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%
110.159134991006916879161091560914420.30
210.069106590982910240.07
单位质量响应值RSD%判断
9009.069048.110.31数据可信
供试品溶液-2024120421批-恩格列净-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%
5min148076-4807647.92448.4215.5547.9248.4215.55
242433-4243342.29942.30
350288-5028850.12950.13
460214-6021460.02460.02
551757-5175751.59351.59
638653-3865338.53138.53
10min188927-8892788.64688.648.7488.7388.728.75
282158-8215881.89881.97
391403-9140391.11491.20
4100116-10011699.79999.90
592542-9254292.24992.34
678359-7835978.11178.18
15min199955-9995599.639100.151.3699.87100.381.37
2100605-100605100.287100.49
3100005-10000599.68999.92
4102400-102400102.076102.34
5101423-101423101.102101.34
698443-9844398.13298.33
20min199876-9987699.560100.570.7599.95100.960.76
2101301-101301100.981101.35
3100260-10026099.943100.34
4101998-101998101.676102.11
5101038-101038100.719101.13
6100838-100838100.519100.88
30min1100155-10015599.838100.670.80100.40101.230.81
2101529-101529101.208101.75
3100107-10010799.790100.36
4102200-102200101.877102.48
5100947-100947100.628101.20
6100998-100998100.679101.20
45min199766-9976699.451100.521.16100.18101.251.15
2100832-100832100.513101.22
399240-9924098.92699.66
4101683-101683101.362102.14
5101180-101180100.860101.60
6102321-102321101.997102.69
60min1100324-100324100.007100.310.92100.90101.210.92
2100726-100726100.408101.29
399210-9921098.89699.80
4102066-102066101.743102.69
5100815-100815100.496101.41
6100641-100641100.323101.19
极限199852-9985299.536100.250.66100.59101.320.67
2101183-101183100.863101.91
399765-9976599.450100.51
4101332-101332101.012102.13
5100766-100766100.447101.53
6100515-100515100.197101.23
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%
19.895397965418525438335443865458115431360.44
29.955441495437465439480.06
单位质量响应值RSD%判断
54917.6954668.140.33数据可信
供试品溶液-2024120421批-二甲双胍-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%
5min1307375-30737550.48850.5012.8950.4950.5012.89
2273201-27320144.87544.87
3318402-31840252.29952.30
4366755-36675560.24260.24
5324225-32422553.25653.26
6254906-25490641.87041.87
10min1515200-51520084.62583.777.0584.7183.857.06
2476775-47677578.31378.39
3524572-52457286.16486.25
4557203-55720391.52491.62
5527034-52703486.56886.66
6459053-45905375.40275.47
15min1558681-55868191.76792.170.9591.9992.390.96
2564269-56426992.68492.89
3561378-56137892.21092.44
4566421-56642193.03893.29
5564199-56419992.67392.91
6551764-55176490.63090.83
20min1559173-55917391.84792.310.4292.2392.690.42
2565492-56549292.88593.25
3560970-56097092.14292.53
4563563-56356392.56892.98
5560190-56019092.01492.40
6562559-56255992.40392.75
30min1558091-55809191.67092.140.4692.2092.670.45
2564171-56417192.66893.18
3559018-55901891.82292.36
4563344-56334492.53293.09
5559022-55902291.82392.36
6561958-56195892.30592.81
45min1555473-55547391.24092.131.0691.9292.811.04
2559299-55929991.86892.54
3554966-55496691.15691.85
4562588-56258892.40893.12
5561853-56185392.28892.98
6571033-57103393.79594.45
60min1556681-55668191.43891.830.4692.2792.670.47
2559612-55961291.91992.74
3555373-55537391.22392.07
4561850-56185092.28793.16
5561249-56124992.18893.04
6559816-55981691.95392.76
极限1555275-55527591.20791.710.4492.2092.700.43
2558639-55863991.76092.73
3556494-55649491.40792.40
4561408-56140892.21493.24
5557467-55746791.56792.57
6560751-56075192.10793.07
