艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273736253718433706603711393721073718750.31
214.323700523698473699500.04
单位质量响应值RSD%判断
26059.9225834.500.62数据可信
供试品溶液-B111406批-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%
5min1302733-30273380.56981.722.3080.5781.722.30
2306977-30697781.69881.70
3318779-31877984.83984.84
4311139-31113982.80682.81
5298921-29892179.55479.55
6303912-30391280.88380.88
10min1330149-33014987.86589.522.3888.0089.652.37
2335263-33526389.22689.36
3350538-35053893.29293.43
4338710-33871090.14490.28
5327940-32794087.27787.41
6335492-33549289.28789.42
15min1336136-33613689.45991.612.7089.7491.892.70
2344484-34448491.68091.97
3359054-35905495.55895.85
4350064-35006493.16593.45
5333963-33396388.88089.16
6341570-34157090.90591.19
20min1339369-33936990.31992.492.3290.7592.932.32
2349702-34970293.06993.51
3360819-36081996.02896.48
4350088-35008893.17293.62
5339391-33939190.32590.75
6345844-34584492.04292.48
30min1346253-34625392.15193.592.0792.7394.192.07
2351632-35163293.58394.18
3364588-36458897.03197.65
4354146-35414694.25294.85
5344292-34429291.62992.21
6349102-34910292.90993.50
45min1351839-35183993.63894.611.7794.3795.361.77
2355693-35569394.66495.41
3366829-36682997.62798.41
4357511-35751195.14795.90
5349486-34948693.01293.74
6351670-35167093.59394.34
60min1353691-35369194.13195.231.6095.0296.141.61
2358577-35857795.43196.34
3368385-36838598.04198.98
4358756-35875695.47996.39
5353276-35327694.02094.90
6354315-35431594.29795.20
极限1357764-35776495.21596.181.4596.2697.251.45
2362049-36204996.35597.42
3371363-37136398.83499.94
4359605-35960595.70596.78
5360628-36062895.97797.02
6356963-35696395.00296.06
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273735493701353696583700683696903706200.45
214.323714693738553726620.46
单位质量响应值RSD%判断
25971.9726023.880.15数据可信
供试品溶液-B111406批-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%
5min1310343-31034382.43281.591.3882.4381.581.38
2301897-30189780.18880.19
3308601-30860181.96981.97
4311047-31104782.61982.62
5309334-30933482.16482.16
6301732-30173280.14480.14
10min1341411-34141190.68490.061.3590.8290.191.35
2335091-33509189.00589.14
3342392-34239290.94491.08
4343072-34307291.12591.26
5340562-34056290.45890.60
6331743-33174388.11688.25
15min1347056-34705692.18391.781.5692.4792.071.56
2340437-34043790.42590.71
3350342-35034293.05693.34
4350243-35024393.03093.32
5347751-34775192.36892.66
6337434-33743489.62789.91
20min1348861-34886192.66392.671.4293.1093.111.42
2342988-34298891.10391.54
3353648-35364893.93494.38
4352480-35248093.62494.07
5352653-35265393.67094.11
6342773-34277391.04591.48
30min1352999-35299993.76294.141.3594.3694.741.35
2347675-34767592.34792.93
3359175-35917595.40296.00
4358982-35898295.35195.95
5357215-35721594.88195.48
6350597-35059793.12493.71
45min1355162-35516294.33694.561.1795.0995.311.17
2349719-34971992.89093.63
3360867-36086795.85196.61
4357240-35724094.88895.65
5359676-35967695.53596.29
6353421-35342193.87494.61
60min1356625-35662594.72594.791.1595.6395.701.15
2351175-35117593.27794.17
3361905-36190596.12797.05
4357077-35707794.84595.76
5360824-36082495.84096.76
6353650-35365093.93594.83
极限1358997-35899795.35595.281.1396.4296.341.13
2354679-35467994.20895.26
3364705-36470596.87197.95
4356858-35685894.78795.86
5362112-36211296.18297.26
6354922-35492294.27295.32
