非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
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(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983021723021143019683023003020513021210.05
210.933028763031143029950.06
单位质量响应值RSD%判断
27515.5727721.410.53数据可信
供试品溶液-6032401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%
5min148446-4844678.93676.3019.5678.9476.3019.56
229494-2949448.05748.06
351515-5151583.93783.94
444868-4486873.10673.11
551568-5156884.02384.02
655077-5507789.74189.74
10min158841-5884195.87495.511.9396.7596.361.92
259254-5925496.54697.08
358031-5803194.55495.49
456607-5660792.23493.05
559531-5953196.99897.93
659431-5943196.83597.83
15min157283-5728393.33595.361.2795.2897.271.19
259369-5936996.73498.34
358772-5877295.76197.74
458312-5831295.01296.85
559116-5911696.32298.33
658305-5830595.00097.07
20min156889-5688992.69395.131.4195.6798.091.35
258895-5889595.96198.64
359112-5911296.31599.36
458477-5847795.28098.17
558849-5884995.88798.97
658073-5807394.62297.75
30min156048-5604891.32394.561.8395.3398.581.82
257906-5790694.35098.10
358121-5812194.70098.82
458294-5829494.98298.93
558913-5891395.991100.14
658924-5892496.009100.19
45min155794-5579490.90992.811.3995.9397.891.37
257224-5722493.23998.03
356451-5645191.97997.15
456909-5690992.72697.73
558114-5811494.68999.90
657282-5728293.33398.58
60min155839-5583990.98292.981.4297.0299.081.36
257714-5771494.03799.87
356617-5661792.25098.44
456865-5686592.65498.69
558093-5809394.655100.92
657252-5725293.28499.57
90min154537-5453788.86192.232.0395.9199.371.93
257106-5710693.04799.92
356808-5680892.56199.78
457013-5701392.89599.96
557919-5791994.371101.69
656249-5624991.65098.97
120min154943-5494389.52291.161.1897.5599.321.08
256545-5654592.132100.04
356082-5608291.37899.62
456417-5641791.924100.02
556372-5637291.851100.22
655330-5533090.15398.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限154254-5425488.40090.951.6197.43100.121.55
256095-5609591.399100.33
355449-5544990.34799.61
456354-5635491.821100.94
556860-5686092.646102.03
655890-5589091.065100.41
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.283883173886293891783895073887823888830.13
211.353909863916703913280.13
单位质量响应值RSD%判断
34475.4434478.240.01数据可信
供试品溶液-6032401批-非奈利酮-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%
5min116087-1608720.97630.3252.8120.9830.3252.81
215718-1571820.49520.49
335597-3559746.41646.42
47078-70789.2299.23
527046-2704635.26635.27
637997-3799749.54549.55
10min150733-5073366.15281.0528.7266.3881.3928.78
269972-6997291.23891.47
373974-7397496.45696.97
430697-3069740.02640.13
574589-7458997.25897.65
672989-7298995.17295.72
15min156354-5635473.48187.9520.6974.4589.1920.84
276380-7638099.593100.83
378007-78007101.715103.30
444069-4406957.46258.01
574961-7496197.74399.22
674940-7494097.71699.32
20min159955-5995578.17690.4215.4979.9692.6315.76
275925-7592599.000101.35
377672-77672101.278104.00
451891-5189167.66268.85
575099-7509997.923100.48
675508-7550898.456101.15
30min165799-6579985.79792.8811.3488.4596.1011.75
274800-7480097.533100.98
376636-7663699.927103.77
457232-5723274.62676.56
575078-7507897.896101.54
677825-77825101.477105.27
45min174345-7434596.94094.067.32100.5598.317.75
274299-7429996.880101.41
373678-7367896.070101.02
461448-6144880.12382.89
573660-7366096.047100.78
675383-7538398.293103.21
60min174745-7474597.46195.065.27102.14100.365.80
274219-7421996.776102.38
374193-7419396.742102.76
465159-6515984.96288.62
573728-7372896.135101.94
675393-7539398.306104.31
90min172488-7248894.51895.021.77100.28101.382.60
273673-7367396.064102.75
374234-7423496.795103.89
470531-7053191.96796.57
573135-7313595.362102.23
673184-7318495.426102.53
120min173374-7337495.67494.431.14102.49101.841.66
272375-7237594.371102.12
373111-7311195.331103.50
471509-7150993.24298.86
571393-7139393.091101.02
672748-7274894.857103.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限172543-7254394.59093.940.79102.47102.401.50
271793-7179393.612102.41
372504-7250494.539103.77
471301-7130192.97199.63
571544-7154493.288102.25
672568-7256894.623103.84
