非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.163091183093093093973088933089763091390.07
211.143095953096563096260.02
单位质量响应值RSD%判断
27700.6327794.080.24数据可信
供试品溶液-6022601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%
5min1220336-22033671.46767.3722.6571.4767.3722.65
2192042-19204262.29062.29
3260134-26013484.37684.38
4141263-14126345.82045.82
5257114-25711483.39783.40
6175293-17529356.85756.86
10min1300490-30049097.46694.972.5197.5895.082.53
2289136-28913693.78393.89
3300544-30054497.48397.62
4282373-28237391.58991.67
5295734-29573495.92396.06
6288414-28841493.54993.64
15min1306341-30634199.36497.211.6499.6597.481.65
2296198-29619896.07496.33
3305035-30503598.94099.24
4294890-29489095.64995.88
5299335-29933597.09197.39
6296334-29633496.11896.37
20min1308932-308932100.20497.911.58100.6598.341.59
2297977-29797796.65197.07
3306464-30646499.40399.87
4297711-29771196.56496.95
5301067-30106797.65398.11
6298949-29894996.96697.38
30min1310840-310840100.82398.401.63101.4499.001.64
2299093-29909397.01397.59
3308127-30812799.943100.58
4299766-29976697.23197.78
5302166-30216698.00998.63
6300224-30022497.38097.95
45min1312595-312595101.39298.811.63102.1799.571.64
2300194-30019497.37098.11
3308806-308806100.163100.96
4302140-30214098.00198.71
5303130-30313098.32299.11
6300938-30093897.61198.35
60min1313471-313471101.67698.941.71102.6399.871.72
2300522-30052297.47698.38
3309451-309451100.372101.34
4302502-30250298.11898.99
5303093-30309398.31099.26
6301256-30125697.71498.61
极限1314086-314086101.87699.141.65103.00100.231.66
2301341-30134197.74298.81
3309449-309449100.372101.51
4303315-30331598.38299.42
5303736-30373698.51999.63
6302018-30201897.96199.02
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111.153987973989853986263981853985053986200.08
211.223986713990523988620.07
单位质量响应值RSD%判断
35750.6735549.200.40数据可信
供试品溶液-6022601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%
5min1114677-11467728.92222.2835.5628.9222.2835.55
259968-5996815.12415.12
3107472-10747227.10527.10
439559-395599.9779.98
594572-9457223.85123.85
6113809-11380928.70328.70
10min1295508-29550874.52867.279.5974.5867.309.61
2250838-25083863.26263.29
3279204-27920470.41670.46
4224007-22400756.49656.51
5280815-28081570.82370.86
6269904-26990468.07168.12
15min1347691-34769187.68983.454.1487.8683.604.16
2329278-32927883.04583.18
3334207-33420784.28884.45
4306223-30622377.23177.34
5336405-33640584.84385.00
6331513-33151383.60983.77
20min1368101-36810192.83789.532.9593.1689.822.97
2356159-35615989.82590.09
3356100-35610089.81090.11
4336171-33617184.78485.02
5358991-35899190.53990.84
6354464-35446489.39789.70
30min1383609-38360996.74894.411.8897.2294.851.90
2376284-37628494.90095.32
3373319-37331994.15394.61
4362369-36236991.39191.77
5377507-37750795.20995.66
6372939-37293994.05794.51
45min1389825-38982598.31696.591.2798.9597.191.29
2385265-38526597.16697.74
3381249-38124996.15396.76
4375446-37544694.68995.22
5384628-38462897.00597.61
6381561-38156196.23196.84
60min1389966-38996698.35197.101.0099.1597.861.03
2387529-38752997.73798.48
3383983-38398396.84297.61
4378627-37862795.49196.18
5385647-38564797.26298.03
6384332-38433296.93097.70
极限1389573-38957398.25297.200.9399.2198.110.95
2387781-38778197.80098.70
3384117-38411796.87697.81
4379221-37922195.64196.49
5385344-38534497.18598.12
6386270-38627097.41998.35
