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%
110.159442194643943989400694826944590.33
210.109368394983943330.98
单位质量响应值RSD%判断
9306.319339.900.26数据可信
供试品溶液-24090301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%
5min152293-5229349.97139.1020.3249.9739.1020.32
238152-3815236.45836.46
336094-3609434.49134.49
431234-3123429.84729.85
549943-4994347.72547.73
637781-3778136.10336.10
10min195170-9517090.94475.7512.7891.0375.8212.79
278806-7880675.30775.37
373362-7336270.10570.16
467487-6748764.49064.54
586862-8686283.00583.08
673930-7393070.64770.71
15min1101954-10195497.42793.363.8397.6693.543.85
299097-9909794.69794.88
396607-9660792.31792.49
491277-9127787.22487.38
5100297-10029795.84496.06
696926-9692692.62292.80
20min1102404-10240497.85797.091.4798.2597.441.49
2102870-10287098.30298.65
3100522-10052296.05996.39
499210-9921094.80595.11
5103010-10301098.43698.81
6101598-10159897.08797.42
30min1102884-10288498.31697.440.8998.8897.950.91
2103036-10303698.46198.97
3101309-10130996.81197.30
4100708-10070896.23696.70
5101724-10172497.20797.75
6102167-10216797.63098.12
45min1102608-10260898.05297.341.0798.7898.011.08
2103157-10315798.57799.25
3101246-10124696.75097.40
4100282-10028295.82996.45
5101304-10130496.80697.51
6102549-10254997.99698.65
60min1102168-10216897.63197.370.7598.5298.200.76
2102840-10284098.27499.11
3101725-10172597.20898.02
4100677-10067796.20796.99
5101534-10153497.02697.89
6102415-10241597.86798.69
极限1103740-10374099.13498.730.60100.1899.730.61
2103412-10341298.82099.82
3102786-10278698.22299.19
4102573-10257398.01898.96
5103191-10319198.60999.64
6104230-10423099.602100.59
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DA-11412209074对照品来源工作对照品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%
110.015176545133175176965139805193915164080.51
29.945029285034855032060.08
单位质量响应值RSD%判断
51589.2150624.351.34数据可信
供试品溶液-24090301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%
5min1345173-34517360.73049.0617.0360.7349.0617.03
2266286-26628646.85146.85
3252606-25260644.44444.44
4222378-22237839.12639.13
5327988-32798857.70757.71
6258521-25852145.48545.48
10min1555135-55513597.67184.7210.8997.7784.8010.90
2473389-47338983.28983.37
3451526-45152679.44279.52
4420231-42023173.93674.00
5534802-53480294.09494.19
6453949-45394979.86879.94
15min1580365-580365102.11099.352.48102.3799.572.50
2570277-570277100.335100.55
3561208-56120898.74098.95
4540061-54006195.01995.21
5573367-573367100.879101.13
6562740-56274099.00999.22
20min1580041-580041102.053101.631.48102.49102.021.48
2578094-578094101.711102.09
3592392-592392104.226104.60
4567132-56713299.782100.13
5574613-574613101.098101.52
6573380-573380100.881101.26
30min1578451-578451101.774101.130.43102.38101.690.44
2577058-577058101.528102.08
3572840-572840100.786101.33
4574734-574734101.120101.63
5572578-572578100.740101.33
6573136-573136100.838101.38
45min1578326-578326101.752100.690.77102.53101.410.79
2576056-576056101.352102.07
3571762-571762100.597101.31
4565941-56594199.572100.25
5570360-570360100.350101.11
6571159-571159100.491101.20
60min1573393-573393100.884100.430.70101.83101.320.72
2575923-575923101.329102.22
3571180-571180100.494101.37
4564196-56419699.265100.11
5570504-570504100.375101.30
6569597-569597100.216101.09
极限1573167-573167100.84499.990.71101.96101.050.74
2571716-571716100.589101.65
3568007-56800799.936100.98
4561606-56160698.81099.82
5567538-56753899.853100.95
6567867-56786799.911100.96