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
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(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983018723019103022033018073017873019160.06
210.933029123024723026920.11
单位质量响应值RSD%判断
27496.9027693.690.51数据可信
供试品溶液-6032401素片批-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%
5min159222-5922296.57591.545.5496.5891.545.54
250344-5034482.09882.10
356471-5647192.08992.09
455482-5548290.47690.48
557956-5795694.51194.51
657318-5731893.47093.47
10min162533-62533101.97598.382.47103.0599.402.45
260919-6091999.343100.25
358613-5861395.58296.61
459351-5935196.78697.79
559301-5930196.70497.75
661259-6125999.897100.94
15min160915-6091599.33696.842.69101.5498.952.65
260750-6075099.067101.08
357267-5726793.38795.47
457678-5767894.05796.14
559264-5926496.64498.77
660428-6042898.542100.69
20min159778-5977897.48295.472.31100.7998.662.28
259965-5996597.787100.90
356832-5683292.67895.80
457138-5713893.17796.30
558246-5824694.98498.18
659310-5931096.71999.96
30min159528-5952897.07495.302.90101.4799.552.84
259979-5997997.810102.01
356879-5687992.75496.91
456505-5650592.14596.31
557428-5742893.65097.90
660320-6032098.366102.68
45min159066-5906696.32194.942.69101.79100.252.58
260958-6095899.406104.70
357891-5789194.40599.59
457231-5723193.32998.51
556655-5665592.38997.68
657523-5752393.80599.22
60min158086-5808694.72392.762.75101.2699.122.69
258599-5859995.559101.95
355216-5521690.04396.27
455352-5535290.26496.49
555861-5586191.09497.42
658171-5817194.861101.31
90min157235-5723593.33591.512.69100.9398.902.63
257953-5795394.506101.96
354013-5401388.08195.31
454972-5497289.64596.87
555580-5558090.63697.97
656956-5695692.880100.39
120min156293-5629391.79990.142.56100.4398.552.50
256733-5673392.516101.02
352911-5291186.28494.50
454560-5456088.97397.19
555058-5505889.78598.13
656111-5611191.502100.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157151-5715193.19890.742.24102.85100.162.21
257010-5701092.968102.50
354310-5431088.56597.74
454931-5493189.57898.79
554535-5453588.93298.27
655938-5593891.220100.78
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.283887233893403894033889853889143890730.08
211.353911443897703904570.25
单位质量响应值RSD%判断
34492.2934401.500.19数据可信
供试品溶液-6032401素片批-非奈利酮-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%
5min159432-5943277.56269.6833.0177.5669.6833.01
223446-2344630.59830.60
359269-5926977.34977.35
464679-6467984.41084.41
571521-7152193.33993.34
642029-4202954.85054.85
10min171643-7164393.49892.1111.8194.3692.8811.97
255036-5503671.82572.16
377046-77046100.549101.41
475846-7584698.98399.92
575889-7588999.039100.08
668020-6802088.77089.38
15min172652-7265294.81594.047.7796.7295.847.99
261010-6101079.62180.76
375607-7560798.671100.65
474555-7455597.29899.34
575909-7590999.065101.20
672615-7261594.76796.36
20min173152-7315295.46793.485.3198.4296.325.61
264442-6444284.10086.12
374567-7456797.314100.39
473566-7356696.00899.13
573688-7368896.16799.41
670351-7035191.81294.46
30min173476-7347695.89095.812.3699.9199.692.57
270539-7053992.05795.01
374176-7417696.804100.96
473136-7313695.44699.63
573268-7326895.61999.93
675871-7587199.016102.68
45min173083-7308395.37796.191.57100.46101.141.45
274452-7445297.164101.14
375343-7534398.327103.56
474141-7414196.758102.00
572128-7212894.13199.50
673107-7310795.409100.18
60min171928-7192893.87094.061.77100.01100.081.52
272222-7222294.25499.31
372172-7217294.188100.51
470662-7066292.21898.54
571138-7113892.83999.25
674339-7433997.016102.85
90min170417-7041791.89892.730.9899.0899.790.68
271721-7172193.60099.71
370480-7048091.98099.35
470582-7058292.11399.46
571086-7108692.771100.22
672041-7204194.017100.92
120min169168-6916890.26891.090.8398.4799.180.73
269987-6998791.33798.48
369727-6972790.99899.39
469371-6937190.53398.90
569699-6969990.96199.44
670819-7081992.423100.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限169231-6923190.35091.441.3899.56100.551.08
270807-7080792.407100.57
370993-7099392.650102.05
469487-6948790.684100.06
568914-6891489.93799.42
670985-7098592.639101.62
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