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%
110.149400194070939649387093927939660.09
210.149371093880937950.13
单位质量响应值RSD%判断
9266.869250.000.13数据可信
加速6月-供试品溶液-2024120421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%
5min142715-4271541.52342.9712.7441.5242.9712.74
237326-3732636.28436.28
353372-5337251.88251.88
446258-4625844.96744.97
545646-4564644.37244.37
639894-3989438.78038.78
10min183528-8352881.19782.128.0681.2782.208.06
274006-7400671.94072.00
392448-9244889.86889.95
489695-8969587.19187.27
587390-8739084.95185.02
679819-7981977.59177.66
15min197924-9792495.19195.611.7895.4095.821.79
295287-9528792.62792.81
399442-9944296.66696.90
499824-9982497.03897.26
599802-9980297.01697.23
697879-9787995.14795.34
20min198881-9888196.12196.480.8996.4896.850.91
298648-9864895.89596.23
3100114-10011497.32097.72
4100083-10008397.28997.67
599795-9979597.00997.39
697984-9798495.24995.60
30min198374-9837495.62896.540.8296.1597.070.83
299022-9902296.25896.75
399538-9953896.76097.32
4100163-10016397.36797.91
5100269-10026997.47098.01
698533-9853395.78396.29
45min1100003-10000397.21296.980.7097.8997.670.71
299688-9968896.90597.56
399806-9980697.02097.74
4100189-10018997.39298.10
5100438-10043897.63598.34
698461-9846195.71396.38
60min198427-9842795.68096.520.7096.5297.370.71
299263-9926396.49297.31
399644-9964496.86397.75
4100150-10015097.35598.22
599712-9971296.92997.79
698528-9852895.77896.61
极限198429-9842995.68296.440.7796.6997.450.77
299700-9970096.91797.89
399435-9943596.66097.70
4100066-10006697.27398.30
599507-9950796.73097.76
698128-9812895.38996.38
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%
110.024963824976374977164975914969834972620.12
210.054938794936904937840.03
单位质量响应值RSD%判断
49626.9549132.740.71数据可信
加速6月-供试品溶液-2024120421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%
5min1253690-25369046.23947.7911.3046.2447.7911.30
2226404-22640441.26641.27
3311398-31139856.75756.76
4271391-27139149.46549.47
5269658-26965849.14949.15
6240500-24050043.83543.83
10min1455143-45514382.95783.726.9783.0383.806.98
2410461-41046174.81374.88
3496310-49631090.46090.55
4484591-48459188.32488.41
5472977-47297786.20786.29
6436413-43641379.54379.62
15min1521299-52129995.01595.261.3795.2395.481.38
2510556-51055693.05793.25
3527614-52761496.16696.41
4528125-52812596.25996.49
5528962-52896296.41196.64
6519301-51930194.65094.86
20min1522313-52231395.19995.700.7295.5796.080.73
2524414-52441495.58295.93
3527433-52743396.13396.54
4528510-52851096.32996.72
5528452-52845296.31896.70
6519218-51921894.63595.00
30min1521337-52133795.02295.610.6895.5596.150.69
2525235-52523595.73296.24
3526181-52618195.90496.47
4527261-52726196.10196.65
5528254-52825496.28296.83
6519283-51928394.64795.17
45min1527151-52715196.08195.760.9296.7796.460.92
2524807-52480795.65496.32
3525547-52554795.78996.51
4526427-52642795.94996.66
5531583-53158396.88997.60
6516887-51688794.21094.89
60min1519775-51977594.73795.220.6695.5996.080.67
2523270-52327095.37496.20
3523592-52359295.43396.32
4525486-52548695.77896.65
5525568-52556895.79396.66
6516984-51698494.22895.06
极限1519005-51900594.59795.040.6595.6196.060.66
2522142-52214295.16896.15
3523297-52329795.37996.42
4524275-52427595.55796.59
5524187-52418795.54196.57
6515841-51584194.02095.01
