恩格列净二甲双胍片项目信息
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%
110.529886699138988959905798761989430.16
210.439889698703988000.14
单位质量响应值RSD%判断
9405.239472.670.51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%
5min138737-3873736.93631.7712.3736.9431.7712.37
229956-2995628.56328.56
336344-3634434.65434.65
434771-3477133.15433.15
527646-2764626.36126.36
632473-3247330.96330.96
10min179320-7932075.63266.5511.3775.6966.6011.37
261585-6158558.72258.77
374836-7483671.35771.41
474082-7408270.63870.69
559190-5919056.43856.48
669755-6975566.51266.56
15min199220-9922094.60787.776.3294.7987.946.32
286625-8662582.59882.74
393633-9363389.28089.46
495385-9538590.95091.12
583620-8362079.73279.87
693844-9384489.48189.64
20min1102149-10214997.40094.832.1097.7595.142.12
298171-9817193.60793.89
397471-9747192.93993.26
499659-9965995.02695.35
597525-9752592.99193.26
6101717-10171796.98897.30
30min1102060-10206097.31596.121.4597.8296.591.45
299778-9977895.13995.58
399171-9917194.56095.04
499749-9974995.11195.59
5101333-10133396.62297.05
6102777-10277797.99998.47
45min1102030-10203097.28696.231.3397.9696.861.33
2101530-10153096.81097.41
398793-9879394.20094.84
499896-9989695.25295.89
5101029-10102996.33296.92
6102265-10226597.51098.15
60min1101548-10154896.82796.511.8197.6697.301.81
299695-9969595.06095.82
398996-9899694.39395.19
4101400-10140096.68697.49
5101414-10141496.69997.45
6104268-10426899.420100.22
极限1101655-10165596.92995.871.2397.9296.821.23
2100110-10011095.45696.37
398986-9898694.38495.34
499611-9961194.98095.94
5100697-10069796.01596.92
6102237-10223797.48498.45
恩格列净二甲双胍片项目信息
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10
标示量(mg)1000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%
110.189401809413199421129417499417509414220.08
210.169429069437159433100.07
单位质量响应值RSD%判断
92477.6092845.470.29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%
5min1450427-45042743.74938.989.9843.7538.989.98
2367044-36704435.65035.65
3432276-43227641.98641.99
4417294-41729440.53140.53
5344888-34488833.49833.50
6396047-39604738.46738.47
10min1812652-81265278.93171.219.3879.0071.279.38
2659617-65961764.06764.13
3777841-77784175.55075.62
4770281-77028174.81674.88
5640913-64091362.25162.31
6737423-73742371.62471.69
15min1963923-96392393.62488.405.1293.8388.585.13
2865371-86537184.05284.22
3921527-92152789.50689.70
4940173-94017391.31791.51
5842179-84217981.79981.96
6927731-92773190.10990.29
20min1979033-97903395.09293.851.4295.4594.181.43
2959064-95906493.15293.46
3950099-95009992.28192.63
4966958-96695893.91994.26
5956671-95667192.92093.22
6985443-98544395.71496.05
30min1980912-98091295.27494.660.9895.7995.150.98
2971153-97115394.32694.79
3962663-96266393.50294.00
4966958-96695893.91994.42
5977568-97756894.94995.40
6988531-98853196.01496.51
45min1977927-97792794.98494.520.9995.6695.160.99
2973549-97354994.55995.18
3959117-95911793.15793.81
4966435-96643593.86894.53
5974671-97467194.66895.28
6987165-98716595.88196.53
60min1974783-97478394.67995.122.6795.5195.922.65
2962251-96225193.46294.24
3955633-95563392.81993.63
4977328-97732894.92695.74
5976492-97649294.84595.61
61029444-102944499.988100.80
极限1974547-97454794.65693.961.0095.6594.921.00
2963982-96398293.63094.56
3954915-95491592.74993.71
4960365-96036593.27894.25
5969058-96905894.12395.05
6981142-98114295.29696.28
恩格列净二甲双胍片项目信息
