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%
111.273116083120393114753119853120233118260.09
211.213136723133623135170.07
单位质量响应值RSD%判断
27668.6827967.620.76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%
5min134312-3431211.1018.4720.5711.108.4720.56
228212-282129.1289.13
327402-274028.8668.87
422418-224187.2537.25
518506-185065.9875.99
626186-261868.4728.47
10min161057-6105719.75419.323.2019.7719.333.22
261872-6187220.01820.03
360730-6073019.64919.66
457950-5795018.74918.76
556947-5694718.42518.43
659736-5973619.32719.34
15min161459-6145919.88419.802.8919.9419.842.90
263730-6373020.61920.67
362389-6238920.18520.23
459800-5980019.34819.39
558817-5881719.03019.07
660970-6097019.72619.77
20min160569-6056919.59619.502.6019.6819.582.60
261201-6120119.80119.88
361278-6127819.82619.91
459127-5912719.13019.21
557657-5765718.65418.73
661737-6173719.97420.05
30min159587-5958719.27919.322.6319.4019.432.64
261301-6130119.83319.95
360366-6036619.53119.64
458215-5821518.83518.94
557546-5754618.61818.72
661250-6125019.81719.93
45min160159-6015919.46419.213.2719.6119.363.28
260984-6098419.73119.88
360113-6011319.44919.60
457653-5765318.65318.79
556346-5634618.23018.36
661069-6106919.75819.90
60min157758-5775818.68719.032.8418.8719.202.83
260275-6027519.50119.68
359378-5937819.21119.39
457925-5792518.74118.91
556566-5656618.30118.47
660931-6093119.71419.89
极限157793-5779318.69818.683.9118.9118.893.91
260566-6056619.59519.81
358288-5828818.85819.07
454928-5492817.77117.97
555312-5531217.89618.09
659572-5957219.27419.49
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%
111.143915973914773912683917433922813916730.10
211.083937263939413938340.04
单位质量响应值RSD%判断
35159.1635544.580.78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%
5min135964-359649.1473.8571.839.153.8571.82
213126-131263.3383.34
39197-91972.3392.34
48284-82842.1072.11
57034-70341.7891.79
617110-171104.3524.35
10min180634-8063420.50816.0223.1420.5216.0223.12
253079-5307913.50013.51
372684-7268418.48618.49
467095-6709517.06517.07
564573-6457316.42316.43
639789-3978910.12010.13
15min181007-8100720.60317.9816.7320.6518.0116.73
271679-7167918.23118.26
379014-7901420.09620.13
473674-7367418.73818.77
570780-7078018.00218.03
648030-4803012.21612.24
20min179841-7984120.30618.2512.7420.3918.3112.76
272194-7219418.36218.42
378349-7834919.92720.00
474136-7413618.85518.92
571587-7158718.20718.27
654353-5435313.82413.87
30min177472-7747219.70418.708.2219.8218.798.25
273931-7393118.80318.89
376983-7698319.58019.68
475481-7548119.19819.29
575827-7582719.28619.38
661455-6145515.63015.70
45min177973-7797319.83118.915.4919.9819.035.54
275125-7512519.10719.23
376090-7609019.35219.49
475379-7537919.17219.30
575124-7512419.10719.23
666298-6629816.86216.96
60min174915-7491519.05418.853.5119.2419.013.57
274357-7435718.91219.06
375536-7553619.21219.38
475438-7543819.18719.35
575577-7557719.22219.38
668909-6890917.52617.65
极限174744-7474419.01018.542.3219.2318.732.40
273962-7396218.81118.99
373657-7365718.73418.93
471671-7167118.22918.42
573245-7324518.62918.82
670159-7015917.84417.99
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%
111.273114203118803120223116773119093117820.08
211.213110353111943111140.04
单位质量响应值RSD%判断
27664.7727753.260.23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%
5min127005-270058.77110.1122.078.7710.1122.07
230104-301049.7789.78
325686-256868.3438.34
441660-4166013.53113.53
524968-249688.1108.11
637412-3741212.15212.15
10min159314-5931419.26519.062.0719.2819.072.07
256494-5649418.35018.37
359082-5908219.19019.20
459908-5990819.45819.48
559144-5914419.21019.22
658111-5811118.87518.89
15min160245-6024519.56819.381.3619.6119.431.35
258339-5833918.94919.00
360272-6027219.57719.62
460359-6035919.60519.66
559094-5909419.19419.24
659649-5964919.37419.43
20min158358-5835818.95519.150.8319.0319.220.85
258552-5855219.01819.10
358909-5890919.13419.21
459762-5976219.41119.50
558979-5897919.15719.23
659107-5910719.19819.28
30min156859-5685918.46818.331.1718.5818.441.15
256071-5607118.21218.32
357065-5706518.53518.65
455289-5528917.95818.08
556744-5674418.43118.54
656614-5661418.38918.50
45min155080-5508017.89018.603.1718.0318.743.16
256129-5612918.23118.37
359157-5915719.21419.36
457590-5759018.70618.86
556080-5608018.21518.36
659559-5955919.34519.49
