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(%) 100.0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%
111.273126103128523125493123513127393126200.07
211.213138973139053139010.01
单位质量响应值RSD%判断
27739.1328001.870.67数据可信
供试品溶液-25112401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%
5min1279951-27995190.40482.9721.1790.4082.9721.17
2283726-28372691.62391.62
3260470-26047084.11384.11
4293764-29376494.86594.86
5148178-14817847.85147.85
6275505-27550588.96988.97
10min1305726-30572698.72896.712.3098.8896.852.32
2295332-29533295.37195.52
3304845-30484598.44398.58
4306436-30643698.95799.12
5291949-29194994.27994.36
6292618-29261894.49594.64
15min1307707-30770799.36897.841.8899.6898.141.89
2300260-30026096.96397.27
3306749-30674999.05899.36
4308993-30899399.783100.11
5299527-29952796.72696.96
6294625-29462595.14395.45
20min1306974-30697499.13197.752.0299.6198.222.02
2297159-29715995.96196.43
3307052-30705299.15699.63
4309888-309888100.072100.56
5300279-30027996.96997.37
6294922-29492295.23995.70
30min1308300-30830099.55998.002.02100.2198.632.02
2297842-29784296.18296.82
3307086-30708699.16799.80
4310706-310706100.336100.99
5301331-30133197.30997.87
6295635-29563595.46996.09
45min1308109-30810999.49797.942.05100.3198.732.05
2297727-29772796.14596.94
3306552-30655298.99599.79
4310902-310902100.399101.22
5301307-30130797.30198.02
6295213-29521395.33396.12
60min1308112-30811299.49897.802.03100.4898.752.03
2297202-29720295.97596.93
3305986-30598698.81299.78
4310190-310190100.169101.16
5300370-30037096.99897.88
6295190-29519095.32596.27
极限1307105-30710599.17397.832.32100.3298.942.32
2295636-29563695.47096.58
3310521-310521100.276101.41
4309560-30956099.966101.12
5299938-29993896.85997.90
6294920-29492095.23896.34
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%
111.144024694026534029754022364031524026970.10
211.084041764038044039900.07
单位质量响应值RSD%判断
36148.7436461.190.61数据可信
供试品溶液-25112401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%
5min1124607-12460730.86026.4138.0130.8626.4138.01
2162759-16275940.30840.31
3105273-10527326.07226.07
4106339-10633926.33626.34
537912-379129.3899.39
6102915-10291525.48825.49
10min1271650-27165067.27665.2313.4167.3365.2813.42
2296394-29639473.40473.47
3267840-26784066.33266.38
4276000-27600068.35368.40
5194282-19428248.11548.13
6274269-27426967.92567.97
15min1322359-32235979.83479.464.6380.0079.614.65
2336389-33638983.30983.50
3325056-32505680.50280.66
4325177-32517780.53280.69
5292380-29238072.41072.51
6323695-32369580.16580.32
20min1344197-34419785.24385.332.2785.5485.622.30
2349156-34915686.47186.80
3351047-35104786.93987.23
4348002-34800286.18586.48
5329436-32943681.58781.80
6345469-34546985.55885.85
30min1365844-36584490.60490.761.4191.0491.181.44
2366948-36694890.87791.35
3373339-37333992.46092.89
4368581-36858191.28291.72
5357505-35750588.53888.89
6366566-36656690.78391.21
45min1379865-37986594.07694.111.1494.6794.691.16
2378760-37876093.80294.43
3386780-38678095.78996.38
4382142-38214294.64095.23
5373760-37376092.56493.06
6378618-37861893.76794.35
60min1385555-38555595.48595.351.1496.2396.081.16
2383270-38327094.91995.70
3391738-39173897.01797.76
4387137-38713795.87796.62
5378658-37865893.77794.43
6383689-38368995.02395.76
极限1387240-38724095.90396.151.7396.8197.041.73
2383256-38325694.91695.85
3400773-40077399.254100.16
4389631-38963196.49597.40
5382166-38216694.64695.46
6386301-38630195.67096.57