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%
110.159139491531912119142490994913110.24
210.069231992421923700.08
单位质量响应值RSD%判断
8996.169181.911.45数据可信
供试品溶液-2024120421批-恩格列净-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%
5min138557-3855738.18346.6611.7538.1846.6611.75
249021-4902148.54648.55
354076-5407653.55253.55
446980-4698046.52546.52
543324-4332442.90442.90
650765-5076550.27350.27
10min174204-7420473.48585.329.2873.5585.409.28
288066-8806687.21287.29
395021-9502194.10094.19
487311-8731186.46586.54
579350-7935078.58178.65
692965-9296592.06492.15
15min197233-9723396.29198.741.5196.4898.961.53
299585-9958598.62098.85
399903-9990398.93599.18
4100214-10021499.24399.46
599413-9941398.44998.65
6101896-101896100.908101.15
20min1102805-102805101.80999.981.30102.16100.371.29
2100090-10009099.12099.51
399660-9966098.69499.11
4100079-10007999.10999.50
5100782-10078299.805100.17
6102347-102347101.355101.76
30min1102916-102916101.919100.041.41102.43100.591.38
299979-9997999.01099.57
399364-9936498.40198.98
4100086-10008699.11699.67
5101507-101507100.523101.06
6102244-102244101.253101.83
45min1103113-103113102.114100.331.52102.80101.041.49
2100682-10068299.706100.43
399479-9947998.51599.25
499852-9985298.88499.60
5102811-102811101.815102.51
6101906-101906100.918101.66
60min1102449-102449101.45699.731.31102.31100.621.29
299705-9970598.73999.63
399162-9916298.20199.10
499924-9992498.95699.84
5101103-101103100.123100.99
6101894-101894100.906101.82
极限1103301-103301102.30099.981.46103.33101.031.44
299924-9992498.956100.01
399559-9955998.59499.66
499774-9977498.80799.85
5101382-101382100.399101.44
6101816-101816100.829101.91
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%
19.895432935444405451875435995435865440210.15
29.955511395507985509680.05
单位质量响应值RSD%判断
55007.1855373.670.47数据可信
供试品溶液-2024120421批-二甲双胍-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%
5min1254628-25462841.52348.9110.0041.5248.9110.00
2310528-31052850.63950.64
3337657-33765755.06355.06
4299387-29938748.82248.82
5277451-27745145.24545.24
6319902-31990252.16852.17
10min1438380-43838071.48881.107.7371.5681.187.73
2505479-50547982.43082.51
3537545-53754587.65987.75
4504372-50437282.25082.33
5466196-46619676.02476.10
6531971-53197186.75086.84
15min1549711-54971189.64391.381.1789.8391.601.19
2560593-56059391.41891.64
3562425-56242591.71791.95
4561038-56103891.49091.71
5558634-55863491.09891.30
6569949-56994992.94493.18
20min1573091-57309193.45692.001.1593.7992.371.13
2560981-56098191.48191.86
3555858-55585890.64691.04
4561294-56129491.53291.90
5563199-56319991.84392.20
6570434-57043493.02393.41
30min1572498-57249893.35991.951.1293.8592.471.10
2560171-56017191.34991.88
3555049-55504990.51491.06
4562177-56217791.67692.20
5563985-56398591.97192.48
6569138-56913892.81193.35
45min1571571-57157193.20892.431.9993.8693.111.96
2566022-56602292.30392.98
3553029-55302990.18490.88
4558421-55842191.06491.74
5585434-58543495.46996.13
6566496-56649692.38193.08
60min1569643-56964392.89491.411.1893.7092.241.16
2557081-55708190.84591.68
3551900-55190090.00090.84
4557439-55743990.90491.73
5560757-56075791.44592.26
6566556-56655692.39093.24
极限1569242-56924292.82891.261.1393.7992.241.11
2556439-55643990.74091.72
3552123-55212390.03791.03
4556378-55637890.73191.71
5558634-55863491.09892.07
6564812-56481292.10693.11
