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%
1103116083120393114753119853120233118260.09
2103136723133623135170.07
单位质量响应值RSD%判断
31182.6031351.700.39数据可信
供试品溶液-25112401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%
5min134312-343129.8777.5320.579.887.5420.57
228212-282128.1218.12
327402-274027.8887.89
422418-224186.4536.45
518506-185065.3275.33
626186-261867.5377.54
10min161057-6105717.57517.193.2017.5917.203.21
261872-6187217.80917.82
360730-6073017.48117.49
457950-5795016.68116.69
556947-5694716.39216.40
659736-5973617.19517.21
15min161459-6145917.69117.612.8917.7417.662.90
263730-6373018.34418.39
362389-6238917.95818.00
459800-5980017.21317.25
558817-5881716.93016.97
660970-6097017.55017.59
20min160569-6056917.43417.352.6017.5117.422.61
261201-6120117.61617.69
361278-6127817.63917.71
459127-5912717.01917.09
557657-5765716.59616.66
661737-6173717.77117.84
30min159587-5958717.15217.192.6317.2617.292.63
261301-6130117.64517.75
360366-6036617.37617.48
458215-5821516.75716.85
557546-5754616.56416.66
661250-6125017.63017.73
45min160159-6015917.31617.093.2717.4517.223.27
260984-6098417.55417.69
360113-6011317.30317.43
457653-5765316.59516.72
556346-5634616.21916.34
661069-6106917.57817.71
60min157758-5775816.62516.932.8416.7917.082.84
260275-6027517.35017.51
359378-5937817.09217.25
457925-5792516.67316.82
556566-5656616.28216.43
660931-6093117.53917.70
极限157793-5779316.63516.623.9116.8216.813.90
260566-6056617.43417.62
358288-5828816.77816.97
454928-5492815.81115.99
555312-5531215.92116.10
659572-5957217.14717.34
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1153915973914773912683917433922813916730.10
2153937263939413938340.04
单位质量响应值RSD%判断
26111.5326255.600.39数据可信
供试品溶液-25112401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%
5min135964-3596412.3505.1971.8312.355.1971.81
213126-131264.5074.51
39197-91973.1583.16
48284-82842.8452.84
57034-70342.4152.42
617110-171105.8755.88
10min180634-8063427.68921.6223.1427.7121.6323.14
253079-5307918.22718.23
372684-7268424.95924.96
467095-6709523.03923.04
564573-6457322.17322.18
639789-3978913.66313.67
15min181007-8100727.81724.2816.7327.8824.3216.73
271679-7167924.61424.65
379014-7901427.13227.18
473674-7367425.29925.34
570780-7078024.30524.35
648030-4803016.49316.53
20min179841-7984127.41624.6412.7427.5324.7212.77
272194-7219424.79024.87
378349-7834926.90427.00
474136-7413625.45725.54
571587-7158724.58224.66
654353-5435318.66418.72
30min177472-7747226.60325.258.2226.7625.378.26
273931-7393125.38725.51
376983-7698326.43526.57
475481-7548125.91926.05
575827-7582726.03826.16
661455-6145521.10321.19
45min177973-7797326.77525.525.4926.9825.695.56
275125-7512525.79725.96
376090-7609026.12826.31
475379-7537925.88426.06
575124-7512425.79725.96
666298-6629822.76622.89
60min174915-7491525.72525.453.5125.9725.663.56
274357-7435725.53325.74
375536-7553625.93826.16
475438-7543825.90426.12
575577-7557725.95226.16
668909-6890923.66223.83
极限174744-7474425.66625.042.3225.9625.292.39
273962-7396225.39825.65
373657-7365725.29325.56
471671-7167124.61124.87
573245-7324525.15125.40
670159-7015924.09224.30
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%
1103114203118803120223116773119093117820.08
2103110353111943111140.04
单位质量响应值RSD%判断
31178.2031111.400.16数据可信
