非奈利酮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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.973058523040913057023061133055853054690.27
211.043049553063003056280.32
单位质量响应值RSD%判断
27845.8527683.700.42数据可信
供试品溶液-25111101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%
5min140417-4041712.87912.1919.1712.8812.2019.16
227069-270698.6258.63
338404-3840412.23712.24
446155-4615514.70714.71
544943-4494314.32114.32
632617-3261710.39310.39
10min160120-6012019.15717.888.2619.1817.908.27
247356-4735615.09015.10
358200-5820018.54518.57
454908-5490817.49617.52
557396-5739618.28918.31
658776-5877618.72918.75
15min160675-6067519.33419.062.1519.3919.102.17
257468-5746818.31218.35
360076-6007619.14319.19
460904-6090419.40719.46
559242-5924218.87718.93
660454-6045419.26319.31
20min159968-5996819.10819.160.8419.1919.240.80
260860-6086019.39319.46
359362-5936218.91519.00
460371-6037119.23719.32
559987-5998719.11419.20
660258-6025819.20119.28
30min161561-6156119.61619.471.5119.7319.581.48
262493-6249319.91320.02
361160-6116019.48819.60
460196-6019619.18119.30
559986-5998619.11419.23
661252-6125219.51819.63
45min156670-5667018.05818.471.4118.2118.611.40
257632-5763218.36418.50
358171-5817118.53618.68
458774-5877418.72818.88
557649-5764918.37018.52
658818-5881818.74218.89
60min156996-5699618.16117.922.6318.3418.092.61
255123-5512317.56517.73
353721-5372117.11817.30
456851-5685118.11518.30
557218-5721818.23218.41
657443-5744318.30418.48
极限156324-5632417.94717.853.7618.1618.053.68
258207-5820718.54718.74
357220-5722018.23318.44
454064-5406417.22717.44
552838-5283816.83717.05
657375-5737518.28218.49
非奈利酮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250201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1000
标示量(mg)20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%
122.147939167892907940637950497934427931520.29
222.167917287949687933480.29
单位质量响应值RSD%判断
35824.3935800.900.05数据可信
供试品溶液-25111101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%
5min114546-145461.8281.4921.281.831.4921.24
210143-101431.2751.27
314828-148281.8631.86
410421-104211.3091.31
512377-123771.5551.56
68646-86461.0861.09
10min141118-411185.1674.2314.235.174.2314.20
229174-291743.6663.67
337640-376404.7304.73
431341-313413.9383.94
533161-331614.1674.17
629490-294903.7063.71
15min157940-579407.2806.399.947.296.399.94
244824-448245.6325.64
353581-535816.7336.74
453117-531176.6746.68
549852-498526.2646.27
645625-456255.7335.74
20min172013-720139.0498.157.239.078.177.21
261673-616737.7497.77
364988-649888.1668.19
468203-682038.5708.59
563266-632667.9507.97
658979-589797.4117.43
30min191486-9148611.49610.864.8411.5310.894.84
286892-8689210.91810.95
386162-8616210.82710.86
490300-9030011.34711.38
583293-8329310.46610.50
680374-8037410.09910.13
45min1110258-11025813.85413.123.9713.9113.173.96
2102008-10200812.81812.87
3101400-10140012.74112.80
4108984-10898413.69413.75
5103105-10310512.95613.01
6100684-10068412.65112.70
60min1124202-12420215.60614.585.2915.6914.655.28
2111795-11179514.04714.12
3106680-10668013.40513.48
4119041-11904114.95815.03
5118639-11863914.90714.98
6115612-11561214.52714.59
极限1141649-14164917.79917.354.1617.9117.454.13
2140457-14045717.64917.74
3143424-14342418.02218.12
4131349-13134916.50516.61
5130250-13025016.36616.46
6141355-14135517.76217.85
非奈利酮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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.973045363052753056173047113058433051960.19