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%
110.159140291231919849170691561915770.32
210.069147291378914250.08
单位质量响应值RSD%判断
9022.369087.970.52数据可信
供试品溶液-2024120521批-恩格列净-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%
5min129400-2940029.22143.1222.0929.2243.1222.09
255044-5504454.70954.71
352044-5204451.72851.73
445778-4577845.50045.50
541040-4104040.79140.79
636980-3698036.75536.76
10min160305-6030559.93880.1216.5159.9980.1916.51
294639-9463994.06494.15
392962-9296292.39792.48
486401-8640185.87685.95
577770-7777077.29777.37
671566-7156671.13171.19
15min182495-8249581.99395.847.9982.1496.058.01
2103178-103178102.551102.80
3101197-101197100.582100.82
4100750-100750100.137100.36
598070-9807097.47497.67
692886-9288692.32192.50
20min196040-9604095.45699.772.7795.74100.132.81
2103449-103449102.820103.24
3101813-101813101.194101.60
4100959-100959100.345100.73
5101965-101965101.345101.70
698051-9805197.45597.79
30min199269-9926998.666100.511.7399.11101.041.77
2103888-103888103.256103.85
3101106-101106100.491101.07
4100893-100893100.280100.83
5102198-102198101.577102.10
699408-9940898.80499.30
45min199311-9931198.707100.131.6899.32100.831.71
2103060-103060102.433103.20
3100808-100808100.195100.94
4100972-100972100.358101.08
5101906-101906101.286101.98
698411-9841197.81398.47
60min198962-9896298.36099.901.8499.13100.771.88
2103031-103031102.405103.34
3100752-100752100.139101.05
4100530-10053099.919100.81
5101839-101839101.220102.09
697964-9796497.36898.19
极限199849-9984999.242100.541.94100.18101.581.97
2103339-103339102.711103.81
3102845-102845102.220103.30
4100648-100648100.036101.09
5102079-102079101.458102.49
698199-9819997.60298.59
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%
19.895428695442265466285435935435585441750.27
29.955425505429815427660.06
单位质量响应值RSD%判断
55022.7554549.350.62数据可信
供试品溶液-2024120521批-二甲双胍-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%
5min1207563-20756334.09846.0017.7434.1046.0017.74
2340566-34056655.94855.95
3323932-32393253.21553.22
4293002-29300248.13448.13
5269610-26961044.29144.29
6245255-24525540.29040.29
10min1375762-37576261.73077.3913.2561.7977.4713.25
2536066-53606688.06488.16
3529500-52950086.98587.07
4497496-49749681.72881.81
5460694-46069475.68275.76
6426947-42694770.13870.21
15min1487688-48768880.11789.565.8180.2889.765.83
2572480-57248094.04694.29
3561632-56163292.26492.50
4563017-56301792.49292.71
5556460-55646091.41491.61
6529571-52957186.99787.18
20min1552756-55275690.80692.321.6491.1092.681.67
2572112-57211293.98694.38
3563532-56353292.57692.96
4562360-56236092.38492.75
5571292-57129293.85194.20
6549855-54985590.32990.66
30min1562952-56295292.48192.800.8792.9393.310.88
2571602-57160293.90294.46
3559497-55949791.91392.46
4562039-56203992.33192.86
5570295-57029593.68794.20
6562938-56293892.47992.96
45min1562301-56230192.37492.321.4092.9792.981.41
2570237-57023793.67894.39
3560978-56097892.15792.85
4560407-56040792.06392.74
5569327-56932793.52894.19
6548461-54846190.10090.73
60min1561738-56173892.28192.131.5993.0392.951.60
2572270-57227094.01294.88
3557364-55736491.56392.41
4559264-55926491.87592.71
5567729-56772993.26694.09
6546582-54658289.79290.58
极限1560000-56000091.99692.451.8992.9093.421.90
2567158-56715893.17294.19
3577355-57735594.84795.85
4557971-55797191.66392.65
5567834-56783493.28394.26
6546164-54616489.72390.66
