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%
19.801372745137404813742021374098137358413737350.05
29.771374712137495313748320.02
单位质量响应值RSD%判断
140177.04140719.750.28数据可信
供试品溶液-2024052511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%
5min11301798-130179883.42081.273.7483.4281.273.74
21266155-126615581.13681.14
31197845-119784576.75976.76
41297291-129729183.13183.13
51226956-122695678.62478.62
61319151-131915184.53284.53
10min11477601-147760194.68691.862.3094.8291.992.30
21419396-141939690.95691.09
31402689-140268989.88590.01
41438277-143827792.16692.30
51397637-139763789.56289.69
61465432-146543293.90694.05
15min11507764-150776496.61993.762.1496.9294.042.15
21445062-144506292.60192.89
31437610-143761092.12392.40
41463933-146393393.81094.10
51431033-143103391.70291.98
61493080-149308095.67895.98
20min11514799-151479997.06994.342.0897.5394.782.08
21454158-145415893.18393.62
31448388-144838892.81493.25
41473178-147317894.40294.85
51439889-143988992.26992.70
61502520-150252096.28396.74
30min11521704-152170497.51294.792.0998.1395.392.09
21460593-146059393.59694.19
31454979-145497993.23693.82
41479657-147965794.81795.42
51447292-144729292.74493.33
61510844-151084496.81697.43
45min11528496-152849697.94795.052.0798.7395.822.07
21464164-146416493.82594.58
31460725-146072593.60494.35
41481166-148116694.91495.68
51453110-145311093.11693.86
61512269-151226996.90797.69
60min11530885-153088598.10095.112.1999.0596.032.19
21464163-146416393.82594.73
31461141-146114193.63194.53
41482474-148247494.99895.92
51450342-145034292.93993.84
61516065-151606597.15198.09
极限11527241-152724197.86794.972.0898.9896.052.08
21462647-146264793.72794.79
31461008-146100893.62294.68
41479093-147909394.78195.86
51450757-145075792.96694.02
61511761-151176196.87597.98
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%
19.801368980136987113704341370745137133513702730.07
29.771372539137242013724800.01
单位质量响应值RSD%判断
139823.78140479.020.34数据可信
供试品溶液-304468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%
5min11160235-116023574.50673.901.7974.5173.901.79
21180658-118065875.81875.82
31144444-114444473.49273.49
41146847-114684773.64773.65
51153876-115387674.09874.10
61118247-111824771.81071.81
10min11429107-142910791.77291.321.0791.9091.441.07
21443915-144391592.72392.85
31414378-141437890.82790.95
41399876-139987689.89590.02
51427770-142777091.68791.81
61416991-141699190.99491.11
15min11476812-147681294.83695.260.9595.1195.530.94
21507279-150727996.79297.07
31478174-147817494.92395.20
41465621-146562194.11794.39
51485700-148570095.40795.68
61486779-148677995.47695.75
20min11484911-148491195.35696.160.9695.7996.600.95
21522836-152283697.79198.23
31495795-149579596.05596.49
41483252-148325295.24995.68
51497862-149786296.18896.62
61500304-150030496.34496.77
30min11487725-148772595.53796.350.9796.1396.940.97
21525842-152584297.98498.59
31500880-150088096.38196.97
41485078-148507895.36795.95
51499325-149932596.28296.88
61503255-150325596.53497.12
45min11490133-149013395.69196.701.0396.4497.451.03
21529034-152903498.18998.96
31514746-151474697.27298.02
41488427-148842795.58296.33
51509199-150919996.91697.67
61503052-150305296.52197.27
60min11485059-148505995.36596.210.9796.2897.120.97
21524432-152443297.89498.83
31497583-149758396.17097.08
41484745-148474595.34596.25
51498385-149838596.22197.14
61498845-149884596.25197.16
极限11480646-148064695.08295.961.0296.1597.041.01
21522303-152230397.75798.85
31495299-149529996.02397.10
41482017-148201795.17096.24
51490275-149027595.70096.78
61495766-149576696.05397.13
