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400
标示量(mg)25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%
110.055622705618145622695618755623075621070.05
210.085615205614235614720.02
单位质量响应值RSD%判断
55931.0455701.590.30数据可信
供试品溶液-2024041111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%
5min1352121-35212156.20472.6814.2656.2072.6814.26
2508327-50832781.13781.14
3458726-45872673.22073.22
4499437-49943779.71879.72
5403565-40356564.41564.42
6509763-50976381.36681.37
10min1519194-51919482.87188.134.3082.9688.254.32
2577766-57776692.22092.36
3546099-54609987.16687.29
4571894-57189491.28391.42
5531171-53117184.78384.89
6566608-56660890.43990.57
15min1555718-55571888.70191.192.2588.9391.462.26
2587736-58773693.81294.10
3563297-56329789.91190.18
4583037-58303793.06293.35
5562207-56220789.73789.99
6576014-57601491.94192.23
20min1564895-56489590.16692.081.7690.5592.501.78
2591830-59183094.46594.91
3568271-56827190.70591.12
4584622-58462293.31593.75
5573600-57360091.55591.95
6578220-57822092.29392.73
30min1569767-56976790.94493.171.9291.4793.741.93
2597761-59776195.41296.01
3573181-57318191.48892.06
4586650-58665093.63894.23
5594069-59406994.82295.37
6580959-58095992.73093.32
45min1572264-57226491.34293.341.8392.0294.071.84
2601948-60194896.08096.84
3575505-57550591.85992.58
4588153-58815393.87894.63
5588406-58840693.91994.63
6582351-58235192.95293.70
60min1574643-57464391.72293.581.8992.5694.461.90
2605497-60549796.64797.57
3576930-57693092.08792.96
4588323-58832393.90594.81
5588696-58869693.96594.83
6583471-58347193.13194.03
极限1621125-62112599.14199.361.38100.13100.401.36
2620429-62042999.030100.11
3619241-61924198.84099.87
4615378-61537898.22499.29
5639496-639496102.073103.10
6619348-61934898.85799.92
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400
标示量(mg)25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%
110.055616395618145618215614285614315616270.04
210.085604755604825604780.01
单位质量响应值RSD%判断
55883.2855602.980.36数据可信
供试品溶液-2024041111批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1447869-44786971.58169.995.9871.5869.985.98
2456224-45622472.91672.92
3469658-46965875.06375.06
4430804-43080468.85368.85
5427594-42759468.34068.34
6395201-39520163.16363.16
10min1554195-55419588.57487.541.3588.6987.661.35
2555878-55587888.84388.96
3549822-54982287.87588.00
4548642-54864287.68787.80
5540351-54035186.36286.48
6537591-53759185.92186.03
15min1575506-57550691.98091.390.7292.2591.650.72
2575503-57550391.98092.25
3570771-57077191.22491.50
4573830-57383091.71291.97
5564803-56480390.27090.53
6570416-57041691.16791.42
20min1582906-58290693.16392.370.7893.5892.790.78
2579534-57953492.62493.05
3575205-57520591.93292.36
4578206-57820692.41292.83
5570555-57055591.18991.60
6581392-58139292.92193.32
30min1588229-58822994.01493.190.8094.5993.760.79
2585654-58565493.60294.18
3581211-58121192.89293.47
4582584-58258493.11293.68
5575170-57517091.92792.49
6585692-58569293.60894.16
45min1591008-59100894.45893.600.9095.1994.320.89
2589011-58901194.13994.87
3583429-58342993.24793.98
4584964-58496493.49294.21
5576638-57663892.16192.87
6588720-58872094.09294.80
60min1592453-59245394.68993.770.9795.5894.640.97
2591788-59178894.58395.47
3583088-58308893.19294.08
4586684-58668493.76794.65
5577424-57742492.28793.15
6588622-58862294.07794.94
极限1620174-62017499.11999.061.31100.17100.091.30
2629282-629282100.575101.62
3615564-61556498.38399.43
4617822-61782298.74499.78
5607731-60773197.13198.15
6628116-628116100.389101.41