60min155570-5557018.04917.981.5118.2218.151.48
255050-5505017.88118.05
356132-5613218.23218.41
453937-5393717.51917.70
556195-5619518.25218.42
655201-5520117.93018.11
极限154362-5436217.65717.931.3517.8618.131.34
255242-5524217.94318.14
354573-5457317.72617.93
456435-5643518.33018.54
555520-5552018.03318.23
655039-5503917.87718.09
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%
111.143921463924523931833924573926963925870.10
211.083918173915123916640.06
单位质量响应值RSD%判断
35241.2035348.740.22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%
5min1-0.0005.4682.590.005.4682.58
2-0.0000.00
339520-3952010.06710.07
434294-342948.7368.74
520906-209065.3265.33
633901-339018.6368.64
10min149474-4947412.60317.3218.2712.6017.3218.31
255211-5521114.06414.06
375413-7541319.21119.23
476546-7654619.49919.51
572462-7246218.45918.47
678767-7876720.06520.08
15min162269-6226915.86218.4010.5015.8818.4410.55
262947-6294716.03516.06
376526-7652619.49419.54
476783-7678319.56019.61
575289-7528919.17919.22
679545-7954520.26320.31
20min165053-6505316.57218.608.1416.6218.668.18
266015-6601516.81716.87
375176-7517619.15019.23
476354-7635419.45019.53
576270-7627019.42919.50
679135-7913520.15920.24
30min173052-7305218.60918.442.7018.6818.542.70
270020-7002017.83717.92
373131-7313118.62918.74
469966-6996617.82317.94
573529-7352918.73118.83
674693-7469319.02719.14
45min171223-7122318.14318.823.0218.2518.953.04
274552-7455218.99119.10
374706-7470619.03119.17
472747-7274718.53218.67
572542-7254218.47918.61
677552-7755219.75619.90
60min171991-7199118.33918.232.7218.4818.392.64
273387-7338718.69518.83
371663-7166318.25518.43
467773-6777317.26417.44
572329-7232918.42518.59
672211-7221118.39518.57
极限170246-7024617.89418.142.3418.0618.342.28
273634-7363418.75718.93
368816-6881617.53017.74
470814-7081418.03918.24
571738-7173818.27418.47
672130-7213018.37418.58
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%
111.273131503129003130263127983132373130220.06
211.213136093138153137120.05
单位质量响应值RSD%判断
27774.8027985.010.54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%
5min1267909-26790986.48682.842.5786.4982.842.57
2250207-25020780.77180.77
3254356-25435682.11182.11
4250595-25059580.89780.90
5258728-25872883.52283.52
6257952-25795283.27183.27
10min1301428-30142897.30696.401.5197.4596.541.51
2294698-29469895.13495.27
3296252-29625295.63595.77
4297298-29729895.97396.11
5295658-29565895.44495.58
6306441-30644198.92599.06
15min1306179-30617998.84098.201.4699.1598.501.46
2299390-29939096.64896.94
3302562-30256297.67297.97
4304518-30451898.30498.60
5300807-30080797.10697.40
6311696-311696100.621100.92
20min1306510-30651098.94798.291.4199.4298.751.41
2299381-29938196.64597.10
3302750-30275097.73398.19
4305122-30512298.49998.96
5301538-30153897.34297.80
6311538-311538100.570101.04
30min1305446-30544698.60398.221.2899.2498.851.28
2299605-29960596.71897.33
3303190-30319097.87598.50
4305313-30531398.56099.18
5301354-30135497.28297.90
6310688-310688100.296100.93
45min1304734-30473498.37498.091.4099.1798.881.39
2298653-29865396.41097.19
3303914-30391498.10998.89
4304429-30442998.27599.06
5300524-30052497.01497.80
6310936-310936100.376101.18
60min1303676-30367698.03297.721.4299.0098.671.42
2297467-29746796.02896.96
3301616-30161697.36798.32
4303510-30351097.97898.93
5299940-29994096.82697.77
6310011-310011100.077101.05
极限1303685-30368598.03597.621.4199.1698.731.41
2296996-29699695.87696.97
3301994-30199497.48998.60
4303252-30325297.89599.01
5299108-29910896.55797.66
6309335-30933599.859101.00
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%
111.143939163937213937583941413944703940010.08
211.083945023946083945550.02
单位质量响应值RSD%判断
35368.1335609.660.49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%
5min1139729-13972935.40034.2612.6435.4034.2612.65
2124545-12454531.55331.55
3127008-12700832.17732.18
4164028-16402841.55641.56
5140691-14069135.64435.64
6115266-11526629.20329.20
10min1284335-28433572.03672.832.5572.1072.882.55
2298012-29801275.50175.55
3277247-27724770.24070.29
4291563-29156373.86773.94
5290243-29024373.53373.59
6283323-28332371.78071.83
15min1344216-34421687.20786.940.9187.3987.120.92
2347326-34732687.99588.17
3338220-33822085.68885.86
4345036-34503687.41587.61
5342483-34248386.76886.95
6341796-34179686.59486.76
20min1364724-36472492.40391.810.6292.7392.130.63