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%
19.801370666136792013684281368109136737213684990.10
29.771376779137694813768640.01
单位质量响应值RSD%判断
139642.76140927.740.65数据可信
供试品溶液-2024052511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%
5min11231828-123182879.03078.931.3979.0378.931.39
21202351-120235177.13877.14
31249932-124993280.19180.19
41245785-124578579.92579.93
51224833-122483378.58178.58
61227052-122705278.72378.72
10min11421055-142105591.17091.311.2491.3091.441.23
21397313-139731389.64689.78
31437979-143797992.25592.39
41428727-142872791.66291.80
51444273-144427392.65992.79
61410326-141032690.48190.61
15min11449711-144971193.00893.471.3593.2993.751.35
21428456-142845691.64591.92
31468184-146818494.19394.48
41466620-146662094.09394.38
51483181-148318195.15595.44
61445233-144523392.72193.00
20min11458127-145812793.54894.331.1693.9994.771.16
21456515-145651593.44593.88
31474799-147479994.61895.06
41488558-148855895.50095.94
51491445-149144595.68696.13
61452670-145267093.19893.63
30min11461508-146150893.76594.061.3894.3694.661.38
21435497-143549792.09692.68
31475897-147589794.68895.29
41474783-147478394.61795.22
51494061-149406195.85396.46
61455187-145518793.35993.95
45min11458536-145853693.57494.161.2594.3394.911.24
21442990-144299092.57793.32
31477474-147747494.78995.55
41474569-147456994.60395.36
51494563-149456395.88696.65
61457710-145771093.52194.27
60min11458907-145890793.59894.061.3994.5094.971.39
21434292-143429292.01992.91
31479414-147941494.91495.83
41473490-147349094.53495.45
51492557-149255795.75796.68
61458135-145813593.54994.45
极限11500414-150041496.26195.541.1897.3296.611.18
21458610-145861093.57994.63
31498906-149890696.16497.24
41501051-150105196.30297.38
51499092-149909296.17697.26
61477152-147715294.76995.83
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%
19.801365727136593313668741366718136650713663520.04
29.771371155137106613711100.01
单位质量响应值RSD%判断
139423.67140338.790.47数据可信
供试品溶液-304468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%
5min11116249-111624971.82170.751.7571.8270.761.75
21130346-113034672.72872.73
31085907-108590769.86869.87
41094287-109428770.40870.41
51086993-108699369.93869.94
61084220-108422069.76069.76
10min11364851-136485187.81687.551.4087.9487.671.40
21380727-138072788.83788.96
31381488-138148888.88689.00
41359381-135938187.46487.58
51338270-133827086.10686.22
61339752-133975286.20186.32
15min11436644-143664492.43591.391.6392.7091.651.63
21435774-143577492.37992.65
31445677-144567793.01693.28
41418319-141831991.25691.52
51394827-139482789.74590.00
61391161-139116189.50989.77
20min11434124-143412492.27392.171.4792.6992.581.47
21449437-144943793.25893.68
31462173-146217394.07894.50
41429153-142915391.95392.37
51407157-140715790.53890.95
61412799-141279990.90191.31
30min11438601-143860192.56192.501.4893.1393.061.48
21454724-145472493.59894.18
31465603-146560394.29894.87
41439910-143991092.64593.21
51412263-141226390.86691.43
61414469-141446991.00891.57
45min11444253-144425392.92592.681.3493.6593.401.34
21459170-145917093.88494.62
31465625-146562594.30095.03
41432939-143293992.19792.92
51419698-141969891.34592.06
61421129-142112991.43792.15
60min11443893-144389392.90192.681.3793.7893.561.37
21462076-146207694.07194.96
31462782-146278294.11795.01
41431848-143184892.12793.00
51413399-141339990.93991.80
61428546-142854691.91492.78
极限11522814-152281497.97996.440.8599.0297.480.85
21499520-149952096.48197.53
31496343-149634396.27697.32
41488248-148824895.75596.79
51488534-148853495.77496.79
61498191-149819196.39597.41
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