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%
110.159366894049939089348093901938010.25
210.109342593204933140.17
单位质量响应值RSD%判断
9241.489239.010.02数据可信
供试品溶液-24090301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%
5min134850-3485033.60140.8121.1533.6040.8121.15
256954-5695454.91354.91
339414-3941438.00238.00
433388-3338832.19132.19
548621-4862146.87946.88
640723-4072339.26439.26
10min169336-6933666.85177.5413.6166.9177.6113.62
297851-9785194.34494.44
374689-7468972.01272.08
472327-7232769.73569.79
588927-8892785.74085.82
679390-7939076.54576.61
15min192344-9234489.03593.863.6589.2094.063.67
2101691-10169198.04798.30
394850-9485091.45191.63
495947-9594792.50992.68
599980-9998096.39796.62
699286-9928695.72895.92
20min199831-9983196.25397.340.8096.5797.700.84
2102145-10214598.48498.90
3101416-10141697.78298.12
4100356-10035696.76097.08
5101062-10106297.44097.82
6100950-10095097.33297.68
30min1101360-10136097.72898.060.5598.2098.570.56
2102527-10252798.85399.43
3102057-10205798.40098.90
4101812-10181298.16398.65
5100972-10097297.35397.90
6101477-10147797.84098.36
45min1101571-10157197.93198.160.5698.5798.840.57
2102374-10237498.70599.45
3102229-10222998.56599.23
4101865-10186598.21498.86
5100797-10079797.18597.89
6102003-10200398.34899.03
60min1101834-10183498.18598.340.5698.9999.180.55
2102267-10226798.60299.51
3102364-10236498.69699.52
4102592-10259298.91599.73
5101003-10100397.38398.25
6101897-10189798.24599.09
极限1104188-104188100.45499.840.87101.42100.850.85
2103758-103758100.040101.11
3104433-104433100.690101.68
4103629-10362999.915100.89
5101889-10188998.23899.27
6103433-10343399.726100.73
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DA-11412209074对照品来源工作对照品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%
110.015090255097845097845083465079475089770.17
29.945042405040185041290.04
单位质量响应值RSD%判断
50846.8550717.200.19数据可信
供试品溶液-24090301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%
5min1245358-24535843.44150.5417.5443.4450.5417.54
2366408-36640864.87364.87
3269328-26932847.68547.68
4232891-23289141.23441.23
5321303-32130356.88756.89
6277578-27757849.14549.15
10min1425976-42597675.42085.2610.9975.4985.3411.00
2562553-56255399.60199.71
3455009-45500980.56080.64
4440760-44076078.03778.11
5525838-52583893.10093.20
6479068-47906884.82084.90
15min1539579-53957995.53399.022.4195.7399.242.43
2572841-572841101.422101.70
3549544-54954497.29797.51
4554431-55443198.16398.36
5568948-568948100.733100.98
6570287-570287100.970101.19
20min1568507-568507100.655101.100.47101.01101.490.49
2572212-572212101.311101.75
3573651-573651101.566101.94
4566992-566992100.387100.75
5573056-573056101.460101.88
6571778-571778101.234101.63
30min1572619-572619101.383101.220.46101.91101.780.43
2570782-570782101.058101.67
3574042-574042101.635102.18
4574518-574518101.719102.25
5567561-567561100.487101.07
6570756-570756101.053101.61
45min1573015-573015101.453101.020.46102.15101.760.43
2569862-569862100.895101.68
3573376-573376101.517102.23
4570680-570680101.040101.74
5566236-566236100.253101.01
6570401-570401100.990101.72
60min1572241-572241101.316101.090.70102.18101.980.67
2568255-568255100.610101.56
3572552-572552101.371102.25
4577209-577209102.195103.06
5565881-565881100.190101.11
6569643-569643100.856101.75
极限1573018-573018101.453100.740.54102.49101.810.52
2567277-567277100.437101.55
3571844-571844101.246102.30
4568267-568267100.612101.65
5564671-56467199.976101.06
6568931-568931100.730101.79