2362101-36210191.73892.06
3358740-35874090.88791.20
4364815-36481592.42692.76
5361957-36195791.70292.03
6361872-36187291.68091.99
30min1378010-37801095.76995.250.8296.2595.720.83
2374936-37493694.99095.47
3371769-37176994.18894.65
4380658-38065896.44096.93
5374435-37443594.86395.34
6375950-37595095.24795.71
45min1381795-38179596.72896.551.0797.3797.181.07
2376401-37640195.36196.00
3376878-37687895.48296.10
4385076-38507697.55998.21
5380201-38020196.32496.96
6386170-38617097.83698.46
60min1383643-38364397.19696.511.1898.0097.301.17
2375427-37542795.11495.91
3376038-37603895.26996.05
4383772-38377297.22998.04
5380358-38035896.36497.16
6386349-38634997.88198.67
极限1384136-38413697.32196.721.1198.2897.681.10
2374946-37494694.99295.95
3382149-38214996.81797.76
4384801-38480197.48998.47
5378691-37869195.94196.90
6385957-38595797.78298.73
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%
111.273067713065413077983072573076053071940.18
211.213094273092043093160.06
单位质量响应值RSD%判断
27257.6827592.860.87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%
5min1255608-25560883.88582.979.0083.8882.969.00
2258422-25842284.80884.81
3207390-20739068.06168.06
4263982-26398286.63386.63
5269104-26910488.31488.31
6262351-26235186.09886.10
10min1293826-29382696.42796.520.7996.5796.660.79
2291367-29136795.62095.76
3291949-29194995.81195.92
4294054-29405496.50296.65
5296421-29642197.27897.43
6297067-29706797.49097.63
15min1297887-29788797.76098.161.5998.0698.461.58
2293411-29341196.29196.59
3299602-29960298.32298.60
4297331-29733197.57797.88
5298656-29865698.01298.32
6307735-307735100.991101.30
20min1299427-29942798.26598.290.9098.7398.750.90
2295675-29567597.03497.49
3301320-30132098.88699.32
4297998-29799897.79698.26
5299111-29911198.16198.63
6303459-30345999.588100.06
30min1297983-29798397.79198.331.4498.4298.961.43
2293369-29336996.27796.90
3303018-30301899.443100.05
4297592-29759297.66398.29
5300312-30031298.55599.19
6305481-305481100.252100.89
45min1300212-30021298.52398.411.1299.3199.201.11
2295584-29558497.00497.79
3302722-30272299.346100.11
4296340-29634097.25298.05
5300522-30052298.62499.42
6303868-30386899.722100.53
60min1300041-30004198.46697.981.4099.4298.931.39
2291452-29145295.64896.59
3302578-30257899.299100.23
4295989-29598997.13798.09
5299460-29946098.27699.24
6301808-30180899.046100.02
极限1299808-29980898.39098.091.8399.5199.211.81
2291373-29137395.62296.73
3305132-305132100.137101.24
4294397-29439796.61497.73
5298164-29816497.85098.98
6304456-30445699.915101.05
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%
111.147738507731787750607739007748727741720.11
211.087778007777817777900.01
单位质量响应值RSD%判断
69494.7970197.650.72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%
5min1293326-29332637.76030.8235.0137.7630.8235.00
2277826-27782635.76435.76
3304220-30422039.16239.16
477511-775119.9789.98
5253911-25391132.68632.69
6229517-22951729.54529.55
10min1573432-57343273.81768.8315.4973.8868.8815.51
2573060-57306073.76973.83
3621486-62148680.00380.07
4380681-38068149.00549.02
5529851-52985168.20768.26
6529591-52959168.17468.22
15min1687036-68703688.44187.873.9488.6388.033.97
2695111-69511189.48189.66
3716333-71633392.21392.41
4638605-63860582.20782.31
5666252-66625285.76685.93
6692144-69214489.09989.26
20min1715235-71523592.07192.421.8892.4092.731.90
2722595-72259593.01993.35
3740490-74049095.32295.67
4706959-70695991.00691.24
5719969-71996992.68192.99
6702467-70246790.42890.74
30min1720710-72071092.77695.171.7793.2695.641.76
2731478-73147894.16294.65
3757210-75721097.47597.99
4741639-74163995.47095.86
5749283-74928396.45496.92
6735466-73546694.67695.14
45min1732577-73257794.30496.131.1694.9596.761.16
2750004-75000496.54797.19
3749651-74965196.50297.18
4740157-74015795.28095.83
5753775-75377597.03397.66
6754560-75456097.13497.75
60min1744029-74402995.77895.392.2496.5896.182.23
2733784-73378494.45995.26
3758945-75894597.69898.53
4743899-74389995.76196.47
5753371-75337196.98197.77
6712250-71225091.68792.47
极限1752716-75271696.89696.471.3397.8597.421.33
2740594-74059495.33696.30
3747382-74738296.21097.21
4737674-73767494.96095.82
5752931-75293196.92497.87
6765270-76527098.51299.45
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原始图谱下载图谱(王丹 于 2025-12-07 12:25:12 完成)
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