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DC033-12306002对照品来源中检院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%
19.89 9200191760920179184492062919370.14
29.929298492876929300.09
单位质量响应值RSD%判断
9295.969367.940.55数据可信
供试品溶液-206397批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132200-3220030.74139.8520.9030.7439.8420.90
247884-4788445.71545.71
353709-5370951.27651.28
435788-3578834.16734.17
546312-4631244.21444.21
634527-3452732.96332.96
10min168074-6807464.99077.5713.4665.0477.6413.47
292276-9227688.09688.17
393537-9353789.30089.39
476672-7667273.19973.26
586079-8607982.18082.25
670892-7089267.68167.74
15min193396-9339689.16595.855.2089.3296.045.22
2106270-106270101.456101.68
3105507-105507100.728100.96
499893-9989395.36895.55
5101804-10180497.19397.40
695489-9548991.16491.33
20min1103285-10328598.606100.771.5398.91101.131.55
2107763-107763102.882103.27
3106510-106510101.685102.09
4104723-10472399.979100.32
5104708-10470899.965100.34
6106323-106323101.507101.83
30min1104449-10444999.718101.131.13100.19101.651.14
2107486-107486102.617103.18
3106390-106390101.571102.14
4105542-105542100.761101.27
5104832-104832100.083100.62
6106868-106868102.027102.52
45min1104588-10458899.850101.281.19100.49101.981.20
2107747-107747102.866103.60
3106724-106724101.890102.63
4105693-105693100.905101.58
5104838-104838100.089100.80
6106935-106935102.091102.75
60min1105070-105070100.311101.140.86101.12102.000.87
2107166-107166102.312103.22
3106373-106373101.555102.47
4105820-105820101.027101.87
5104760-104760100.015100.89
6106445-106445101.623102.45
极限1104749-104749100.004101.281.07100.98102.311.09
2107585-107585102.712103.79
3106632-106632101.802102.88
4106198-106198101.387102.40
5104747-104747100.002101.04
6106615-106615101.786102.78
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%
110.159081109085269088179085039090919086090.05
210.109165499165069165280.01
单位质量响应值RSD%判断
89518.1390745.350.97数据可信
供试品溶液-206397批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369435-36943536.89146.0117.7336.8946.0117.73
2516210-51621051.54851.55
3572478-57247857.16757.17
4407666-40766640.70940.71
5505630-50563050.49150.49
6392879-39287939.23239.23
10min1683349-68334968.23878.4911.0068.3078.5611.00
2875583-87558387.43487.52
3881922-88192288.06788.16
4752126-75212675.10675.17
5821503-82150382.03482.12
6701455-70145570.04670.11
15min1879791-87979187.85592.773.9188.0392.983.93
2969178-96917896.78197.01
3964883-96488396.35296.59
4927266-92726692.59592.79
5938153-93815393.68393.90
6894715-89471589.34589.53
20min1948899-94889994.75696.301.1295.0896.661.14
2977184-97718497.58097.97
3971523-97152397.01597.42
4962098-96209896.07496.42
5955535-95553595.41895.80
6970819-97081996.94497.28
30min1955861-95586195.45196.470.8695.9396.990.87
2975922-97592297.45498.01
3969501-96950196.81397.38
4966521-96652196.51597.02
5956578-95657895.52296.06
6971920-97192097.05497.55
45min1956699-95669995.53496.500.8396.1797.180.84
2975269-97526997.38998.11
3971860-97186097.04897.77
4967490-96749096.61297.28
5956586-95658695.52396.22
6970397-97039796.90297.56
60min1959251-95925195.78996.340.6696.5997.190.67
2971203-97120396.98397.86
3967770-96777096.64097.53
4967036-96703696.56797.40
5954812-95481295.34696.20
6968764-96876496.73997.56
极限1954682-95468295.33396.220.8096.2997.220.81
2971805-97180597.04398.08
3967315-96731596.59597.64
4965655-96565596.42997.42
5953453-95345395.21096.22
6968470-96847096.71097.69