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400
标示量(mg)25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%
110.055605505613095607985608965609155608940.05
210.085616925615425616170.02
单位质量响应值RSD%判断
55810.3555715.970.12数据可信
供试品溶液-2024041111批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1491458-49145878.51975.133.5878.5275.133.58
2451506-45150672.13672.14
3482816-48281677.13877.14
4480634-48063476.78976.79
5460480-46048073.56973.57
6454485-45448572.61272.61
10min1581077-58107792.83790.891.2592.9791.011.25
2566131-56613190.44990.57
3571714-57171491.34191.47
4568544-56854490.83590.96
5560329-56032989.52289.64
6565397-56539790.33290.45
15min1599370-59937095.75993.921.0896.0594.191.09
2585507-58550793.54593.82
3586562-58656293.71393.99
4586499-58649993.70393.98
5580212-58021292.69992.97
6588857-58885794.08094.35
20min1619000-61900098.89695.391.9199.3495.821.91
2593540-59354094.82895.25
3593738-59373894.86095.30
4591978-59197894.57895.01
5586277-58627793.66894.09
6597707-59770795.49495.92
30min1613094-61309497.95296.171.2198.5696.761.21
2603185-60318596.36996.95
3600655-60065595.96596.56
4598961-59896195.69496.29
5591083-59108394.43595.02
6604794-60479496.62697.21
45min1618244-61824498.77596.861.3099.5597.611.30
2608667-60866797.24597.99
3606878-60687896.95997.71
4602517-60251796.26297.01
5594333-59433394.95595.69
6607019-60701996.98297.73
60min1620435-62043599.12597.700.84100.0698.610.84
2610666-61066697.56498.47
3609714-60971497.41298.33
4604654-60465496.60497.52
5612444-61244497.84898.75
6610997-61099797.61798.53
极限1630592-630592100.74899.780.82101.85100.860.82
2626243-626243100.053101.12
3622479-62247999.452100.53
4627954-627954100.326101.40
5616013-61601398.41899.48
6623923-62392399.682100.76
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400
标示量(mg)25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%
110.055614905613765617255616115616965615800.03
210.085621165620755620960.01
单位质量响应值RSD%判断
55878.6155763.490.15数据可信
供试品溶液-2024041111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%
5min1458829-45882973.23068.414.5273.2368.414.52
2436566-43656669.67669.68
3407476-40747665.03465.03
4428607-42860768.40668.41
5407832-40783265.09065.09
6432311-43231168.99769.00
10min1562809-56280989.82587.481.6289.9587.601.62
2548135-54813587.48387.60
3545236-54523687.02087.13
4552352-55235288.15688.27
5537016-53701685.70885.82
6543188-54318886.69386.81
15min1584796-58479693.33492.811.3593.6193.071.35
2585618-58561893.46593.73
3586557-58655793.61593.87
4588483-58848393.92394.18
5569165-56916590.83991.09
6574450-57445091.68391.94
20min1590954-59095494.31794.700.7594.7495.110.75
2597074-59707495.29495.71
3595924-59592495.11095.52
4597888-59788895.42495.84
5586467-58646793.60194.00
6591862-59186294.46294.87
30min1597588-59758895.37695.990.5495.9696.560.54
2602883-60288396.22196.80
3606200-60620096.75097.32
4602942-60294296.23096.81
5600403-60040395.82596.38
6598480-59848095.51896.09
45min1599964-59996495.75596.680.7396.5097.410.72
2607435-60743596.94797.68
3612151-61215197.70098.43
4606730-60673096.83597.57
5606500-60650096.79897.52
6601607-60160796.01796.75
60min1601469-60146995.99597.060.7896.9097.950.76
2609709-60970997.31098.21
3615358-61535898.21299.10
4608724-60872497.15398.05
5608612-60861297.13598.02
6604951-60495196.55197.44
极限1603224-60322496.27597.801.2497.3498.851.23
2612309-61230997.72598.79
3623399-62339999.495100.55
4609669-60966997.30498.36
5619987-61998798.95199.99
6608022-60802297.04198.09
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