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(%) 100.0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%
111.273092903095083095173098733097673095910.08
211.213095193096233095710.03
单位质量响应值RSD%判断
27470.3627615.610.38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%
5min123664-236647.73310.2227.287.7310.2227.29
238404-3840412.54912.55
334170-3417011.16611.17
417743-177435.7985.80
537813-3781312.35612.36
635827-3582711.70711.71
10min151022-5102216.67218.515.7716.6918.535.77
260315-6031519.70919.73
356435-5643518.44118.46
455315-5531518.07518.08
558342-5834219.06419.08
658513-5851319.12019.14
15min155651-5565118.18518.472.9218.2318.522.91
255459-5545918.12218.18
356840-5684018.57318.62
457903-5790318.92118.96
558828-5882819.22319.28
654433-5443317.78717.84
20min157388-5738818.75218.892.0118.8218.962.03
259936-5993619.58519.67
356594-5659418.49318.57
457136-5713618.67018.74
558084-5808418.98019.06
657652-5765218.83918.92
30min158640-5864019.16118.792.3319.2618.902.31
257503-5750318.79018.91
356085-5608518.32718.44
456885-5688518.58818.69
556358-5635818.41618.53
659496-5949619.44119.55
45min159245-5924519.35918.981.7319.4919.121.72
258343-5834319.06419.21
356472-5647218.45318.59
457346-5734618.73918.87
558325-5832519.05919.21
658704-5870419.18219.33
60min151475-5147516.82018.314.3416.9918.494.32
257705-5770518.85619.04
357779-5777918.88019.05
455936-5593618.27818.44
555669-5566918.19118.37
657705-5770518.85619.03
极限158498-5849819.11518.481.9519.3118.681.93
257000-5700018.62618.84
356147-5614718.34718.55
455574-5557418.16018.35
555590-5559018.16518.37
656475-5647518.45418.66
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%
111.143858363860393858043863653852713858630.11
211.083855903855733855820.01
单位质量响应值RSD%判断
34637.6134799.820.34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%
5min1-0.0004.4872.740.004.4872.76
224980-249806.4696.47
314524-145243.7613.76
410977-109772.8432.84
536881-368819.5519.55
616348-163484.2344.23
10min129686-296867.68814.3735.857.6914.3835.85
277688-7768820.11920.13
356373-5637314.59914.61
456682-5668214.67914.68
576414-7641419.78919.80
636036-360369.3329.34
15min144262-4426211.46215.9924.3211.4816.0324.35
272175-7217518.69118.74
368640-6864017.77617.81
466217-6621717.14817.18
577469-7746920.06220.11
641784-4178410.82110.84
20min150095-5009512.97317.1119.5613.0017.1719.61
276926-7692619.92120.00
374777-7477719.36519.43
468747-6874717.80317.86
576392-7639219.78319.87
649572-4957212.83812.88
30min158124-5812415.05217.8611.3615.1117.9411.42
274301-7430119.24219.35
375614-7561419.58219.67
471951-7195118.63318.72
573870-7387019.13019.25
659831-5983115.49415.56
45min165300-6530016.91118.636.9916.9918.747.08
274715-7471519.34919.49
376096-7609619.70619.83
474455-7445519.28119.40
575310-7531019.50319.65
665670-6567017.00617.09
60min161446-6144615.91318.498.7216.0218.648.77
273740-7374019.09619.27
379930-7993020.69920.86
473096-7309618.93019.08
572267-7226718.71518.89
667857-6785717.57317.69
极限174085-7408519.18618.822.4619.3218.992.47
272268-7226818.71518.92
375021-7502119.42819.62
472394-7239418.74818.93
572313-7231318.72718.94
669844-6984418.08718.23
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(%) 100.0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%
111.273099263098363096073100313099133098630.06
211.213121743125233123480.08
单位质量响应值RSD%判断
27494.5027863.340.95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%
5min135036-3503611.39312.2814.9711.3912.2814.98
232445-3244510.55010.55
338566-3856612.54112.54
445785-4578514.88814.89
531964-3196410.39410.39
642792-4279213.91513.91
10min157209-5720918.60319.051.6518.6219.071.67
258331-5833118.96818.99
359797-5979719.44419.47
459084-5908419.21219.24
557854-5785418.81218.83
659251-5925119.26719.29
15min157967-5796718.84918.821.6618.9018.871.65
256126-5612618.25118.30
357599-5759918.73018.78
458565-5856519.04419.10
558757-5875719.10619.15
658291-5829118.95519.01
20min157538-5753818.71018.732.5918.7918.822.57
258233-5823318.93619.02
359678-5967819.40619.49
455175-5517517.94118.03
557046-5704618.55018.63
658007-5800718.86218.95
30min152744-5274417.15118.314.6217.2618.424.60
253432-5343217.37517.49
358994-5899419.18319.30
457660-5766018.74918.87
558190-5819018.92219.03
656814-5681418.47418.59
45min157064-5706418.55618.602.0718.7018.742.06
