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%
19.805475695475975474475479155487915478640.10
29.825516235517035516630.02
单位质量响应值RSD%判断
55904.4956177.490.35数据可信
供试品溶液-2024052811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%
5min1445516-44551670.82675.508.2770.8375.508.27
2489355-48935577.79677.80
3528917-52891784.08584.08
4487688-48768877.53177.53
5482268-48226876.66976.67
6415794-41579466.10166.10
10min1547689-54768987.06987.982.0587.1988.112.06
2552599-55259987.85087.98
3569949-56994990.60890.75
4562246-56224689.38389.51
5550568-55056887.52787.65
6537638-53763885.47185.58
15min1577847-57784791.86491.571.0892.1391.851.08
2573449-57344991.16491.44
3586382-58638293.22093.51
4577984-57798491.88592.16
5571313-57131390.82591.10
6569169-56916990.48490.74
20min1587822-58782293.44993.431.2893.8793.861.28
2576160-57616091.59592.02
3595126-59512694.61195.06
4587965-58796593.47293.90
5596156-59615694.77495.20
6582993-58299392.68293.09
30min1597104-59710494.92594.511.5895.5095.091.58
2583314-58331492.73393.31
3611162-61116297.16097.76
4592915-59291594.25994.85
5589512-58951293.71894.30
6592949-59294994.26494.82
45min1606800-60680096.46695.351.5597.2096.091.55
2589504-58950493.71794.45
3614377-61437797.67198.44
4598779-59877995.19195.94
5592980-59298094.26995.01
6596202-59620294.78295.50
60min1609131-60913196.83795.791.4097.7396.691.40
2595676-59567694.69895.59
3615681-61568197.87898.81
4601935-60193595.69396.60
5593871-59387194.41195.31
6598867-59886795.20596.08
极限1616472-61647298.00497.151.6199.0698.211.60
2602562-60256295.79396.84
3626466-62646699.593100.68
4608502-60850296.73797.80
5599571-59957195.31796.37
6613196-61319697.48398.51
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%
19.805501035503455506785511315509765506470.08
29.825537895539825538860.03
单位质量响应值RSD%判断
56188.4756403.870.28数据可信
供试品溶液-2024052811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%
5min1453808-45380871.81774.385.3771.8274.385.37
2502730-50273079.55979.56
3499384-49938479.03079.03
4468055-46805574.07274.07
5445329-44532970.47570.48
6450713-45071371.32771.33
10min1560179-56017988.65189.622.3188.7789.752.31
2569291-56929190.09390.23
3574987-57498790.99491.13
4584960-58496092.57392.70
5547416-54741686.63186.75
6561124-56112488.80188.92
15min1588346-58834693.10992.902.1893.3893.172.17
2584852-58485292.55692.84
3593309-59330993.89494.18
4604691-60469195.69595.97
5565831-56583189.54589.81
6584986-58498692.57792.84
20min1601814-60181495.24093.952.3195.6694.382.31
2587879-58787993.03593.47
3600025-60002594.95795.40
4609069-60906996.38896.83
5569968-56996890.20090.61
6593088-59308893.85994.28
30min1611147-61114796.71795.002.2197.3095.582.21
2592979-59297993.84294.43
3607049-60704996.06896.67
4609946-60994696.52797.12
5576702-57670291.26691.83
6603955-60395595.57996.16
45min1620230-62023098.15495.932.3198.9096.672.31
2599000-59900094.79595.54
3610901-61090196.67897.44
4614291-61429197.21497.97
5581385-58138592.00792.72
6611242-61124296.73297.47
60min1621629-62162998.37696.092.2099.2896.992.19
2599537-59953794.88095.79
3610249-61024996.57597.49
4613976-61397697.16598.09
5584260-58426092.46293.33
6613353-61335397.06697.96
极限1629164-62916499.56897.001.99100.6498.061.98
2602763-60276395.39096.45
3611261-61126196.73597.82
4617291-61729197.68998.77
5596027-59602794.32495.35
6620956-62095698.26999.33
