恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.805423865424105425805424715423735424440.02
29.775471845440535456180.41
单位质量响应值RSD%判断
55351.4355846.260.63数据可信
供试品溶液-2024053011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%
5min1515723-51572383.48486.321.9783.4886.311.97
2541129-54112987.59687.60
3544453-54445388.13488.13
4537132-53713286.94986.95
5533819-53381986.41386.41
6527033-52703385.31585.31
10min1576004-57600493.24295.121.2893.3895.261.28
2586624-58662494.96195.11
3597387-59738796.70396.85
4589574-58957495.43995.58
5592624-59262495.93296.08
6583326-58332694.42794.57
15min1584748-58474894.65796.471.2294.9596.771.22
2594282-59428296.20196.50
3605695-60569598.04898.36
4597382-59738296.70297.01
5600951-60095197.28097.58
6592536-59253695.91896.22
20min1587355-58735595.07996.901.2295.5397.361.22
2597651-59765196.74697.21
3608506-60850698.50398.97
4599586-59958697.05997.52
5603690-60369097.72498.19
6594903-59490396.30196.76
30min1589210-58921095.38097.231.2595.9997.861.26
2599849-59984997.10297.73
3610833-61083398.88099.52
4600768-60076897.25197.88
5606297-60629798.14698.77
6596887-59688796.62297.24
45min1592004-59200495.83297.891.6696.6098.681.65
2602350-60235097.50798.29
3612155-61215599.09499.89
4602767-60276797.57498.36
5620221-620221100.400101.19
6598982-59898296.96197.74
60min1589523-58952395.43097.521.3096.3698.471.30
2603087-60308797.62698.58
3612328-61232899.122100.09
4602926-60292697.60098.55
5607663-60766398.36799.33
6598998-59899896.96497.91
极限1590066-59006695.51897.431.2596.6198.541.25
2602673-60267397.55998.67
3611426-61142698.976100.11
4601622-60162297.38998.50
5607601-60760198.35799.48
6597849-59784996.77897.88
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.805431685434585435815437235438185435500.05
29.775457485457825457650.01
单位质量响应值RSD%判断
55464.2955861.310.51数据可信
供试品溶液-301670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%
5min1505021-50502181.65780.132.5381.6680.132.53
2505517-50551781.73781.74
3487086-48708678.75778.76
4494680-49468079.98579.98
5475141-47514176.82676.83
6505929-50592981.80481.80
10min1598379-59837996.75295.841.5596.8995.971.55
2602152-60215297.36297.50
3598996-59899696.85296.98
4584308-58430894.47794.61
5579074-57907493.63093.76
6593398-59339895.94696.08
15min1612541-61254199.04298.431.4099.3498.721.40
2618857-618857100.063100.36
3612921-61292199.10399.40
4596823-59682396.50096.79
5599907-59990796.99997.28
6611420-61142098.86099.16
20min1613312-61331299.16698.691.5499.6399.151.54
2620829-620829100.382100.85
3613841-61384199.25299.71
4596603-59660396.46596.92
5601270-60127097.21997.67
6616471-61647199.677100.14
30min1631959-631959102.18199.092.11102.8199.712.10
2619597-619597100.183100.82
3613255-61325599.15799.78
4595543-59554396.29396.91
5601965-60196597.33297.94
6614538-61453899.36599.99
45min1612276-61227698.99998.601.5299.8099.391.52
2620474-620474100.324101.12
3613779-61377999.242100.03
4595787-59578796.33397.11
5601586-60158697.27098.04
6615050-61505099.447100.24
60min1610306-61030698.68098.371.6299.6499.321.62
2619331-619331100.140101.11
3612085-61208598.96899.92
4594542-59454296.13197.06
5598444-59844496.76297.69
6615755-61575599.561100.52
极限1609256-60925698.51198.421.9899.6499.531.97
2627691-627691101.491102.62
3610733-61073398.74999.87
4593002-59300295.88296.98
5598891-59889196.83597.93
6612425-61242599.023100.15