211.043083883080163082020.09
单位质量响应值RSD%判断
27820.9727916.850.25数据可信
供试品溶液-25111102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%
5min138399-3839912.19011.3115.6512.1911.3115.68
228776-287769.1359.13
342353-4235313.44513.45
429958-299589.5109.51
534087-3408710.82110.82
640219-4021912.76812.77
10min157956-5795618.39818.511.6518.4218.531.66
257478-5747818.24618.26
358360-5836018.52618.55
459034-5903418.74018.76
557260-5726018.17718.20
659782-5978218.97819.00
15min160348-6034819.15818.932.9019.2118.982.87
258843-5884318.68018.73
357592-5759218.28318.34
462258-6225819.76419.81
558268-5826818.49718.55
660549-6054919.22119.27
20min160593-6059319.23518.962.1319.3219.042.11
259433-5943318.86718.94
358801-5880118.66618.75
461751-6175119.60319.68
558234-5823418.48618.57
659521-5952118.89518.98
30min160536-6053619.21718.892.3319.3319.012.33
258429-5842918.54818.66
359179-5917918.78618.90
461576-6157619.54719.66
557780-5778018.34218.45
659620-5962018.92619.04
45min158925-5892518.70618.502.4618.8518.652.45
256871-5687118.05418.19
356299-5629917.87218.02
460110-6011019.08219.23
558602-5860218.60318.74
658932-5893218.70818.86
60min154263-5426317.22618.132.8917.4018.312.87
257243-5724318.17218.34
356418-5641817.91018.09
459067-5906718.75118.93
557825-5782518.35718.53
657887-5788718.37618.56
极限156677-5667717.99218.113.4518.2018.313.42
253634-5363417.02617.23
356525-5652517.94418.15
458719-5871918.64018.85
559098-5909818.76118.96
657589-5758918.28218.49
非奈利酮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250201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1000
标示量(mg)20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%
122.147906607922257935117908637934907921500.18
222.167999937990377995150.09
单位质量响应值RSD%判断
35779.1336079.200.60数据可信
供试品溶液-25111102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%
5min116757-167572.0991.7515.862.101.7515.90
213659-136591.7111.71
313700-137001.7161.72
410724-107241.3431.34
516244-162442.0352.03
612966-129661.6241.62
10min149707-497076.2265.0612.906.235.0612.91
241497-414975.1975.20
333986-339864.2574.26
438804-388044.8604.86
539641-396414.9654.97
638561-385614.8304.83
15min170120-701208.7827.2812.728.807.3012.73
259583-595837.4637.47
347438-474385.9425.95
459603-596037.4657.48
554979-549796.8866.90
657150-571507.1587.17
20min184818-8481810.6238.9811.4910.659.0011.48
273474-734749.2039.23
359948-599487.5087.53
473630-736309.2229.24
567039-670398.3978.42
671192-711928.9178.94
30min1105567-10556713.22211.4210.2713.2711.4610.27
291702-9170211.48611.52
377973-779739.7669.80
494463-9446311.83111.87
584647-8464710.60210.64
692834-9283411.62711.66
45min1123002-12300215.40613.779.3715.4713.829.37
2108053-10805313.53313.59
392504-9250411.58611.63
4116066-11606614.53714.59
5107321-10732113.44213.50
6112654-11265414.11014.17
60min1125261-12526115.68915.156.7215.7815.236.73
2121608-12160815.23115.31
3105352-10535213.19513.26
4128550-12855016.10116.18
5121035-12103515.15915.24
6124169-12416915.55215.63
极限1137262-13726217.19216.857.8517.3116.967.83
2133602-13360216.73316.84
3116245-11624514.56014.65
4144108-14410818.04918.16
5145011-14501118.16218.26
6130957-13095716.40216.51
非奈利酮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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.973046823051253046193047493055183049390.13
211.043087933096463092200.20
单位质量响应值RSD%判断
27797.5428009.060.54数据可信
