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)0
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%
110.081411381141046014083981407783140686414089770.14
210.111406156140639314062740.02
单位质量响应值RSD%判断
139779.46139097.330.35数据可信
长期12月-供试品溶液-2024052411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%
5min1841343-84134354.30456.628.0954.3056.628.10
21015375-101537565.53765.54
3876374-87637456.56656.57
4813335-81333552.49752.50
5859158-85915855.45455.45
6857410-85741055.34255.34
10min11131178-113117873.01276.834.3873.1076.924.38
21283981-128398182.87582.98
31188675-118867576.72376.82
41154549-115454974.52074.61
51190893-119089376.86676.96
61192688-119268876.98277.07
15min11206361-120636177.86582.234.1978.0882.464.19
21367055-136705588.23788.48
31274387-127438782.25582.48
41242845-124284580.21980.43
51279496-127949682.58582.81
61274190-127419082.24382.46
20min11239749-123974980.02084.664.2880.3685.024.28
21407857-140785790.87091.26
31317486-131748685.03785.40
41276803-127680382.41182.76
51314826-131482684.86585.22
61313294-131329484.76785.12
30min11255575-125557581.04187.535.1681.5288.035.16
21449812-144981293.57894.12
31413793-141379391.25391.75
41308810-130881084.47784.96
51353670-135367087.37387.87
61354910-135491087.45387.95
45min11276341-127634182.38189.164.8882.9989.814.88
21479222-147922295.47696.18
31402029-140202990.49491.15
41344184-134418486.76087.38
51395356-139535690.06390.71
61391053-139105389.78690.43
60min11292683-129268383.43690.324.7684.1891.124.76
21487729-148772996.02596.89
31426267-142626792.05892.86
41358198-135819887.66588.43
51411730-141173091.12091.92
61419509-141950991.62292.42
极限11494129-149412996.43996.660.7597.3397.610.77
21514532-151453297.75598.78
31480300-148030095.54696.50
41494629-149462996.47197.39
51501249-150124996.89897.85
61500361-150036196.84197.79
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)0
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%
110.081401587139937013993291400467140061714002740.07
210.111407422140785914076400.03
单位质量响应值RSD%判断
138916.07139232.440.17数据可信
长期12月-供试品溶液-2024052411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%
5min1796711-79671151.55858.1010.0451.5658.1010.04
21026864-102686466.45266.45
3990801-99080164.11864.12
4850460-85046055.03655.04
5868401-86840156.19756.20
6853374-85337455.22555.23
10min11164690-116469075.37179.976.0675.4680.076.07
21344930-134493087.03587.15
31278519-127851982.73882.84
41181920-118192076.48676.58
51167616-116761675.56175.65
61276809-127680982.62782.72
15min11263287-126328781.75285.515.6981.9685.745.69
21412636-141263691.41791.67
31362106-136210688.14788.39
41284989-128498983.15683.38
51222434-122243479.10879.33
61382702-138270289.48089.71
20min11302108-130210884.26487.755.2984.6188.125.29
21441458-144145893.28293.69
31392421-139242190.10990.50
41342021-134202186.84787.20
51249998-124999880.89281.24
61407996-140799691.11791.50
30min11355343-135534387.70990.265.0988.2090.785.09
21470744-147074495.17795.74
31423338-142333892.10992.65
41401671-140167190.70791.21
51274152-127415282.45582.94
61443672-144367293.42593.96
45min11482790-148279095.95792.254.8096.5992.924.79
21435502-143550292.89793.62
31441610-144161093.29293.99
41434889-143488992.85793.51
51291461-129146183.57584.20
61466713-146671394.91695.60
60min11457557-145755794.32493.024.8895.1293.844.87
21487951-148795196.29197.17
31443328-144332893.40394.25
41460013-146001394.48395.29
51298101-129810184.00584.77
61477662-147766295.62596.47
极限11500779-150077997.12196.640.6398.0797.620.59
21490116-149011696.43197.47
31478902-147890295.70596.71
41505044-150504497.39798.36
51495592-149559296.78597.69
61489534-148953496.39397.40