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273695793695873698913698803696883697250.05
214.323708073703553705810.09
单位质量响应值RSD%判断
25909.2525878.560.09数据可信
供试品溶液-Z005796批-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%
5min1207214-20721455.26062.538.8855.2662.548.88
2244957-24495765.32565.33
3215784-21578457.54657.55
4233225-23322562.19762.20
5240910-24091064.24664.25
6264800-26480070.61770.62
10min1336797-33679789.81790.993.0289.9191.093.01
2334530-33453089.21389.32
3343692-34369291.65691.75
4338255-33825590.20690.31
5360745-36074596.20496.31
6333042-33304288.81688.93
15min1348826-34882693.02593.472.6393.2793.722.63
2343523-34352391.61191.87
3360045-36004596.01796.27
4347365-34736592.63692.89
5363156-36315696.84797.11
6339953-33995390.65990.92
20min1351547-35154793.75193.762.3794.1594.172.36
2345782-34578292.21492.62
3358202-35820295.52695.93
4348754-34875493.00693.41
5363960-36396097.06197.49
6341248-34124891.00491.42
30min1357488-35748895.33594.562.3095.8995.132.29
2349514-34951493.20993.77
3361072-36107296.29196.86
4351590-35159093.76294.33
5364989-36498997.33697.93
6342871-34287191.43792.01
45min1361854-36185496.50095.302.1297.2196.032.11
2353025-35302594.14594.86
3364153-36415397.11397.84
4357651-35765195.37996.10
5363083-36308396.82797.58
6344446-34444691.85792.58
60min1359397-35939795.84495.972.2996.7296.852.27
2355905-35590594.91395.79
3372578-37257899.360100.25
4360179-36017996.05396.93
5363381-36338196.90797.82
6347749-34774992.73893.61
极限1360595-36059596.16495.962.0697.2097.002.05
2357592-35759295.36396.40
3367616-36761698.03699.09
4363712-36371296.99598.03
5363089-36308996.82997.90
6346362-34636292.36893.40
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273694083692483701763692543690933694360.12
214.323733153731613732380.03
单位质量响应值RSD%判断
25889.0026064.110.48数据可信
供试品溶液-Z005796批-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%
5min1256755-25675568.25565.749.4368.2565.749.43
2275185-27518573.15473.15
3229356-22935660.97160.97
4213832-21383256.84456.84
5266758-26675870.91470.91
6241925-24192564.31264.31
10min1340226-34022690.44491.062.0790.5691.182.07
2346223-34622392.03892.16
3345046-34504691.72691.83
4336708-33670889.50989.60
5333854-33385488.75088.87
6353302-35330293.92094.03
15min1351262-35126293.37893.702.3893.6493.962.38
2354314-35431494.18994.46
3354130-35413094.14094.39
4351446-35144693.42793.67
5338758-33875890.05490.32
6364922-36492297.00997.27
20min1348768-34876892.71593.552.4093.1493.972.40
2357429-35742995.01795.45
3354824-35482494.32594.74
4349547-34954792.92293.32
5338268-33826889.92490.34
6362660-36266096.40896.83
30min1351697-35169793.49494.102.0694.0794.672.05
2356991-35699194.90195.49
3354405-35440594.21494.78
4356041-35604194.64895.20
5341399-34139990.75691.32
6363286-36328696.57497.16
45min1354490-35449094.23694.221.5494.9794.941.54
2354632-35463294.27495.02
3356033-35603394.64695.37
4353454-35345493.96194.67
5345459-34545991.83592.55
6362427-36242796.34697.09
60min1353917-35391794.08494.651.2994.9795.541.29
2355112-35511294.40195.31
3357939-35793995.15396.04
4355970-35597094.63095.50
5349734-34973492.97293.84
6363560-36356096.64797.55
极限1355407-35540794.48094.700.9495.5295.750.94
2353389-35338993.94395.01
3358047-35804795.18296.22
4355830-35583094.59295.62
5352921-35292193.81994.84
6361922-36192296.21297.28
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