二甲双胍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101566-202301对照品来源中检院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2000
标示量(mg)5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%
110.109148891013914179142491062912810.25
210.149183192034919320.16
单位质量响应值RSD%判断
9037.729066.270.23数据可信
供试品溶液-2024120421批-恩格列净-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%
5min138000-3800037.78241.7914.3137.7841.7914.31
234578-3457834.37934.38
344124-4412443.87143.87
448451-4845148.17348.17
548962-4896248.68148.68
638098-3809837.87937.88
10min176451-7645176.01280.408.2176.0880.478.21
271817-7181771.40571.46
383793-8379383.31283.38
486571-8657186.07486.15
589024-8902488.51388.59
677555-7755577.11077.17
15min199790-9979099.21797.653.1299.4197.863.12
294534-9453493.99194.17
3101153-101153100.572100.78
494548-9454894.00594.23
5101144-101144100.563100.79
698133-9813397.57097.76
20min1102588-102588101.99999.772.01102.35100.132.00
2100113-10011399.53899.87
3101729-101729101.145101.52
496840-9684096.28496.66
5101105-101105100.524100.92
699687-9968799.11599.47
30min1102705-102705102.115100.151.77102.64100.681.76
2100618-100618100.040100.54
3102418-102418101.830102.38
497845-9784597.28397.82
5100858-100858100.279100.84
699936-9993699.36299.88
45min1102663-102663102.074100.151.59102.77100.861.58
2100598-100598100.020100.69
3101815-101815101.230101.95
497980-9798097.41798.12
5100987-100987100.407101.14
6100347-10034799.771100.46
60min1102812-102812102.222100.171.53103.09101.041.52
2100538-10053899.961100.79
3101489-101489100.906101.79
498126-9812697.56398.43
5100624-100624100.046100.94
6100893-100893100.314101.17
极限1103121-103121102.529100.721.45103.56101.751.44
2100403-10040399.827100.83
3102638-102638102.049103.10
499211-9921198.64199.67
5100756-100756100.177101.24
6101673-101673101.089102.11
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.805099605100435104005099635099025100540.04
29.835207055217745212400.15
单位质量响应值RSD%判断
52046.3353025.431.32数据可信
供试品溶液-2024120421批-二甲双胍-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%
5min1247991-24799142.48746.3612.6042.4946.3612.61
2228421-22842139.13539.13
3282279-28227948.36248.36
4310341-31034153.17053.17
5306614-30661452.53152.53
6248029-24802942.49442.49
10min1450819-45081977.23781.357.2577.3181.427.26
2428808-42880873.46673.53
3489313-48931383.83283.91
4505726-50572686.64486.73
5516801-51680188.54288.63
6457400-45740078.36578.44
15min1565600-56560096.90295.552.3597.1095.772.35
2543026-54302693.03593.22
3570962-57096297.82198.04
4540976-54097692.68392.92
5568649-56864997.42597.66
6557197-55719795.46395.66
20min1576387-57638798.75097.021.4799.1197.391.46
2567115-56711597.16297.50
3572676-57267698.11598.50
4552748-55274894.70095.09
5566699-56669997.09097.49
6562165-56216596.31496.67
30min1574813-57481398.48197.261.2599.0197.801.25
2568702-56870297.43497.94
3576216-57621698.72199.27
4558037-55803795.60696.15
5566421-56642197.04397.60
6562039-56203996.29296.81
45min1574838-57483898.48597.021.0499.1797.711.03
2566764-56676497.10297.77
3570589-57058997.75798.47
4559141-55914195.79696.50
5565427-56542796.87397.59
6560910-56091096.09996.78
60min1573121-57312198.19197.050.8999.0497.900.88
2566515-56651597.05997.89
3568853-56885397.46098.33
4558464-55846495.68096.54
5563400-56340096.52597.41
6568257-56825797.35798.20
极限1572557-57255798.09497.031.0499.1198.051.02
2565053-56505396.80897.80
3571452-57145297.90598.94
4556943-55694395.41996.44
5563293-56329396.50797.55
6568877-56887797.46498.47
