非奈利酮恩格列净项目信息
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%
111.103002843000562999693003923001453001690.06
211.173044703046463045580.05
单位质量响应值RSD%判断
27042.2527265.710.59数据可信
供试品溶液-3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%
5min138339-3833912.49111.0032.9912.4911.0032.99
233167-3316710.80610.81
316118-161185.2515.25
426071-260718.4948.49
544462-4446214.48614.49
644425-4442514.47414.47
10min162509-6250920.36618.3112.2020.3918.3212.21
259456-5945619.37219.39
345326-4532614.76814.78
450199-5019916.35616.37
561215-6121519.94519.97
658399-5839919.02719.05
15min162690-6269020.42519.684.1420.4819.734.17
261953-6195320.18520.24
359580-5958019.41219.45
455778-5577818.17318.21
561033-6103319.88519.94
661426-6142620.01320.07
20min162447-6244720.34619.853.9320.4319.933.93
260938-6093819.85419.94
362742-6274220.44220.51
456228-5622818.32018.39
561722-6172220.11020.20
661401-6140120.00520.09
30min161402-6140220.00619.811.3320.1319.921.33
259256-5925619.30619.42
360785-6078519.80519.90
461126-6112619.91620.02
561403-6140320.00620.13
660862-6086219.83019.95
45min162373-6237320.32220.201.4220.4820.351.41
262765-6276520.45020.60
361053-6105319.89220.02
463118-6311820.56520.70
561158-6115819.92620.08
661506-6150620.04020.20
60min161870-6187020.15819.651.8120.3519.841.79
260586-6058619.74019.92
360120-6012019.58819.75
461103-6110319.90820.08
559218-5921819.29419.48
659052-5905219.24019.43
极限160283-6028319.64119.561.3719.8619.771.33
259865-5986519.50519.72
359973-5997319.54019.74
461448-6144820.02120.22
559669-5966919.44119.66
658970-5897019.21319.43
非奈利酮恩格列净项目信息
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%
122.107176937167337173407172127169887171930.06
222.147275937278887277400.03
单位质量响应值RSD%判断
32452.1732869.920.91数据可信
供试品溶液-3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%
5min118265-182652.5172.0621.572.522.0621.50
212297-122971.6941.69
310860-108601.4961.50
413032-130321.7961.80
517378-173782.3942.39
617665-176652.4342.43
10min147005-470056.4775.5214.526.485.5214.52
240635-406355.5995.60
332992-329924.5464.55
434035-340354.6894.69
545929-459296.3286.33
639894-398945.4975.50
15min164667-646678.9107.9511.478.937.9611.47
261121-611218.4228.43
349712-497126.8506.86
449543-495436.8266.84
562989-629898.6798.69
657983-579837.9898.00
20min178022-7802210.7509.859.1310.789.889.13
274927-7492710.32410.35
366788-667889.2029.22
461208-612088.4348.46
577013-7701310.61110.64
671037-710379.7889.81
30min195820-9582013.20312.447.1113.2512.487.13
292585-9258512.75712.80
386133-8613311.86811.90
480405-8040511.07911.11
597598-9759813.44713.49
689081-8908112.27412.32
45min1115184-11518415.87115.225.4315.9415.285.44
2116902-11690216.10716.17
3106396-10639614.66014.72
4102022-10202214.05714.11
5114721-11472115.80715.88
6107369-10736914.79414.86
60min1123646-12364617.03616.194.7317.1316.284.74
2122475-12247516.87516.97
3112971-11297115.56615.65
4110542-11054215.23115.31
5120998-12099816.67216.77
6114289-11428915.74715.84
极限1130580-13058017.99217.643.7718.1217.763.79
2130888-13088818.03418.15
3127013-12701317.50017.61
4119279-11927916.43516.54
5132918-13291818.31418.44
6127669-12766917.59117.71
非奈利酮恩格列净项目信息
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%
111.103006303004463006353007203003773005620.05