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%
110.149569795757955749532995670956050.18
210.149459694549945720.04
单位质量响应值RSD%判断
9428.509326.630.77数据可信
加速6月-供试品溶液-2024120421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%
5min139029-3902937.45942.6220.9537.4642.6220.95
262441-6244159.92959.93
336828-3682835.34635.35
442633-4263340.91840.92
540278-4027838.65738.66
645224-4522443.40443.40
10min175917-7591772.86378.6610.8572.9278.7310.86
298275-9827594.32194.42
374519-7451971.52171.58
482215-8221578.90778.98
576402-7640273.32873.39
684407-8440781.01181.08
15min195086-9508691.26093.122.6191.4493.322.63
299990-9999095.96796.22
393512-9351289.75089.93
497559-9755993.63493.83
596409-9640992.53092.72
699557-9955795.55195.76
20min197864-9786493.92794.981.1794.2695.341.18
299729-9972995.71696.13
398247-9824794.29494.62
498004-9800494.06194.42
599145-9914595.15695.50
6100798-10079896.74297.11
30min198176-9817694.22695.281.2094.7295.801.22
2100047-10004796.02296.60
398226-9822694.27494.76
498212-9821294.26194.77
5100437-10043796.39696.90
6100568-10056896.52297.05
45min198015-9801594.07195.141.2294.7295.811.23
299864-9986495.84696.58
397974-9797494.03294.67
498179-9817994.22994.90
5100066-10006696.04096.70
6100652-10065296.60297.29
60min198021-9802194.07795.300.9694.8896.130.98
299563-9956395.55796.45
398288-9828894.33395.13
499495-9949595.49296.32
599875-9987595.85796.68
6100500-10050096.45697.31
极限198529-9852994.56595.351.0495.5396.351.05
299568-9956895.56296.62
398386-9838694.42895.38
498519-9851994.55595.54
5100417-10041796.37797.36
6100688-10068896.63797.65
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%
110.024963594961974960694957424962754961280.05
210.054939764942054940900.04
单位质量响应值RSD%判断
49513.7749163.180.51数据可信
加速6月-供试品溶液-2024120421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%
5min1234950-23495042.85947.7617.7542.8647.7617.75
2351847-35184764.18264.18
3223918-22391840.84640.85
4254058-25405846.34446.34
5240473-24047343.86643.87
6265509-26550948.43348.43
10min1417653-41765376.18681.579.3776.2681.659.38
2524266-52426695.63495.74
3413367-41336775.40575.47
4449521-44952182.00082.08
5420641-42064176.73276.80
6457460-45746083.44883.53
15min1508420-50842092.74494.432.0392.9494.642.06
2529953-52995396.67296.94
3504710-50471092.06792.26
4521128-52112895.06295.28
5513232-51323293.62293.82
6528440-52844096.39696.62
20min1519505-51950594.76695.750.9295.1296.120.94
2529215-52921596.53796.96
3521203-52120395.07695.42
4522922-52292295.38995.76
5524613-52461395.69896.05
6531964-53196497.03997.42
30min1519735-51973594.80895.931.0395.3296.461.04
2528355-52835596.38096.97
3521205-52120595.07695.58
4522720-52272095.35295.88
5532529-53252997.14297.66
6530869-53086996.83997.38
45min1519863-51986394.83195.630.8195.5096.320.83
2527971-52797196.31097.06
3520221-52022194.89695.56
4521854-52185495.19495.88
5525791-52579195.91396.59
6529810-52981096.64697.35
60min1517859-51785994.46695.620.8795.2996.470.89
2526385-52638596.02196.93
3519380-51938094.74395.57
4527237-52723796.17697.03
5524928-52492895.75596.59
6529233-52923396.54097.41
极限1516951-51695194.30095.270.8695.2896.280.88
2525297-52529795.82296.89
3517864-51786494.46795.45
4520187-52018794.89095.90
5525887-52588795.93096.93
6527414-52741496.20997.23
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%
