-30188695.67096.38
60min1291099-29109992.25294.152.3093.1695.052.30
2308788-30878897.85798.81
3293518-29351893.01893.89
4294559-29455993.34894.26
5292794-29279492.78993.65
6301787-30178795.63996.51
极限1290300-29030091.99894.472.1293.0695.522.11
2305977-30597796.96798.08
3296513-29651393.96794.99
4294221-29422193.24194.31
5296075-29607593.82894.85
6305459-30545996.80297.83
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%
122.017961577962517958557967877961217962340.05
221.988005648031098018360.23
单位质量响应值RSD%判断
36176.0136480.250.60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%
5min1146752-14675218.17913.4530.6218.1813.4530.62
2148884-14888418.44318.44
366846-668468.2808.28
4104520-10452012.94712.95
5101074-10107412.52012.52
683501-8350110.34410.34
10min1296220-29622036.69431.4616.0036.7231.4816.01
2292536-29253636.23736.27
3192852-19285223.88923.90
4250915-25091531.08231.10
5269103-26910333.33533.36
6222327-22232727.54027.56
15min1376915-37691546.69042.5410.1846.7842.6110.19
2374733-37473346.41946.51
3287005-28700535.55235.61
4341231-34123142.26942.34
5360174-36017444.61644.69
6320351-32035139.68339.75
20min1431408-43140853.44050.036.8853.6150.186.90
2428699-42869953.10453.27
3361587-36158744.79144.90
4401369-40136949.71949.86
5418217-41821751.80651.96
6382001-38200147.32047.45
30min1500778-50077862.03359.444.3962.2959.674.42
2497843-49784361.66961.93
3449891-44989155.72955.92
4480857-48085759.56559.79
5490576-49057660.76961.01
6458920-45892056.84857.06
45min1564658-56465869.94667.992.9070.3168.322.93
2559865-55986569.35269.71
3522635-52263564.74065.02
4549848-54984868.11168.44
5558190-55819069.14569.48
6538240-53824066.67366.98
60min1606982-60698275.18973.372.4675.6773.812.50
2603963-60396374.81575.29
3568348-56834870.40370.79
4593961-59396173.57674.02
5598018-59801874.07874.53
6582435-58243572.14872.56
极限1625062-62506277.42875.971.9078.0376.541.93
2619299-61929976.71477.31
3593644-59364473.53774.04
4613852-61385276.04076.60
5621525-62152576.99077.57
6606487-60648775.12775.66
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%
110.582937372938862936262930282924872933530.20
210.572956172959852958010.09
单位质量响应值RSD%判断
27727.1327984.960.66数据可信
供试品溶液批-恩格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1239733-23973376.14074.524.0976.1474.524.09
2232791-23279173.93573.94
3246415-24641578.26278.26
4218640-21864069.44169.44
5239277-23927775.99576.00
6230976-23097673.35973.36
10min1282306-28230689.66290.091.0289.7990.221.02
2278411-27841188.42488.55
3285622-28562290.71590.85
4284550-28455090.37490.49
5285268-28526890.60290.73
6285782-28578290.76590.89
15min1285623-28562390.71591.991.7390.9992.271.72
2282210-28221089.63189.90
3289560-28956091.96592.25
4293848-29384893.32793.59
5291297-29129792.51792.79
6295364-29536493.80994.08
20min1288363-28836391.58592.651.6792.0193.071.67
2283946-28394690.18290.60
3291943-29194392.72293.16
4294460-29446093.52293.94
5293934-29393493.35593.79
6297575-29757594.51194.94
30min1287939-28793991.45192.501.6692.0393.081.66
2284355-28435590.31290.88
3289986-28998692.10192.69
4296499-29649994.16994.75
5292205-29220592.80593.39
6296531-29653194.17994.77
45min1286556-28655691.01192.341.8591.7493.081.84
2282709-28270989.79090.51
3289550-28955091.96292.71
4294933-29493393.67294.41
5294864-29486493.65094.39
6295782-29578293.94294.69
60min1287111-28711191.18892.771.7092.0793.661.70
2285146-28514690.56491.43
3292186-29218692.79993.70
4294590-29459093.56394.45
5297074-29707494.35295.25
6296469-29646994.16095.06
极限1297722-29772294.55895.281.7995.5996.321.78
2293531-29353193.22794.25
3296365-29636594.12795.18
4303098-30309896.26597.31
5308581-30858198.00799.06
6300594-30059495.47096.53
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%
122.017948227918947944467928407910067930020.21
221.987985617996597991100.10
单位质量响应值RSD%判断
36029.1736356.230.64数据可信
供试品溶液批-非奈利酮
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190120-9012011.2056.7236.3111.216.7236.32
245827-458275.6985.70
361829-618297.6887.69
440232-402325.0025.00
548592-485926.0426.04
637525-375254.6664.67
10min1258401-25840132.12925.9014.8732.1525.9114.89
2226990-22699028.22328.23
3212339-21233926.40226.41
4188480-18848023.43523.44
5190163-19016323.64423.65
6173658-17365821.59221.60
15min1448629-44862955.78143.7124.4455.8543.7624.42
2435474-43547454.14654.20
3401922-40192249.97450.03
4276425-27642534.37034.42
5274037-27403734.07334.12
6272680-27268033.90433.95
20min1548105-54810568.15054.2925.0768.3154.4225.06
2542819-54281967.49267.64
3517244-51724464.31364.45
4337631-33763141.98042.08
5332623-33262341.35741.46
6341420-34142042.45142.55
30min1626843-62684377.94064.1921.7978.2264.4021.79
2623139-62313977.47977.74
3605297-60529775.26175.51
4417297-41729751.88552.06
5400471-40047149.79349.97
6424295-42429552.75652.93
45min1681974-68197484.79572.1017.4285.2072.4217.44
2669228-66922883.21083.60
3664254-66425482.59182.96
4486559-48655960.49760.76
5482138-48213859.94860.21
6495026-49502661.55061.81
60min1709714-70971488.24477.0414.8088.7977.4814.84
2697758-69775886.75787.28
3701958-70195887.27987.79
4528831-52883165.75366.12
5543522-54352267.58067.94
6535905-53590566.63366.99
极限1735575-73557591.45980.7713.0492.1681.3513.09
2724145-72414590.03890.71
3720592-72059289.59690.25
4569678-56967870.83271.30
5578410-57841071.91872.39
6569425-56942570.80171.27
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