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(%) 100.0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%
111.273137133139363139653138433138163138550.04
211.213141093145713143400.11
单位质量响应值RSD%判断
27848.7128041.030.49数据可信
供试品溶液-25112402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%
5min1248955-24895580.18082.3811.6080.1882.3811.60
2281635-28163590.70590.71
3271288-27128887.37387.37
4216286-21628669.65869.66
5288806-28880693.01593.01
6227697-22769773.33473.33
10min1295196-29519695.07395.411.2195.2195.551.20
2291995-29199594.04294.19
3293689-29368994.58794.73
4299311-29931196.39896.51
5301537-30153797.11597.27
6295810-29581095.27095.39
15min1297323-29732395.75895.931.2196.0596.221.20
2293748-29374894.60694.91
3294935-29493594.98995.29
4302382-30238297.38797.66
5301936-30193697.24397.56
6296757-29675795.57595.86
20min1297105-29710595.68895.971.1796.1496.431.16
2294054-29405494.70595.17
3295663-29566395.22395.68
4302199-30219997.32897.77
5302302-30230297.36197.84
6296631-29663195.53595.98
30min1296892-29689295.61996.031.2996.2396.651.28
2294566-29456694.87095.49
3295006-29500695.01295.63
4303133-30313397.62998.23
5302837-30283797.53498.17
6296607-29660795.52796.13
45min1297073-29707395.67795.951.2496.4596.731.23
2294228-29422894.76195.54
3294963-29496394.99895.78
4302890-30289097.55198.31
5302086-30208697.29298.10
6296290-29629095.42596.18
60min1296280-29628095.42295.781.2596.3596.711.24
2293799-29379994.62395.56
3294310-29431094.78795.72
4302905-30290597.55698.48
5300903-30090396.91197.88
6296113-29611395.36896.29
极限1294447-29444794.83295.491.3195.9296.581.31
2292501-29250194.20595.30
3293728-29372894.60095.69
4302066-30206697.28598.37
5300459-30045996.76897.90
6295687-29568795.23196.31
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%
111.144038314038504045164042394038364040540.08
211.084042674044474043570.04
单位质量响应值RSD%判断
36270.5636494.310.44数据可信
供试品溶液-25112402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%
5min197032-9703223.97924.2016.2323.9824.2016.23
2109323-10932327.01727.02
377536-7753619.16119.16
4101761-10176125.14825.15
582458-8245820.37820.38
6119397-11939729.50629.51
10min1265877-26587765.70566.172.4165.7566.212.41
2280769-28076969.38669.43
3264376-26437665.33465.37
4266292-26629265.80865.85
5264539-26453965.37565.41
6264615-26461565.39465.44
15min1322499-32249979.69879.441.6979.8579.591.69
2329754-32975481.49181.65
3322252-32225279.63779.78
4320394-32039479.17879.33
5320937-32093779.31279.46
6312791-31279177.29977.46
20min1344441-34444185.12184.931.3585.4085.211.35
2350247-35024786.55686.85
3344427-34442785.11785.39
4342580-34258084.66184.94
5344380-34438085.10685.38
6335868-33586883.00283.29
30min1365046-36504690.21389.941.0390.6490.361.02
2368248-36824891.00491.44
3364238-36423890.01390.43
4363357-36335789.79590.22
5365528-36552890.33290.75
6357119-35711988.25488.68
45min1378240-37824093.47393.090.9894.0593.660.98
2380452-38045294.02094.61
3377092-37709293.19093.76
4376234-37623492.97893.55
5378241-37824193.47494.04
6369765-36976591.37991.95
60min1382957-38295794.63994.490.9295.3795.220.92
2386013-38601395.39496.14
3382284-38228494.47395.19
4382357-38235794.49195.22
5384713-38471395.07395.80
6375852-37585292.88393.61
极限1383610-38361094.80094.860.6895.6995.740.68
2386835-38683595.59796.51
3383899-38389994.87295.75
4383890-38389094.87095.76
5385546-38554695.27996.16
6379240-37924093.72094.60
