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%
110.065499035501515507515510465509415505580.10
210.105503365508765506060.07
单位质量响应值RSD%判断
54727.4454515.450.28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%
5min1427031-42703169.65268.542.8969.6568.542.89
2436846-43684671.25371.25
3416461-41646167.92867.93
4427083-42708369.66069.66
5407334-40733466.43966.44
6406581-40658166.31666.32
10min1571277-57127793.17989.682.5593.3089.802.56
2559797-55979791.30791.43
3549739-54973989.66689.78
4538958-53895887.90888.02
5546448-54644889.12989.24
6532722-53272286.89187.00
15min1604074-60407498.52994.902.5298.8095.162.52
2588378-58837895.96996.24
3584949-58494995.40995.67
4568026-56802692.64992.91
5581969-58196994.92395.18
6563652-56365291.93692.19
20min1621310-621310101.34096.982.44101.7897.402.44
2595700-59570097.16397.59
3595136-59513697.07197.49
4584239-58423995.29395.71
5591209-59120996.43096.85
6579959-57995994.59595.00
30min1627865-627865102.40998.462.19103.0199.042.19
2602718-60271898.30798.90
3604417-60441798.58599.17
4600637-60063797.96898.54
5598028-59802897.54298.12
6588195-58819595.93996.50
45min1631496-631496103.00199.082.20103.7899.822.20
2604312-60431298.56799.32
3610683-61068399.607100.35
4605857-60585798.81999.56
5600045-60004597.87198.61
6592218-59221896.59597.32
60min1634556-634556103.50099.452.31104.45100.362.31
2605419-60541998.74899.67
3614997-614997100.310101.22
4608159-60815999.195100.10
5601768-60176898.15399.06
6593512-59351296.80697.69
极限1636285-636285103.782100.432.22104.90101.502.21
2606090-60609098.85799.94
3626414-626414102.172103.25
4618140-618140100.823101.89
5604838-60483898.65399.72
6602582-60258298.28599.33
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%
110.065533895530885528205534915523565530290.09
210.105499125498675498900.01
单位质量响应值RSD%判断
54973.0654444.550.69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%
5min1403160-40316065.65471.946.8765.6571.946.87
2432403-43240370.41770.42
3416143-41614367.76967.77
4471581-47158176.79776.80
5479643-47964378.11078.11
6447615-44761572.89472.89
10min1499229-49922981.29984.143.8981.4184.263.89
2507287-50728782.61182.73
3502879-50287981.89482.01
4543120-54312088.44788.57
5541535-54153588.18988.32
6505995-50599582.40182.52
15min1522995-52299585.17087.533.0285.4187.803.02
2534621-53462187.06387.32
3527483-52748385.90086.15
4558568-55856890.96391.24
5556945-55694590.69890.98
6524502-52450285.41585.67
20min1525166-52516685.52388.232.7985.9188.642.80
2548811-54881189.37489.77
3532540-53254086.72487.12
4560325-56032591.24991.68
5555788-55578890.51090.94
6528091-52809185.99986.40
30min1525399-52539985.56188.272.6286.0988.822.62
2550955-55095589.72390.27
3534865-53486587.10387.64
4558369-55836990.93091.51
5554072-55407290.23090.81
6528510-52851086.06886.61
45min1525596-52559685.59387.962.3186.2788.662.31
2548274-54827489.28689.98
3534129-53412986.98387.67
4555595-55559590.47891.21
5549037-54903789.41090.14
6528219-52821986.02086.71
60min1524091-52409185.34887.392.0786.1688.242.09
2543865-54386588.56889.42
3530340-53034086.36687.19
4551481-55148189.80890.69
5543393-54339388.49189.37
6526555-52655585.74986.58
极限1585110-58511095.28594.950.9496.2495.940.92
2582634-58263494.88295.88
3590456-59045696.15697.13
4585700-58570095.38196.41
5574661-57466193.58394.61
6579717-57971794.40795.38
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%
110.061394731139573313964611393295139372613947890.10