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%
110.529902799073993289928299093991610.14
210.439928699407993460.09
单位质量响应值RSD%判断
9425.959525.020.74数据可信
供试品溶液-311952B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%
5min118864-1886417.91817.077.3617.9217.077.38
217924-1792417.02517.03
316006-1600615.20315.20
418514-1851417.58517.59
519600-1960018.61718.62
616909-1690916.06116.06
10min141283-4128339.21238.967.0539.2438.997.05
242355-4235540.23140.26
337599-3759935.71335.74
445560-4556043.27543.30
541070-4107039.01039.04
638267-3826736.34836.37
15min159894-5989456.89058.418.4656.9958.508.45
266114-6611462.79862.89
356284-5628453.46153.55
469549-6954966.06166.16
559541-5954156.55556.65
657559-5755954.67254.76
20min176863-7686373.00874.567.8273.2074.757.82
284114-8411479.89580.10
374168-7416870.44870.62
488094-8809483.67683.89
574264-7426470.53970.73
673460-7346069.77669.95
30min195311-9531190.53191.382.0690.8491.702.07
298001-9800193.08693.42
396275-9627591.44691.74
497834-9783492.92793.28
597093-9709392.22392.53
692726-9272688.07588.37
45min199235-9923594.25894.050.6794.7294.520.67
2100104-10010495.08395.57
398739-9873993.78794.23
498454-9845493.51694.02
598307-9830793.37693.84
699285-9928594.30594.75
60min1100003-10000394.98794.140.6495.6194.760.63
299436-9943694.44995.10
398780-9878093.82694.43
498610-9861093.66494.33
598348-9834893.41594.03
699465-9946594.47695.08
极限199137-9913794.16593.900.6494.9494.680.63
299614-9961494.61895.42
398925-9892593.96394.72
498186-9818693.26194.08
598010-9801093.09493.87
699249-9924994.27195.03
恩格列净二甲双胍片项目信息
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10
标示量(mg)1000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%
110.189404759424029435079426399425159423080.12
210.169583059593299588170.08
单位质量响应值RSD%判断
92564.6494371.751.37数据可信
供试品溶液-311952B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%
5min1257069-25706924.75524.025.7824.7624.025.78
2247253-24725323.81023.81
3227161-22716121.87521.88
4259448-25944824.98424.98
5266136-26613625.62825.63
6239435-23943523.05723.06
10min1488070-48807047.00046.556.4347.0446.596.43
2496295-49629547.79247.83
3447950-44795043.13743.17
4533765-53376551.40151.44
5480011-48001146.22446.27
6454573-45457343.77543.81
15min1663430-66343063.88764.467.5764.0164.587.56
2709941-70994168.36668.49
3618192-61819259.53159.64
4748771-74877172.10572.23
5648594-64859462.45962.58
6627276-62727660.40660.52
20min1808470-80847077.85478.367.0878.0878.597.08
2860565-86056582.87183.10
3770874-77087474.23474.44
4905470-90547087.19587.44
5772661-77266174.40674.63
6764521-76452173.62273.83
30min1956592-95659292.11892.361.8592.4792.721.86
2967447-96744793.16493.54
3954246-95424691.89292.22
4980442-98044294.41594.81
5967405-96740593.16093.51
6928371-92837189.40189.74
45min1995212-99521295.83794.570.8796.3595.080.88
2986515-98651595.00095.53
3973554-97355493.75294.24
4984593-98459394.81595.36
5973202-97320293.71894.22
6979065-97906594.28294.77
60min1998806-99880696.18394.610.9496.8595.280.95
2984592-98459294.81595.50
3973553-97355393.75294.39
4982652-98265294.62895.34
5973826-97382693.77894.44
6981584-98158494.52595.17
极限1994521-99452195.77194.630.7696.6095.460.77
2984756-98475694.83095.67
3972796-97279693.67994.48
4983413-98341394.70195.57
5976871-97687194.07194.89
6983902-98390294.74895.55
恩格列净二甲双胍片项目信息
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%
