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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 1368086136853913688681369745136951613689510.06
29.821374469137491913746940.03
单位质量响应值RSD%判断
139688.88139989.210.16数据可信
供试品溶液-2024052411批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1904115-90411557.60159.246.2557.6059.246.25
2912123-91212358.11158.11
31036050-103605066.00666.01
4882156-88215656.20256.20
5955398-95539860.86860.87
6888874-88887456.63056.63
10min11223456-122345677.94681.174.0978.0481.274.09
21306829-130682983.25883.35
31363844-136384486.89087.00
41242728-124272879.17479.27
51248414-124841479.53679.64
61259162-125916280.22180.32
15min11335278-133527885.07088.002.8885.3088.232.87
21420769-142076990.51790.75
31435079-143507991.42991.68
41383205-138320588.12488.35
51351307-135130786.09186.33
61361470-136147086.73986.97
20min11392495-139249588.71690.952.0489.0891.332.04
21452868-145286892.56292.95
31464345-146434593.29393.70
41439243-143924391.69492.07
51401586-140158689.29589.67
61414466-141446690.11590.49
30min11448671-144867192.29493.451.2092.8193.981.21
21484421-148442194.57295.11
31488907-148890794.85895.42
41471403-147140393.74394.27
51459027-145902792.95493.48
61448556-144855692.28792.81
45min11479883-147988394.28394.831.0494.9595.511.05
21503756-150375695.80496.50
31506648-150664895.98896.71
41492900-149290095.11295.79
51480566-148056694.32695.01
61466622-146662293.43894.11
60min11493366-149336695.14295.371.0395.9796.221.03
21512076-151207696.33497.19
31510341-151034196.22397.10
41505908-150590895.94196.78
51487592-148759294.77495.61
61472689-147268993.82594.66
极限11551846-155184698.86897.341.6499.8598.341.63
21534119-153411997.73898.76
31552146-155214698.88799.93
41526938-152693897.28198.28
51516012-151601296.58597.58
61485854-148585494.66395.65
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 1372575137354613741611374597137368913737140.06
29.821380730138043613805830.02
单位质量响应值RSD%判断
140174.90140588.900.21数据可信
供试品溶液-2024052411批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1982714-98271462.36657.148.5462.3757.148.54
2893356-89335656.69556.70
3973771-97377161.79961.80
4778372-77837249.39849.40
5919008-91900858.32358.32
6854755-85475554.24654.25
10min11295591-129559182.22378.823.5682.3378.923.57
21212045-121204576.92177.02
31266859-126685980.39980.50
41171642-117164274.35674.44
51262455-126245580.12080.22
61243079-124307978.89078.98
15min11404646-140464689.14486.142.1489.3886.372.14
21323236-132323683.97784.20
31361570-136157086.41086.65
41334007-133400784.66184.87
51370277-137027786.96387.19
61350160-135016085.68685.91
20min11433970-143397091.00589.221.1391.3989.591.13
21391234-139123488.29388.66
31399405-139940588.81189.19
41397654-139765488.70089.05
51414721-141472189.78390.16
61398342-139834288.74489.11
30min11459533-145953392.62791.951.0393.1792.471.02
21442505-144250591.54692.06
31423350-142335090.33190.86
41463803-146380392.89893.39
51447228-144722891.84692.37
61456999-145699992.46692.98
45min11475911-147591193.66693.451.1994.3694.121.17
21473406-147340693.50794.17
31441585-144158591.48892.17
41492145-149214594.69795.35
51467466-146746693.13093.81
61484277-148427794.19794.86
60min11483867-148386794.17194.041.2995.0294.861.27
21485309-148530994.26395.08
31448939-144893991.95592.79
41506488-150648895.60796.41
51475434-147543493.63694.47
61490617-149061794.60095.42
极限11504292-150429295.46895.881.5996.4896.871.57
21510801-151080195.88196.86
31476174-147617493.68394.67
41550792-155079298.41999.39
51514941-151494196.14397.13
61507731-150773195.68696.67