210.101399771140113014004500.07
单位质量响应值RSD%判断
138647.02138658.420.01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%
5min1930884-93088459.81455.765.7559.8155.765.75
2814957-81495752.36552.36
3845296-84529654.31454.31
4828805-82880553.25553.25
5927463-92746359.59459.59
6859739-85973955.24255.24
10min11254591-125459180.61377.572.5680.7177.662.56
21179284-117928475.77575.86
31181014-118101475.88675.98
41191867-119186776.58376.67
51235085-123508579.36079.46
61201059-120105977.17477.27
15min11336243-133624385.86083.172.4386.0983.392.43
21280298-128029882.26582.48
31259760-125976080.94681.16
41312085-131208584.30884.52
51315149-131514984.50584.74
61262454-126245481.11981.34
20min11363610-136361087.61885.052.1988.0085.422.19
21307038-130703883.98384.33
31291785-129178583.00383.36
41346675-134667586.53086.89
51334796-133479685.76786.14
61298339-129833983.42483.78
30min11403277-140327790.16786.902.3790.6987.402.37
21328670-132867085.37385.86
31320948-132094884.87785.37
41376333-137633388.43688.94
51352651-135265186.91487.43
61332904-133290485.64586.14
45min11434780-143478092.19187.972.8892.8688.612.88
21337286-133728685.92786.56
31342058-134205886.23486.87
41387482-138748289.15289.80
51378979-137897988.60689.27
61333506-133350685.68486.32
60min11443930-144393092.77988.763.1093.6189.563.10
21338871-133887186.02986.81
31348121-134812186.62387.40
41400578-140057889.99490.79
51409727-140972790.58291.39
61347445-134744586.58087.36
极限11523902-152390297.91897.380.7098.9098.330.72
21513493-151349397.24998.17
31504127-150412796.64797.57
41515535-151553597.38098.33
51531211-153121198.38899.35
61505155-150515596.71397.64
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%
110.061385064138705413837851384836138756513856610.12
210.101392825139159013922080.07
单位质量响应值RSD%判断
137739.66137842.380.06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%
5min1880496-88049656.93059.998.9656.9359.998.96
2939670-93967060.75660.76
31051775-105177568.00468.00
4801188-80118851.80251.80
5943185-94318560.98360.98
6951091-95109161.49461.49
10min11082237-108223769.97473.995.0670.0774.095.06
21110693-111069371.81471.91
31241743-124174380.28780.40
41107188-110718871.58771.67
51173131-117313175.85175.95
61151150-115115074.42974.53
15min11155832-115583274.73276.784.0374.9477.004.03
21133702-113370273.30173.52
31269424-126942482.07782.32
41170168-117016875.65975.86
51209905-120990578.22878.46
61185673-118567376.66276.89
20min11185667-118566776.66178.173.7877.0078.523.78
21146300-114630074.11674.46
31275206-127520682.45182.83
41185419-118541976.64576.98
51225392-122539279.23079.59
61235885-123588579.90880.26
30min11195664-119566477.30879.742.3877.7780.222.40
21214679-121467978.53779.00
31278064-127806482.63583.16
41219394-121939478.84279.30
51248046-124804680.69481.18
61244075-124407580.43880.93
45min11200224-120022477.60279.672.0678.2080.292.08
21234725-123472579.83380.43
31275131-127513182.44683.10
41214151-121415178.50379.09
51236999-123699979.98080.61
61232223-123222379.67180.29
60min11210431-121043178.26279.461.6678.9880.211.68
21228168-122816879.40980.14
31265756-126575681.84082.64
41209886-120988678.22778.95
51230640-123064079.56980.33
61229292-122929279.48280.24
极限11454800-145480094.06293.301.0794.9194.181.07
21444063-144406393.36894.23
31459837-145983794.38895.32
41418880-141888091.74092.59
51449281-144928193.70694.60
61431561-143156192.56093.45
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