供试品溶液-25111101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%
5min1192768-19276861.12064.3911.7761.1264.3911.77
2176836-17683656.06856.07
3229380-22938072.72872.73
4177556-17755656.29756.30
5214829-21482968.11568.11
6227176-22717672.02972.03
10min1301160-30116095.48796.150.5595.5996.260.56
2302503-30250395.91396.01
3305644-30564496.90997.03
4302128-30212895.79495.89
5303707-30370796.29596.41
6304417-30441796.52096.64
15min1307932-30793297.63497.690.1897.9097.960.19
2307862-30786297.61297.87
3309065-30906597.99398.28
4308418-30841897.78898.04
5307474-30747497.48997.76
6307933-30793397.63497.92
20min1307091-30709197.36797.660.3097.7998.090.31
2306881-30688197.30197.72
3309374-30937498.09198.54
4307987-30798797.65298.07
5308173-30817397.71198.15
6308517-30851797.82098.26
30min1307365-30736597.45497.710.3098.0498.300.31
2306729-30672997.25397.83
3308989-30898997.96998.58
4308760-30876097.89798.48
5308325-30832597.75998.36
6308868-30886897.93198.54
45min1305817-30581796.96497.580.4697.7198.340.47
2306234-30623497.09697.84
3308911-30891197.94598.72
4308377-30837797.77598.52
5308172-30817297.71098.47
6309090-30909098.00198.77
60min1305513-30551396.86797.350.4097.7898.270.41
2305765-30576596.94797.85
3307545-30754597.51198.45
4307530-30753097.50798.41
5307133-30713397.38198.31
6308756-30875697.89598.83
极限1304892-30489296.67097.140.4697.7498.220.47
2304468-30446896.53697.60
3306937-30693797.31998.42
4307197-30719797.40198.47
5306646-30664697.22698.31
6308100-30810097.68798.78
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201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1000
标示量(mg)20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%
122.147907657913027901497905467920257909570.10
222.168004318024928014620.19
单位质量响应值RSD%判断
35725.2536167.060.87数据可信
供试品溶液-25111101批-非奈利酮-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%
5min187832-8783210.9969.2716.9611.009.2716.99
273269-732699.1739.17
371647-716478.9708.97
451306-513066.4236.42
578918-789189.8809.88
681116-8111610.15510.16
10min1235117-23511729.43528.853.2429.4528.863.24
2232915-23291529.15929.17
3229770-22977028.76528.78
4215831-21583127.02027.03
5233781-23378129.26829.28
6235376-23537629.46729.48
15min1319792-31979240.03539.731.8240.1039.791.82
2322911-32291140.42640.49
3313492-31349239.24739.31
4307884-30788438.54538.60
5317788-31778839.78539.85
6322241-32224140.34240.41
20min1375477-37547747.00746.941.3747.1447.071.37
2380022-38002247.57647.71
3369399-36939946.24646.37
4368226-36822646.09946.22
5376496-37649647.13447.27
6380035-38003547.57747.71
30min1449956-44995656.33156.400.9556.5456.610.95
2454063-45406356.84557.06
3445236-44523655.74055.95
4446750-44675055.93056.13
5450572-45057256.40856.62
6456497-45649757.15057.36
45min1513017-51301764.22664.610.6164.5364.920.62
2518684-51868464.93565.24
3514749-51474964.44264.74
4513616-51361664.30164.59
5515547-51554764.54264.85
6521091-52109165.23665.54
60min1552659-55265969.18869.600.6069.6070.010.60
2558515-55851569.92270.34
3554983-55498369.47969.89
4554502-55450269.41969.82
5553650-55365069.31369.72
6561311-56131170.27270.69
极限1572272-57227271.64472.060.5172.1772.580.51
2577165-57716572.25672.79
3575280-57528072.02072.54
4574974-57497471.98272.50
5573357-57335771.78072.31
6580356-58035672.65673.19
非奈利酮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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.973059903065833070803063673070303066100.15