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 1375079137570113761141375271137510213754530.04
29.821384069138463113843500.03
单位质量响应值RSD%判断
140352.35140972.510.32数据可信
供试品溶液-2024052511批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11018092-101809264.48359.9110.5864.4859.9110.58
2897650-89765056.85556.85
3953193-95319360.37260.37
4782844-78284449.58349.58
5952083-95208360.30260.30
61071497-107149767.86567.87
10min11304142-130414282.60181.275.3682.7181.375.37
21253575-125357579.39879.49
31294673-129467382.00182.10
41164736-116473673.77173.85
51313969-131396983.22383.32
61367935-136793586.64186.75
15min11417027-141702789.75088.442.4990.0088.682.50
21377805-137780587.26687.49
31409169-140916989.25389.49
41333708-133370884.47384.68
51416366-141636689.70889.95
61423942-142394290.18890.45
20min11462924-146292492.65791.471.5193.0591.861.52
21444797-144479791.50991.88
31454264-145426492.10992.49
41401693-140169388.77989.13
51449969-144996991.83792.23
61451799-145179991.95392.36
30min11489337-148933794.33093.660.8394.8894.190.85
21487556-148755694.21794.74
31482307-148230793.88594.42
41455432-145543292.18392.68
51480824-148082493.79194.33
61477075-147707593.55494.11
45min11502084-150208495.13894.670.6095.8495.360.62
21502367-150236795.15595.84
31497537-149753794.85095.55
41478070-147807093.61794.26
51494375-149437594.64995.35
61493613-149361394.60195.32
60min11509502-150950295.60795.110.5496.4795.960.55
21510279-151027995.65796.50
31502150-150215095.14296.00
41488376-148837694.26995.07
51501028-150102895.07195.93
61498247-149824794.89595.77
极限11519616-151961696.24896.020.5097.2797.030.49
21529883-152988396.89897.90
31511656-151165695.74496.76
41511293-151129395.72196.68
51512304-151230495.78596.80
61511755-151175595.75096.78
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 1370118137021613703691370516137051913703480.02
29.821372717137289613728060.01
单位质量响应值RSD%判断
139831.43139796.950.02数据可信
供试品溶液-2024052511批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1920262-92026258.64059.154.5758.6459.144.57
2883366-88336656.28956.29
3949647-94964760.51260.51
41002502-100250263.88063.88
5905360-90536057.69057.69
6908097-90809757.86557.86
10min11218570-121857077.64981.493.1677.7581.603.15
21323962-132396284.36484.46
31286467-128646781.97582.08
41260500-126050080.32080.43
51262562-126256280.45280.55
61321405-132140584.20184.30
15min11382706-138270688.10788.602.8888.3388.842.87
21462700-146270093.20593.44
31385648-138564888.29588.53
41339541-133954185.35785.60
51380192-138019287.94788.18
61391942-139194288.69688.93
20min11451054-145105492.46391.752.7192.8492.132.70
21503140-150314095.78296.17
31436927-143692791.56291.95
41382519-138251988.09588.48
51438891-143889191.68892.06
61426813-142681390.91891.30
30min11493655-149365595.17794.312.2495.7194.852.24
21529324-152932497.45098.00
31476565-147656594.08894.63
41428924-142892491.05291.58
51486609-148660994.72895.26
61465517-146551793.38493.92
45min11524817-152481797.16395.892.0097.8596.581.99
21544690-154469098.42999.14
31498407-149840795.48096.17
41455986-145598692.77793.46
51509006-150900696.15596.84
61496215-149621595.34096.03
60min11528572-152857297.40296.381.8398.2597.241.83
21553013-155301398.96099.84
31505545-150554595.93596.79
41470909-147090993.72894.56
51515542-151554296.57297.42
61502021-150202195.71096.56
极限11531060-153106097.56197.291.1198.5798.301.11
21556330-155633099.171100.21
31527361-152736197.32598.34
41506419-150641995.99196.98
51523148-152314897.05798.07
61516755-151675596.64997.66
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