256855-5685518.48818.63
358587-5858719.05119.20
457808-5780818.79818.95
557684-5768418.75718.90
655123-5512317.92418.07
60min156206-5620618.27718.411.2018.4518.581.19
255874-5587418.16918.34
356823-5682318.47718.66
457610-5761018.73318.91
557102-5710218.56818.74
656062-5606218.23018.41
极限155965-5596518.19818.360.9118.4018.570.89
256497-5649718.37118.57
356674-5667418.42918.64
456024-5602418.21718.43
557342-5734218.64618.85
656271-5627118.29818.51
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%
111.143861903857823857973861463862673860360.06
211.083885793889953887870.08
单位质量响应值RSD%判断
34653.1435089.080.89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%
5min115007-150073.8696.4730.643.876.4730.65
217314-173144.4644.46
330750-307507.9297.93
430833-308337.9507.95
523407-234076.0356.04
633154-331548.5498.55
10min156143-5614314.47618.7711.7114.4818.7811.72
275821-7582119.55019.56
377617-7761720.01320.03
476401-7640119.70019.71
571689-7168918.48518.49
679030-7903020.37820.39
15min163570-6357016.39118.956.8916.4218.996.90
273763-7376319.01919.06
375265-7526519.40719.45
475853-7585319.55819.60
574673-7467319.25419.29
677898-7789820.08620.13
20min166592-6659217.17019.045.7617.2319.115.77
276606-7660619.75219.82
377383-7738319.95320.03
471891-7189118.53718.62
573031-7303118.83118.90
677469-7746919.97520.06
30min165668-6566816.93218.805.5617.0218.905.57
270675-7067518.22318.33
376486-7648619.72219.83
474764-7476419.27819.39
574516-7451619.21419.32
675309-7530919.41819.53
45min174552-7455219.22319.221.0619.3419.351.06
274802-7480219.28719.42
375615-7561519.49719.64
474914-7491419.31619.46
573833-7383319.03719.17
673428-7342818.93319.08
60min174341-7434119.16819.000.8619.3219.170.84
273390-7339018.92319.09
373248-7324818.88719.06
474252-7425219.14619.32
572823-7282318.77718.95
674164-7416419.12319.30
极限173500-7350018.95218.870.9419.1319.070.91
273899-7389919.05519.25
372239-7223918.62618.84
472442-7244218.67918.88
573231-7323118.88219.08
673725-7372519.01019.22
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(%) 100.0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%
111.273106333106003107073108593102743106150.07
211.213111833111593111710.01
单位质量响应值RSD%判断
27561.2227758.340.51数据可信
供试品溶液-G79580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%
5min148014-4801415.62315.072.6015.6215.072.59
247496-4749615.45515.45
344777-4477714.57014.57
445956-4595614.95314.95
545774-4577414.89414.89
645950-4595014.95214.95
10min156273-5627318.31018.031.6818.3418.061.68
253754-5375417.49117.52
356005-5600518.22318.25
455877-5587718.18218.21
554921-5492117.87117.90
655582-5558218.08618.11
15min157908-5790818.84218.552.0118.9018.602.00
255542-5554218.07318.13
358702-5870219.10119.16
456953-5695318.53218.59
556612-5661218.42118.48
656278-5627818.31218.37
20min158391-5839119.00018.682.1519.0918.772.15
256009-5600918.22518.31
359361-5936119.31519.40
457205-5720518.61418.70
556663-5666318.43718.52
656899-5689918.51418.60
30min157291-5729118.64218.323.1618.7618.433.14
253024-5302417.25317.37
358181-5818118.93119.05
456599-5659918.41718.53
556764-5676418.47018.59
655862-5586218.17718.29
45min156895-5689518.51318.105.5218.6618.255.47
256361-5636118.33918.48
359019-5901919.20419.35
449857-4985716.22316.37
555718-5571818.13018.28
655921-5592118.19618.34
60min159278-5927819.28818.542.1619.4718.722.16
257069-5706918.56918.74
356735-5673518.46118.64
456949-5694918.53018.71
555831-5583118.16718.34
656027-5602718.23018.41
极限156588-5658818.41318.641.4518.6318.851.43
258585-5858519.06319.27
357943-5794318.85419.07
457338-5733818.65718.86
556674-5667418.44118.65
656614-5661418.42118.63
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%
111.143871723869333869743872763867093870130.06
211.083876083875343875710.02
单位质量响应值RSD%判断
34740.8434979.330.49数据可信
供试品溶液-G79580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%
5min110716-107162.7642.2815.942.762.2815.91
210232-102322.6392.64
37709-77091.9881.99
47296-72961.8821.88
57987-79872.0602.06
69115-91152.3512.35
10min122681-226815.8505.686.195.855.686.18
224389-243896.2906.29
320973-209735.4095.41
420968-209685.4085.41
521015-210155.4205.42
622153-221535.7145.72
15min131320-313208.0787.886.398.097.896.38
234110-341108.7988.81
329904-299047.7137.73
429393-293937.5817.59
528706-287067.4047.42