110.149543795313953089517095515953490.14
210.149337793577934770.16
单位质量响应值RSD%判断
9403.259218.641.41数据可信
加速6月-供试品溶液-2024120521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%
5min136478-3647835.26341.6511.0435.2641.6511.04
249505-4950547.85647.86
344275-4427542.80142.80
440603-4060339.25139.25
540718-4071839.36239.36
646945-4694545.38245.38
10min173028-7302870.59679.857.3970.6579.927.40
288493-8849385.54685.63
386764-8676483.87583.95
479976-7997677.31377.38
579580-7958076.93077.00
687746-8774684.82484.90
15min192461-9246189.38294.622.8189.5694.822.82
298243-9824394.97195.19
3100171-10017196.83597.05
498458-9845895.17995.37
599351-9935196.04396.24
698574-9857495.29195.51
20min197917-9791794.65696.311.4894.9896.671.48
298791-9879195.50195.88
3102028-10202898.63099.00
4100458-10045897.11397.47
599777-9977796.45496.81
698812-9881295.52195.90
30min198595-9859595.31296.261.0195.7996.781.01
298798-9879895.50896.05
3100506-10050697.15997.70
4100532-10053297.18497.70
5100402-10040297.05997.57
698596-9859695.31395.85
45min198534-9853495.25396.210.9895.8996.890.98
298749-9874995.46196.16
3100338-10033896.99797.70
4100564-10056497.21597.89
5100306-10030696.96697.64
698638-9863895.35396.05
60min198759-9875995.47096.161.3996.2797.001.38
298236-9823694.96595.82
3101553-10155398.17199.03
4100245-10024596.90797.75
5100056-10005696.72497.56
698015-9801594.75195.60
极限199302-9930295.99596.351.0396.9697.351.03
298809-9880995.51996.53
3100929-10092997.56898.59
4100520-10052097.17398.17
5100143-10014396.80897.81
698315-9831595.04196.05
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%
110.024952534947084953914942904944814948250.10
210.054895514901694898600.09
单位质量响应值RSD%判断
49383.7348742.290.93数据可信
加速6月-供试品溶液-2024120521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%
5min1220900-22090040.52346.9410.1740.5246.9310.17
2291369-29136953.45053.45
3260077-26007747.71047.71
4242804-24280444.54144.54
5241602-24160244.32144.32
6278364-27836451.06551.06
10min1408076-40807674.86083.266.7974.9383.346.79
2487719-48771989.47089.56
3472149-47214986.61486.69
4440316-44031680.77480.85
5435591-43559179.90779.98
6479354-47935487.93588.02
15min1495849-49584990.96196.262.7991.1596.482.80
2532884-53288497.75597.99
3532951-53295197.76797.99
4525722-52572296.44196.65
5534609-53460998.07298.28
6526387-52638796.56396.79
20min1520990-52099095.57397.601.7695.9297.981.76
2534278-53427898.01198.41
3548469-548469100.614101.00
4532723-53272397.72698.10
5528577-52857796.96597.34
6527135-52713596.70197.09
30min1522572-52257295.86397.070.8696.3797.610.87
2532651-53265197.71298.28
3534073-53407397.97398.53
4532093-53209397.61098.14
5527742-52774296.81297.34
6525843-52584396.46397.02
45min1523016-52301695.94596.930.7696.6197.630.77
2531300-53130097.46598.19
3533278-53327897.82798.55
4530622-53062297.34098.04
5527136-52713696.70197.39
6524929-52492996.29697.01
60min1523250-52325095.98897.111.6796.8197.981.67
2530370-53037097.29498.18
3546168-546168100.192101.07
4529007-52900797.04497.90
5525512-52551296.40397.26
6521973-52197395.75496.63
极限1522554-52255495.86096.560.8096.8497.580.81
2529170-52917097.07498.13
3531013-53101397.41298.46
4530013-53001397.22898.25
5523951-52395196.11697.13
6521372-52137295.64396.68
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%
