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%
114.493703223703293706893705243700933703910.07
214.573706493706183706340.01
单位质量响应值RSD%判断
25561.8425438.160.35数据可信
供试品溶液-25102001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%
5min1110274-11027429.74024.2840.0929.7424.2840.10
281640-8164022.01822.02
393634-9363425.25225.25
4145212-14521239.16339.16
570316-7031618.96418.96
639166-3916610.56310.56
10min1196619-19661953.02744.3820.3353.0844.4220.35
2165918-16591844.74744.78
3167699-16769945.22745.27
4204479-20447955.14655.21
5122626-12262633.07133.10
6129916-12991635.03735.05
15min1257252-25725269.37957.5515.4869.5257.6615.49
2208852-20885256.32656.44
3216031-21603158.26258.38
4234801-23480163.32463.48
5158959-15895942.87042.96
6204368-20436855.11655.19
20min1289348-28934878.03565.6313.3478.2965.8413.35
2233795-23379563.05363.26
3254315-25431568.58768.80
4250258-25025867.49367.76
5189583-18958351.12951.29
6242775-24277565.47465.64
30min1319820-31982086.25374.8510.2486.6475.1710.25
2257410-25741069.42169.73
3301888-30188881.41781.75
4268019-26801972.28372.66
5243656-24365665.71265.96
6274377-27437773.99774.27
45min1335026-33502690.35482.128.2190.8882.578.18
2271574-27157473.24173.67
3328488-32848888.59189.06
4282272-28227276.12776.62
5308903-30890383.30983.66
6300792-30079281.12181.52
60min1342417-34241792.34786.798.7893.0387.388.73
2279649-27964975.41975.97
3338233-33823391.21991.83
4291813-29181378.70079.32
5339375-33937591.52792.02
6339466-33946691.55192.09
极限1344676-34467692.95693.641.8593.7994.371.78
2353388-35338895.30695.98
3344403-34440392.88393.65
4337428-33742891.00291.76
5354536-35453695.61696.26
6348833-34883394.07794.77
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%
114.493709663712213712583710603708463710700.05
214.573698603695763697180.06
单位质量响应值RSD%判断
25608.7025375.290.65数据可信
供试品溶液-25102002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%
5min1177901-17790147.99428.8744.3647.9928.8644.35
234127-341279.2079.21
392083-9208324.84224.84
4131330-13133035.43035.43
5109607-10960729.57029.57
696932-9693226.15026.15
10min1286452-28645277.27948.2235.1677.3648.2735.17
2115377-11537731.12631.14
3129852-12985235.03235.07
4214021-21402157.73957.80
5166459-16645944.90744.96
6160231-16023143.22743.27
15min1326268-32626888.02161.3528.8188.2361.4828.83
2161450-16145043.55643.62
3153119-15311941.30941.41
4245455-24545566.21966.37
5263735-26373571.15171.27
6214393-21439357.83957.95
20min1342041-34204192.27673.9719.8692.6374.2019.88
2186476-18647650.30850.45
3255342-25534268.88669.05
4259834-25983470.09870.36
5317280-31728085.59685.84
6284103-28410376.64676.86
30min1352322-35232295.05084.6615.5595.5685.0115.57
2223254-22325460.23060.45
3322724-32272487.06587.35
4296443-29644379.97580.36
5342589-34258992.42492.81
6345464-34546493.20093.54
45min1357440-35744096.43089.8612.2697.1090.3612.30
2250945-25094567.70068.02
3339016-33901691.46091.89
4346584-34658493.50294.02
5348092-34809293.90994.45
6356486-35648696.17396.67
60min1360454-36045497.24491.2610.0798.0791.9010.13
2270100-27010072.86873.30
3341697-34169792.18392.76
4350660-35066094.60195.27
5348750-34875094.08694.78
6357926-35792696.56297.22
极限1361928-36192897.64194.802.1198.6395.592.21
2345445-34544593.19493.75
3342305-34230592.34793.08
4351442-35144294.81295.64
5349381-34938194.25695.11
6357835-35783596.53797.35
