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%
110.065490225490375488545489535478985487530.09
210.105492595493615493100.02
单位质量响应值RSD%判断
54548.0154387.130.21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%
5min1336314-33631455.01061.356.8155.0161.356.80
2380905-38090562.30462.30
3397321-39732164.98964.99
4400102-40010265.44465.44
5383536-38353662.73462.73
6352193-35219357.60757.61
10min1478651-47865178.29284.423.9078.3884.523.90
2516610-51661084.50184.60
3518783-51878384.85684.96
4538516-53851688.08488.19
5518072-51807284.74084.84
6526247-52624786.07786.17
15min1523863-52386385.68789.992.9885.9190.232.98
2556423-55642391.01391.26
3543516-54351688.90289.15
4564945-56494592.40792.66
5544264-54426489.02489.27
6567886-56788692.88893.13
20min1537542-53754287.92492.012.9988.2992.402.99
2578810-57881094.67495.07
3555605-55560590.87991.28
4572746-57274693.68394.09
5551831-55183190.26290.66
6578488-57848894.62295.02
30min1547549-54754989.56193.873.4790.0794.423.47
2601574-60157498.39898.95
3568438-56843892.97893.53
4580816-58081695.00395.57
5557746-55774691.22991.77
6587300-58730096.06396.62
45min1554322-55432290.66995.243.9191.3395.943.90
2616165-616165100.785101.50
3587285-58728596.06196.77
4581705-58170595.14895.87
5560138-56013891.62092.32
6594009-59400997.16197.87
60min1557089-55708991.12295.894.0991.9396.754.08
2619003-619003101.249102.13
3599611-59961198.07798.94
4582399-58239995.26196.14
5561335-56133591.81692.67
6597944-59794497.80498.68
极限1609165-60916599.640100.761.30100.60101.781.30
2627687-627687102.669103.72
3620790-620790101.541102.57
4605993-60599399.121100.16
5614032-614032100.436101.44
6618461-618461101.160102.20
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%
110.065518375517635555825550155553995539190.36
210.105480135478705479420.02
单位质量响应值RSD%判断
55061.5354251.681.05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%
5min1428528-42852869.85470.203.7169.8570.203.71
2417498-41749868.05668.06
3459314-45931474.87374.87
4432963-43296370.57770.58
5414297-41429767.53567.53
6431295-43129570.30670.31
10min1544807-54480788.80989.571.1088.9389.691.10
2541725-54172588.30788.42
3553097-55309790.16090.29
4552217-55221790.01790.13
5547028-54702889.17189.28
6557936-55793690.94991.07
15min1575496-57549693.81295.121.7294.0895.381.72
2602296-60229698.18098.44
3583080-58308095.04895.32
4576480-57648093.97294.24
5577972-57797294.21594.48
6585750-58575095.48395.75
20min1588571-58857195.94396.040.9696.3696.470.95
2579854-57985494.52294.95
3590806-59080696.30796.74
4590402-59040296.24296.67
5588301-58830195.89996.32
6597213-59721397.35297.78
30min1601076-60107697.98297.640.7498.5698.230.73
2592137-59213796.52497.11
3597225-59722597.35497.95
4602217-60221798.16898.75
5597103-59710397.33497.91
6604276-60427698.50399.09
45min1608232-60823299.14898.470.5599.8999.220.55
2602926-60292698.28399.03
3600594-60059497.90398.66
4603586-60358698.39199.14
5601063-60106397.97998.72
6607906-60790699.09599.85
60min1611088-61108899.61498.830.66100.5299.740.65
2608868-60886899.252100.16
3601920-60192098.11999.04
4603939-60393998.44899.36
5602461-60246198.20799.11
6609480-60948099.352100.27
极限1619419-619419100.97299.901.26102.05100.981.24
2624981-624981101.878102.95
3608968-60896899.268100.35
4604713-60471398.57499.65
5609360-60936099.332100.40
6609690-60969099.386100.47
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%
110.061376118137756313800411379090138052613786680.14