211.043099693099593099640.01
单位质量响应值RSD%判断
27949.8628076.450.32数据可信
供试品溶液-25111102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%
5min1234417-23441774.03366.4720.4974.0366.4720.49
2241099-24109976.14376.14
3229345-22934572.43172.43
4217079-21707968.55768.56
5216184-21618468.27568.27
6124715-12471539.38739.39
10min1308004-30800497.27397.671.0797.4097.781.08
2310901-31090198.18898.31
3304996-30499696.32396.44
4312078-31207898.56098.67
5313243-31324398.92899.04
6306391-30639196.76496.83
15min1310872-31087298.17998.861.2698.4699.141.26
2313548-31354899.02499.31
3306357-30635796.75397.03
4316667-316667100.009100.29
5316732-316732100.030100.31
6314069-31406999.18899.42
20min1311957-31195798.52199.171.2498.9799.611.23
2315067-31506799.50499.96
3307380-30738097.07697.52
4318037-318037100.442100.89
5317005-317005100.116100.56
6314561-31456199.34499.74
30min1310313-31031398.00298.931.4198.6299.541.40
2314560-31456099.34499.96
3306274-30627496.72797.33
4318353-318353100.541101.15
5316706-316706100.021100.63
6313352-31335298.96299.52
45min1311028-31102898.22899.021.5099.0099.791.49
2315092-31509299.512100.30
3305175-30517596.38097.15
4317568-317568100.294101.07
5317018-317018100.120100.90
6315395-31539599.607100.33
60min1307571-30757197.13698.521.5398.0899.451.52
2313761-31376199.091100.04
3304736-30473696.24197.17
4316640-316640100.000100.95
5315821-31582199.742100.69
6313175-31317598.90699.79
极限1310202-31020297.96798.501.4199.0799.601.40
2312181-31218198.59299.71
3304241-30424196.08597.17
4316225-31622599.869100.98
5315732-31573299.714100.83
6312821-31282198.79499.85
非奈利酮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250201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1000
标示量(mg)20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%
122.147939347955077964177947807964757954230.14
222.168028668035938032300.07
单位质量响应值RSD%判断
35926.9636246.840.63数据可信
供试品溶液-25111102批-非奈利酮-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%
5min197771-9777112.19210.7724.1912.1910.7724.17
294636-9463611.80111.80
3101194-10119412.61912.62
498824-9882412.32312.32
578897-788979.8399.84
646953-469535.8555.86
10min1233665-23366529.13828.803.4429.1628.823.46
2227976-22797628.42928.45
3240996-24099630.05330.07
4235501-23550129.36729.39
5229874-22987428.66628.68
6217670-21767027.14427.15
15min1313544-31354439.09939.071.2639.1739.131.27
2307968-30796838.40438.47
3318055-31805539.66239.73
4315603-31560339.35639.43
5315330-31533039.32239.39
6309212-30921238.55938.61
20min1370239-37023946.16946.220.6146.3046.360.61
2366929-36692945.75745.89
3373376-37337646.56146.70
4371683-37168346.34946.48
5371972-37197246.38546.52
6369842-36984246.12046.24
30min1441149-44114955.01255.150.4955.2255.350.49
2438374-43837454.66654.87
3443484-44348455.30355.52
4443947-44394755.36155.57
5442674-44267455.20255.41
6443740-44374055.33555.53
45min1504687-50468762.93563.230.7463.2463.530.73
2504145-50414562.86863.17
3504666-50466662.93363.24
4506454-50645463.15663.46
5508341-50834163.39163.69
6513976-51397664.09464.38
60min1541057-54105767.47167.970.7667.8868.370.75
2541892-54189267.57567.98
3543051-54305167.71968.13
4544910-54491067.95168.36
5547039-54703968.21768.62
6552244-55224468.86669.26
极限1564665-56466570.41570.460.7270.9370.980.71
2559908-55990869.82170.34
3562818-56281870.18470.71
4564210-56421070.35870.88
5566938-56693870.69871.22
6571734-57173471.29671.81
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