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%
114.623805873802453803473812293800463804910.12
214.723806183800923803550.10
单位质量响应值RSD%判断
26025.3825839.330.51数据可信
供试品溶液-25112801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%
5min1265050-26505070.29166.547.1670.2966.547.16
2260990-26099069.21469.21
3215979-21597957.27757.28
4256234-25623467.95367.95
5258539-25853968.56468.56
6248723-24872365.96165.96
10min1341336-34133690.52187.802.9490.6487.912.94
2340609-34060990.32990.44
3315471-31547183.66283.76
4330830-33083087.73587.85
5332538-33253888.18888.30
6325573-32557386.34186.45
15min1367626-36762697.49395.351.9097.7695.601.90
2367610-36761097.48997.76
3353143-35314393.65393.89
4354847-35484794.10594.36
5360501-36050195.60495.87
6353439-35343993.73193.98
20min1372632-37263298.82197.721.5199.2598.141.51
2377249-377249100.045100.47
3366718-36671897.25397.64
4362478-36247896.12896.54
5367925-36792597.57397.99
6363957-36395796.52096.93
30min1377275-377275100.05298.851.47100.6599.441.47
2381152-381152101.081101.68
3370450-37045098.24298.80
4366418-36641897.17397.75
5371823-37182398.60699.19
6369405-36940597.96598.54
45min1380012-380012100.77899.411.41101.54100.151.42
2382694-382694101.489102.25
3373189-37318998.96999.69
4369372-36937297.95798.69
5372611-37261198.81599.56
6371147-37114798.42799.16
60min1383285-383285101.64699.711.51102.58100.621.51
2382703-382703101.492102.42
3372840-37284098.87699.76
4370434-37043498.23899.14
5375073-37507399.468100.38
6371493-37149398.51999.42
极限1385050-385050102.11499.752.05103.21100.822.04
2384480-384480101.963103.07
3373304-37330498.999100.05
4377579-377579100.133101.20
5366054-36605497.07798.15
6370292-37029298.20099.26
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%
114.623791693797343794703792223791293793450.07
214.723795443794283794860.03
单位质量响应值RSD%判断
25946.9925780.300.46数据可信
供试品溶液-25112802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%
5min1264991-26499170.46165.376.3870.4665.376.38
2226852-22685260.32060.32
3252015-25201567.01167.01
4239780-23978063.75863.76
5260301-26030169.21469.21
6231148-23114861.46361.46
10min1336093-33609389.36887.392.4189.4887.492.42
2318458-31845884.67884.78
3332592-33259288.43788.55
4331041-33104188.02488.13
5334778-33477889.01889.13
6318886-31888684.79284.89
15min1360890-36089095.96194.702.2096.2394.952.21
2344821-34482191.68891.93
3362457-36245796.37896.64
4360755-36075595.92596.18
5360460-36046095.84796.11
6347403-34740392.37592.62
20min1370979-37097998.64497.252.4199.0797.662.41
2350794-35079493.27793.67
3372394-37239499.02099.44
4371674-37167498.82999.24
5369346-36934698.21098.63
6359172-35917295.50495.90
30min1374180-37418099.49598.412.16100.0998.982.17
2356865-35686594.89195.44
3376427-376427100.092100.68
4375724-37572499.905100.48
5373773-37377399.38799.97
6363634-36363496.69197.25
45min1375630-37563099.88199.081.94100.6499.821.95
2359844-35984495.68396.39
3378944-378944100.762101.51
4377767-377767100.449101.19
5375014-37501499.717100.47
6368536-36853697.99498.71
60min1375916-37591699.95799.451.95100.88100.361.96
2360806-36080695.93996.81
3379343-379343100.868101.79
4378233-378233100.573101.48
5379392-379392100.881101.80
6370473-37047398.50999.39
极限1378167-378167100.555100.630.68101.64101.700.69
2375258-37525899.782100.81
3383022-383022101.846102.93
4378993-378993100.775101.85
5377370-377370100.343101.43
6377983-377983100.506101.55
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%