非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.163093953091543090903090813093823092200.06
211.143093343095393094360.05
单位质量响应值RSD%判断
27707.8927777.020.18数据可信
供试品溶液-6022602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%
5min1161905-16190552.52451.8213.5752.5251.8213.57
2159304-15930451.68051.68
3154484-15448450.11750.12
4177709-17770957.65157.65
5183258-18325859.45159.45
6121803-12180339.51439.51
10min1281745-28174591.40290.615.0991.4990.705.10
2283314-28331491.91192.00
3289453-28945393.90293.99
4286657-28665792.99593.09
5283808-28380892.07192.17
6250843-25084381.37781.44
15min1293967-29396795.36795.071.5195.6195.301.53
2290734-29073494.31894.56
3298440-29844096.81897.06
4294772-29477295.62895.88
5294777-29477795.63095.88
6285537-28553792.63292.83
20min1297147-29714796.39895.971.3696.8096.361.37
2293127-29312795.09495.49
3300847-30084797.59998.00
4297450-29745096.49796.91
5296975-29697596.34396.75
6289322-28932293.86094.22
30min1298891-29889196.96496.531.3797.5297.081.38
2294979-29497995.69596.25
3302447-30244798.11898.68
4299429-29942997.13997.71
5298718-29871896.90897.48
6290863-29086394.36094.87
45min1301280-30128097.73997.011.4898.4697.731.49
2295972-29597296.01796.73
3303329-30332998.40499.13
4301387-30138797.77498.51
5300768-30076897.57398.31
6291528-29152894.57595.25
60min1302075-30207597.99797.261.4298.8898.131.43
2296810-29681096.28997.16
3303741-30374198.53899.43
4302440-30244098.11599.01
5301026-30102697.65798.55
6292643-29264394.93795.76
极限1304288-30428898.71597.741.4699.7698.781.47
2298417-29841796.81097.85
3305127-30512798.987100.04
4304279-30427998.71299.77
5301789-30178997.90498.96
6293861-29386195.33296.32
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111.153985883982083980423981963983513982770.06
211.223984133984423984280.01
单位质量响应值RSD%判断
35719.9135510.520.42数据可信
供试品溶液-6022602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%
5min168316-6831617.24616.6211.4317.2516.6211.43
269913-6991317.65017.65
364281-6428116.22816.23
477073-7707319.45719.46
557702-5770214.56714.57
657754-5775414.58014.58
10min1254396-25439664.22262.666.3664.2562.696.36
2268788-26878867.85667.89
3258526-25852665.26565.29
4247564-24756462.49862.53
5232587-23258758.71758.74
6227461-22746157.42357.45
15min1337982-33798285.32484.522.0385.4684.652.04
2344817-34481787.04987.19
3336316-33631684.90385.04
4333726-33372684.24984.39
5324575-32457581.93982.06
6331358-33135883.65183.77
20min1363587-36358791.78891.361.7092.0791.631.70
2371431-37143193.76894.06
3361801-36180191.33791.61
4360627-36062791.04091.32
5352325-35232588.94589.20
6361471-36147191.25491.51
30min1381185-38118596.23096.321.5096.6696.741.50
2391615-39161598.86399.31
3380289-38028996.00496.43
4380152-38015295.97096.40
5374026-37402694.42394.83
6381982-38198296.43296.84
45min1389082-38908298.22498.681.2298.8299.271.22
2399418-399418100.833101.44
3389386-38938698.30198.89
4389545-38954598.34198.93
5385412-38541297.29797.86
6392547-39254799.09999.67
60min1390385-39038598.55399.251.2299.31100.001.22
2401532-401532101.367102.14
3391299-39129998.78499.54
4391912-39191298.93899.69
5388232-38823298.00998.74
6395632-39563299.877100.61
极限1390609-39060998.60999.461.2899.53100.381.28
2402506-402506101.613102.56
3393254-39325499.277100.20
4391626-39162698.86699.78
5388911-38891198.18199.07
6397062-397062100.238101.14
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