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DC033-12306002对照品来源中检院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%
19.89 9224792195922439240392154922480.11
29.929283592694927640.11
单位质量响应值RSD%判断
9327.409351.210.19数据可信
供试品溶液-206397批-二甲双胍-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%
5min133488-3348831.94534.9115.3631.9534.9115.35
240537-4053738.67038.67
345415-4541543.32343.32
432687-3268731.18131.18
530329-3032928.93228.93
637137-3713735.42635.43
10min174818-7481871.37274.9011.0171.4274.9611.01
286581-8658182.59382.66
388423-8842384.35084.42
473996-7399670.58870.64
565632-6563262.60962.66
681628-8162877.86877.93
15min198752-9875294.20394.545.7294.3894.725.73
2103185-10318598.43298.63
3103955-10395599.16799.38
498543-9854394.00494.17
588485-8848584.40984.56
6101722-10172297.03697.23
20min1104800-10480099.973100.252.63100.30100.582.65
2105644-105644100.778101.14
3107196-107196102.258102.64
4106418-106418101.516101.84
599725-9972595.13195.42
6106737-106737101.820102.17
30min1105524-105524100.663101.480.82101.16101.990.83
2105947-105947101.067101.60
3107412-107412102.464103.01
4107438-107438102.489102.98
5105556-105556100.694101.15
6106412-106412101.510102.03
45min1105292-105292100.442101.490.74101.11102.170.75
2106293-106293101.397102.10
3107210-107210102.272102.99
4107157-107157102.221102.89
5105706-105706100.837101.46
6106696-106696101.781102.47
60min1104992-104992100.156101.480.84100.99102.320.83
2105530-105530100.669101.54
3106962-106962102.035102.92
4107014-107014102.085102.92
5106966-106966102.039102.83
6106813-106813101.893102.75
极限1105483-105483100.624101.410.87101.62102.420.87
2105252-105252100.404101.44
3107110-107110102.176103.24
4107599-107599102.643103.65
5105985-105985101.103102.06
6106387-106387101.487102.52
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%
110.159094499090629094599091799079719090240.07
210.109133649129819131720.03
单位质量响应值RSD%判断
89559.0190413.070.68数据可信
供试品溶液-206397批-恩格列净-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%
5min1389154-38915438.92241.9513.0338.9241.9513.03
2454420-45442045.45045.45
3506388-50638850.64850.65
4383514-38351438.35838.36
5357147-35714735.72135.72
6425922-42592242.60042.60
10min1741285-74128574.14276.949.0774.2177.019.07
2832200-83220083.23583.31
3847175-84717584.73384.82
4733729-73372973.38673.45
5662698-66269866.28266.34
6798515-79851579.86679.94
15min1919655-91965591.98291.854.6592.1792.054.66
2945451-94545194.56294.78
3953574-95357495.37495.60
4916254-91625491.64291.83
5836477-83647783.66383.83
6938788-93878893.89594.10
20min1956532-95653295.67095.782.0696.0196.132.08
2960359-96035996.05396.43
3973533-97353397.37197.76
4968071-96807196.82497.16
5919414-91941491.95892.27
6967947-96794796.81297.17
30min1957273-95727395.74496.430.7296.2596.940.73
2958708-95870895.88896.42
3971889-97188997.20697.75
4972214-97221497.23997.74
5958293-95829395.84696.31
6966164-96616496.63497.16
45min1956104-95610495.62796.530.6796.2997.210.68
2965803-96580396.59797.29
3971414-97141497.15997.87
4971764-97176497.19497.86
5959184-95918495.93596.56
6966659-96665996.68397.37
60min1954154-95415495.43296.360.7196.2597.190.71
2956491-95649195.66696.52
3969453-96945396.96397.83
4970677-97067797.08597.91
5963964-96396496.41497.20
6965883-96588396.60597.45
极限1953778-95377895.39596.080.7396.3797.070.74
2953828-95382895.40096.41
3967786-96778696.79697.83
4968670-96867096.88497.87
5955700-95570095.58796.53
6963719-96371996.38997.39