210.101376191137942113778060.17
单位质量响应值RSD%判断
137044.53136416.440.33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%
5min1788912-78891251.40452.098.7551.4052.098.75
2720189-72018946.92646.93
3817949-81794953.29653.30
4858034-85803455.90855.91
5721313-72131347.00047.00
6889864-88986457.98257.98
10min11098978-109897871.60872.635.4871.6972.725.48
21062189-106218969.21169.29
31118510-111851072.88072.97
41133655-113365573.86773.96
51052967-105296768.61068.69
61221675-122167579.60279.70
15min11202737-120273778.36879.575.5578.5779.785.55
21174132-117413276.50576.70
31223455-122345579.71879.93
41202788-120278878.37278.59
51170353-117035376.25876.45
61353363-135336388.18388.41
20min11233945-123394580.40282.256.0980.7482.596.09
21206671-120667178.62578.95
31257665-125766581.94882.29
41233660-123366080.38380.73
51226455-122645579.91480.23
61415545-141554592.23592.61
30min11256128-125612881.84784.456.2682.3284.936.26
21246097-124609781.19481.65
31297474-129747484.54185.02
41257911-125791181.96482.44
51261533-126153382.20082.65
61457627-145762794.97795.51
45min11278647-127864783.31585.976.4683.9286.596.45
21264893-126489382.41883.01
31327138-132713886.47487.09
41275000-127500083.07783.69
51283116-128311683.60684.20
61487456-148745696.92097.61
60min11283020-128302083.60086.556.7084.3487.316.70
21270747-127074782.80083.52
31345355-134535587.66188.43
41282226-128222683.54884.30
51286892-128689283.85284.58
61501742-150174297.85198.70
极限11496106-149610697.48498.690.8598.3799.600.88
21505524-150552498.09898.96
31527077-152707799.502100.41
41520703-152070399.08799.98
51510454-151045498.41999.29
61528215-152821599.576100.59
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%
110.061376184137695313776831378203138172113781490.16
210.101409181140727314082270.10
单位质量响应值RSD%判断
136992.94139428.421.25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%
5min1948650-94865061.15560.424.3661.1560.424.36
2881218-88121856.80856.81
3953858-95385861.49161.49
4891654-89165457.48157.48
5976298-97629862.93762.94
6971909-97190962.65462.65
10min11252595-125259580.74981.571.8180.8581.671.82
21253395-125339580.80080.90
31287834-128783483.02183.12
41232050-123205079.42479.52
51289392-128939283.12183.23
61276436-127643682.28682.39
15min11332685-133268585.91287.711.3486.1587.941.34
21380253-138025388.97889.21
31369761-136976188.30288.54
41344210-134421086.65586.88
51371380-137138088.40688.65
61364777-136477787.98188.22
20min11364564-136456487.96790.231.5688.3590.621.56
21430033-143003392.18792.57
31413001-141300191.09091.48
41393614-139361489.84090.21
51401134-140113490.32590.72
61396092-139609289.99990.39
30min11389942-138994289.60392.952.4190.1393.482.40
21468849-146884994.69095.22
31489788-148978896.04096.58
41442908-144290893.01793.54
51427097-142709791.99892.54
61432247-143224792.33092.87
45min11417554-141755491.38394.502.3292.0695.192.31
21493627-149362796.28796.98
31511925-151192597.46798.17
41469580-146958094.73795.41
51444682-144468293.13293.83
61458313-145831394.01194.70
60min11434923-143492392.50395.062.1393.3395.912.12
21495136-149513696.38497.23
31517514-151751497.82798.69
41489459-148945996.01896.85
51447155-144715593.29194.14
61463678-146367894.35695.21
极限11484292-148429295.68597.031.7496.6798.031.73
21521484-152148498.08399.09
31530787-153078798.68399.71
41526565-152656598.41099.41
51465191-146519194.45495.46
61502375-150237596.85197.86
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