211.173025453027073026260.04
单位质量响应值RSD%判断
27077.6627092.750.04数据可信
供试品溶液-3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%
5min145463-4546314.85013.2924.0014.8513.2923.99
240756-4075613.31213.31
332923-3292310.75410.75
426166-261668.5478.55
545539-4553914.87514.87
653314-5331417.41417.41
10min163981-6398120.89820.318.2420.9220.338.24
265223-6522321.30421.33
362217-6221720.32220.34
452147-5214717.03317.05
563253-6325320.66120.69
666261-6626121.64321.67
15min164454-6445421.05321.063.2821.1121.123.30
265201-6520121.29721.35
365977-6597721.55021.60
460555-6055519.77919.82
564252-6425220.98721.05
666495-6649521.72021.78
20min163911-6391120.87621.401.5720.9721.501.55
265496-6549621.39321.49
366978-6697821.87721.97
466210-6621021.62721.70
565255-6525521.31521.41
665328-6532821.33821.44
30min164027-6402720.91421.271.8721.0421.401.84
264505-6450521.07021.20
364588-6458821.09721.22
467153-6715321.93522.05
564435-6443521.04721.18
666079-6607921.58421.72
45min163915-6391520.87721.221.7121.0421.381.69
265047-6504721.24721.41
364945-6494521.21321.37
466309-6630921.65921.81
563508-6350820.74420.91
666015-6601521.56321.74
60min163659-6365920.79321.071.2420.9921.271.20
265314-6531421.33421.53
364532-6453221.07821.27
465609-6560921.43021.61
563878-6387820.86521.06
664070-6407020.92821.14
极限161444-6144420.07020.721.7820.3020.951.76
263231-6323120.65420.89
363585-6358520.76921.00
464683-6468321.12821.35
563314-6331420.68120.91
664289-6428920.99921.24
非奈利酮恩格列净项目信息
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%
122.107181117181057180167179307179717180270.02
222.147226357229887228120.04
单位质量响应值RSD%判断
32489.9132647.340.35数据可信
供试品溶液-3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%
5min115806-158062.1842.5233.842.182.5233.81
219961-199612.7582.76
321369-213692.9532.95
46796-67960.9390.94
522609-226093.1243.12
622904-229043.1653.16
10min143061-430615.9505.7020.195.955.7020.19
246349-463496.4046.41
343868-438686.0616.07
424449-244493.3783.38
544125-441256.0976.10
645722-457226.3176.32
15min159344-593448.2007.9316.238.217.9416.27
262392-623928.6218.64
361702-617028.5258.54
438482-384825.3175.32
560796-607968.4008.42
661453-614538.4918.51
20min172729-7272910.0499.7112.1810.089.7412.19
275131-7513110.38110.41
375062-7506210.37110.40
452983-529837.3217.34
573587-7358710.16810.20
672097-720979.9629.99
30min192391-9239112.76612.149.3112.8112.189.33
292680-9268012.80612.85
389621-8962112.38312.43
471360-713609.8609.89
590815-9081512.54812.59
690445-9044512.49712.54
45min1111113-11111315.35314.688.3415.4214.748.38
2112455-11245515.53815.61
3108937-10893715.05215.12
488511-8851112.23012.27
5108146-10814614.94315.01
6108342-10834214.97015.04
60min1122372-12237216.90816.097.5117.0016.187.55
2122581-12258116.93717.03
3119476-11947616.50816.60
499368-9936813.73013.79
5119294-11929416.48316.58
6115773-11577315.99616.09
极限1128940-12894017.81617.963.1317.9318.083.17
2129927-12992717.95218.07
3133141-13314118.39618.52
4122581-12258116.93717.03
5133701-13370118.47418.59
6131675-13167518.19418.31
非奈利酮恩格列净项目信息
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%
111.103009363012603012013013983011493011890.06
211.172994692994282994480.01
单位质量响应值RSD%判断
27134.1426808.240.86数据可信
供试品溶液-2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%