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%
19.805507935512365514315502125501595507660.11
29.825600285598205599240.03
单位质量响应值RSD%判断
56200.6157018.741.03数据可信
供试品溶液-2024052911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%
5min1462910-46291072.85667.9212.2572.8667.9212.25
2368608-36860858.01458.01
3476301-47630174.96374.96
4460136-46013672.41972.42
5462201-46220172.74472.74
6358988-35898856.50056.50
10min1540818-54081885.11784.355.3285.2484.465.33
2488073-48807376.81676.91
3554871-55487187.32987.45
4555092-55509287.36487.48
5560917-56091788.28088.40
6516059-51605981.22081.31
15min1565146-56514688.94688.443.1689.2188.693.17
2529821-52982183.38683.61
3568434-56843489.46489.73
4575778-57577890.61990.89
5577531-57753190.89591.16
6554806-55480687.31987.55
20min1577018-57701890.81590.102.0891.2390.502.09
2550245-55024586.60186.96
3574645-57464590.44190.86
4582055-58205591.60792.02
5581567-58156791.53091.95
6569428-56942889.62090.00
30min1592757-59275793.29292.001.5293.8592.551.53
2568585-56858589.48790.00
3582428-58242891.66692.24
4588295-58829592.58993.16
5591557-59155793.10393.68
6583570-58357091.84692.37
45min1608773-60877395.81293.111.8596.5393.821.86
2577044-57704490.81991.48
3586782-58678292.35193.07
4592293-59229393.21993.94
5598081-59808194.13094.86
6586670-58667092.33493.01
60min1608065-60806595.70193.441.5796.5894.301.58
2580489-58048991.36192.17
3590521-59052192.94093.82
4592036-59203693.17894.06
5599340-59934094.32895.21
6591637-59163793.11593.95
极限1620110-62011097.59796.511.2198.6397.531.22
2601311-60131194.63895.60
3618550-61855097.35198.38
4616867-61686797.08698.12
5615303-61530396.84097.88
6607233-60723395.57096.56
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%
19.805513945516475514925511555512445513860.04
29.825509065511575510320.04
单位质量响应值RSD%判断
56263.8856113.240.19数据可信
供试品溶液-2024052911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%
5min1396130-39613062.80964.616.6562.8164.616.65
2399333-39933363.31763.32
3384584-38458460.97960.98
4388907-38890761.66461.66
5418577-41857766.36966.37
6457225-45722572.49672.50
10min1543000-54300086.09784.302.7586.2084.402.75
2549635-54963587.14987.25
3521030-52103082.61382.71
4512163-51216381.20781.31
5524388-52438883.14683.26
6539722-53972285.57785.70
15min1570480-57048090.45488.472.4290.7088.722.42
2575499-57549991.25091.50
3549766-54976687.17087.41
4541966-54196685.93386.17
5547895-54789586.87387.12
6562235-56223589.14789.41
20min1573354-57335490.91089.942.4291.3190.332.42
2586832-58683293.04793.45
3559160-55916088.65989.04
4555828-55582888.13188.51
5551791-55179187.49187.88
6576319-57631991.38091.79
30min1578610-57861091.74391.582.5192.2992.122.51
2595615-59561594.43995.00
3571781-57178190.66091.19
4569894-56989490.36190.89
5557282-55728288.36188.90
6592242-59224293.90494.47
45min1586370-58637092.97392.502.6693.6893.202.65
2599369-59936995.03495.75
3576329-57632991.38192.06
4578394-57839491.70992.39
5559439-55943988.70389.39
6600288-60028895.18095.90
60min1583748-58374892.55893.032.6493.4293.882.63
2600309-60030995.18396.06
3586341-58634192.96993.80
4583957-58395792.59193.42
5561073-56107388.96289.80
6605027-60502795.93296.81
极限1611897-61189797.02196.901.6998.0397.911.69
2617295-61729597.87798.91
3600590-60059095.22896.22
4614939-61493997.50398.49
5597537-59753794.74495.73
6624625-62462599.039100.08
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