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%
110.159086891329910929062191193910210.31
210.069123891438913380.16
单位质量响应值RSD%判断
8967.599079.320.88数据可信
供试品溶液-2024120521批-恩格列净-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%
5min129376-2937629.30141.0526.2129.3041.0526.20
248309-4830948.18548.19
341802-4180241.69541.69
456728-5672856.58356.58
528980-2898028.90628.91
641734-4173441.62741.63
10min162776-6277662.61578.3117.2562.6678.3817.26
290449-9044990.21790.30
378978-7897878.77678.85
495932-9593295.68695.78
563616-6361663.45363.50
679324-7932479.12179.19
15min185080-8508084.86295.327.9285.0295.527.94
2102192-102192101.930102.16
398404-9840498.15298.35
4101709-101709101.449101.70
586947-8694786.72486.88
699082-9908298.82899.03
20min196498-9649896.25199.502.7696.5599.862.80
2102783-102783102.520102.92
3101267-101267101.008101.37
4101812-101812101.551101.97
596377-9637796.13096.43
699782-9978299.52699.89
30min197963-9796397.712100.081.7798.17100.601.81
2102399-102399102.137102.71
3101241-101241100.982101.51
4101811-101811101.550102.14
598731-9873198.47898.94
699848-9984899.592100.12
45min197746-9774697.496100.111.7998.11100.801.83
2102731-102731102.468103.21
3100889-100889100.631101.33
4101426-101426101.166101.93
598901-9890198.64899.27
6100503-100503100.246100.94
60min197564-9756497.31499.971.8498.09100.831.88
2102765-102765102.502103.41
3100968-100968100.709101.58
4101241-101241100.982101.91
598929-9892998.67699.46
699914-9991499.658100.52
极限197941-9794197.69099.981.6998.63101.001.74
2102388-102388102.126103.21
3100757-100757100.499101.54
4101731-101731101.470102.57
599055-9905598.80199.75
699528-9952899.273100.30
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%
19.895418305417425411785415575410235414660.07
29.955416735438405427560.29
单位质量响应值RSD%判断
54748.8454548.340.26数据可信
供试品溶液-2024120521批-二甲双胍-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%
5min1205794-20579433.89243.8721.0133.8943.8721.01
2307093-30709350.57550.57
3270165-27016544.49344.49
4343336-34333656.54456.54
5200296-20029632.98732.99
6271667-27166744.74144.74
10min1382064-38206462.92275.7514.0962.9875.8314.10
2521423-52142385.87385.96
3463254-46325476.29376.37
4536866-53686688.41688.51
5388200-38820063.93263.99
6468107-46810777.09277.17
15min1494741-49474181.47889.116.0481.6489.316.06
2573350-57335094.42594.65
3555256-55525691.44591.65
4558414-55841491.96592.21
5505038-50503883.17483.34
6559601-55960192.16092.36
20min1547523-54752390.17192.121.9390.4792.471.96
2573677-57367794.47894.86
3568573-56857393.63893.99
4557749-55774991.85592.25
5547364-54736490.14590.45
6561427-56142792.46192.82
30min1549864-54986490.55792.341.4891.0092.841.51
2573173-57317394.39594.94
3564973-56497393.04593.55
4557122-55712291.75292.30
5555296-55529691.45191.90
6563795-56379592.85193.36
45min1549135-54913590.43792.221.3791.0392.871.40
2570736-57073693.99494.69
3563341-56334192.77693.44
4555428-55542891.47392.17
5556715-55671591.68592.29
6564252-56425292.92693.59
60min1546817-54681790.05592.081.5790.8092.881.59
2573247-57324794.40895.26
3563009-56300992.72193.54
4555169-55516991.43092.28
5558015-55801591.89992.65
6558343-55834391.95392.77
极限1548948-54894890.40691.751.2791.3092.711.30
2568787-56878793.67394.69
3561256-56125692.43393.41
4555936-55593691.55792.56
5552351-55235190.96691.88
6555404-55540491.46992.44
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