110.529920399089992639903799106991400.10
210.439946499752996080.21
单位质量响应值RSD%判断
9423.959550.140.95数据可信
供试品溶液-301793A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%
5min133373-3337331.66126.5115.5631.6626.5115.55
231095-3109529.50029.50
323970-2397022.74022.74
422953-2295321.77621.78
530788-3078829.20929.21
625457-2545724.15124.15
10min165146-6514661.80455.889.5661.8655.929.57
261412-6141258.26258.31
355320-5532052.48252.52
450561-5056147.96748.00
564074-6407460.78760.84
656902-5690253.98354.02
15min184990-8499080.63077.545.5880.7977.685.59
283023-8302378.76478.91
379800-7980075.70775.83
473853-7385370.06570.18
586794-8679482.34282.49
681963-8196377.75977.89
20min194176-9417689.34589.571.3589.6489.841.35
294424-9442489.58089.86
395708-9570890.79991.05
492097-9209787.37387.61
594737-9473789.87790.16
695354-9535490.46390.72
30min198463-9846393.41295.302.2693.8595.722.23
299081-9908193.99994.43
3102086-10208696.84997.25
4102121-10212196.88397.26
597811-9781192.79493.23
6103164-10316497.87298.28
45min199928-9992894.80295.772.0595.4096.352.02
299106-9910694.02294.61
3101804-10180496.58297.15
4103110-10311097.82198.36
598477-9847793.42594.02
6103285-10328597.98798.56
60min198484-9848493.43295.492.2594.1896.222.22
299098-9909894.01594.75
3101748-10174896.52997.25
4102823-10282397.54998.25
598384-9838493.33794.08
6103362-10336298.06098.80
极限198748-9874893.68395.702.5894.5996.602.55
298678-9867893.61694.51
3101563-10156396.35397.24
4103535-10353598.22499.09
598516-9851693.46294.37
6104222-10422298.87699.78
恩格列净二甲双胍片项目信息
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10
标示量(mg)1000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%
110.189383229392389383639373019387329383910.08
210.169451119459869455480.07
单位质量响应值RSD%判断
92179.8693065.750.68数据可信
供试品溶液-301793A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%
5min1414264-41426440.25434.7713.1140.2534.7713.11
2390069-39006937.90337.90
3317682-31768230.86930.87
4303098-30309829.45229.45
5393784-39378438.26438.26
6328176-32817631.88931.89
10min1730956-73095671.02764.139.2771.0964.199.27
2686097-68609766.66866.73
3625380-62538060.76860.82
4570985-57098555.48355.53
5715157-71515769.49269.56
6631535-63153561.36761.42
15min1899777-89977787.43283.605.6187.6283.775.62
2875968-87596885.11885.29
3839682-83968281.59281.75
4780414-78041475.83375.97
5914613-91461388.87389.05
6851699-85169982.76082.92
20min1976471-97647194.88493.761.8195.2294.061.83
2975081-97508194.74995.07
3971619-97161994.41394.70
4932144-93214490.57790.84
5975930-97593094.83295.16
6958130-95813093.10293.40
30min11008520-100852097.99898.120.5898.4998.580.56
21009643-100964398.10898.58
31014695-101469598.59899.04
41010936-101093698.23398.65
5999377-99937797.11097.60
61015567-101556798.68399.13
45min11016206-101620698.74598.480.4999.4099.110.48
21010866-101086698.22698.86
31017279-101727998.85099.46
41016400-101640098.76499.35
51004515-100451597.60998.26
61015668-101566898.69399.31
60min11008242-100824297.97198.270.4998.7999.050.46
21008781-100878198.02498.83
31015317-101531798.65999.43
41013548-101354898.48799.23
51004534-100453497.61198.42
61017235-101723598.84599.62
极限11008163-100816397.96498.280.7198.9499.230.68
21005865-100586597.74098.71
31013267-101326798.46099.40
41020151-102015199.129100.04
51002556-100255697.41998.39
61018576-101857698.97699.92
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