供试品溶液-25112402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%
5min127005-270057.8049.0022.077.809.0022.07
230104-301048.6998.70
325686-256867.4237.42
441660-4166012.03912.04
524968-249687.2157.22
637412-3741210.81110.81
10min159314-5931417.14016.962.0817.1516.972.07
256494-5649416.32516.34
359082-5908217.07317.09
459908-5990817.31217.33
559144-5914417.09117.10
658111-5811116.79316.81
15min160245-6024517.40917.241.3617.4517.281.36
258339-5833916.85816.90
360272-6027217.41717.46
460359-6035917.44217.49
559094-5909417.07717.12
659649-5964917.23717.28
20min158358-5835816.86417.030.8316.9317.100.86
258552-5855216.92016.99
358909-5890917.02317.09
459762-5976217.27017.35
558979-5897917.04317.11
659107-5910717.08017.16
30min156859-5685916.43116.311.1716.5316.411.15
256071-5607116.20316.30
357065-5706516.49016.59
455289-5528915.97716.08
556744-5674416.39716.49
656614-5661416.36016.46
45min155080-5508015.91716.553.1716.0416.683.16
256129-5612916.22016.34
359157-5915717.09517.22
457590-5759016.64216.78
556080-5608016.20616.33
659559-5955917.21117.34
60min155570-5557016.05815.991.5116.2116.151.47
255050-5505015.90816.06
356132-5613216.22116.37
453937-5393715.58615.75
556195-5619516.23916.39
655201-5520115.95216.11
极限154362-5436215.70915.951.3515.8916.131.35
255242-5524215.96316.14
354573-5457315.77015.95
456435-5643516.30816.50
555520-5552016.04416.22
655039-5503915.90516.09
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1153921463924523931833924573926963925870.10
2153918173915123916640.06
单位质量响应值RSD%判断
26172.4726110.930.17数据可信
供试品溶液-25112402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%
5min1-0.0007.3782.590.007.3782.59
2-0.0000.00
339520-3952013.59213.59
434294-3429411.79511.79
520906-209067.1907.19
633901-3390111.66011.66
10min149474-4947417.01623.3818.2717.0223.3918.29
255211-5521118.98918.99
375413-7541325.93725.96
476546-7654626.32726.35
572462-7246224.92224.93
678767-7876727.09127.11
15min162269-6226921.41624.8410.5021.4424.8910.55
262947-6294721.65021.68
376526-7652626.32026.39
476783-7678326.40826.47
575289-7528925.89425.95
679545-7954527.35827.42
20min165053-6505322.37425.118.1422.4425.208.19
266015-6601522.70522.77
375176-7517625.85625.97
476354-7635426.26126.37
576270-7627026.23226.33
679135-7913527.21727.33
30min173052-7305225.12524.902.7025.2325.042.72
270020-7002024.08224.19
373131-7313125.15225.31
469966-6996624.06424.21
573529-7352925.28925.43
674693-7469325.68925.84
45min171223-7122324.49625.413.0224.6425.593.05
274552-7455225.64125.79
374706-7470625.69425.89
472747-7274725.02025.21
572542-7254224.95025.13
677552-7755226.67326.87
60min171991-7199124.76024.612.7224.9424.832.66
273387-7338725.24025.43
371663-7166324.64724.88
467773-6777323.30923.54
572329-7232924.87625.10
672211-7221124.83625.08
极限170246-7024624.16024.502.3424.3924.762.28
273634-7363425.32525.56
368816-6881623.66823.95
470814-7081424.35524.63
571738-7173824.67324.94
672130-7213024.80825.09
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%
1103131503129003130263127983132373130220.06
2103136093138153137120.05
单位质量响应值RSD%判断
31302.2031371.200.16数据可信
供试品溶液-G79580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%
5min1267909-26790976.94473.702.5776.9473.702.57
2250207-25020771.86071.86
3254356-25435673.05273.05