110.149610996043958299570195821959010.18
210.149412494424942740.23
单位质量响应值RSD%判断
9457.699297.241.21数据可信
加速6月-供试品溶液-2024120521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%
5min153088-5308850.95541.9014.1350.9541.9014.13
234142-3414232.77032.77
341798-4179840.11840.12
445985-4598544.13744.14
544390-4439042.60642.61
642549-4254940.83940.84
10min189121-8912185.54078.237.6185.6278.307.62
270416-7041667.58767.64
382393-8239379.08279.15
484645-8464581.24481.32
581699-8169978.41678.49
680754-8075477.50977.58
15min1100782-10078296.73293.142.8196.9693.342.83
292438-9243888.72488.89
397314-9731493.40493.60
497344-9734493.43393.64
598088-9808894.14794.35
696237-9623792.37092.57
20min1100979-10097996.92194.251.7297.3194.601.73
296815-9681592.92593.24
397780-9778093.85194.21
497594-9759493.67294.04
599395-9939595.40195.76
696604-9660492.72293.07
30min1101086-10108697.02494.501.7297.5795.011.73
297659-9765993.73594.20
397877-9787793.94494.45
497315-9731593.40593.93
599977-9997795.96096.48
696796-9679692.90793.41
45min1101025-10102596.96694.531.7397.6895.201.74
297681-9768193.75694.38
397693-9769393.76794.43
497485-9748593.56894.24
5100222-10022296.19596.87
696821-9682192.93193.59
60min1100923-10092396.86894.381.6297.7495.211.63
297689-9768993.76494.55
397620-9762093.69794.52
497178-9717893.27394.11
599641-9964195.63796.48
696928-9692893.03393.85
极限1102164-10216498.05994.752.0999.0995.742.10
297918-9791893.98394.92
398045-9804594.10595.09
497266-9726693.35894.35
5100184-10018496.15897.16
696711-9671192.82593.80
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%
110.024970924968824969194972834971494970650.04
210.055019375021965020660.04
单位质量响应值RSD%判断
49607.2949956.820.50数据可信
加速6月-供试品溶液-2024120521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%
5min1302672-30267254.72046.7412.0554.7246.7412.05
2207543-20754337.52237.52
3249218-24921845.05645.06
4271425-27142549.07149.07
5264767-26476747.86747.87
6255470-25547046.18646.19
10min1480222-48022286.81980.906.3886.9180.986.39
2395056-39505671.42271.48
3452753-45275381.85381.93
4462278-46227883.57583.66
5448788-44878881.13781.22
6445810-44581080.59880.68
15min1529563-52956395.74093.871.9395.9894.081.95
2500498-50049890.48590.67
3521867-52186794.34894.56
4519014-51901493.83394.05
5525234-52523494.95795.17
6519135-51913593.85594.07
20min1530058-53005895.82995.000.9696.2295.360.96
2520782-52078294.15294.48
3524108-52410894.75495.12
4520073-52007394.02494.40
5532615-53261596.29296.66
6525147-52514794.94195.31
30min1529376-52937695.70694.801.0096.2695.321.01
2522470-52247094.45794.95
3522891-52289194.53495.06
4518943-51894393.82094.35
5532118-53211896.20296.74
6520308-52030894.06794.59
45min1528856-52885695.61294.591.0496.3395.271.05
2521294-52129494.24594.89
3521757-52175794.32995.01
4517463-51746393.55294.24
5530806-53080695.96596.66
6518906-51890693.81394.50
60min1527912-52791295.44194.490.9996.3295.340.99
2521002-52100294.19295.00
3521170-52117094.22295.06
4516912-51691293.45394.30
5529942-52994295.80896.66
6519006-51900693.83194.67
极限1530060-53006095.83094.301.1796.8695.301.18
2519203-51920393.86794.83
3519799-51979993.97594.97
4514659-51465993.04594.05
5528082-52808295.47296.49
6517699-51769993.59594.59
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