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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41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%
114.493671753675823675083671893674893673890.06
214.573672323673253672780.02
单位质量响应值RSD%判断
25354.6625207.820.42数据可信
供试品溶液-25102001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%
5min1189297-18929751.49450.6032.4751.4950.6032.47
277568-7756821.10121.10
3219655-21965559.75259.75
4161042-16104243.80843.81
5239490-23949065.14865.15
6228932-22893262.27662.28
10min1257772-25777270.12174.3012.3470.2174.3812.36
2222257-22225760.46060.49
3291145-29114579.19979.30
4255798-25579869.58469.66
5312112-31211284.90385.01
6299720-29972081.53281.64
15min1284469-28446977.38385.375.7077.5985.585.70
2307476-30747683.64283.78
3313646-31364685.32085.55
4315473-31547385.81786.01
5338168-33816891.99192.24
6323675-32367588.04888.29
20min1299990-29999081.60589.204.8081.9489.564.80
2332873-33287390.55090.83
3321916-32191687.57087.94
4334879-33487991.09691.43
5346164-34616494.16694.57
6331701-33170190.23190.62
30min1329115-32911589.52892.372.7990.0092.872.78
2344247-34424793.64494.07
3329365-32936589.59690.12
4346160-34616094.16594.65
5352181-35218195.80396.36
6336372-33637291.50292.04
45min1337228-33722891.73593.592.6092.3594.242.59
2348669-34866994.84795.43
3333467-33346790.71291.38
4350299-35029995.29195.93
5356200-35620096.89697.62
6338376-33837692.04792.74
60min1338821-33882192.16893.822.5692.9494.632.55
2348650-34865094.84295.58
3334820-33482091.08091.90
4351083-35108395.50496.30
5357456-35745697.23798.12
6338577-33857792.10292.94
极限1339815-33981592.43993.952.5193.3694.912.50
2348366-34836694.76595.66
3336343-33634391.49492.47
4351147-35114795.52196.48
5358321-35832197.47398.52
6338192-33819291.99792.99
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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41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%
114.493663963661953663913661793662093662740.03
214.573671123675103673110.08
单位质量响应值RSD%判断
25277.7125210.090.19数据可信
供试品溶液-25102002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%
5min1255474-25547469.59867.404.2369.6067.404.23
2260723-26072371.02871.03
3247138-24713867.32767.33
4230216-23021662.71762.72
5245412-24541266.85766.86
6245445-24544566.86666.87
10min1317493-31749386.49485.563.1486.6185.673.14
2327842-32784289.31389.43
3320388-32038887.28287.39
4300215-30021581.78781.89
5308033-30803383.91684.03
6310352-31035284.54884.66
15min1333966-33396690.98190.782.6091.2491.042.60
2346607-34660794.42594.69
3338665-33866592.26192.52
4322371-32237187.82388.06
5326650-32665088.98889.24
6331118-33111890.20590.46
20min1339443-33944392.47392.302.3892.8992.712.38
2352345-35234595.98896.41
3340781-34078192.83893.25
4329858-32985889.86290.25
5331358-33135890.27190.67
6339061-33906192.36992.77
30min1343477-34347793.57293.492.5694.1494.042.56
2355772-35577296.92297.51
3350058-35005895.36595.93
4333011-33301190.72191.26
5334634-33463491.16391.71
6341993-34199393.16893.72
45min1345824-34582494.21294.082.4694.9394.802.46
2356675-35667597.16897.91
3353306-35330696.25096.98
4335509-33550991.40292.09
5337114-33711491.83992.54
6343655-34365593.62194.33
60min1346688-34668894.44794.132.4595.3395.002.45
2356604-35660497.14998.06
3352910-35291096.14297.03
4335469-33546991.39192.23
5336788-33678891.75092.61
6344649-34464993.89294.76
极限1347864-34786494.76894.511.9995.8095.542.00
2356693-35669397.17398.24
3351986-35198695.89096.94
4340691-34069192.81393.81
5338241-33824192.14693.15
6345954-34595494.24795.27