114.623794753795153796983793223793803794780.04
214.723798693799303799000.02
单位质量响应值RSD%判断
25956.0925808.420.41数据可信
供试品溶液-25112801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%
5min1264216-26421670.20571.892.7770.2071.892.77
2284986-28498675.72375.72
3269069-26906971.49471.49
4269790-26979071.68671.69
5270066-27006671.75971.76
6265304-26530470.49470.49
10min1346325-34632592.02291.641.4292.1491.761.42
2352965-35296593.78693.91
3344554-34455491.55191.67
4345756-34575691.87191.99
5339201-33920190.12990.25
6340630-34063090.50990.63
15min1369248-36924898.11397.931.3598.3898.201.35
2376713-376713100.096100.38
3368703-36870397.96898.24
4365420-36542097.09697.37
5361823-36182396.14096.41
6369468-36946898.17198.44
20min1375816-37581699.85899.361.43100.2999.801.43
2383186-383186101.816102.27
3373110-37311099.13999.57
4370720-37072098.50498.94
5367474-36747497.64198.07
6373362-37336299.20699.64
30min1381888-381888101.471100.321.46102.07100.921.46
2385120-385120102.330102.95
3377991-377991100.436101.04
4374182-37418299.424100.02
5369623-36962398.21298.81
6376544-376544100.051100.65
45min1382617-382617101.665100.701.35102.43101.471.34
2385287-385287102.374103.16
3380199-380199101.022101.79
4376190-37619099.957100.72
5370805-37080598.52699.28
6378929-378929100.685101.45
60min1382536-382536101.643100.821.19102.58101.761.19
2384587-384587102.188103.15
3381014-381014101.239102.18
4376949-376949100.159101.09
5371907-37190798.81999.74
6379625-379625100.870101.80
极限1382099-382099101.527101.181.10102.64102.281.10
2384265-384265102.103103.23
3385685-385685102.480103.58
4378897-378897100.677101.77
5374076-37407699.396100.48
6379730-379730100.898102.00
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%
114.623815803815293813913812093811563813730.05
214.723806373799883803120.13
单位质量响应值RSD%判断
26085.7025836.410.68数据可信
供试品溶液-25112802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%
5min1260584-26058469.03170.061.9769.0370.061.97
2266397-26639770.57070.57
3263686-26368669.85269.85
4267733-26773370.92470.92
5271461-27146171.91271.91
6256947-25694768.06768.07
10min1345728-34572891.58690.831.2191.7090.951.21
2344122-34412291.16091.28
3342422-34242290.71090.83
4343792-34379291.07391.19
5346272-34627291.73091.85
6334896-33489688.71688.83
15min1368882-36888297.71997.381.1697.9997.641.16
2370014-37001498.01998.29
3366948-36694897.20797.47
4369500-36950097.88398.15
5370888-37088898.25198.52
6359334-35933495.19095.45
20min1375821-37582199.55898.961.0999.9999.391.09
2372493-37249398.67699.11
3374804-37480499.28899.72
4376480-37648099.732100.17
5375983-37598399.600100.04
6365841-36584196.91497.33
30min1379130-379130100.434100.111.11101.03100.711.11
2376094-37609499.630100.23
3379552-379552100.546101.14
4381262-381262100.999101.60
5381145-381145100.968101.57
6370274-37027498.08898.67
45min1382654-382654101.368100.761.13102.13101.531.13
2378267-378267100.206100.97
3384283-384283101.799102.56
4383295-383295101.537102.31
5380952-380952100.917101.69
6372809-37280998.76099.50
60min1381964-381964101.185100.760.80102.12101.690.81
2379536-379536100.542101.47
3382497-382497101.326102.26
4381800-381800101.141102.08
5381764-381764101.132102.07
6374492-37449299.206100.12
极限1381264-381264100.999101.240.35102.10102.340.35
2383383-383383101.561102.66
3383641-383641101.629102.73
4382186-382186101.244102.35
5382478-382478101.321102.43
6380155-380155100.706101.78
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