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%
114.493774223775953773073771403769123772750.07
214.403758943758263758600.02
单位质量响应值RSD%判断
26036.9226101.390.18数据可信
供试品溶液-2026032321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%
5min1219090-21909058.03456.893.4058.0356.893.40
2203950-20395054.02454.02
3212731-21273156.35056.35
4220035-22003558.28558.28
5223224-22322459.13059.13
6209663-20966355.53755.54
10min1271568-27156871.93571.433.2772.0371.533.28
2256310-25631067.89467.98
3261764-26176469.33869.43
4277244-27724473.43973.54
5278449-27844973.75873.86
6272653-27265372.22372.32
15min1292584-29258477.50276.792.5877.7277.012.58
2280298-28029874.24874.45
3280465-28046574.29274.50
4295205-29520578.19778.42
5296240-29624078.47178.69
6294647-29464778.04978.26
20min1307840-30784081.54380.032.6481.8980.372.64
2292594-29259477.50577.83
3291252-29125277.14977.48
4305919-30591981.03581.38
5308251-30825181.65282.00
6306988-30698881.31881.66
30min1323542-32354285.70385.051.5586.1885.531.56
2317026-31702683.97784.43
3313485-31348583.03983.50
4321438-32143885.14585.63
5324160-32416085.86686.35
6326888-32688886.58987.07
45min1341193-34119390.37889.611.6891.0090.231.68
2332037-33203787.95388.55
3332982-33298288.20388.80
4339808-33980890.01190.64
5336569-33656989.15389.78
6347192-34719291.96792.59
60min1353817-35381793.72291.792.0294.5092.552.01
2339274-33927489.87090.61
3345141-34514191.42492.17
4340954-34095490.31591.09
5343597-34359791.01591.80
6356294-35629494.37895.15
极限1380505-380505100.79296.013.20101.7296.933.19
2347879-34787992.14993.04
3352566-35256693.39194.29
4368210-36821097.53598.46
5361567-36156795.77596.71
6364065-36406596.43797.37
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%
114.493757303757063758993759243757013757920.03
214.403760533761463761000.02
单位质量响应值RSD%判断
25934.5826118.060.50数据可信
供试品溶液-2026032321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%
5min1210888-21088855.95456.857.7655.9556.857.76
2230939-23093961.27561.27
3230144-23014461.06461.06
4206716-20671654.84754.85
5186910-18691049.59249.59
6219964-21996458.36358.36
10min1278214-27821473.81873.104.5373.9173.204.53
2290031-29003176.95377.06
3285728-28572875.81275.91
4259757-25975768.92169.01
5261378-26137869.35169.43
6278006-27800673.76373.86
15min1305554-30555481.07278.944.3681.2979.164.36
2310240-31024082.31582.55
3306519-30651981.32881.56
4279035-27903574.03674.24
5283904-28390475.32875.53
6299837-29983779.55579.78
20min1319300-31930084.71982.254.0885.0782.604.08
2320805-32080585.11885.49
3317604-31760484.26984.63
4290968-29096877.20277.53
5297346-29734678.89479.22
6313852-31385283.27483.63
30min1333434-33343488.46986.463.6588.9686.953.65
2333164-33316488.39888.91
3333084-33308488.37688.88
4305460-30546081.04781.51
5317094-31709484.13484.59
6332965-33296588.34588.84
45min1343542-34354291.15190.633.3791.7991.263.38
2348109-34810992.36393.02
3348384-34838492.43693.09
4322253-32225385.50386.10
5333952-33395288.60789.20
6353307-35330793.74294.38
60min1348041-34804192.34593.213.6893.1493.993.68
2357804-35780494.93595.75
3366119-36611997.14297.95
4333439-33343988.47189.21
5340243-34024390.27691.02
6362158-36215896.09196.89
极限1352429-35242993.50995.832.8994.4696.772.89
2370546-37054698.31699.29
3371521-37152198.57599.54
4347518-34751892.20693.09
5356232-35623294.51895.41
6368901-36890197.88098.83