4250595-25059571.97271.97
5258728-25872874.30874.31
6257952-25795274.08574.08
10min1301428-30142886.57185.771.5186.7085.891.50
2294698-29469884.63884.76
3296252-29625285.08585.21
4297298-29729885.38585.50
5295658-29565884.91485.04
6306441-30644188.01188.13
15min1306179-30617987.93687.371.4688.2187.631.46
2299390-29939085.98686.25
3302562-30256286.89787.16
4304518-30451887.45987.72
5300807-30080786.39386.66
6311696-31169689.52089.79
20min1306510-30651088.03187.451.4188.4587.861.41
2299381-29938185.98386.39
3302750-30275086.95187.36
4305122-30512287.63288.04
5301538-30153886.60387.01
6311538-31153889.47589.89
30min1305446-30544687.72587.391.2888.2987.941.28
2299605-29960586.04886.60
3303190-30319087.07787.63
4305313-30531387.68788.24
5301354-30135486.55087.10
6310688-31068889.23189.80
45min1304734-30473487.52187.271.4088.2387.971.39
2298653-29865385.77486.47
3303914-30391487.28587.98
4304429-30442987.43388.13
5300524-30052486.31287.01
6310936-31093689.30290.02
60min1303676-30367687.21786.941.4288.0787.791.41
2297467-29746785.43486.27
3301616-30161686.62587.47
4303510-30351087.16988.02
5299940-29994086.14486.99
6310011-31001189.03689.90
极限1303685-30368587.21986.851.4188.2287.841.41
2296996-29699685.29886.27
3301994-30199486.73487.72
4303252-30325287.09588.09
5299108-29910885.90586.89
6309335-30933588.84289.86
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1153939163937213937583941413944703940010.08
2153945023946083945550.02
单位质量响应值RSD%判断
26266.7326303.670.10数据可信
供试品溶液-G79580批-非奈利酮-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%
5min1139729-13972947.79546.2512.6447.8046.2512.64
2124545-12454542.60142.60
3127008-12700843.44443.44
4164028-16402856.10756.11
5140691-14069148.12448.12
6115266-11526639.42739.43
10min1284335-28433597.25898.332.5597.3498.402.55
2298012-298012101.937102.01
3277247-27724794.83494.91
4291563-29156399.73199.82
5290243-29024399.27999.36
6283323-28332396.91296.98
15min1344216-344216117.741117.390.91117.98117.630.92
2347326-347326118.805119.05
3338220-338220115.690115.92
4345036-345036118.022118.28
5342483-342483117.148117.39
6341796-341796116.913117.14
20min1364724-364724124.756123.950.62125.19124.380.63
2362101-362101123.859124.30
3358740-358740122.709123.13
4364815-364815124.787125.24
5361957-361957123.809124.25
6361872-361872123.780124.20
30min1378010-378010129.301128.600.82129.95129.240.83
2374936-374936128.249128.89
3371769-371769127.166127.79
4380658-380658130.206130.87
5374435-374435128.078128.72
6375950-375950128.596129.22
45min1381795-381795130.595130.351.07131.46131.211.07
2376401-376401128.750129.61
3376878-376878128.913129.75
4385076-385076131.717132.60
5380201-380201130.050130.91
6386170-386170132.092132.93
60min1383643-383643131.227130.301.18132.31131.381.17
2375427-375427128.417129.49
3376038-376038128.626129.68
4383772-383772131.271132.37
5380358-380358130.104131.18
6386349-386349132.153133.22
极限1384136-384136131.396130.591.11132.69131.881.10
2374946-374946128.252129.54
3382149-382149130.716131.99
4384801-384801131.623132.94
5378691-378691129.533130.83
6385957-385957132.019133.30
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%
1103067713065413077983072573076053071940.18
2103094273092043093160.06
单位质量响应值RSD%判断
30719.4030931.600.49数据可信