5min1226805-22680574.39974.8616.0074.4074.8616.00
2266771-26677187.50987.51
3266940-26694087.56487.56
4236666-23666677.63377.63
5181120-18112059.41359.41
6190998-19099862.65362.65
10min1302902-30290299.36199.610.8299.4899.730.84
2307484-307484100.864101.01
3304809-30480999.986100.13
4303205-30320599.46099.59
5299905-29990598.37798.48
6303624-30362499.59799.70
15min1306709-306709100.609101.460.88100.90101.750.88
2312838-312838102.620102.93
3308034-308034101.044101.36
4311401-311401102.148102.44
5306231-306231100.453100.72
6310597-310597101.885102.16
20min1307677-307677100.927101.710.92101.38102.180.93
2313205-313205102.740103.23
3308176-308176101.091101.57
4311804-311804102.281102.75
5306788-306788100.635101.07
6312821-312821102.614103.05
30min1310818-310818101.957101.880.82102.58102.510.83
2312886-312886102.636103.29
3308362-308362101.152101.80
4312303-312303102.444103.08
5306675-306675100.598101.20
6312541-312541102.522103.13
45min1308237-308237101.111101.730.94101.91102.540.94
2313122-313122102.713103.54
3308023-308023101.040101.86
4312688-312688102.571103.38
5306455-306455100.526101.29
6312299-312299102.443103.23
60min1308404-308404101.165101.680.90102.13102.650.90
2312412-312412102.480103.48
3308324-308324101.139102.13
4312126-312126102.386103.36
5305994-305994100.375101.31
6312528-312528102.518103.47
极限1307439-307439100.849101.460.87101.98102.600.87
2312629-312629102.551103.72
3307754-307754100.952102.11
4311536-311536102.193103.34
5305843-305843100.325101.43
6310652-310652101.903103.03
非奈利酮恩格列净项目信息
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%
122.107191597190977190297192337190137191060.02
222.147157527152287154900.06
单位质量响应值RSD%判断
32538.7332316.620.49数据可信
供试品溶液-2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%
5min185523-8552311.86811.6019.1711.8711.6019.14
275505-7550510.47810.48
399547-9954713.81413.81
4101763-10176314.12214.12
558694-586948.1458.15
680548-8054811.17811.18
10min1203561-20356128.24927.585.1528.2727.605.15
2187568-18756826.02926.05
3210698-21069829.23929.26
4204918-20491828.43728.46
5184988-18498825.67125.68
6200559-20055927.83227.85
15min1270572-27057237.54837.082.6937.6137.142.69
2259323-25932335.98736.05
3276489-27648938.36938.44
4269527-26952737.40337.47
5257854-25785435.78335.84
6269356-26935637.37937.44
20min1318731-31873144.23143.661.7444.3643.781.74
2308610-30861042.82642.95
3321421-32142144.60444.74
4314321-31432143.61943.75
5307909-30790942.72942.85
6316600-31660043.93544.06
30min1383785-38378553.25952.321.1953.4652.521.19
2373106-37310651.77751.97
3379745-37974552.69852.91
4374398-37439851.95652.16
5372462-37246251.68751.87
6378713-37871352.55552.76
45min1433413-43341360.14659.700.5660.4459.990.56
2430383-43038359.72560.00
3429291-42929159.57459.87
4427107-42710759.27059.56
5428655-42865559.48559.76
6432498-43249860.01960.31
60min1466808-46680864.78064.490.6665.1764.880.66
2465970-46597064.66465.04
3463763-46376364.35764.75
4460180-46018063.86064.25
5462900-46290064.23864.61
6468724-46872465.04665.43
极限1483268-48326867.06466.780.6667.5667.270.65
2484712-48471267.26467.75
3479636-47963666.56067.06
4476031-47603166.06066.56
5480679-48067966.70567.18
6482972-48297267.02367.52
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