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%
114.493767873768113768403767713765933767600.03
214.403780753781763781260.02
单位质量响应值RSD%判断
26001.3826258.750.70数据可信
供试品溶液-2026032421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%
5min1183602-18360248.52255.807.6148.5255.807.61
2222336-22233658.75858.76
3206164-20616454.48454.48
4230295-23029560.86260.86
5214534-21453456.69656.70
6209893-20989355.47055.47
10min1253280-25328066.93673.545.7267.0273.635.72
2294712-29471277.88677.98
3276254-27625473.00873.10
4296319-29631978.31078.41
5272081-27208171.90572.00
6276912-27691273.18273.27
15min1279070-27907073.75279.624.9373.9479.844.93
2317727-31772783.96884.20
3298090-29809078.77878.99
4315736-31573683.44283.67
5291438-29143877.02077.23
6305664-30566480.78080.99
20min1299060-29906079.03583.663.8479.3584.013.84
2328737-32873786.87887.25
3319941-31994184.55384.90
4322500-32250085.22985.60
5303948-30394880.32780.67
6325265-32526585.96086.31
30min1325044-32504485.90287.802.7686.3588.282.76
2341274-34127490.19190.70
3333601-33360188.16388.65
4337782-33778289.26889.78
5317469-31746983.90084.38
6338095-33809589.35189.84
45min1342575-34257590.53591.521.9291.1392.151.92
2350719-35071992.68793.35
3347383-34738391.80592.44
4350173-35017392.54393.20
5334687-33468788.45089.07
6352232-35223293.08793.73
60min1349008-34900892.23592.621.3192.9893.411.32
2353540-35354093.43394.25
3352896-35289693.26294.05
4355101-35510193.84594.66
5342368-34236890.48091.24
6349982-34998292.49293.29
极限1351688-35168892.94393.690.9993.8494.631.01
2354637-35463793.72394.70
3357094-35709494.37295.31
4356891-35689194.31895.29
5348979-34897992.22793.14
6357772-35777294.55195.50
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%
114.493755403755013761083754123755933756310.08
214.403786573787423787000.02
单位质量响应值RSD%判断
25923.4626298.611.02数据可信
供试品溶液-2026032421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%
5min1220787-22078758.39357.672.5158.3957.672.51
2218734-21873457.85057.85
3222572-22257258.86558.87
4221870-22187058.68058.68
5216549-21654957.27257.27
6207851-20785154.97254.97
10min1288487-28848776.29874.312.6076.4074.402.59
2278937-27893773.77273.87
3274963-27496372.72172.82
4270628-27062871.57571.67
5287588-28758876.06076.16
6285140-28514075.41375.50
15min1311246-31124682.31779.652.7082.5479.872.70
2300274-30027479.41679.63
3294717-29471777.94678.17
4290436-29043676.81477.03
5309560-30956081.87282.09
6300741-30074179.53979.76
20min1320883-32088384.86682.702.6085.2383.062.60
2312883-31288382.75083.10
3303439-30343980.25380.60
4303670-30367080.31480.66
5322503-32250385.29585.65
6312841-31284182.73983.09
30min1333760-33376088.27286.952.6788.7887.442.67
2335902-33590288.83889.33
3316623-31662383.74084.22
4319340-31934084.45884.94
5337223-33722389.18889.69
6329807-32980787.22687.71
45min1343049-34304990.72989.712.3491.3890.342.34
2343387-34338790.81891.46
3328087-32808786.77287.39
4332108-33210887.83588.45
5349588-34958892.45893.11
6338854-33885489.61990.25
60min1350438-35043892.68391.232.4593.4892.022.45
2350273-35027392.63993.43
3332823-33282388.02488.79
4338189-33818989.44390.21
5355044-35504493.90194.70
6343003-34300390.71691.50
极限1347586-34758691.92992.471.5992.8893.401.59
2356091-35609194.17895.12
3347339-34733991.86392.78
4343307-34330790.79791.71
5356914-35691494.39695.36
6346536-34653691.65192.58
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