二甲双胍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101566-202301对照品来源中检院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2000
标示量(mg)5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%
110.109149391348910409140891293913160.19
210.149121391109911610.09
单位质量响应值RSD%判断
9041.198990.240.40数据可信
供试品溶液-2024120621批-恩格列净-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%
5min161295-6129561.18947.9323.2661.1947.9323.26
245778-4577845.69945.70
343798-4379843.72243.72
457814-5781457.71457.71
529960-2996029.90829.91
649417-4941749.33149.33
10min1101270-101270101.09487.1115.10101.2087.1915.11
285241-8524185.09385.17
382097-8209781.95582.03
497711-9771197.54197.64
564797-6479764.68564.73
692473-9247392.31392.39
15min1102886-102886102.70899.355.42102.9899.575.44
2103218-103218103.039103.26
3100527-100527100.353100.56
4100030-10003099.856100.12
588830-8883088.67688.83
6101616-101616101.440101.68
20min1102702-102702102.524101.431.94102.97101.821.96
2103901-103901103.721104.11
3102601-102601102.423102.80
4100280-100280100.106100.53
598438-9843898.26798.57
6101692-101692101.516101.92
30min1102493-102493102.315101.581.55102.93102.141.56
2103789-103789103.609104.17
3102400-102400102.222102.77
499897-9989799.724100.32
599842-9984299.669100.14
6102102-102102101.925102.50
45min1102530-102530102.352101.531.53103.14102.261.54
2103560-103560103.380104.12
3102591-102591102.413103.13
499734-9973499.561100.32
599917-9991799.744100.38
6101880-101880101.703102.45
60min1102262-102262102.085101.191.44103.04102.091.45
2103325-103325103.146104.05
3101875-101875101.698102.59
499409-9940999.237100.16
599983-9998399.810100.61
6101353-101353101.177102.09
极限1102168-102168101.991101.651.47103.11102.711.47
2103594-103594103.414104.49
3102423-102423102.245103.30
499706-9970699.533100.62
5100334-100334100.160101.13
6102719-102719102.541103.62
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.805129755125685122375121105122045124190.07
29.835120105119045119570.02
单位质量响应值RSD%判断
52287.6552081.080.28数据可信
供试品溶液-2024120621批-二甲双胍-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%
5min1373756-37375664.46051.9220.0864.4651.9220.08
2287787-28778749.63449.63
3278131-27813147.96847.97
4355160-35516061.25361.25
5204531-20453135.27535.27
6306937-30693752.93652.94
10min1573326-57332698.87987.4513.0098.9987.5413.01
2495247-49524785.41385.50
3480818-48081882.92583.00
4561094-56109496.77096.87
5394523-39452368.04268.10
6537418-53741892.68692.77
15min1576442-57644299.41797.374.2299.6997.604.24
2580197-580197100.064100.29
3570263-57026398.35198.57
4565953-56595397.60897.87
5517215-51721589.20289.37
6577468-57746899.59499.84
20min1576002-57600299.34198.801.3899.7899.201.39
2582474-582474100.457100.85
3575767-57576799.30099.68
4565222-56522297.48297.91
5561552-56155296.84997.17
6576250-57625099.38499.79
30min1574644-57464499.10798.691.0899.7199.251.08
2579198-57919899.892100.45
3574579-57457999.09599.64
4563090-56309097.11497.70
5566455-56645597.69498.18
6575574-57557499.26799.84
45min1572502-57250298.73798.591.2099.5199.321.20
2579132-57913299.881100.61
3572572-57257298.74999.46
4562065-56206596.93797.69
5565412-56541297.51498.16
6578310-57831099.739100.48
60min1571824-57182498.62098.191.1399.5599.081.13
2577321-57732199.568100.46
3572285-57228598.70099.58
4559315-55931596.46397.37
5564488-56448897.35598.16
6570792-57079298.44299.35
极限1569255-56925598.17798.231.4099.2799.281.41
2576690-57669099.459100.52
3571286-57128698.52799.57
4558547-55854796.33097.40
5562449-56244997.00397.97
6579147-57914799.883100.95
