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%
114.574979934973524973094968824961384971350.14
214.544975284965034970160.15
单位质量响应值RSD%判断
34120.4534182.670.13数据可信
供试品溶液-2026020221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%
5min1458198-45819892.26789.513.7192.2789.513.71
2458378-45837892.30492.30
3451509-45150990.92190.92
4451823-45182390.98490.98
5423299-42329985.24085.24
6423962-42396285.37385.37
10min1471545-47154594.95593.451.4595.1193.601.45
2471721-47172194.99195.14
3463483-46348393.33293.48
4464340-46434093.50493.66
5456768-45676891.98092.12
6456598-45659891.94592.09
15min1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
20min1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
30min1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
45min1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
60min1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
极限1-0.0000.00-0.310.311.69
2-0.0000.31
3-0.0000.31
4-0.0000.31
5-0.0000.30
6-0.0000.30
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%
114.573753733752773750493750583753583752230.05
214.543745343747863746600.05
单位质量响应值RSD%判断
25753.1225767.540.04数据可信
供试品溶液-2026020221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1368272-36827298.31696.752.7798.3296.762.77
2366254-36625497.77797.78
3344786-34478692.04692.05
4362482-36248296.77096.77
5373797-37379799.79199.79
6358952-35895295.82895.83
10min1249200-24920066.52865.363.8566.6965.523.84
2228546-22854661.01461.18
3239640-23964063.97564.13
4250892-25089266.97967.14
5254529-25452967.95068.12
6246187-24618765.72365.88
15min1320206-32020685.48484.621.6585.7684.901.65
2308095-30809582.25182.52
3314148-31414883.86784.13
4322107-32210785.99186.26
5320464-32046485.55385.83
6316896-31689684.60084.87
20min1348423-34842393.01792.800.9093.4393.210.91
2343191-34319191.62092.02
3344553-34455391.98492.38
4349725-34972593.36493.78
5348320-34832092.98993.41
6351397-35139793.81194.22
30min1360906-36090696.34995.980.6496.9296.550.64
2357993-35799395.57296.13
3355660-35566094.94995.50
4360159-36015996.15096.72
5360613-36061396.27196.85
6361826-36182696.59597.16
45min1367990-36799098.24097.750.8698.9798.480.86
2365857-36585797.67198.38
3361707-36170796.56397.27
4363322-36332296.99497.73
5369719-36971998.70299.44
6368430-36843098.35899.09
60min1370137-37013798.81498.490.9399.7199.380.93
2369114-36911498.54199.42
3364716-36471697.36698.24
4365186-36518697.49298.39
5373579-37357999.733100.63
6370747-37074798.97699.87
极限1371102-37110299.07198.881.09100.1399.931.09
2371587-37158799.201100.24
3365350-36535097.53698.57
4366061-36606197.72598.78
5375957-375957100.367101.44
6372243-37224399.376100.43
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%
114.573740183740873740633739273736233739440.06
214.543728383731303729840.06
单位质量响应值RSD%判断
25665.3425652.270.04数据可信
供试品溶液-2026020221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%
5min1249236-24923666.80169.254.1766.8069.254.17
2245769-24576965.87165.87
3251004-25100467.27467.27
4268261-26826171.90071.90
5267600-26760071.72271.72
6268377-26837771.93171.93
10min1324990-32499087.10486.723.1087.2286.843.10
2314479-31447984.28784.40
3308357-30835782.64682.76
4331537-33153788.85988.98
5333520-33352089.39089.51
6328439-32843988.02988.15
15min1352195-35219594.39693.323.1894.6593.583.18
2336965-33696590.31490.56
3332877-33287789.21889.47
4356251-35625195.48395.75
5361175-36117596.80397.07
6349609-34960993.70393.97
20min1363043-36304397.30395.963.0397.7296.383.03
2345698-34569892.65493.06
3345213-34521392.52492.92
4366349-36634998.18998.62
5371178-37117899.48499.91
6356662-35666295.59396.02
30min1368325-36832598.71997.212.8299.2997.792.82
2350041-35004193.81894.37
3352536-35253694.48795.04
4369623-36962399.06799.66
5375729-375729100.703101.30
6359977-35997796.48197.06
45min1371660-37166099.61398.132.69100.3598.862.69
2353100-35310094.63895.35
3358331-35833196.04096.75
4372056-37205699.719100.47
5379275-379275101.654102.42
6362314-36231497.10897.85
60min1375465-375465100.63398.592.75101.5499.492.75
2353938-35393894.86395.73
3360410-36041096.59897.47
4372249-37224999.771100.69
5380932-380932102.098103.03
6364144-36414497.59898.50
极限1380217-380217101.90699.012.72102.98100.082.72
2357694-35769495.87096.90
3359822-35982296.44097.47
4373212-373212100.029101.12
5380522-380522101.988103.09
6365053-36505397.84298.91
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%
114.573743013745413739803741123742393742350.06
214.543727293725543726420.04
单位质量响应值RSD%判断
25685.3125628.750.16数据可信
供试品溶液-2026020221批-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%
5min1230612-23061261.81367.364.5861.8167.364.58
2259559-25955969.57269.57
3256049-25604968.63168.63
4245259-24525965.73965.74
5255890-25589068.58968.59
6260449-26044969.81169.81
10min1285875-28587576.62682.293.8576.7382.403.85
2314221-31422184.22484.34
3307844-30784482.51582.63
4301979-30197980.94281.05
5318165-31816585.28185.40
6313884-31388484.13484.25
15min1306591-30659182.17987.203.2482.4187.453.24
2332283-33228389.06589.32
3326934-32693487.63187.88
4319956-31995685.76186.01
5333946-33394689.51189.77
6332223-33222389.04989.31
20min1315211-31521184.48989.733.1784.8690.133.17
2343239-34323992.00292.41
3337332-33733290.41990.82
4330857-33085788.68389.07
5342711-34271191.86092.27
6339318-33931890.95191.36
30min1323975-32397586.83892.803.4087.3593.353.40
2357624-35762495.85896.42
3346712-34671292.93393.48
4346458-34645892.86593.40
5353904-35390494.86095.42
6348676-34867693.45994.02
45min1332566-33256689.14195.473.3589.7996.173.35
2366341-36634198.19498.91
3360228-36022896.55697.26
4360269-36026996.56797.26
5359400-35940096.33497.05
6358214-35821496.01696.73
60min1338109-33810990.62796.313.2491.4397.173.23
2370211-37021199.231100.11
3356199-35619995.47696.34
4368692-36869298.82499.68
5361774-36177496.97097.85
6360963-36096396.75397.62
极限1374215-374215100.30599.422.11101.26100.442.09
2376535-376535100.926101.97
3357785-35778595.90196.92
4375218-375218100.573101.59
5376887-376887101.021102.06
6364842-36484297.79298.83
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