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%
114.493730873736333731293731213728413731620.08
214.573704553706243705400.04
单位质量响应值RSD%判断
25753.0725431.710.89数据可信
供试品溶液-25102003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%
5min1214277-21427757.58256.706.4057.5856.706.41
2191064-19106451.34451.34
3202966-20296654.54354.54
4207214-20721455.68455.68
5228343-22834361.36261.36
6222112-22211259.68859.69
10min1290605-29060578.09479.482.1078.1979.582.10
2295891-29589179.51479.60
3289973-28997377.92478.01
4291821-29182178.42078.51
5304846-30484681.92082.02
6301553-30155381.03681.14
15min1318188-31818885.50686.951.7385.7387.181.73
2326774-32677487.81388.03
3318549-31854985.60385.82
4319020-31902085.72985.95
5330500-33050088.81489.05
6328330-32833088.23188.47
20min1329739-32973988.61089.821.5888.9890.191.58
2338517-33851790.96991.33
3330157-33015788.72289.09
4328579-32857988.29888.66
5340265-34026591.43991.83
6338176-33817690.87791.26
30min1337894-33789490.80191.671.6091.3292.191.60
2347898-34789893.49094.01
3338312-33831290.91491.43
4333423-33342389.60090.11
5345283-34528392.78793.33
6343950-34395092.42992.96
45min1341480-34148091.76592.481.6792.4393.161.67
2351416-35141694.43595.11
3341412-34141291.74792.41
4335562-33556290.17590.84
5347832-34783293.47294.17
6347150-34715093.28993.98
60min1343385-34338592.27792.741.5893.1093.561.58
2351947-35194794.57895.41
3342387-34238792.00992.82
4336617-33661790.45891.27
5348665-34866593.69694.55
6347560-34756093.39994.24
极限11309-13090.35277.4748.801.3378.4548.20
2351526-35152694.46595.45
3343388-34338892.27893.25
4337135-33713590.59791.56
5348317-34831793.60294.61
6347941-34794193.50194.50
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%
114.493716383712083717853713463715303715010.07
214.573715833716963716400.03
单位质量响应值RSD%判断
25638.4425507.210.37数据可信
供试品溶液-B111406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%
5min1213989-21398957.54758.207.5457.5558.207.54
2207058-20705855.68355.68
3227046-22704661.05861.06
4189567-18956750.97950.98
5228003-22800361.31661.32
6232756-23275662.59462.59
10min1291894-29189478.49778.353.1778.5978.453.17
2282396-28239675.94376.04
3305388-30538882.12682.23
4282712-28271276.02876.11
5286987-28698777.17877.28
6298711-29871180.33180.43
15min1310738-31073883.56584.061.8383.7984.291.83
2307374-30737482.66082.88
3321424-32142486.43986.68
4312015-31201583.90884.12
5306875-30687582.52682.76
6317086-31708685.27285.51
20min1318133-31813385.55486.181.8885.9286.541.87
2314650-31465084.61784.97
3328093-32809388.23288.61
4324639-32463987.30387.65
5313221-31322184.23384.60
6324016-32401687.13687.52
30min1322494-32249486.72687.542.1687.2488.052.15
2319076-31907685.80786.31
3331855-33185589.24489.77
4332815-33281589.50290.00
5316642-31664285.15385.66
6330237-33023788.80989.33
45min1326020-32602087.67588.412.1788.3389.062.17
2323075-32307586.88387.52
3337165-33716590.67291.35
4333937-33393789.80490.45
5318988-31898885.78486.43
6333316-33331689.63790.31
60min1330652-33065288.92089.512.6089.7290.322.59
2324816-32481687.35188.14
3340363-34036391.53292.36
4342646-34264692.14692.94
5321378-32137886.42687.22
6337258-33725890.69791.52
极限1357369-35736996.10596.861.3397.0597.811.32
2358549-35854996.42297.35
3359855-35985596.77497.76
4368746-36874699.165100.11
5354946-35494695.45496.39
6361602-36160297.24498.22
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