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(%) 100.0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%
111.273131913133363134523136863131753133680.07
211.213163973168503166240.11
单位质量响应值RSD%判断
27805.5028244.781.11数据可信
供试品溶液-2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%
5min1286756-28675692.09591.521.6292.0991.521.62
2289864-28986493.09393.09
3286654-28665492.06292.06
4276326-27632688.74588.74
5284270-28427091.29691.30
6285965-28596591.84191.84
10min1300692-30069296.57094.831.3596.7294.981.35
2299193-29919396.08996.24
3295293-29529394.83694.99
4290402-29040293.26593.41
5292875-29287594.06094.21
6293188-29318894.16094.31
15min1301116-30111696.70695.101.3497.0295.411.33
2300552-30055296.52596.84
3296111-29611195.09995.41
4291458-29145893.60593.91
5293584-29358494.28794.60
6293915-29391594.39494.70
20min1297426-29742695.52194.911.1296.0095.381.12
2300889-30088996.63397.11
3295755-29575594.98595.45
4291809-29180993.71794.18
5293167-29316794.15394.62
6294044-29404494.43594.90
30min1299261-29926196.11195.321.1596.7595.951.15
2302002-30200296.99197.63
3297000-29700095.38596.01
4292622-29262293.97894.59
5294600-29460094.61495.24
6295328-29532894.84895.47
45min1297801-29780195.64295.191.1496.4495.981.14
2302286-30228697.08297.88
3296144-29614495.11095.90
4292609-29260993.97494.75
5294923-29492394.71795.50
6294606-29460694.61695.40
60min1298732-29873295.94194.991.2296.9095.931.22
2301347-30134796.78197.74
3295372-29537294.86295.81
4291873-29187393.73894.67
5293530-29353094.27095.21
6293690-29369094.32195.26
极限1297292-29729295.47894.821.0896.5995.931.08
2300430-30043096.48697.61
3294845-29484594.69295.80
4291577-29157793.64394.73
5293234-29323494.17595.27
6294122-29412294.46095.56
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%
111.144035614032714032744033044034474033710.04
211.084071404075824073610.08
单位质量响应值RSD%判断
36209.2536765.431.08数据可信
供试品溶液-2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%
5min1228383-22838356.28055.943.3856.2855.943.38
2227942-22794256.17156.17
3233191-23319157.46557.46
4212155-21215552.28152.28
5227742-22774256.12256.12
6232549-23254957.30757.31
10min1310032-31003276.40176.401.2376.4976.491.23
2309606-30960676.29676.39
3312923-31292377.11377.21
4303174-30317474.71174.80
5310440-31044076.50176.59
6314019-31401977.38377.48
15min1340500-34050083.90983.730.8884.1383.950.88
2337968-33796883.28583.51
3340889-34088984.00584.23
4335300-33530082.62782.84
5339863-33986383.75283.97
6344158-34415884.81085.03
20min1355192-35519287.52987.410.7787.8987.770.77
2352380-35238086.83687.20
3355785-35578587.67688.04
4351162-35116286.53686.89
5354830-35483087.44087.80
6358899-35889988.44388.81
30min1372533-37253391.80391.520.8692.3192.030.86
2368183-36818390.73191.24
3371357-37135791.51392.02
4368186-36818690.73291.23
5371382-37138291.51992.03
6376762-37676292.84593.36
45min1382118-38211894.16594.130.8894.8294.790.88
2378410-37841093.25193.91
3381133-38113393.92294.59
4378814-37881493.35194.00
5384091-38409194.65195.31
6387281-38728195.43796.11
60min1388646-38864695.77395.150.9796.5995.960.97
2381603-38160394.03894.85
3385033-38503394.88395.70
4382840-38284094.34395.14
5386952-38695295.35696.17
6391654-39165496.51597.34
极限1389239-38923995.92095.501.0396.9096.481.02
2381977-38197794.13095.10
3387027-38702795.37596.35
4384901-38490194.85195.81
5388606-38860695.76496.74
6393564-39356496.98597.97
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