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(%)0.41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%
114.273661273657533656553655303652313656590.09
214.323638443648393643420.20
单位质量响应值RSD%判断
25624.3225442.880.51数据可信
供试品溶液-2026032421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%
5min1266909-26690971.88969.152.3371.8969.152.33
2255958-25595868.93968.94
3258898-25889869.73169.73
4249282-24928267.14167.14
5256357-25635769.04769.05
6252978-25297868.13768.14
10min1328455-32845588.46684.852.2688.5984.972.26
2316743-31674385.31185.43
3311074-31107483.78483.90
4308844-30884483.18483.30
5311459-31145983.88884.00
6313604-31360484.46684.58
15min1343909-34390992.62889.361.9892.9089.621.99
2333698-33369889.87890.13
3328900-32890088.58688.84
4325750-32575087.73787.99
5327350-32735088.16888.42
6331087-33108789.17589.43
20min1348591-34859193.88991.151.7394.3191.561.73
2341039-34103991.85592.26
3336525-33652590.63991.04
4332110-33211089.45089.85
5334307-33430790.04290.44
6338053-33805391.05191.45
30min1353014-35301495.08093.211.2595.6693.771.25
2349192-34919294.05194.61
3343440-34344092.50293.06
4341291-34129191.92392.47
5344055-34405592.66793.22
6345417-34541793.03493.59
45min1352620-35262094.97494.470.8495.7195.180.85
2354849-35484995.57596.29
3347117-34711793.49294.20
4348130-34813093.76594.46
5352063-35206394.82495.53
6349621-34962194.16794.88
60min1352940-35294095.06094.930.5795.9695.800.57
2356201-35620195.93996.81
3350654-35065494.44595.31
4351116-35111694.56995.42
5351866-35186694.77195.64
6351900-35190094.78095.65
极限1352335-35233594.89895.300.5995.9596.330.58
2357873-35787396.38997.43
3353822-35382295.29896.32
4353219-35321995.13696.15
5352480-35248094.93795.96
6353195-35319595.12996.15
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(%)0.41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%
114.273653543654573655293656323654383654820.03
214.323656473659203657840.06
单位质量响应值RSD%判断
25611.9125543.580.19数据可信
供试品溶液-2026032421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%
5min1252774-25277467.96468.741.5267.9668.741.51
2257646-25764669.27469.27
3250214-25021467.27567.28
4256799-25679969.04669.05
5261248-26124870.24270.24
6255178-25517868.61068.61
10min1311518-31151883.75885.141.7183.8785.261.71
2324228-32422887.17687.29
3312514-31251484.02684.14
4314379-31437984.52784.64
5322654-32265486.75286.87
6314752-31475284.62884.74
15min1330271-33027188.80089.911.5989.0590.161.60
2342125-34212591.98892.25
3329584-32958488.61688.87
4332421-33242189.37889.63
5339990-33999091.41491.68
6331963-33196389.25589.51
20min1336780-33678090.55091.741.4490.9592.151.44
2348711-34871193.75894.17
3337418-33741890.72291.12
4339460-33946091.27191.68
5345854-34585492.99093.40
6339089-33908991.17191.58
30min1343918-34391892.47093.860.9993.0294.420.99
2353020-35302094.91795.49
3346105-34610593.05893.61
4350016-35001694.10994.67
5349842-34984294.06294.63
6351581-35158194.53095.09
45min1346518-34651893.16994.700.9693.8795.420.96
2353291-35329194.99095.72
3352695-35269594.83095.54
4353773-35377395.11995.83
5350584-35058494.26294.99
6356448-35644895.83996.55
60min1347075-34707593.31895.591.8894.1896.461.87
2353121-35312194.94495.83
3356131-35613195.75396.62
4366577-36657798.56299.43
5351704-35170494.56395.45
6358525-35852596.39797.27
极限1358827-35882796.47895.771.0697.4996.801.04
2352764-35276494.84895.89
3358478-35847896.38497.41
4356523-35652395.85996.90
5350567-35056794.25795.30
6359988-35998896.79097.82