供试品溶液-BJ84960批-恩格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255608-25560874.63073.819.0074.6373.819.00
2258422-25842275.45175.45
3207390-20739060.55260.55
4263982-26398277.07577.07
5269104-26910478.57078.57
6262351-26235176.59876.60
10min1293826-29382685.78885.870.7985.9186.000.79
2291367-29136785.07085.20
3291949-29194985.24085.34
4294054-29405485.85585.98
5296421-29642186.54686.68
6297067-29706786.73586.86
15min1297887-29788786.97487.331.5987.2487.591.58
2293411-29341185.66785.93
3299602-29960287.47587.72
4297331-29733186.81287.08
5298656-29865687.19887.47
6307735-30773589.84990.12
20min1299427-29942787.42487.440.9087.8487.860.90
2295675-29567586.32886.74
3301320-30132087.97688.37
4297998-29799887.00687.42
5299111-29911187.33187.75
6303459-30345988.60189.02
30min1297983-29798387.00287.481.4487.5688.041.43
2293369-29336985.65586.21
3303018-30301888.47289.01
4297592-29759286.88887.45
5300312-30031287.68288.25
6305481-30548189.19189.76
45min1300212-30021287.65387.551.1288.3688.261.11
2295584-29558486.30287.00
3302722-30272288.38689.07
4296340-29634086.52287.23
5300522-30052287.74388.46
6303868-30386888.72089.44
60min1300041-30004187.60387.171.4088.4588.021.39
2291452-29145285.09585.94
3302578-30257888.34489.17
4295989-29598986.42087.27
5299460-29946087.43388.29
6301808-30180888.11988.98
极限1299808-29980887.53587.271.8388.5388.261.81
2291373-29137385.07286.05
3305132-30513289.08990.07
4294397-29439785.95586.95
5298164-29816487.05588.06
6304456-30445688.89289.90
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1157738507731787750607739007748727741720.11
2157778007777817777900.01
单位质量响应值RSD%判断
51611.4751852.670.33数据可信
供试品溶液-BJ84960批-非奈利酮
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1293326-29332650.98041.6135.0150.9841.6035.01
2277826-27782648.28648.29
3304220-30422052.87452.87
477511-7751113.47113.47
5253911-25391144.13044.13
6229517-22951739.89039.89
10min1573432-57343299.66392.9315.4999.7593.0015.51
2573060-57306099.59899.68
3621486-621486108.014108.10
4380681-38068166.16266.18
5529851-52985192.08892.16
6529591-52959192.04392.11
15min1687036-687036119.407118.633.94119.66118.863.97
2695111-695111120.811121.06
3716333-716333124.499124.77
4638605-638605110.990111.12
5666252-666252115.795116.02
6692144-692144120.295120.51
20min1715235-715235124.308124.781.88124.76125.201.90
2722595-722595125.587126.04
3740490-740490128.697129.17
4706959-706959122.870123.19
5719969-719969125.131125.55
6702467-702467122.089122.51
30min1720710-720710125.260128.491.77125.92129.121.76
2731478-731478127.131127.79
3757210-757210131.603132.29
4741639-741639128.897129.42
5749283-749283130.226130.85
6735466-735466127.824128.45
45min1732577-732577127.322129.791.16128.19130.641.17
2750004-750004130.351131.22
3749651-749651130.290131.20
4740157-740157128.640129.38
5753775-753775131.006131.85
6754560-754560131.143131.98
60min1744029-744029129.312128.792.24130.39129.852.23
2733784-733784127.532128.62
3758945-758945131.905133.03
4743899-743899129.290130.24
5753371-753371130.936132.00
6712250-712250123.789124.84
极限1752716-752716130.822130.251.33132.12131.531.33
2740594-740594128.715130.01
3747382-747382129.895131.24
4737674-737674128.208129.38
5752931-752931130.860132.14
6765270-765270133.004134.27
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