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DC033-12306002对照品来源中检院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%
19.89 9196392026920269206292255920660.13
29.929240992210923100.16
单位质量响应值RSD%判断
9309.009305.440.03数据可信
供试品溶液-206397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%
5min132948-3294831.53935.3212.5331.5435.3212.52
232605-3260531.21031.21
342408-4240840.59440.59
438186-3818636.55336.55
542081-4208140.28140.28
633178-3317831.75931.76
10min167214-6721464.33973.239.8364.3973.299.84
270674-7067467.65167.70
384406-8440680.79580.86
479626-7962676.22076.28
584945-8494581.31181.38
672156-7215669.06969.12
15min188553-8855384.76593.606.0284.9293.786.02
293845-9384589.83190.00
3102988-10298898.58398.78
4101977-10197797.61597.80
5102855-10285598.45598.66
696474-9647492.34792.52
20min1101663-10166397.314100.442.1797.62100.782.18
2103920-10392099.47599.79
3106932-106932102.358102.72
4106069-106069101.532101.88
5107506-107506102.907103.27
6103476-10347699.05099.37
30min1103395-10339598.972101.511.3399.44102.021.34
2107117-107117102.535103.02
3107133-107133102.550103.09
4105973-105973101.440101.96
5106761-106761102.194102.73
6105898-105898101.368101.86
45min1103460-10346099.034101.461.2699.66102.131.27
2107172-107172102.588103.24
3106809-106809102.240102.95
4105882-105882101.353102.04
5106617-106617102.056102.76
6105999-105999101.465102.12
60min1103119-10311998.708101.361.4199.50102.201.42
2107411-107411102.816103.64
3106657-106657102.095102.97
4105650-105650101.131101.99
5106531-106531101.974102.85
6105978-105978101.445102.27
极限1102815-10281598.417101.301.5299.37102.311.53
2107412-107412102.817103.81
3106372-106372101.822102.87
4106401-106401101.850102.88
5106493-106493101.938102.99
6105443-105443100.933101.93
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%
110.159062359059739050809054599056259056740.05
210.109065379077969071660.10
单位质量响应值RSD%判断
89228.9789818.420.47数据可信
供试品溶液-206397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%
5min1371554-37155437.35340.6710.4537.3540.6810.45
2362157-36215736.40936.41
3452259-45225945.46745.47
4416790-41679041.90141.90
5454162-45416245.65845.66
6370632-37063237.26137.26
10min1643814-64381464.72572.028.2464.7972.098.25
2669643-66964367.32167.38
3779727-77972778.38878.46
4742976-74297674.69474.76
5780132-78013278.42978.51
6681930-68193068.55768.62
15min1798108-79810880.23686.984.9180.4187.164.92
2838440-83844084.29184.46
3902029-90202990.68490.89
4895841-89584190.06290.26
5902225-90222590.70490.91
6854233-85423385.87986.06
20min1887171-88717189.19091.451.7189.4991.781.73
2903319-90331990.81391.13
3924314-92431492.92493.28
4916778-91677892.16792.51
5926660-92666093.16093.52
6899805-89980590.46090.78
30min1895506-89550690.02892.141.2090.4892.621.21
2924718-92471892.96593.43
3923711-92371192.86493.38
4917428-91742892.23292.73
5922298-92229892.72293.23
6915335-91533592.02192.49
45min1895093-89509389.98792.011.1890.5992.651.19
2925564-92556493.05093.67
3921015-92101592.59393.26
4915339-91533992.02292.67
5920973-92097392.58893.26
6913609-91360991.84892.47
60min1893491-89349189.82591.931.2190.5892.721.22
2925003-92500392.99393.77
3920500-92050092.54193.36
4913872-91387291.87492.68
5919357-91935792.42693.25
6914342-91434291.92292.70
极限1891339-89133989.60991.691.2390.5192.631.24
2923336-92333692.82693.76
3917267-91726792.21693.19
4912723-91272391.75992.72
5917709-91770992.26093.24
6909687-90968791.45492.38
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