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.805427735428395427055423425428175426950.04
29.775423195420705421940.04
单位质量响应值RSD%判断
55377.0455495.800.16数据可信
供试品溶液-2024053011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%
5min1521802-52180284.71485.361.8084.7185.361.80
2516187-51618783.80283.80
3534017-53401786.69786.70
4522283-52228384.79284.79
5519919-51991984.40884.41
6540638-54063887.77287.77
10min1571797-57179792.83093.752.1592.9793.892.15
2562479-56247991.31891.46
3588216-58821695.49695.64
4570903-57090392.68592.83
5575148-57514893.37493.51
6596157-59615796.78596.93
15min1578459-57845993.91294.902.1694.2195.202.16
2568626-56862692.31592.61
3595449-59544996.67096.97
4577963-57796393.83194.13
5583735-58373594.76895.06
6603039-60303997.90298.21
20min1580231-58023194.20095.032.1694.6595.492.16
2569556-56955692.46692.91
3596933-59693396.91197.38
4578524-57852493.92294.37
5583258-58325894.69195.15
6603657-60365798.00398.47
30min1580678-58067894.27295.172.2294.8895.792.22
2570676-57067692.64893.25
3597868-59786897.06397.69
4578911-57891193.98594.59
5583677-58367794.75995.37
6605624-60562498.32298.96
45min1581704-58170494.43995.342.1195.2196.122.11
2571838-57183892.83793.59
3598825-59882597.21898.01
4581481-58148194.40295.17
5584665-58466594.91995.69
6605182-60518298.25099.05
60min1581767-58176794.44995.422.1595.3796.352.15
2573194-57319493.05793.97
3598579-59857997.17898.13
4580606-58060694.26095.18
5585359-58535995.03295.96
6606987-60698798.54399.51
极限1594320-59432096.48797.571.3797.5798.661.38
2594675-59467596.54497.61
3607616-60761698.64599.76
4602995-60299597.89598.98
5593326-59332696.32597.41
6613065-61306599.530100.66
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.805472195472725466055471335470325470520.05
29.775428895428305428600.01
单位质量响应值RSD%判断
55821.6355563.970.33数据可信
供试品溶液-301670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%
5min1482943-48294378.04478.421.5878.0478.421.58
2497417-49741780.38380.38
3475373-47537376.82176.82
4485457-48545778.45178.45
5489693-48969379.13579.14
6480628-48062877.67077.67
10min1578027-57802793.41092.041.6193.5492.171.61
2577248-57724893.28493.42
3556638-55663889.95490.08
4572964-57296492.59292.72
5572738-57273892.55592.69
6559625-55962590.43690.57
15min1583756-58375694.33693.581.4894.6293.871.48
2587057-58705794.86995.16
3567178-56717891.65791.93
4584953-58495394.52994.81
5582270-58227094.09694.38
6569404-56940492.01792.30
20min1586552-58655294.78893.881.5595.2394.321.55
2588877-58887795.16395.61
3568046-56804691.79792.23
4586650-58665094.80495.25
5584620-58462094.47694.92
6571016-57101692.27792.71
30min1586978-58697894.85793.971.5295.4694.571.52
2590204-59020495.37895.98
3569176-56917691.98092.56
4587799-58779994.98995.59
5582933-58293394.20394.80
6572028-57202892.44193.03
45min1588230-58823095.05994.191.5295.8294.941.51
2591122-59112295.52696.29
3570160-57016092.13992.88
4588944-58894495.17495.93
5585013-58501394.53995.30
6573490-57349092.67793.42
60min1589130-58913095.20494.221.5796.1295.131.57
2591962-59196295.66296.59
3570674-57067492.22293.11
4589544-58954495.27196.19
5583999-58399994.37595.29
6572833-57283392.57193.47
极限1613801-61380199.19197.721.62100.2798.781.62
2614793-61479399.352100.44
3594739-59473996.11197.16
4612018-61201898.90399.98
5596587-59658796.40997.48
6596077-59607796.32797.38
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