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)0
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%
110.081377525137908713789511379386137969613789290.07
210.111398304139894113986220.04
单位质量响应值RSD%判断
136798.51138340.450.80数据可信
长期12月-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%
5min1786080-78608051.42855.7810.1551.4355.7810.15
2870927-87092756.97956.98
3857316-85731656.08956.09
4793929-79392951.94251.94
5794239-79423951.96251.96
61013222-101322266.28966.29
10min11228844-122884480.39580.985.0180.4881.085.01
21234745-123474580.78180.88
31227473-122747380.30680.40
41213648-121364879.40179.49
51168145-116814576.42476.51
61354280-135428088.60288.71
15min11367953-136795389.49689.174.6389.7289.404.63
21348810-134881088.24488.47
31379001-137900190.21990.45
41367906-136790689.49389.71
51259030-125903082.37082.58
61455250-145525095.20895.47
20min11429615-142961593.53092.574.3493.9092.954.34
21411932-141193292.37492.75
31439546-143954694.18094.56
41424281-142428193.18293.55
51300318-130031885.07185.42
61483985-148398597.08897.50
30min11466284-146628495.92995.253.9996.4595.783.99
21467500-146750096.00996.54
31476846-147684696.62097.16
41471382-147138296.26396.79
51342342-134234287.82188.31
61510737-151073798.83899.42
45min11505075-150507598.46797.153.7199.1597.843.71
21497036-149703697.94198.63
31506440-150644098.55799.25
41503264-150326498.34999.03
51374163-137416389.90390.54
61523781-152378199.691100.43
60min11511015-151101598.85697.643.3799.7098.493.37
21504332-150433298.41999.27
31514071-151407199.05699.92
41506770-150677098.57899.43
51391283-139128391.02391.81
61526815-152681599.890100.80
极限11524767-152476799.75699.790.34100.77100.810.34
21529945-1529945100.094101.11
31525332-152533299.793100.82
41515658-151565899.160100.17
51528090-152809099.973100.91
61528250-152825099.984101.06
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)0
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%
110.081390685139075713912491390578139020613906950.03
210.111408724140850914086160.02
单位质量响应值RSD%判断
137965.77139328.980.70数据可信
长期12月-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%
5min1812108-81210852.71854.026.8052.7254.026.80
2892993-89299357.96857.97
3867548-86754856.31656.32
4778085-77808550.50950.51
5760050-76005049.33849.34
6882452-88245257.28457.28
10min11176424-117642476.36779.085.1876.4579.165.18
21248883-124888381.07181.17
31261171-126117181.86881.96
41202314-120231478.04878.13
51123561-112356172.93573.02
61296578-129657884.16784.26
15min11262197-126219781.93586.334.8682.1586.564.87
21356316-135631688.04488.28
31362729-136272988.46188.69
41327233-132723386.15786.37
51250654-125065481.18681.39
61420661-142066192.22192.46
20min11304500-130450084.68189.504.6885.0389.874.68
21411294-141129491.61391.99
31410285-141028591.54891.93
41391916-139191690.35590.71
51296733-129673384.17784.52
61457983-145798394.64495.03
30min11347182-134718287.45292.544.0987.9493.064.09
21460193-146019394.78895.32
31449425-144942594.08994.62
41443484-144348493.70394.21
51360740-136074088.33288.81
61492595-149259596.89197.44
45min11390004-139000490.23194.503.6090.8795.163.61
21480332-148033296.09596.78
31482748-148274896.25296.94
41470388-147038895.44996.11
51392860-139286090.41791.04
61517947-151794798.53799.25
60min11407301-140730191.35495.353.2192.1496.173.22
21495329-149532997.06897.92
31493859-149385996.97397.82
41483697-148369796.31397.14
51412703-141270391.70592.48
61520003-152000398.67099.54
极限11472978-147297895.61897.231.1096.5698.221.12
21497666-149766697.22098.23
31502743-150274397.55098.56
41500233-150023397.38798.37
51490513-149051396.75697.69
61523138-152313898.87499.91
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