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%
110.159328093112932769293793312931830.17
210.109368793871937790.14
单位质量响应值RSD%判断
9180.599285.050.81数据可信
供试品溶液-24090301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%
5min152408-5240850.57243.0420.4350.5743.0420.44
245876-4587644.26944.27
338018-3801836.68636.69
434927-3492733.70333.70
557946-5794655.91655.92
638467-3846737.11937.12
10min194134-9413490.83679.5412.9090.9279.6112.91
284905-8490581.93182.00
371819-7181969.30369.36
471681-7168169.17069.23
595180-9518091.84691.94
676823-7682374.13274.19
15min199939-9993996.43892.874.1396.6793.084.15
299850-9985096.35296.56
391047-9104787.85888.03
491890-9189088.67188.84
598717-9871795.25995.51
696031-9603192.66792.85
20min1100379-10037996.86395.121.4697.2695.481.49
299523-9952396.03796.41
396881-9688193.48793.81
496859-9685993.46693.79
599136-9913695.66396.07
698659-9865995.20395.54
30min1100761-10076197.23195.801.0097.7996.321.03
299638-9963896.14896.68
398347-9834794.90295.38
498022-9802294.58895.06
599610-9961096.12196.69
699266-9926695.78996.29
45min1100789-10078997.25896.360.7097.9897.040.74
2100049-10004996.54497.24
399418-9941895.93596.57
498773-9877395.31395.95
5100261-10026196.74997.47
699840-9984096.34397.00
60min1100771-10077197.24196.901.0298.1297.741.04
2100186-10018696.67697.53
3100367-10036796.85197.65
499095-9909595.62496.42
5102155-10215598.57699.46
699952-9995296.45197.27
极限1102233-10223398.65298.500.4999.7099.500.48
2102512-10251298.92199.93
3102738-10273899.139100.10
4101682-10168298.12099.07
5101461-10146197.90798.96
6101855-10185598.28799.27
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DA-11412209074对照品来源工作对照品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%
110.015040615035125037815035175033755036490.06
29.945070835067895069360.05
单位质量响应值RSD%判断
50314.5950999.600.96数据可信
供试品溶液-24090301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%
5min1340020-34002060.35252.8116.9960.3552.8216.99
2303869-30386953.93553.94
3262684-26268446.62546.63
4242934-24293443.12043.12
5372226-37222666.06866.07
6263540-26354046.77746.78
10min1548711-54871197.39487.4710.4697.4987.5610.47
2503596-50359689.38689.48
3443068-44306878.64378.72
4440952-44095278.26778.34
5556486-55648698.77498.88
6464131-46413182.38182.46
15min1565866-565866100.43998.622.67100.7098.852.69
2573757-573757101.839102.08
3536642-53664295.25295.46
4539645-53964595.78595.99
5562658-56265899.869100.14
6555093-55509398.52798.74
20min1566803-566803100.60599.850.45101.04100.240.48
2563600-563600100.037100.45
3560900-56090099.55799.92
4559485-55948599.30699.67
5562284-56228499.803100.24
6562115-56211599.773100.15
30min1564908-564908100.26999.960.28100.87100.530.27
2564045-564045100.116100.69
3563357-56335799.993100.53
4563872-563872100.085100.61
5560501-56050199.486100.09
6562457-56245799.834100.38
45min1563106-56310699.94999.750.40100.71100.480.39
2562600-56260099.859100.60
3565375-565375100.352101.05
4560163-56016399.426100.12
5559160-55916099.248100.02
6561552-56155299.673100.39
60min1562736-56273699.883100.191.15100.81101.091.16
2561678-56167899.695100.60
3561256-56125699.620100.49
4559285-55928599.271100.13
5577162-577162102.444103.38
6564820-564820100.253101.13
极限1562912-56291299.91499.390.72101.01100.460.70
2560616-56061699.507100.58
3566108-566108100.482101.52
4557136-55713698.88999.91
5555883-55588398.66799.78
6557205-55720598.90199.95
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