629777-297777.6807.69
20min137592-375929.6969.515.919.729.545.89
240834-4083410.53210.56
336513-365139.4179.44
436083-360839.3079.33
534589-345898.9218.95
635629-356299.1899.22
30min145412-4541211.71311.693.7811.7611.733.79
248268-4826812.44912.50
344843-4484311.56611.61
445699-4569911.78711.83
544642-4464211.51411.55
643064-4306411.10711.15
45min154393-5439314.02914.066.9114.0914.126.89
260621-6062115.63515.70
355993-5599314.44214.50
449428-4942812.74812.81
554547-5454714.06914.13
652152-5215213.45113.51
60min164100-6410016.53316.064.4016.6216.154.40
266217-6621717.07917.17
360565-6056515.62115.71
463020-6302016.25416.34
561185-6118515.78115.86
658547-5854715.10015.18
极限168459-6845917.65717.784.5917.7717.904.59
275216-7521619.40019.52
368076-6807617.55817.67
467066-6706617.29817.41
568319-6831917.62117.73
666532-6653217.16017.27
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(%) 100.0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%
111.273111033112243114443114213115183113420.06
211.213122373117913120140.11
单位质量响应值RSD%判断
27625.7327833.540.53数据可信
供试品溶液-BJ84960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%
5min1154441-15444150.12648.9833.0150.1348.9833.01
292087-9208729.88829.89
3167844-16784454.47754.48
4146341-14634147.49747.50
5234469-23446976.10176.10
6110344-11034435.81435.81
10min1295436-29543695.88995.551.6295.9795.631.64
2293998-29399895.42295.47
3295538-29553895.92296.01
4290725-29072594.36094.44
5302242-30224298.09898.22
6288450-28845093.62193.68
15min1307125-30712599.68398.861.4099.9399.101.40
2304188-30418898.72998.94
3304189-30418998.73098.98
4296958-29695896.38396.62
5305547-30554799.17099.46
6309551-309551100.470100.69
20min1308073-30807399.99099.181.22100.4099.581.21
2305147-30514799.04199.41
3304416-30441698.80399.22
4299904-29990497.33997.74
5304969-30496998.98399.44
6310895-310895100.906101.29
30min1309008-309008100.29499.161.19100.8799.731.18
2304634-30463498.87499.41
3304171-30417198.72499.30
4299706-29970697.27597.83
5306075-30607599.34299.96
6309547-309547100.469101.02
45min1308287-308287100.06099.121.27100.8099.861.27
2305566-30556699.17799.88
3303761-30376198.59199.34
4298681-29868196.94297.66
5306448-30644899.463100.25
6309586-309586100.481101.20
60min1308134-308134100.01098.861.10100.9299.761.10
2304200-30420098.73399.60
3303621-30362198.54599.45
4298732-29873296.95997.84
5305636-30563699.199100.15
6307194-30719499.705100.59
极限1307466-30746699.79399.071.37100.87100.141.36
2308972-308972100.282101.32
3303615-30361598.54399.62
4298183-29818396.78097.82
5304183-30418398.72899.85
6309072-309072100.315101.37
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%
111.143874373876403876183879743878653877070.06
211.083883433883313883370.01
单位质量响应值RSD%判断
34803.1435048.470.50数据可信
供试品溶液-BJ84960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%
5min164800-6480016.68218.1931.1916.6818.1931.21
245464-4546411.70411.70
366399-6639917.09317.09
486539-8653922.27822.28
5105881-10588127.25727.26
654905-5490514.13414.13
10min1227784-22778458.63959.915.2958.6759.945.30
2227401-22740158.54158.56
3231103-23110359.49459.52
4243501-24350162.68662.72
5250338-25033864.44664.49
6216144-21614455.64355.67
15min1291248-29124874.97775.771.0975.1075.901.10
2294639-29463975.85075.97
3291571-29157175.06075.19
4298068-29806876.73376.87
5298241-29824176.77876.93
6292186-29218675.21975.34
20min1318278-31827881.93682.570.9482.1982.820.94
2322990-32299083.14983.39
3316233-31623381.40981.66
4323703-32370383.33283.60
5320344-32034482.46882.75
6322860-32286083.11583.36
30min1343198-34319888.35188.740.9888.7489.130.98
2346049-34604989.08589.47
3339437-33943787.38387.77
4347728-34772889.51789.93
5343328-34332888.38588.80
6348464-34846489.70790.09
45min1357786-35778692.10792.581.1292.6493.121.10
2363521-36352193.58394.11
3354006-35400691.13391.67
4361045-36104592.94593.50
5357144-35714491.94192.51
6364278-36427893.77894.31
60min1363546-36354693.58994.010.9794.2894.710.97
2368101-36810194.76295.45
3360226-36022692.73593.42
4368230-36823094.79595.51
5362528-36252893.32794.05
6368417-36841794.84395.53
极限1366302-36630294.29994.821.4095.1495.681.38
2374385-37438596.38097.22
3362555-36255593.33494.17
4370893-37089395.48196.35
5362907-36290793.42594.30
6373002-37300296.02496.87
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