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-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(%)0.41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%
114.273640293642623644013642753646403643210.07
214.323668623671893670260.07
单位质量响应值RSD%判断
25530.5525630.310.28数据可信
供试品溶液-2026032421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%
5min1250542-25054267.35765.881.2867.3665.881.28
2243015-24301565.33365.33
3246420-24642066.24866.25
4241779-24177965.00165.00
5243825-24382565.55165.55
6244733-24473365.79565.79
10min1312327-31232783.96784.041.2284.0884.141.21
2306935-30693582.51782.63
3318749-31874985.69485.80
4311490-31149083.74283.85
5312969-31296984.14084.25
6313013-31301384.15184.26
15min1334147-33414789.83389.390.8190.0989.640.81
2328713-32871388.37288.62
3329612-32961288.61488.87
4334586-33458689.95190.20
5334987-33498790.05990.31
6332982-33298289.52089.77
20min1342288-34228892.02291.740.9992.4292.130.99
2336519-33651990.47190.86
3338533-33853391.01291.41
4343212-34321292.27092.67
5345935-34593593.00293.40
6340872-34087291.64192.04
30min1348182-34818293.60693.310.7994.1693.860.79
2342924-34292492.19392.74
3344768-34476892.68993.24
4349860-34986094.05894.61
5349432-34943293.94394.50
6347313-34731393.37393.92
45min1352627-35262794.80194.470.6895.5195.180.68
2353405-35340595.01195.71
3347464-34746493.41394.12
4353547-35354795.04995.76
5351514-35151494.50295.21
6349758-34975894.03094.74
60min1354251-35425195.23894.710.7096.1195.580.71
2348481-34848193.68794.54
3350014-35001494.09994.96
4354528-35452895.31396.18
5353143-35314394.94095.81
6353356-35335694.99795.86
极限1354940-35494095.42394.870.7596.4595.890.74
2349696-34969694.01395.03
3349622-34962293.99495.01
4355097-35509795.46696.49
5354994-35499495.43896.46
6352845-35284594.86095.88
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(%)0.41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%
114.273667113667503666403667173665713666780.02
214.323665533668873667200.07
单位质量响应值RSD%判断
25695.7325608.940.24数据可信
供试品溶液-2026032421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%
5min1247769-24776966.42466.411.6466.4266.401.64
2244224-24422465.47465.47
3253587-25358767.98467.98
4251508-25150867.42767.43
5245261-24526165.75265.75
6243838-24383865.37065.37
10min1308049-30804982.58582.881.5482.7083.001.54
2308890-30889082.81082.92
3307678-30767882.48582.60
4318366-31836685.35185.46
5307491-30749182.43582.54
6304527-30452781.64181.75
15min1333741-33374189.47388.491.6289.7288.741.62
2328679-32867988.11588.36
3325531-32553187.27187.52
4339085-33908590.90591.16
5327528-32752887.80788.05
6325852-32585287.35887.60
20min1336225-33622590.13890.591.4790.5490.981.47
2338403-33840390.72291.12
3333640-33364089.44589.84
4347503-34750393.16293.57
5336492-33649290.21090.60
6335107-33510789.83990.23
30min1344115-34411592.25492.481.2892.8093.031.28
2346757-34675792.96293.51
3338936-33893690.86591.41
4352279-35227994.44295.00
5343473-34347392.08292.63
6344178-34417892.27192.81
45min1349038-34903893.57393.731.1494.2794.431.14
2353163-35316394.67995.38
3344320-34432092.30993.01
4354991-35499195.16995.89
5346562-34656292.91093.61
6349646-34964693.73694.43
60min1352759-35275994.57194.480.8095.4395.340.79
2354882-35488295.14096.00
3347926-34792693.27594.13
4355477-35547795.30096.18
5350729-35072994.02794.88
6352844-35284494.59495.44
极限1357667-35766795.88795.370.7796.9096.380.77
2357214-35721495.76596.78
3352787-35278794.57995.58
4357905-35790595.95196.99
5351760-35176094.30395.31
6357061-35706195.72496.73
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