二甲双胍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101566-202301对照品来源中检院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2000
标示量(mg)5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%
110.109168791191916769165291710915830.25
210.149130091348913240.04
单位质量响应值RSD%判断
9067.629006.310.48数据可信
供试品溶液-2024120621批-恩格列净-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%
5min149103-4910348.90345.6618.7148.9045.6618.71
246840-4684046.64946.65
331140-3114031.01331.01
457613-5761357.37857.38
544844-4484444.66144.66
645513-4551345.32745.33
10min186703-8670386.34984.3812.7886.4384.4612.78
286361-8636186.00986.09
365405-6540565.13865.19
498986-9898698.58298.68
584695-8469584.35084.42
686214-8621485.86285.94
15min1100776-100776100.36598.924.82100.5999.134.84
2101375-101375100.961101.18
389619-8961989.25389.41
4102144-102144101.727101.99
5101080-101080100.668100.88
6100936-100936100.524100.74
20min1101059-101059100.647100.860.79101.04101.240.82
2101788-101788101.373101.76
399882-9988299.47599.78
4102219-102219101.802102.23
5101384-101384100.970101.35
6101328-101328100.915101.30
30min1100727-100727100.316100.950.62100.88101.500.64
2102009-102009101.593102.15
3100782-100782100.371100.85
4102190-102190101.773102.37
5101070-101070100.658101.21
6101430-101430101.016101.57
45min1100537-100537100.127100.920.48100.85101.640.49
2101759-101759101.344102.07
3101393-101393100.979101.62
4101776-101776101.361102.13
5100997-100997100.585101.30
6101536-101536101.122101.84
60min1100395-10039599.985100.750.64100.88101.640.63
2102265-102265101.848102.74
3101395-101395100.981101.79
4101249-101249100.836101.77
5100776-100776100.365101.25
6100919-100919100.507101.40
极限1100791-100791100.380101.040.58101.44102.090.56
2102121-102121101.704102.77
3102032-102032101.616102.59
4101740-101740101.325102.43
5100949-100949100.537101.59
6101094-101094100.682101.74
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.805147545140775140625140025137915141370.08
29.835131075132475131770.02
单位质量响应值RSD%判断
52462.9652205.190.35数据可信
供试品溶液-2024120621批-二甲双胍-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%
5min1308278-30827853.01650.2016.2453.0250.2016.24
2296183-29618350.93650.94
3209983-20998336.11136.11
4356889-35688961.37561.38
5289461-28946149.78049.78
6290665-29066549.98749.99
10min1503361-50336186.56585.0311.0586.6585.1211.06
2501345-50134586.21886.30
3396215-39621568.13868.20
4565621-56562197.27297.37
5497528-49752885.56185.64
6502698-50269886.45186.53
15min1569986-56998698.02297.043.8998.2597.263.91
2573641-57364198.65198.88
3519886-51988689.40689.58
4577285-57728599.27899.54
5575165-57516598.91399.14
6569520-56952097.94298.17
20min1568878-56887897.83298.310.6598.2398.700.68
2573360-57336098.60399.00
3566700-56670097.45797.78
4576635-57663599.16699.60
5574271-57427198.75999.15
6570230-57023098.06498.45
30min1567769-56776997.64198.320.6298.2098.870.64
2572456-57245698.44799.00
3570446-57044698.10198.59
4577699-57769999.34999.94
5572898-57289898.52399.08
6568999-56899997.85398.41
45min1564523-56452397.08397.960.5597.8098.680.56
2570216-57021698.06298.78
3569198-56919897.88798.54
4573885-57388598.69399.45
5571441-57144198.27298.99
6568605-56860597.78598.50
60min1564874-56487497.14397.970.8898.0398.840.88
2576930-57693099.216100.10
3569717-56971797.97698.79
4573183-57318398.57299.50
5569563-56956397.95098.83
6563717-56371796.94497.82
极限1561091-56109196.49397.500.5997.5498.540.59
2568267-56826797.72798.78
3568810-56881097.82098.80
4570311-57031198.07899.17
5567969-56796997.67598.72
6565176-56517697.19598.24
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