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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41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%
114.493676743677113673343670763668983673390.10
214.573678903679833679360.02
单位质量响应值RSD%判断
25351.2125252.990.28数据可信
供试品溶液-25102003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%
5min1257434-25743469.97165.704.7769.9765.704.77
2241330-24133065.59465.59
3231233-23123362.84962.85
4226043-22604361.43961.44
5247796-24779667.35167.35
6246509-24650967.00167.00
10min1317033-31703386.17083.522.8886.2983.632.88
2311819-31181984.75384.86
3297874-29787480.96281.07
4297710-29771080.91881.02
5316081-31608185.91186.02
6303142-30314282.39482.51
15min1334843-33484391.01188.782.8191.2789.032.81
2333481-33348190.64090.89
3316440-31644086.00986.25
4317561-31756186.31386.55
5336213-33621391.38391.64
6321380-32138087.35187.60
20min1341521-34152192.82690.662.6293.2491.052.62
2339699-33969992.33092.73
3324278-32427888.13988.52
4324855-32485588.29688.68
5342843-34284393.18593.59
6328048-32804889.16489.56
30min1346732-34673294.24276.4548.7794.8177.0048.42
2345454-34545493.89594.45
3330011-33001189.69790.23
4330641-33064189.86990.40
51698-16980.4621.02
6333182-33318290.55991.10
45min1349271-34927194.93292.972.5295.6693.642.49
2348545-34854594.73595.45
3332311-33231190.32291.00
4334597-33459790.94491.62
5351534-35153495.54796.11
6336040-33604091.33692.03
60min1349344-34934494.95293.322.4295.8394.152.39
2350115-35011595.16296.03
3333714-33371490.70491.53
4336910-33691091.57292.40
5352866-35286695.90996.63
6337200-33720091.65192.50
极限1350015-35001595.13493.822.2296.1794.812.18
2350953-35095395.38996.42
3335314-33531491.13992.12
4342969-34296993.21994.20
5354079-35407996.23997.12
6337823-33782391.82192.82
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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41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%
114.493691713692333688983690923689493690690.04
214.573688263690253689260.04
单位质量响应值RSD%判断
25470.6025320.930.42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%
5min1287576-28757677.87574.294.2277.8874.304.22
2285137-28513777.21577.22
3273278-27327874.00474.00
4276759-27675974.94674.95
5266610-26661072.19872.20
6256734-25673469.52369.52
10min1348751-34875194.44292.492.9094.5792.622.90
2344533-34453393.29993.43
3339188-33918891.85291.98
4350008-35000894.78294.91
5322975-32297587.46287.58
6343847-34384793.11493.23
15min1357830-35783096.90095.552.7697.1995.832.76
2353092-35309295.61795.90
3350812-35081295.00095.28
4359749-35974997.42097.70
5334654-33465490.62490.89
6360988-36098897.75598.03
20min1358376-35837697.04896.062.9097.5096.502.90
2354199-35419995.91796.36
3353154-35315495.63496.07
4361855-36185597.99098.44
5335826-33582690.94291.36
6364936-36493698.82599.26
30min1359974-35997497.48196.983.0098.0997.582.99
2360956-36095697.74798.35
3356876-35687696.64297.24
4363353-36335398.39699.00
5338027-33802791.53892.11
6369518-369518100.065100.66
45min1358838-35883897.17396.892.8597.9597.652.84
2355528-35552896.27797.04
3356437-35643796.52397.28
4365211-36521198.89999.67
5340494-34049492.20692.93
6370286-370286100.273101.04
60min1358860-35886097.17997.002.7698.1197.922.76
2354406-35440695.97396.90
3357049-35704996.68997.60
4365296-36529698.92299.86
5342307-34230792.69793.57
6371169-371169100.512101.45
极限1358550-35855097.09597.821.9798.1998.901.96
2354268-35426895.93697.02
3358277-35827797.02198.10
4370131-370131100.231101.33
5355924-35592496.38497.41
6370177-370177100.244101.34
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